[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12466]
[[Page Unknown]]
[Federal Register: May 25, 1994]
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Part III
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
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9 CFR Parts 317 and 381
Nutrition Labeling; Health Claims on Meat and Poultry Products;
Proposed Rule
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. 93-002P]
RIN 0583-AB64
Nutrition Labeling; Health Claims on Meat and Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat and poultry products inspection regulations by
proposing requirements for permitting the use of health claims that
characterize the relationship of a substance (food or food component)
to a disease or health-related condition on the labeling of meat and
poultry products. FSIS is also proposing regulations establishing a
labeling application process for such health claims. This proposal
would permit health claims relating to the association between: (1)
Adequate calcium intake and reduced risk of osteoporosis; (2) diets low
in fat and reduced risk of cancer; (3) sodium reduction and reduced
risk of high blood pressure; (4) reduction in dietary saturated fat and
cholesterol and reduced risk of coronary heart disease; (5) diets low
in fat and high in fiber-containing grain products, fruits, and
vegetables and reduced risk of cancer; (6) diets low in saturated fat
and cholesterol and high in fruits, vegetables, and grain products that
contain dietary fiber and reduced risk of coronary heart disease; (7)
substances in diets low in fat and high in fruits and vegetables (foods
that are low in fat and may contain dietary fiber, vitamin A, or
vitamin C) and reduced risk of cancer; and, (8) folate and reduced risk
of neural tube birth defects. FSIS is taking this action to provide
consumers with accurate, informative labeling on meat and poultry
products that conforms with such labeling on other foods. FSIS is
proposing regulations to permit health claims that are designed to
parallel those issued by the Food and Drug Administration (FDA) for
other foods.
DATES: Comments must be received on or before July 25, 1994.
ADDRESSES: Written comments to: Policy Office, ATTN: Diane Moore, FSIS
Hearing Clerk, room 3171, South Building, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250. Oral
comments as provided by the Poultry Products Inspection Act should be
directed to Mr. Charles Edwards at (202) 254-2565. (See also Comments
under Supplementary Information.)
FOR FURTHER INFORMATION CONTACT: Charles Edwards, Director, Product
Assessment Division, Regulatory Programs, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250, (202)
254-2565.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This proposed rule has been reviewed under Executive Order 12866.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirement on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA or PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat and poultry products that are misbranded or
adulterated under the FMIA or PPIA, or, in the case of imported
articles, which are not at such an establishment, after their entry
into the United States. Under the FMIA and PPIA, States that maintain
meat and poultry inspection programs must impose requirements that are
at least equal to those required under the FMIA and PPIA. The States
may, however, impose more stringent requirements on such State
inspected products and establishments.
No retroactive effect will be given to this proposed rule. The
administrative procedures specified in 9 CFR 306.5 and 381.35 must be
exhausted prior to any judicial challenge of the application of the
provisions of this proposed rule, if the challenge involves any
decision of an inspector relating to inspection services provided under
the FMIA or PPIA. The administrative procedures specified in 9 CFR
parts 335 and 381, subpart W, must be exhausted prior to any judicial
challenge of the application of the provisions of this proposed rule
with respect to labeling decisions.
Effect on Small Entities
The Administrator has determined that this proposed rule would not
have a significant effect on small entities, as defined by the
Regulatory Flexibility Act (5 U.S.C. 601). The proposed regulation
would permit the use of health claims on the labeling of meat and
poultry products. Small meat and poultry establishments are exempt from
nutrition labeling, provided the labeling of their products bears no
nutrition claims or nutrition information.
However, small entities with products that currently bear labeling
that FSIS is proposing to regulate as a health claim, e.g. labeling
bearing claims that are implied health claims under FSIS's proposed
definition of health claim, may be adversely affected by this
regulation. Such labeling would need to be changed to conform to the
health claims regulations. FSIS believes that the number of small firms
with products bearing such labeling would not be substantial because
FSIS's current labeling policy does not permit health-related claims
which specifically relate foods or food components to diseases.
Small manufacturers opting to use health claims on their labeling,
as proposed by this regulation, would be required to comply with the
nutrition labeling requirements, thereby, incurring the costs
associated with such compliance. However, the use of health claims on
the labeling would be voluntary. Decisions by individual manufacturers
on whether to use such health claims on their product labeling would be
based on their conclusions that the benefits would outweigh the costs
of including such health claims on the labeling.
Paperwork Requirements
This proposed rule would specify the health claims that would be
permitted to be used on the labeling of meat and poultry products. The
proposal would also establish a labeling application process whereby
any interested person may submit a labeling application to FSIS for
approval of the use of a health claim not provided for in 9 CFR 317.371
and 381.471.
The proposed labeling application process would require any such
labeling application to be submitted in a specific format and
accompanied by the following information:
(1) An explanation of how the substance conforms to the
requirements of 9 CFR 317.314 and 381.414,
(2) A summary of scientific data justifying the connection of the
health claim to the health benefit;
(3) Analytical data that show the amount of the substance that is
present in product candidates for the use of the proposed health claim,
(4) A model health claim; and
(5) Copies of all information supporting the use of the proposed
health claim.
The paperwork requirements contained in this proposal have been
submitted to the Office of Management and Budget for approval under the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). If you wish to
comment on the paperwork burden of this proposed rule, send your
comments to: Office of Management and Budget, Desk Officer for FSIS,
Office of Information and Regulatory Affairs, Room 3208, New Executive
Office Building, Washington, DC 20503 and to the Clearance Office, room
404-W, USDA Administration Building, Washington DC 20250.
Comments
Interested persons are invited to submit comments concerning this
proposal. Written comments should be sent to the Policy Office and
refer to Docket No. 93-002P. Any person desiring an opportunity for an
oral presentation of views, as provided by the Poultry Products
Inspection Act, should make such a request to Mr. Charles Edwards, so
that arrangements can be made for such views to be presented. A record
will be made of all views orally presented. All comments submitted in
response to this proposal will be available for public inspection at
the Policy Office from 9 a.m. to 12:30 p.m. and from 1:30 p.m. to 4
p.m., Monday through Friday.
Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.)
authorize the Secretary of Agriculture to establish and maintain
inspection programs designed to assure consumers that meat and poultry
products distributed to them (including imports) are wholesome, not
adulterated, and are properly marked, labeled, and packaged. FSIS's
authority to require nutrition labeling on meat and poultry products is
based upon the statutory provisions on misbranding in the FMIA and PPIA
(21 U.S.C. 601(n)(1), (6), (10), and (12) for the FMIA and 21 U.S.C.
453(h)(1), (6), (10), and (12) for the PPIA), and the general
rulemaking provisions of these Acts (21 U.S.C. 621 and 453,
respectively).
Based upon the Secretary of Agriculture's belief that meat or
poultry product labeling would be false or misleading without nutrition
information, FSIS published final regulations on nutrition labeling in
the Federal Register on January 6, 1993 (58 FR 632). Corrections and
technical amendments to the final regulations were published on August
18, 1993 (58 FR 43787), and September 10, 1993 (58 FR 47624),
respectively. The final regulations permit voluntary nutrition labeling
on single-ingredient, raw meat and poultry products and establishes
mandatory nutrition labeling for all other meat and poultry products,
with certain exceptions. The final regulations parallel to the maximum
extent possible FDA's nutrition labeling regulations promulgated under
the Nutrition Labeling and Education Act of 1990 (NLEA).
NLEA Provisions
The NLEA (Pub. L. 101-535) requires mandatory nutrition labeling
for most FDA-regulated packaged food products. The NLEA addresses
health claims by amending the Federal Food, Drug, and Cosmetic Act to
specify, in part, that a food is misbranded if it bears a claim that
expressly or by implication characterizes the relationship of certain
nutrients to a disease or health-related condition unless the claim is
made in accordance with a regulation authorizing its use. FDA is
directed by the NLEA to adopt health claim regulations to describe the
relationship between the nutrient and the disease or health-related
condition, and the significance of the nutrient in affecting the
disease or health-related condition.
The NLEA requires the regulations to prohibit health claims for
foods which FDA determines contain any nutrient in an amount which
increases to persons in the general population the risk of a diet-
related disease or health condition, taking into account the
significance of the food in the total daily diet. However, the NLEA
also provides that FDA may by regulation permit such a claim based on a
finding that it would assist consumers in maintaining healthy dietary
practices, and based on a requirement that the label or labeling
disclose the presence of the nutrient in conjunction with the claim.
To assure the validity of health claims, the NLEA requires that
such claims be supported by a sound body of scientific evidence that
establishes the relationship between a food or food component and a
particular disease or health-related condition. The data must clearly
demonstrate that the proposed claim is valid, and that the benefits
featured in the claim pertain to the general U.S. population or to an
identified U.S. population subgroup, e.g., the elderly. A few
unconfirmed studies, preliminary or incompletely documented data, or
significantly contradictory findings do not constitute a sound body of
evidence. In addition, the NLEA requires that significant agreement
exists among qualified experts that the claim is valid. ``Qualified
experts'' include individuals whose training and experience have
produced a general or specific scientific expertise in the diet/health
topic being considered for a specific claim.
Current FSIS Policy
FSIS does not permit health claims explicitly linking foods or food
components to diet-related diseases or health conditions. FSIS does
permit statements informing consumers that a food can be part of a
specific dietary pattern to meet an organization's dietary guidelines
or that a product was developed to help consumers follow a specific
dietary pattern. The rationale adopted by FSIS for approving such
statements is to encourage labeling which supplements the information
contained in the nutrition label with information that provides
truthful data about a product's nutritional characteristics, and
provides generally accepted information about how a product satisfies
consumers' total dietary requirements.
To implement the use of health-related claims on labeling, FSIS
provides general guidelines and objectives which permit statements if
they are based on a consensus of medical and scientific information,
emphasize that good nutrition is a function of the total diet, and are
reasonably uniform from product to product. The following is an example
of a health-related claim that would be permitted currently:
This product was specifically developed to help you follow the
Dietary Guidelines for Americans for sodium, fat, and cholesterol.
For further information on the Dietary Guidelines call * * *.
FSIS Regulatory Actions
FSIS published an advance notice of proposed rulemaking (ANPR) in
the Federal Register on April 2, 1991 (56 FR 13564), advising of its
intent to publish a proposed rule on nutrition labeling. In regard to
health claims, FSIS stated that it expected to adopt the health claim
policies established by FDA, as appropriate, to meet the needs of meat
and poultry products. In its proposed regulations on nutrition labeling
published in the Federal Register on November 27, 1991 (56 FR 60302),
and in its final nutrition labeling regulations, FSIS reiterated its
intent to publish a proposed regulation on health claims in line with
FDA's policies. At the time FSIS's final nutrition labeling regulations
were published, the health claims issue was still under study by FSIS.
Most of the comments received in response to the ANPR regarding
health claims addressed the need for these types of claims to inform
and remind consumers about the relationship between diet and health.
The comments stressed that such claims must be supported by strong
scientific consensus. Commenters also emphasized the importance of
working with FDA to bring about uniformity in health claims regulations
so that health messages may be of substantial use to consumers.
Alternative Considered
In developing this proposed rule, FSIS considered an alternative to
improve the efficiency of establishing regulations to permit health
claims on the labeling of meat and poultry products. Under the
alternative, FSIS would not issue regulations to authorize the use of
health claims, but, rather, would permit health claims that are
authorized by FDA. In approving labeling applications, FSIS would refer
to FDA regulations to specify the conditions under which health claims
may be used on the labeling of products under USDA inspection. FSIS
relied heavily on FDA's decisions about the validity and significance
of the relationship between the substances and diseases that are
subjects of this proposal, and would continue to do so for future
claims.
Because health claims are diet-related, FSIS believes they are
invariably applicable to food products regulated by both FSIS and FDA.
Many foods from different food categories can be used alone or as
ingredients in other products; for example, as components of meals
containing fish, meat, or poultry. FSIS is interested in receiving
comments on the alternative approach it considered. Comments should
address the impact such an alternative might have on the use of health
claims on meat and poultry products, and what other actions FSIS should
take to ensure that health claims and criteria for their use are
compatible for all food products. Such comments will be given serious
consideration in FSIS's decision on a final rule for health claims.
FDA Health Claims Regulations
In response to the provisions of the NLEA that bear on health
claims, FDA adopted general requirements for such claims in a final
regulation published in the Federal Register on January 6, 1993 (58 FR
2478). FDA's approach to establish general requirements in conformity
to the NLEA provisions is detailed in its proposed regulation on this
subject published in the Federal Register on November 27, 1991 (56 FR
60537). Among other things, the regulation FDA adopted at 21 CFR 101.14
defines a health claim, including implied claims, and disqualifying
nutrient levels for total fat, saturated fat, cholesterol, or sodium.
The regulation prohibits health claims on the label or in labeling for
a food that exceeds any one of the disqualifying nutrient levels,
unless an exception is made under a specific provision authorizing a
health claim.
As provided in 21 CFR 101.14, when a health claim is made about the
effects of consuming a substance at decreased levels, the substance in
the food bearing the claim must meet a regulatory definition for
``low,'' unless an alternative level is established in the specific
regulation authorizing the claim. If the claim is about the effects of
consuming a substance at other than decreased levels, the level of the
substance must be sufficiently high to justify the claim. The
regulation also prohibits health claims for any food that contains less
than 10 percent of the Reference Daily Intake or Daily Reference Value
for vitamin A, vitamin C, iron, calcium, protein, or fiber per
reference amount customarily consumed prior to any nutrient addition.
Health claims are not allowed for foods when a substance, other than
one for which a disqualifying nutrient level is established, is present
at an inappropriate level as set forth in a specific provision
authorizing a claim. Also, health claims are not allowed on foods for
children less than 2 years of age unless they are specifically provided
for by regulation.
As mandated by the NLEA, FDA evaluated relationships associating
nutrients with disease or health-related conditions with respect to
their appropriateness for health claims. The results of the evaluation
and detailed discussion on each relationship, including the materials
(studies, publications, etc.) to evaluate their validity, and the
conditions of their use are contained in proposed regulations published
in the Federal Register on November 21, 1991 (56 FR 60566 through
60855), and final regulations published in the Federal Register on
January 6, 1993 (58 FR 2537, 2552, 2622, 2665, 2739, 2787, and 2820).
FDA's final regulations were developed in accordance with the general
requirements contained in 21 CFR 101.14, and authorize seven health
claims to describe the following associations:
(1) Calcium and osteoporosis, (58 FR 2665);
(2) Dietary lipids and cancer, (58 FR 2787);
(3) Sodium and hypertension, (58 FR 2820);
(4) Dietary saturated fat and cholesterol and risk of coronary
heart disease, (58 FR 2739);
(5) Fiber-containing grain products, fruits, and vegetables and
cancer, (58 FR 2537);
(6) Fruits, vegetables, and grain products that contain fiber,
particularly soluble fiber, and risk of coronary heart disease, (58 FR
2552); and
(7) Fruits and vegetables and cancer, (58 FR 2622).
More recently, FDA published a proposed rule in the Federal
Register on October 14, 1993 (58 FR 53254), to authorize the use of a
health claim about the relationship between folate and neural tube
defects. On January 4, 1994, FDA published a notice in the Federal
Register (59 FR 433) that the proposed regulation is considered a final
regulation for dietary supplements. FDA advises that it has no
intention of taking action against foods in conventional form that are
naturally high in folate that bear a claim about this nutrient-disease
relationship so long as the claim complies with the provisions of 21
CFR 101.79 that have become final for dietary supplements by operation
of law. However, FDA strongly discourages use of the claim on foods
fortified with folic acid until it finalizes the October 14, 1993,
proposal.
In reaching its decision regarding the health claims, FDA reviewed
the conclusions of many Federal government consensus documents, Life
Sciences Research Office reports, and recent scientific articles. In
addition, it considered all comments received in response to its
proposed rules. Among the scientific evidence reviewed were the
Department of Health and Human Services (DHHS) publication ``The
Surgeon General's Report on Nutrition and Health,'' U.S. Government
Printing Office, Washington, DC, 1988; the USDA and DHHS publication
``Nutrition and Your Health: Dietary Guidelines for Americans,'' 3rd
ed., Home and Garden Bulletin No. 232, U.S. Government Printing Office,
Washington DC, 1990; and the DHHS publication ``The Lipid Research
Clinics Population Studies Data Book,'' vol. II, ``The Prevalence
Study-Nutrient Intake,'' NIH Publication No. 82-2014, 1982. Also
considered were reports of recognized non-governmental scientific
bodies that bear on these topics. These included the Committee on Diet
and Health, Food and Nutrition Board, Commission of Life Sciences,
National Research Council's ``Diet and Health: Implications for
Reducing Chronic Disease Risk,'' National Academy Press, Washington,
DC, 1989, and the World Health Organization's ``Diet, Nutrition, the
Prevention of Chronic Diseases,'' Technical Report Series 797, 1990,
and the Subcommittee on the Tenth Edition of the RDAs, Food and
Nutrition Board, Commission on Life Sciences, National Research
Council's ``Recommended Dietary Allowances,'' National Academy Press,
Washington, DC, 1989.
1. Calcium and Osteoporosis
Based on significant scientific evidence and overwhelming
concurrence among experts in this area, FDA authorizes a health claim
relating to an association between adequate calcium intake and
osteoporosis on the labels and labeling of products that meet the
regulatory specifications set forth in 21 CFR 101.72. The health claim
will relay the message that an adequate intake of calcium throughout
life may delay the development of osteoporosis, and ultimately reduce
the risk of bone fracture in some individuals later in life. Adequate
calcium intake levels for the healthy population as established by the
Subcommittee on the Tenth Edition of the RDAs, Food and Nutrition
Board, Commission on Life Sciences, National Research Council are: 800
milligrams per day for males and females 25 years of age and older,
1,200 milligrams per day for males and females 11 to 24 years of age,
and 800 milligrams per day for children (1 to 10 years). By definition,
RDAs are the levels of intakes of essential nutrients that, on the
basis of scientific knowledge, are judged by the Food and Nutrition
Board to be adequate to meet the known nutrient needs of practically
all healthy persons. To bear this claim, a product must be high in
calcium (i.e., contain a minimum of 20 percent of the Reference Daily
Intake of 1,000 milligrams adopted for nutrition labeling, which is 200
milligrams per reference amount customarily consumed for the product).
2. Dietary Lipids and Cancer
FDA concludes that all publicly available information and
authoritative reports support an association between diets low in fat
and risk of some types of cancer. Based on this evidence, FDA
authorizes the use of claims relating fat reduction to reduced risk of
some cancers provided that such statements comply with the requirements
of 21 CFR 101.73. The claim would convey the message that diets low in
fat may reduce the risk of some types of cancer. The message may not
refer to specific sites of cancer and may not specify types of fat or
fatty acids that may be related to the risk of cancer because of the
inconclusiveness of the relevant scientific evidence on these issues.
FDA limits this claim to low fat products, except that fish and game
meats may be extra lean.
3. Sodium and Hypertension
FDA finds significant scientific agreement that claims relating
sodium reduction to reduced risk of high blood pressure are justified.
The scientific evidence shows diets high in sodium are associated with
a high prevalence of hypertension and with increases in blood pressure
with age, and that diets low in sodium are associated with a low
prevalence of hypertension and with a low or no increase of blood
pressure with age. Therefore, FDA authorizes in 21 CFR 101.74 claims on
the relationship of dietary sodium and high blood pressure on food
labels and labeling. Only food products low in sodium are eligible to
carry this claim.
4. Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart
Disease
Coronary heart disease (CHD) is the most common and serious form of
cardiovascular disease. High blood total- and low density lipoprotein
(LDL)-cholesterol levels are major risk factors in the development of
CHD. FDA concludes that the totality of a large body of scientific
evidence provides strong and consistent support that diets high in
saturated fat and cholesterol are associated with increased levels of
blood total- and LDL-cholesterol and, thus, with increased risk of CHD.
Based on this conclusion, FDA authorizes claims on foods relating the
reduction in dietary saturated fat and cholesterol to reduced risk of
CHD when provided in accordance with the requirements of 21 CFR 101.75.
The requirements limit this claim to products that are low in fat, low
in saturated fat, and low in cholesterol, except that fish and game
meats may be extra lean.
5. Fiber-Containing Grain Products, Fruits, and Vegetables and Cancer
FDA concludes that publicly available scientific evidence indicates
that diets low in fat and rich in fiber-containing grain products,
fruits, and vegetables are associated with a decreased risk of some
types of cancer. While there is significant scientific agreement that
evidence supports this association, the specific role of total dietary
fiber, fiber components, and other nutrients and substances in these
foods in reducing cancer risk is not fully understood. Based on the
evidence, FDA authorizes a health claim in 21 CFR 101.76 relating diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables to reduced risk of some cancers. The message may include a
reference to dietary fiber in a statement about the value of grain
products, fruits, and vegetables in reducing cancer risk because fiber
is an identifying marker of the types of foods correlated with the risk
reduction. Only low fat products may convey this claim.
6. Fruits, Vegetables, and Grain Products That Contain Fiber,
Particularly Soluble Fiber, and Risk of Coronary Heart Disease
On the basis of scientific evidence, including recent evidence, FDA
finds support for a claim associating diets low in saturated fat and
cholesterol and high in fruits, vegetables (including legumes), and
grain products, foods that are low in saturated fat and cholesterol and
are good sources of dietary fiber, to reduced risk of heart disease. In
authorizing this claim in 21 CFR 101.77, FDA permits the message about
the value of these foods to include reference to dietary fiber and
specifies a qualifying criterion for soluble fiber content in the food
product bearing the claim. Other qualifying criteria limit fat,
saturated fat, and cholesterol to low levels in the product.
7. Fruits and Vegetables and Cancer
FDA concludes that the evidence is not sufficient to attribute
reduction in risk of some types of cancer specifically to vitamin A as
beta-carotene, vitamin C, or vitamin E, alone or in combination, or to
other components of diets low in fat and high in fruits and vegetables.
However, the evidence does indicate that diets rich in fruits and
vegetables, which are generally low in fat and high in vitamin A as
beta-carotene, vitamin C, and dietary fiber, are associated with
decreased risk. Therefore, FDA authorizes a health claim relating
substances in diets low in fat and high in fruits and vegetables to a
reduced risk of cancer. The message must characterize fruits and
vegetables as foods that are low in fat and contribute vitamins A and C
and dietary fiber to the diet. Any product displaying this claim must
have a low fat content.
8. Folate and Neural Tube Defects
After reviewing new scientific data, public comments, and
recommendations provided by the Folic Acid Subcommittee of its Food
Advisory Committee, FDA has proposed to authorize a health claim for
folate and neural tube defects. These serious birth defects include
anencephaly and spina bifida and, although rare, can result in infant
mortality or serious disability. According to proposed 21 CFR 101.79,
the claim would specify that women who are capable of becoming pregnant
and who consume adequate amounts of folate daily during their
childbearing years may reduce their risk of having a pregnancy affected
by neural tube defects. To bear this proposed claim, a food would need
to be a good source of folate.
FSIS Proposal
FSIS agrees with FDA that Congress enacted the health claims
provisions of the NLEA to help U.S. consumers maintain healthy dietary
practices and to protect these consumers from unfounded health claims.
As mentioned previously, FSIS regulates the labeling of meat and
poultry products, and has statutory authority to determine that an
article is misbranded if it is false or misleading in any particular.
FSIS is proposing regulatory health claims because of the potential
that health claims may be false or misleading to consumers.
FSIS has evaluated FDA's proposed and final regulations for health
claims, and has concluded to propose parallel regulations for meat and
poultry products. Based on review of the scientific evidence, FSIS is
proposing to authorize the use of health claims relating to the
association between:
(1) Adequate calcium intake and reduced risk of osteoporosis;
(2) Diets low in fat and reduced risk of cancer;
(3) Sodium reduction and reduced risk of high blood pressure;
(4) Reduction in dietary saturated fat and cholesterol and reduced
risk of coronary heart disease;
(5) Diets low in fat and high in fiber-containing grain products,
fruits, and vegetables and reduced risk of cancer;
(6) Diets low in saturated fat and cholesterol and high in fruits,
vegetables, and grain products that contain dietary fiber and reduced
risk of coronary heart disease;
(7) Substances in diets low in fat and high in fruits and
vegetables (foods that are low in fat and may contain dietary fiber,
vitamin A, or vitamin C) and reduced risk of cancer; and
(8) Folate and reduced risk of neural tube birth defects.
The Administrator of FSIS believes that the use of these health
claims on the labeling of meat and poultry products would not be false
or misleading. Although FSIS agrees with FDA that there is significant
scientific agreement among qualified experts to support the use of
these health claims for the reasons cited in FDA's proposed regulations
published November 27, 1991 (56 FR 60537), final regulations published
January 6, 1993 (58 FR 2478), and proposed regulations published
October 14, 1993 (58 FR 53254), FSIS is requesting comments on the use
of these claims.
As noted previously, the NLEA establishes two distinct components
to assure the validity of health claims--a body of evidence component
and a review component that there be significant scientific agreement
about the support for the claim. FDA chose not to define ``significant
scientific agreement'' among experts because each situation may differ
with the nature of the claimed substance/disease relationship. The
evaluation of scientific evidence and opinions about that evidence may
be somewhat subjective, and not every expert in the field would be
expected to approve or agree with a claim. In deciding whether
significant agreement exists, it is necessary to consider both the
extent of agreement and nature of the disagreement on a case-by-case
basis. If agreement were assessed under inflexible criteria, some valid
claims could be disallowed where disagreement is not persuasive. FSIS
proposes to use the same flexible approach adopted by FDA in assessing
significant scientific agreement about the validity of health of health
claims.
Definition of Health Claim
FSIS concurs with FDA's definition of a health claim and,
accordingly, is proposing to define a health claim as any claim made on
the label or in labeling of a meat or poultry product that expressly or
by implication, including third party references, written statements
(e.g., a brand name including a term such as ``heart''), symbols (e.g.,
a heart symbol), or vignettes, characterizes the relationship of any
substance to a disease or health-related condition. Implied health
claims would include those statements, symbols, vignettes, or other
forms of communication that suggest, within the context in which they
are presented, that a relationship exists between the presence or level
of a substance in the meat or poultry product and a disease or health-
related condition. FSIS is proposing to permit express or implied
health claims on the labeling of meat or poultry products if the claim
is specifically provided for in proposed 9 CFR 317.371 and 381.471 for
meat and poultry products, respectively.
FSIS views third party endorsements on product labeling as
references, made through a name or logo, to an organization such as a
professional society or association that is independent of the
product's manufacturer or distributor, to promote that organization's
approval of a product. If the name of an endorsing organization
references a particular disease and the endorsement references a
particular food or nutrient, a third party endorsement would constitute
an implied health claim. While third party references often include
general information about dietary recommendations or good nutrition,
FSIS is proposing that they be regulated as a health claim if they
characterize the relationship of a substance to a disease or health-
related condition. FSIS believes that it would not be misleading to
include such references on food labeling provided such statements are
made in a manner that is in compliance with all applicable provisions
of proposed 9 CFR 317.314, 317.371, 381.414, and 381.471.
Disqualifying Nutrient Levels
FSIS is proposing to adopt the disqualifying nutrient levels
defined by FDA at 21 CFR 101.14(a)(5) with minor modifications. FDA
defines disqualifying levels at 21 CFR 101.14(a)(5) for total fat,
saturated fat, cholesterol, or sodium for individual foods as 13.0
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of
cholesterol, or 480 mg of sodium per reference amount customarily
consumed, per label serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tablespoons or less,
per 50 g. The levels for a main dish product, as defined in 21 CFR
101.13(m) and that weighs at least 6 ounces, are defined as 19.5 g of
fat, 6.0 g of saturated fat, 90 mg of cholesterol or 720 mg of sodium
per label serving size. The levels for a meal product, as defined in 21
CFR 101.13(l) and that weighs at least 10 ounces per labeled serving,
are defined as 26.0 g of fat, 8.0 g of saturated fat, 120 mg of
cholesterol, or 960 mg of sodium per label serving size.
FDA's disqualifying levels for total fat, saturated fat,
cholesterol, or sodium represent 20, 30, and 40 percent of the Daily
Reference Value established for each nutrient for individual foods,
main dish products, and meal products, respectively. FSIS believes
these levels are appropriate to meet the intent of the NLEA requirement
that health claims be prohibited for foods that, taking into account
the makeup of the total daily diet, increase the risk of diet-related
diseases or health conditions for persons in the general population. In
setting these levels, FSIS agrees with FDA that risk not be considered
in terms of the impact of consuming a particular food, but, rather, in
terms of the role a food plays in the total diet, and the effects its
nutrient levels have on a person's ability to construct a healthy diet.
Consistent with FDA's general requirements for health claims on
labeling of products under its jurisdiction, FSIS is proposing that any
one of the levels would disqualify a meat or poultry product from
bearing a health claim, unless an exception is provided under a
specific provision authorizing a health claim.
The disqualifying levels set by FDA for total fat and saturated fat
are expressed to one-tenth of a gram. FSIS's nutrition labeling
regulations require that fat and saturated fat be declared in labeling
in half-gram increments below 3 g per serving and to the nearest gram
above 3 g. FSIS intends to amend its regulations to change the 3 g to 5
g in a proposed regulation on technical amendments to be published in
the near future. FSIS established the reporting increments taking into
account the adequacy of analytical methods for determining fat and
fatty acids in food products. FSIS is concerned that method precision
and natural variations in fat content in foods are such that
measurements cannot be made reliably at higher fat contents to support
disqualifying levels with the degree of accuracy implied by levels set
at one-tenth of a gram. Accordingly, FSIS is proposing to adopt
disqualifying levels for fat and saturated fat expressed at increments
required for labeling declarations.
For purposes of making a nutrient content claim, FSIS defines a
meal-type product at 9 CFR 317.313(l) and 381.413(l), in part, as a
product that weighs at least 6 ounces, but no more than 12 ounces per
serving (container). Meal-type products weighing more than 12 ounces
are evaluated for use of nutrient content claims on a case-by-case
basis when labels are submitted for prior approval. In its final rule
on nutrition labeling, FSIS stated that it believes the majority of
meal-type products fall under its purview, and that 78.7 percent of
frozen dinners (6.0 to 24.0 ounces) fall between 6 ounces and 12
ounces. FSIS concludes that its definition of meal-type product
encompasses the types of products that FDA defines as main dish
products and meal products. To provide consistency with FDA's
requirements for health claims on these types of products, FSIS is
proposing to apply FDA's disqualifying levels for main dish products to
FSIS-regulated meal products weighing at least 6 ounces, but less than
10 ounces, and FDA's disqualifying levels for meal products to FSIS-
regulated meal products weighing 10 ounces or more, including those
weighing more than 12 ounces.
FSIS does not believe that FDA's cholesterol disqualifying level of
90 mg per label serving for main dish products differs measurably from
the cholesterol criterion of less than 95 mg per 100 g and labeled
serving for ``lean'' and ``extra lean'' claims on meal-type products at
9 CFR 317.362(c) and 381.462(c) when taking into account that
cholesterol is declared in labeling to the nearest 5 mg per serving.
Because FSIS requires a minimum weight of 6 ounces (170 g) for a meal-
type product, the labeled-serving basis becomes the limiting basis.
Regardless of its weight, an entire meal-type product must contain less
than 95 mg of cholesterol to qualify to use ``lean'' or ``extra lean''
claims. For these reasons, FSIS concludes that raising the cholesterol
disqualifying level from 90 to 95 mg per labeled serving for meal-type
products weighing at least 6 ounces, but less than 10 ounces, is
warranted. This action would provide greater consistency in qualifying
criteria for health claims and nutrient content claims on meal-type
products in the weight range of 6 ounces up to 10 ounces.
Substances Consumed at Decreased Levels
FSIS is proposing to adopt FDA's policy that, when a health claim
is made about the effects of consuming a substance at decreased dietary
levels, the substance must be a nutrient that meets ``low''
requirements in the food to justify the claim. To meet ``low''
requirements, FDA requires that the nutrient must meet a regulatory
definition for ``low,'' or a specific level established for the
nutrient in the regulation authorizing the claim. Of the eight health
claims, FSIS is proposing to authorize six concern effects of consuming
nutrients at decreased levels, i.e., the claim related to hypertension,
the three claims related to cancer, and the two claims related to
coronary heart disease.
Scientific evidence discussed previously shows that dietary sodium
is associated with hypertension, and that total fat intake provides the
strongest dietary association with cancer. Also, saturated fat and
cholesterol in diets are the major dietary risk factors for heart
disease, while total fat in diets affects the risk indirectly through
effects on obesity and reduction of intake of saturated fat and
cholesterol. FSIS is proposing that health claims associating diets
with risk of hypertension, cancer, and coronary heart disease may only
be made on the labeling of meat and poultry products that meet the
following requirements:
(1) To bear the proposed claim about hypertension, a product must
meet the nutrient content requirements for a ``low sodium'' claim at 9
CFR 317.361 and 381.461;
(2) To bear the proposed claims about cancer, a product must meet
the nutrient content requirements for a ``low fat'' claim at 9 CFR
317.362 and 381.462; and
(3) To bear the proposed claims about coronary heart disease, a
product must meet the nutrient content requirements for claims for
``low fat,'' ``low saturated fat,'' and ``low cholesterol'' at 9 CFR
317.362 and 381.462.
In response to comments on its proposed rules about lipids and
cancer and lipids and cardiovascular disease, FDA provides in its final
regulations on dietary lipids and cancer and on dietary saturated fat
and cholesterol and risk of coronary heart disease that these claims
may be made on fish and game meats that meet the requirements for
``extra lean'' in 21 CFR 101.62. FSIS agrees with FDA that, without
such alternative qualifying criteria, many meat, poultry, and fish
products would be prohibited from bearing health claims.
FSIS has examined the nutritional values for meat and poultry
products reported in USDA's Agriculture Handbook No. 8 and concludes
that no single-ingredient cut of beef, pork, or lamb can meet the
criteria for ``low fat'' or ``low saturated fat'' or the disqualifying
level for cholesterol. While skinless chicken breast meat does meet
``low fat'' and ``low saturated fat'' criteria, its cholesterol content
exceeds the disqualifying level. Of the products examined, only
skinless light meat turkey meets all three requirements. Meat and
poultry products that are individual foods and that meet the ``low
fat'' and ``low saturated fat'' criteria, as well as the disqualifying
level for cholesterol, tend to be those that contain lesser amounts of
meat or poultry, such as soups, or have 55-gram reference amounts and
are cured or have added water or other ingredients, such as certain
luncheon products.
Many recommendations from public health organizations and
authorities and the Dietary Guidelines for Americans advise choosing
lean meats, fish, and poultry without skin as a means of achieving
nutritious diets low in fat, saturated fat, and cholesterol. To
preclude health claims on many of these products may obstruct the
dietary guidance goals of encouraging consumption of a variety of foods
and increased selection of lean meats and poultry by consumers. Meat
and poultry products play an important role in the U.S. dietary pattern
because they are consumed by most Americans on a daily basis and
provide protein, B-vitamins, and essential minerals, such as iron and
zinc.
The FSIS regulatory definition for ``extra lean'' may be used on
the label or in labeling of a meat or poultry product when the product
contains less than 5 g of fat, less than 2 g of saturated fat, and less
than 95 mg of cholesterol per 100 g and reference amount customarily
consumed for individual foods and per 100 g and labeled serving size
for meal-type products. For individual foods, the 100-gram density
criterion controls qualification for the claim when reference amounts
are below 100 g. For example, products such as cooked meat or poultry
cuts with a reference amount of 85 g meet ``extra lean'' requirements
only when 85 g of the products contain less than 4.3 g of fat, 1.7 g of
saturated fat, and 81 mg of cholesterol. Products such as luncheon
meats or poultry lunch products with a reference amount of 55 g meet
the requirements only when 55 g of the products contain less than 2.8 g
of fat, 1.1 g of saturated fat, and 52 mg of cholesterol.
Individual foods with reference amounts exceeding 100 g such as
mixed dishes not measurable with a cup having a reference amount of 140
g may not contain more than 5 g of fat, 2 g of saturated fat, and 95 mg
of cholesterol in 140 g of the products to use ``extra lean'' claims.
Meal-type products are restricted to no more than 5 g of fat, 2 g of
saturated fat, and 95 mg of cholesterol in the entire serving
(container) to carry the claim. FSIS concludes that only individual
food products with reference amounts over about 2 ounces (56 g) would
be subject to somewhat less stringent requirements than permitted by
``low fat'' and ``low saturated fat'' criteria and the disqualifying
level for cholesterol if permitted to qualify for health claims based
on requirements for ``extra lean'' claims. FSIS also believes, as
stated in its proposed rule on nutrition labeling, that the ``extra
lean'' criteria recognize the practice of dietary planning in which a
person consumes servings of a variety of foods that contain different
levels of fat, saturated fat, and cholesterol, and allow for a diet
that will meet the dietary guidelines.
Because FSIS is convinced that it is important to communicate
consistent messages about dietary goals, and about the role meat and
poultry products can play in meeting dietary recommendations, it is
proposing to provide, as an option, for meat and poultry products that
meet the ``total fat'' and ``cholesterol'' criteria for ``extra lean''
to carry health claims about cancer, and products that meet all the
requirements for the ``extra lean'' claim to carry health claims about
heart disease. Because many meat and poultry products, including
individual foods such as mixed dishes and meal-type products, contain
ample amounts of foods from the fruit and vegetable group and/or the
grain products group to be suitable in nature to bear claims about
cancer and heart disease, FSIS believes it is appropriate to allow meat
and poultry products meeting ``extra lean'' criteria to qualify for the
companion claims about the relationships of diets high in fruits,
vegetables, and grain products to cancer and heart disease. Such action
would be consistent with dietary guidance efforts to encourage
healthful diets by choosing diets with plenty of fruits, vegetables,
and grain products, as well as choosing lean meats and poultry.
To be consistent with the use of ``extra lean'' criteria for health
claims about cancer and heart disease, FSIS believes it is appropriate
to permit meat and poultry products that are individual foods to meet
the ``extra lean'' cholesterol criterion to carry the calcium/
osteoporosis, sodium/hypertension, and folate/neural tube defects
health claims. To not make this allowance would introduce disparity
among meat and poultry products to qualify for all claims. Therefore,
FSIS is proposing to permit meat and poultry products which meet the
``cholesterol'' criterion for ``extra lean'' to carry health claims
about osteoporosis, hypertension, and neural tube defects, provided
they meet all other requirements to bear those claims.
FSIS proposes to require that the labeling of a product disclose
the presence of any nutrient that exceeds the disqualifying level in
conjunction with a claim when FSIS permits the claim. Therefore, when a
claim is allowed on an individual food despite the fact that its
cholesterol level exceeds the disqualifying level, the labeling would
be required to carry a disclosure statement to read ``See [appropriate
panel or Nutrition Facts] for information about [nutrient requiring
disclosure] and other nutrients,'' e.g., ``See side panel for
information about cholesterol and other nutrients,'' or ``See Nutrition
Facts for information about cholesterol and other nutrients.'' This
action would be consistent with FDA's disclosure requirements.
Nutritive Value
FSIS agrees with FDA that when claims are made about the effects of
consuming a substance at other than decreased levels, the level of the
substance must be sufficiently high to justify the claim. For such
claims, FSIS is proposing to adopt levels required to meet regulatory
definitions for ``good source'' or ``high'' prior to any nutrient
addition. However, in defining requirements for nutrient content claims
for ``good source'' and ``high'' at 9 CFR 317.354 and 381.454 for meat
and poultry products, respectively, FSIS did not provide a specific
definition for a meal-type product. Rather, the claims are allowed for
a food contained in a meal-type product based on the reference amount
customarily consumed of the component food. Because the actual serving
of a component food, when used as a side dish in a meal, may be much
less than the reference amount, FSIS is concerned that the actual
quantitative amount of the substance, e.g., calcium or dietary fiber,
in the entire meal may not be sufficient to justify use of the claim on
the product. To ensure sufficient levels of substances in a meal-type
product, FSIS is proposing to base the qualifying nutrient criteria on
the labeled serving of the entire product.
FSIS believes health claims should not be made on foods that do not
make a nutritional contribution to the diet. Therefore, FSIS is
proposing, as a general requirement, to prohibit health claims for any
product that contains less than 10 percent of the Reference Daily
Intake or Daily Reference Value for vitamin A, vitamin C, iron,
calcium, protein, or fiber per reference amount customarily consumed
prior to any nutrient addition for individual foods and per labeled
serving prior to any nutrient addition for meal-type products. FSIS
interprets nutrient addition as addition specifically to meet the
requirements for a health claim. For example, the requirement does not
preclude claims on products where a nutrient is added to meet a
standard of identity; a nutrient is added for technological purposes,
e.g., L-ascorbic acid (vitamin C) in curing meats; a non-meat or non-
poultry ingredient fortified in accordance with FDA requirements and
policy is used; or, an ingredient that is a nutrient source, e.g.,
textured vegetable protein, is used.
Additional Limits on Claims
FSIS agrees with FDA that claims should be prohibited for any
product where a substance, other than one for which a disqualifying
nutrient level is established, is present at an inappropriate level as
specified in the provision authorizing the claim. For example, a
product containing more phosphorus than calcium on a weight-per-weight
basis would not be eligible to bear the calcium/osteoporosis health
claim because high levels of dietary phosphorus, when calcium intake is
low, would impair the utilization of calcium by bone. The presence of
the claim on a product not having an appropriate calcium to phosphorus
ratio would be misleading in that it would not be possible to get the
full calcium benefits from such a product.
FSIS also agrees with FDA that health claims for children less than
2 years of age should be established by specific regulations providing
for their use. Health claims that concern dietary recommendations for
the U.S. adult population are not meant to apply to children less than
2 years of age. For example, the Dietary Guidelines for Americans
states that the guidelines are ``advice for healthy Americans ages 2
years and over--not for younger children and infants whose dietary
needs differ.'' Accordingly, FSIS is proposing to prohibit only those
claims on foods for this age group that are not specifically provided
for by regulation. FSIS will consider health claims on these products
and, where appropriate, will establish specific regulations for their
use.
Labeling Applications
FSIS is proposing to establish a labeling application process
whereby interested parties may submit a labeling application to FSIS
for approval of the use of a particular health claim in the labeling of
a meat or poultry product. The labeling application would include: (1)
An explanation of how the substance qualifies for a health claim under
the requirements in proposed 9 CFR 317.314 and 381.414; (2) a summary
of scientific data providing the basis upon which authorizing a health
claim can be justified as providing a health benefit; (3) analytical
data showing the amount of the substance that is present in the meat or
poultry product that would be a candidate to bear the claim; (4) a
model health claim that represents label statements for use on a label
or in labeling for a meat or poultry product to characterize the
relationship between the substance to a disease or health-related
condition; (5) documentation supporting the summary of scientific data,
including copies of any literature searches done by the applicant and
of articles cited in the literature and other information, such as
copies of publications cited in review articles and used to perform the
analyses; and (6) a statement signed by the person responsible for
preparing the labeling application that, to the best of his or her
knowledge, it is a representative and balanced submission that includes
unfavorable, as well as favorable, information known to him or her to
be pertinent to the evaluation of the proposed health claim. The
labeling application would be required to be signed by the applicant or
by the applicant's responsible officer or agent.
Upon receipt and review of the labeling application, FSIS would
notify the applicant, in writing, that the labeling application is
either being considered for further review or that it has been denied
by the Administrator. If the Administrator summarily denies the
labeling application, he or she would notify the applicant, in writing,
as to the reason(s) for the denial, including why the proposed health
claim in the labeling was determined by FSIS to be false or misleading,
and would afford the applicant an opportunity to submit a written
statement by way of answer to the notification, and a right to request
a hearing with respect to the merits or validity of the Administrator's
decision to deny the use of the proposed health claim. If the applicant
fails to accept the determination of the Administrator and files an
answer and requests a hearing, and the Administrator, after review of
the answer, determines the initial determination to be correct, the
Administrator would file with the Hearing Clerk of the Department the
notification, answer, and the request for hearing, which would
constitute the complaint and answer in the proceeding, which would
thereafter be conducted in accordance with the Department's Uniform
Rules of Practice. The hearing would be conducted before an
administrative law judge with the opportunity for appeal to the
Department's Judicial Officer, who is delegated the authority to make
the final determination for the Secretary. Any such determination by
the Secretary would be conclusive unless, within thirty days after
receipt of notice of such final determination, the applicant appealed
to the United States Court of Appeals for the circuit in which the
applicant has its principal place of business or to the United States
Court of Appeals for the District of Columbia Circuit.
If the Administrator does not summarily deny the labeling
application, he or she would publish in the Federal Register a proposed
rule to amend the regulations to authorize the use of the health claim.
The proposal would also summarize the labeling application, including
where the supporting documentation could be reviewed. The
Administrator's proposed rule would seek comment from consumers, the
industry, consumer and industry groups, medical and scientific
professionals, and other interested persons on the labeling application
and the use of the proposed health claim. FSIS believes that the use of
health claims has great overall significance to consumer health.
Because of the highly sensitive nature of such claims and the vast
amount of medical and scientific studies which are being conducted in
this area, FSIS believes that the solicitation of comments by the
Administrator from the public on whether to approve the use of a
particular health claim would foster an open environment and lead to
the most informed and well-supported decision. After public comment has
been received and reviewed by FSIS, the Administrator will make a
determination on whether the proposed health claim will be approved for
use on the labeling.
If the claim is denied following the review of the public comments,
FSIS would notify the applicant by letter of the basis for the denial,
including the reason why the claim on the labeling was determined by
the Administrator to be false or misleading. The applicant would have
the opportunity to appeal this decision by instituting a proceeding
that would be conducted under the same procedures specified above if a
labeling application were summarily denied by the Administrator during
the initial review. If the claim is approved by the Administrator, FSIS
would notify the applicant by letter and would also publish in the
Federal Register a final regulation regarding the approval of the
claim. The final regulation would amend the regulations to authorize
the use of the health claim in the labeling of meat and poultry
products.
FSIS's proposed labeling application process concerning health
claims differs from that of FDA as detailed in 21 CFR 101.70. Although
FSIS has attempted to harmonize to the maximum extent possible with FDA
in most aspects of nutrition labeling, FDA's rulemaking process
regarding health claims differs from FSIS's statutory authority
mandated by Congress under section 7(e) of the FMIA (21 U.S.C. 607(e)
and section 8(d) of the PPIA (21 U.S.C. 457(d)). These statutes afford
applicants whose labeling claims are denied by the Administrator the
right to appeal that decision to a Federal court of appeals. Because of
these statutory requirements, the Department has promulgated
regulations (9 CFR 335.12, 9 CFR 381.233, and 7 CFR 1.130 et seq.) that
specify the hearing procedures and rules of practice which are used in
proceedings before the Secretary under section 7(e) of the FMIA and
section 8(d) of the PPIA. Accordingly, the labeling application process
proposed by FSIS concerning health claims provides applicants with
those same rights to a due process administrative hearing if their
claims are denied by the Administrator, and is thereby consistent with
FSIS's statutory requirements.
When the Administrator has determined that a health claim may be
used, firms may make claims based on the regulation provided that:
1. All label or labeling statements about the substance-disease or
health-related relationship are based on, and consistent with, the
conclusions prescribed in the summary of scientific information and
proposed health claims;
2. The claim is limited to describing the value that ingestion of
the substance may have on a particular disease or health-related
condition;
3. The claim is complete, truthful, and not misleading;
4. All information required to be included in the claim appears in
one place without other intervening material, except that the label may
bear the statement, ``See ____ for information about the relationship
between ____ and ____,'' with the blanks filled in with references to
the location of the labeling containing the health claim, the name of
the substance, and the disease or health-related condition, with the
entire claim appearing on the other labeling;
5. The claim enables the public to comprehend the information
provided and to understand the relative significance of such
information in the context of the total daily diet; and,
6. If the claim is about the effects of consuming the substance at
decreased dietary levels, the level of the substance in the food is
sufficiently low to justify the claim, or, if the claim is about the
effects of consuming the substance at other than decreased dietary
levels, the level of the substance in the food is sufficiently high to
justify the claim.
Proposed Effective Date
Because of the nature and complexity of health claims and the
consumer's reliance on them in making decisions on food purchases, FSIS
believes it is essential that health claims be conveyed to consumers in
an accurate and informative manner. Therefore, if this proposal is
adopted as a final regulation, FSIS would make the final regulation
effective 6 months from the date of publication of the final
regulation. FSIS believes that this would provide sufficient time for
meat and poultry producers to conform to the new health claim
requirements. It is noted, therefore, that the health claim
requirements would not become effective on July 6, 1994, along with the
mandatory nutrition labeling regulations.
List of Subjects
9 CFR Part 317
Food labeling, Food packaging, Meat inspection, Recordkeeping and
reporting requirements.
9 CFR Part 381
Food labeling, Poultry and poultry products, Poultry inspection,
Recordkeeping and reporting requirements.
Proposed Rule
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR parts 317 and 381 of the Federal meat and poultry products
inspection regulations as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for Part 317 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
2. A new section 317.314 would be added to read as follows:
Sec. 317.314 Health claims; general requirements.
(a) Definitions. For purposes of this section, the following
definitions apply:
(1) Health claim means any claim made on the label or in labeling
of a meat or meat food product that expressly or by implication,
including third party references, written statements (e.g., a brand
name including a term such as ``heart''), symbols (e.g., a heart
symbol), or vignettes, characterizes the relationship of any substance
to a disease or health-related condition. Implied health claims include
those statements, symbols, vignettes, or other forms of communication
that suggest, within the context in which they are presented, that a
relationship exists between the presence or level of a substance in the
meat or meat food product and a disease or health-related condition.
(2) Substance means a specific food or component of a food.
(3) Nutritive value means a value in sustaining human existence by
such processes as promoting growth, replacing loss of essential
nutrients, or providing energy.
(4) Disqualifying nutrient levels mean the levels of total fat,
saturated fat, cholesterol, or sodium in a meat or meat food product
above which the product will be disqualified from making a health
claim. These levels are 13 grams (g) of fat, 4 g of saturated fat, 60
milligrams (mg) of cholesterol, or 480 mg of sodium per reference
amount customarily consumed, per labeled serving size, and, only for
foods with reference amounts customarily consumed of 30 g or less or 2
tablespoons or less, per 50 g. For dehydrated products that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 317.309(g)(1),
of all nutrients, the per 50-g criterion refers to the prepared form.
Any one of the levels, on a per reference amount customarily consumed,
a per labeled serving size or, when applicable, a per 50-g basis, will
disqualify a meat or meat food product from making a health claim
unless an exception is provided for in Sec. 317.371, except that:
(i) The levels for a meal product, as defined in Sec. 317.313(l),
that weighs at least 6 ounces (oz) but less than 10 oz per serving
(container), are 20 g of fat, 6 g of saturated fat, 95 mg of
cholesterol, or 720 mg of sodium per labeled serving size.
(ii) The levels for a meal product, as defined in Sec. 317.313(l),
that weighs 10 oz or more per serving (container), are 26 g of fat, 8 g
of saturated fat, 120 mg of cholesterol, or 960 mg of sodium per
labeled serving size.
(5) Disease or health-related condition means damage to an organ,
part, structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health leading
to such dysfunctioning (e.g., hypertension); except that diseases
resulting from essential nutrient deficiencies (e.g., scurvy, pellagra)
are not included in this definition and, thereby, claims pertaining to
such diseases are not subject to Sec. 317.314 or Sec. 317.370.
(b) Eligibility. For a substance to be eligible for a health claim:
(1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an
identified U.S. population subgroup (e.g., the elderly) is at risk, or,
alternatively, the labeling application submitted by the proponent of
the claim otherwise explains the prevalence of the disease or health-
related condition in the U.S. population and the relevance of the claim
in context of the total daily diet and satisfies the other requirements
of this section.
(2) If the substance is to be consumed as a component of a meat or
meat food product at decreased dietary levels, the substance must be a
nutrient that is required to be included in the label or labeling as
set forth in Sec. 317.309(b); or
(3) If the substance is to be consumed at other than decreased
dietary levels:
(i) The substance must contribute taste, aroma, or nutritive value,
or any technical effect listed in 21 CFR 170.3(o), to the food and must
retain that attribute when consumed at levels that are necessary to
justify a claim; and
(ii) The substance must be a food or a food ingredient or a
component of a food ingredient whose use at the levels necessary to
justify a claim has been demonstrated by the proponent of the claim to
be safe and lawful under the applicable food safety provisions of the
Federal Food, Drug, and Cosmetic Act and the Federal Meat Inspection
Act.
(c) Validity requirement. The Administrator will approve the use of
a health claim only when he or she determines that the claim is not
false or misleading, because it is supported by:
(1) The totality of publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles); and
(2) Significant scientific agreement among experts qualified by
scientific training and experience to evaluate such claims.
(d) General health claim labeling requirements. (1) When the
Administrator determines that a health claim meets the requirements of
paragraph (c) of this section, the Agency will notify the applicant, in
writing, and will institute rulemaking to amend the regulations to
authorize the use of that claim. If the claim pertains to a substance
not provided for in Part 317 of the regulations, the Administrator will
institute rulemaking to amend the regulations to include declaration of
the substance.
(2) When a regulation has been established in this Part providing
for a health claim, firms may make claims based on the regulation in
this part; Provided, That:
(i) All label or labeling statements about the substance-disease
relationship that is the subject of the claim are based on, and
consistent with, the conclusions set forth in Sec. 317.371;
(ii) The claim is limited to describing the value that ingestion
(or reduced ingestion) of the substance, as part of a total dietary
pattern, may have on a particular disease or health-related condition;
(iii) The claim is otherwise complete, truthful, and not
misleading. Where factors other than dietary intake of the substance
affect the relationship between the substance and the disease or
health-related condition, such factors may be required to be addressed
in the claim by a specific provision in Sec. 317.371;
(iv) All information required to be included in the claim appears
in one place without other intervening material, except that the
principal display panel of the label or labeling may bear the reference
statement, ``See ______ for information about the relationship between
______ and ______,'' with the blanks filled in with the location of the
labeling containing the health claim, the name of the substance, and
the disease or health-related condition (e.g., ``See attached pamphlet
for information about calcium and osteoporosis''), with the entire
claim appearing elsewhere on the other labeling; Provided, That, where
any graphic material (e.g., a heart symbol) constituting an explicit or
implied health claim appears on the label or labeling, the reference
statement or the complete claim shall appear in immediate proximity to
such graphic material;
(v) The claim enables the public to comprehend the information
provided and to understand the relative significance of such
information in the context of the total daily diet; and
(vi) If the claim is about the effects of consuming the substance
at decreased dietary levels, the level of the substance in the meat or
meat food product is sufficiently low to justify the claim. To meet
this requirement, if a definition for use of the term ``low'' has been
established for that substance under this Part, the substance must be
present at a level that meets the requirements for use of that term,
unless a specific alternative level has been established for the
substance in Sec. 317.371. If no definition for ``low'' has been
established, the level of the substance must meet the level established
in the regulation authorizing the claim; or
(vii) If the claim is about the effects of consuming the substance
at other than decreased dietary levels, the level of the substance is
sufficiently high to justify the claim. To meet this requirement, if a
definition for use of the term ``high'' for that substance has been
established under this Part, the substance must be present at a level
that meets the requirements for use of that term, unless a specific
alternative level has been established for the substance in
Sec. 317.371. If no definition for ``high'' has been established (e.g.,
where the claim pertains to a food either as a whole food or as an
ingredient in another food), the claim must specify the daily dietary
intake necessary to achieve the claimed effect, as established in the
regulation authorizing the claim; Provided, That, where the meat or
meat food product that bears the claim meets the requirements of
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its
reference amount customarily consumed, and the labeled serving size
differs from that amount, the claim shall be followed by a statement
explaining that the claim is based on the reference amount rather than
the labeled serving size (e.g., ``Diets low in sodium may reduce the
risk of high blood pressure, a disease associated with many factors. A
serving ______ of ounces of this product conforms to such a diet.'')
(3) Nutrition labeling shall be provided in the label or labeling
of any meat or meat food product for which a health claim is made in
accordance with Sec. 317.309.
(e) Prohibited health claims. No express or implied health claim
may be made on the label or in labeling for a meat or meat food product
unless:
(1) The claim is specifically provided for in Sec. 317.371; and
(2) The claim conforms to all general provisions of this section as
well as to all specific provisions in the appropriate section of
Sec. 317.371;
(3) None of the disqualifying levels identified in paragraph (a)(4)
of this section is exceeded in the meat or meat food product, unless
specific alternative levels have been established for the substance in
Sec. 317.371; or, unless the Administrator has permitted a claim
despite the fact that a disqualifying level of a nutrient is present in
the product based on a finding that such a claim will assist consumers
in maintaining healthy dietary practices, and, in accordance with the
regulation in this part that makes such a finding, the labeling bears a
referral statement disclosing the nutrient(s) that exceeds the
disqualifying level as follows: ``See [appropriate panel or Nutrition
Facts] for information about [nutrient requiring disclosure] and other
nutrients.'' The statement shall be in easily legible boldface print or
type, in distinct contrast to other printed or graphic matter, that is
no less than that required for net quantity of contents, except where
the size of the claim is less than two times the required size of the
net quantity of contents statement, in which case the referral
statement shall be no less than one-half the size of the claim but no
smaller than one-sixteenth of an inch.
(4) Except as provided in paragraph (e)(3) of this section, no
substance is present at an inappropriate level as determined in the
specific provision authorizing the claim in Sec. 317.371.
(5) The label does not represent or purport that the food is for
infants and toddlers less than 2 years of age, except if the claim is
specifically provided for in Sec. 317.371.
(6) Except where provided for in other regulations in this Part,
the meat or meat food product contains 10 percent or more of the
Reference Daily Intake or the Daily Reference Value as defined in
Sec. 317.309 for vitamin A, vitamin C, iron, calcium, protein, or fiber
per reference amount customarily consumed prior to any nutrient
addition, except the basis for meal-type products as defined in
Sec. 317.313(l) shall be per labeled serving size prior to any nutrient
addition.
(f) Applicability. The requirements of this section apply to meat
and meat food products intended for human consumption that are offered
for sale.
3. A new section 317.370 would be added to read as follows:
Sec. 317.370 Labeling applications for health claims.
(a) Any interested person may submit a labeling application to FSIS
for approval of the use of a particular health claim in the labeling of
a meat or meat food product. The labeling application shall be
submitted in quadruplicate, except that the supporting documentation
may be submitted on a computer readable disk. Contents of the disk
should be in a standard format, such as ASCII format. (Applicants
interested in submitting a disk should contact the Director, Product
Assessment Division, Regulatory Programs, FSIS, Washington, DC 20250
for details). If any part of the material submitted is in a foreign
language, it shall be accompanied by an accurate and complete English
translation. The labeling application shall state the applicant's post
office address.
(b) Pertinent information will be considered as part of a labeling
application on the basis of specific reference to such information
submitted to and retained in the files of FSIS. Such information may
include any findings, along with the basis of the findings, of an
outside panel with expertise in the subject area. However, any
reference to unpublished information furnished by a person other than
the applicant will not be considered unless use of such information is
authorized (with the understanding that such information may in whole
or in part be subject to release to the public) in a written statement
signed by the person who submitted it. Any reference to published
information shall be accompanied by reprints or easily readable copies
of such references.
(c) If nonclinical laboratory studies accompany a labeling
application, the applicant shall include, with respect to each
nonclinical study included with the labeling application, either a
statement that the study has been conducted in compliance with the good
laboratory practice regulations as set forth in part 58 of chapter I,
title 21, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the
noncompliance.
(d) If clinical or other human investigations accompany a labeling
application, the applicant shall include, with respect to each clinical
investigation included with the application, either a statement that
the investigation was conducted in compliance with the requirements for
institutional review set forth in part 56 of chapter I, title 21, or
was not subject to such requirements in accordance with 21 CFR 56.104
or 56.105, and that it was conducted in compliance with the
requirements for informed consent set forth in part 50 of chapter I,
title 21.
(e) All data and information in a health claim labeling application
are available for public disclosure after the notice of filing of
labeling application is issued to the applicant (Sec. 317.370(j)(2)),
except that clinical investigation reports, adverse reaction reports,
product experience reports, consumer complaints, and other similar data
and information shall only be available after deletion of:
(1) Names and any information that would identify the person using
the meat or meat food product.
(2) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(f) Labeling applications for a health claim shall be submitted to
the Director, Food Labeling Division, Regulatory Programs, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250 and shall include the following data and be submitted in the
following form:
----------------------------------------------------------------------
(Date)
Name of applicant------------------------------------------------------
Post office address----------------------------------------------------
Subject of the labeling application------------------------------------
The undersigned, ______ submits this labeling application
pursuant to 9 CFR 317.370 with respect to (statement of the
substance and its health claim).
Attached hereto, and constituting a part of this labeling
application, are the following:
A. Preliminary requirements. A complete explanation of how the
substance conforms to the requirements of Sec. 317.314(b). For
labeling applications where the subject substance is a food
ingredient or a component of a food ingredient, the applicant should
compile a comprehensive list of the specific ingredients that will
be added to the meat or meat food product to supply the substance in
the meat or meat food product bearing the health claim. For each
such ingredient listed, the applicant should state how the
ingredient complies with the requirements of Sec. 317.314(b)(3)(ii),
e.g., that its use is generally recognized as safe (GRAS), listed as
a food additive, or authorized by a prior sanction issued by FSIS,
and what the basis is for the GRAS claim, the food additive status,
or prior sanctioned status.
B. Summary of scientific data. The summary of scientific data
provides the basis upon which authorizing a health claim can be
justified as providing the health benefit. The summary must
establish that, based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner which is consistent with generally recognized
scientific procedures and principles), there is significant
scientific agreement among experts qualified by scientific training
and experience to evaluate such claims, that the claim is supported
by such evidence.
The summary shall state what public health benefit will derive
from use of the claim as proposed. If the claim is intended for a
specific group within the population, the summary shall specifically
address nutritional needs of such group and shall include scientific
data showing how the claim is likely to assist in meeting such
needs.
The summary shall concentrate on the findings of appropriate
review articles, National Institutes of Health consensus development
conferences, and other appropriate resource materials. Issues
addressed in the summary shall include answers to such questions as:
1. Is there an optimum level of the particular substance to be
consumed beyond which no benefit would be expected?
2. Is there any level at which an adverse effect from the
substance or from meat or meat food products containing the
substance occurs for any segment of the population?
3. Are there certain populations that must receive special
consideration?
4. What other nutritional or health factors (both positive and
negative) are important to consider when consuming the substance?
In addition, the summary of scientific data shall include a
detailed analysis of the potential effect of the use of the proposed
claim on food consumption, specifically any change due to
significant alterations in eating habits and corresponding changes
in nutrient intake resulting from such changes in food consumption.
The latter item shall specifically address the effect on the intake
of nutrients that have beneficial and negative consequences in the
total diet.
If the claim is intended for a significant subpopulation within
the general U.S. population, the analysis shall specifically address
the dietary practices of such group, and shall include data
sufficient to demonstrate that the dietary analysis is
representative of such group (e.g., adolescents or the elderly).
If appropriate, the labeling application shall explain the
prevalence of the disease or health-related condition in the U.S.
population or subpopulation and the relevance of the claim in the
context of the total daily diet.
Also, the summary shall demonstrate that the substance that is
the subject of the proposed claim conforms to the definition of the
term ``substance'' in Sec. 317.314(a)(2).
C. Analytical data. Analytical data that show the amount of the
substance that is present in representative meat and meat food
products that would be candidates to bear the claim should be
obtained from representative samples using methods in accordance
with Sec. 317.309(h). If no USDA or AOAC methods are available, the
applicant shall submit the assay method used, and data establishing
the validity of the method for assaying the substance in the meat or
meat food product. The validation data shall include a statistical
analysis of the analytical and product variability.
D. Model health claim. One or more model health claims that
represent label statements that may be used on a label or in
labeling for a meat or meat food product to characterize the
relationship between the substance to a disease or health-related
condition that is justified by the summary of scientific data
provided in section B of the labeling application. The model health
claim shall include:
1. A brief capsulized statement of the relevant conclusions of
the summary, and
2. A statement of how this substance helps the consumer to
attain a total dietary pattern or goal associated with the health
benefit that is provided.
E. Supporting Documentation. The labeling application shall
include the following attachments:
1. Copies of any computer literature searches done by the
applicant (e.g., Medline).
2. Copies of articles cited in the literature searches and other
information as follows:
a. All information relied upon for the support of the health
claim, including copies of publications or other information cited
in review articles and used to perform meta-analyses.
b. All information concerning adverse consequences to any
segment of the population (e.g., sensitivity to the substance).
c. All information pertaining to the U.S. population.
F. The applicant is required to submit either a claim for
categorical exclusion under 21 CFR 25.24 or an environmental
assessment under 21 CFR 25.31.
Yours very truly,
Applicant--------------------------------------------------------------
By---------------------------------------------------------------------
(Indicate authority)
(g) The data specified under the several lettered headings should
be submitted on separate pages or sets of pages, suitably identified.
If such data have already been submitted with an earlier application
from the applicant or any other final labeling application, the present
labeling application may incorporate it by specific reference to the
earlier application.
(h) The labeling application shall include a statement signed by
the person responsible for the labeling application that, to the best
of his or her knowledge, it is a representative and balanced submission
that includes unfavorable information, as well as favorable
information, known to him or her to be pertinent to the evaluation of
the proposed health claim.
(i) The labeling application shall be signed by the applicant or by
his or her attorney or agent, or, if a corporation, by its responsible
officer or agent.
(j) FSIS action on the labeling application. (1) Upon receipt of
the labeling application and supporting documentation, the applicant
shall be notified, in writing, of the date on which the labeling
application was received. Such notice shall inform the applicant that
the labeling application is undergoing FSIS review and that the
applicant shall subsequently be notified of FSIS's decision to consider
for further review or deny the labeling application.
(2) Upon review of the labeling application and supporting
documentation, FSIS shall notify the applicant, in writing, that the
labeling application is either being considered for further review or
that it has been summarily denied by the Administrator. FSIS shall deny
a labeling application without reviewing the information contained in
subsection B of this part, Summary of Scientific Data, if the
information in subsection A of this part, Preliminary Requirements, is
inadequate to explain how the substance conforms to the requirements of
Sec. 317.314(b).
(3) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefore, including why FSIS has determined that the proposed health
claim is false or misleading. The notification letter shall inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed health claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(4) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register
a proposed rule to amend the regulations to authorize the use of the
health claim. The proposal shall also summarize the labeling
application, including where the supporting documentation can be
reviewed. The Administrator's proposed rule shall seek comment from
consumers, the industry, consumer and industry groups, medical and
scientific professionals, and other interested persons on the labeling
application and the use of the proposed health claim. After public
comment has been received and reviewed by FSIS, the Administrator shall
make a determination on whether the proposed health claim shall be
approved for use on the labeling of meat or meat food products.
(i) If the claim is denied by the Administrator following the
review of the public comments, FSIS shall notify the applicant, in
writing, of the basis for the denial, including the reason why the
claim on the labeling was determined by FSIS to be false or misleading.
The notification letter shall also inform the applicant that the
applicant may submit a written statement by way of answer to the
notification, and that the applicant shall have the right to request a
hearing with respect to the merits or validity of the Administrator's
decision to deny the use of the proposed health claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall thereafter be conducted in
accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, FSIS shall notify the applicant, in
writing, and shall also publish in the Federal Register a final rule
amending the regulations to authorize the use of the claim.
4. A new Sec. 317.371 would be added to read as follows:
Sec. 317.371 Health claims.
(a) Calcium and osteoporosis--(1) Relationship between calcium and
osteoporosis. An inadequate calcium intake contributes to low peak bone
mass and has been identified as one of the many risk factors in the
development of osteoporosis. Peak bone mass is the total quantity of
bone present at maturity, and experts believe that it has the greatest
bearing on whether or not a person will be at risk of developing
osteoporosis and related bone fractures later in life. Another factor
that influences total bone mass susceptibility to osteoporosis is the
rate of bone loss after skeletal maturity. An adequate intake of
calcium is thought to exert a positive effect during adolescence and
early adulthood in optimizing the amount of bone that is laid down.
However, the upper limit of peak bone mass is genetically determined.
The mechanism through which an adequate calcium intake and optimal peak
bone mass reduce the risk of osteoporosis is thought to be as follows.
All persons lose bone with age. Hence those with higher bone mass at
maturity take longer to reach the critically reduced mass at which
bones can fracture easily. The rate of bone loss after skeletal
maturity also influences the amount of bone present at old age and can
influence an individual's risk of developing osteoporosis. Maintenance
of an adequate intake of calcium later in life is thought to be
important in reducing the rate of bone loss particularly in the elderly
and in women during the first decade following menopause.
(2) Significance of calcium. Calcium intake is not the only
recognized risk factor in the development of osteoporosis, a
multifactorial bone disease. Other factors including a person's sex,
race, hormonal status, family history, body stature, level of exercise,
general diet, and specific life style choices such as smoking and
excess alcohol consumption affect the risk of osteoporosis.
(i) Heredity and being female are two key factors identifying those
individuals at risk for the development of osteoporosis. Hereditary
risk factors include race: Notably, Caucasians and Asians are
characterized by low peak bone mass at maturity. Caucasian women,
particularly those of northern European ancestry, experience the
highest incidence of osteoporosis-related bone fracture. American women
of African heritage are characterized by the highest peak bone mass and
lowest incidence osteoporotic fracture, despite the fact that they have
low calcium intake.
(ii) Maintenance of an adequate intake of calcium throughout life
is particularly important for a subpopulation of individuals at
greatest risk of developing osteoporosis and for whom adequate dietary
calcium intake may have the most important beneficial effects on bone
health. This target subpopulation includes adolescent and young adult
Caucasian and Asian American women.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating calcium with reduced risk of osteoporosis may be made on
the label or labeling of a meat or meat food product described in
paragraph (a)(3)(ii)(B) of this section; Provided, That:
(1) The claim makes clear that adequate calcium intake throughout
life is not the only recognized risk factor in this multifactorial bone
disease by listing specific factors, including a sex, race, and age
that place persons at risk of developing osteoporosis and stating that
an adequate level of exercise and a healthful diet are also needed;
(2) The claim does not state or imply that the risk of osteoporosis
is equally applicable to the general United States population. The
claim shall identify the populations at particular risk for the
development of osteoporosis. These populations include white (or the
term ``Caucasian'') women and Asian women in their bone forming years
(approximately 11 to 35 years of age or the phrase ``during teen years
or early adult years'' may be used). The claim may also include
menopausal (or the term ``middle-aged'') women, persons with a family
history of disease, and elderly (or ``older'') men and women as being
at risk;
(3) The claim states that adequate calcium intake throughout life
is linked to reduced risk of osteoporosis through the mechanism of
optimizing peak bone mass during adolescence and early adulthood. The
phrase ``build and maintain good bone health'' may be used to convey
the concept of optimizing peak bone mass. When reference is made to
persons with a family history of the disease, menopausal women, and
elderly men and women, the claim may also state that adequate calcium
intake is linked to reduced risk of osteoporosis through the mechanism
of slowing the rate of the bone loss;
(4) The claim does not attribute any degree of reduction in risk of
osteoporosis to maintaining an adequate calcium intake throughout life;
and
(5) The claim states that a total dietary intake greater than 200
percent of the Recommended Daily Intake (2,000 mg of calcium) has no
further known benefit to bone health. This requirement does not apply
to meat or meat food products that contain less than 40 percent of the
Recommended Daily Intake of 1,000 mg of calcium per day or 400 mg of
calcium per reference amount customarily consumed as defined in
Sec. 317.312(b), except the basis for meal-type products as defined in
Sec. 317.313(l) shall be per labeled serving size.
(B) Nature of the food. (1) The product shall meet or exceed the
requirements for a ``high'' level of calcium as defined in
Sec. 317.354, except the basis for meal-type products as defined in
Sec. 317.313(l) shall be per labeled serving size;
(2) The product shall not contain more phosphorus than calcium on a
weight-per-weight basis; and
(3) The product may meet the cholesterol criterion for ``extra
lean'' as defined in Sec. 317.362.
(4) Optional information. (i) The claim may include information
from paragraphs (a) (1) and (2) of this section, which summarizes the
relationship between calcium and osteoporosis and the significance of
the relationship.
(ii) The claim may include information on the number of people in
the United States who have osteoporosis. The source of this information
must be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between calcium and
osteoporosis:
(i) Regular exercise and a healthy diet with enough calcium helps
teens and young adult white and Asian women maintain good bone health
and may reduce their high risk of osteoporosis later in life.
(ii) [FOR FOODS EXCEPTIONALLY HIGH IN CALCIUM] Regular exercise and
a healthy diet with enough calcium helps teens and young adult white
and Asian women maintain good bone health and may reduce their high
risk of osteoporosis later in life. Adequate calcium intake is
important, but daily intakes above about 2,000 mg are not likely to
provide any additional benefit.
(b) Dietary lipids and cancer--(1) Relationship between lipids and
cancer. (i) Cancer is a constellation of more than 100 different
diseases, each characterized by the uncontrolled growth and spread of
abnormal cells. Cancer has many causes and stages in its development.
Both genetic and environmental risk factors may affect the risk of
cancer. Risk factors include a family history of a specific type of
cancer, cigarette smoking, alcohol consumption, overweight and obesity,
ultraviolet or ionizing radiation, exposure to cancer-causing
chemicals, and dietary factors.
(ii) Among dietary factors, the strongest positive association has
been found between total fat intake and risk of some types of cancer.
Based on the totality of the publicly available scientific evidence,
there is significant scientific agreement among experts, qualified by
training and experience to evaluate such evidence, that diets high in
total fat are associated with an increased cancer risk. Research to
date, although not conclusive, demonstrates that the total amount of
fats, rather than any specific type of fat, is positively associated
with cancer risk. The mechanism by which total fat affects cancer has
not yet been established.
(iii) A question that has been the subject of considerable research
is whether the effect of fat on cancer is site-specific. Neither human
nor animal studies are consistent in the association of fat intake with
specific cancer sites.
(iv) Another question that has been raised is whether the
association of total fat intake to cancer risk is independently
associated with energy intakes, or whether the association of fat with
cancer risk is the result of the higher energy (caloric) intake
normally associated with high fat intake. FSIS has concluded that
evidence from both animal and human studies indicates that total fat
intake alone, independent of energy intake, is associated with cancer
risk.
(2) Significance of the relationship between fat intake and risk of
cancer. (i) Cancer is ranked as a leading cause of death in the United
States. The overall economic costs of cancer, including direct health
care costs and losses due to morbidity and mortality, are very high.
(ii) U.S. diets tend to be high in fat and high in calories. The
average U.S. diet is estimated to contain 36 to 37 percent of calories
from total fat. Current dietary guidelines from the Federal Government
and nationally recognized health professional organizations recommend
that dietary fat intake be reduced to a level of 30 percent or less of
energy (calories) from total fat. In order to reduce intake of total
fat, individuals should choose diets which are high in vegetables,
fruits, and grain products (particularly whole grain products), choose
lean cuts of meats, fish, and poultry, substitute low-fat dairy
products for higher fat products, and use fats and oils sparingly.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating diets low in fat with reduced risk of cancer may be made on
the label or labeling of a meat or meat food product described in
paragraph (b)(3)(ii)(B) of this section; Provided, That:
(1) The claim states that diets low in fat ``may'' or ``might''
reduce the risk of some cancers;
(2) In specifying the disease, the claim uses the terms ``some
types of cancer'' or ``some cancers'';
(3) In specifying the nutrient, the claim uses the terms ``total
fat'' or ``fat'';
(4) The claim does not specify types of fat or fatty acids that may
be related to the risk of cancer;
(5) The claim does not attribute any degree of cancer risk
reduction to diets low in fat; and
(6) The claim indicates that the development of cancer depends on
many factors.
(B) Nature of the food. The product shall meet the requirements for
``low fat'' as defined in Sec. 317.362, except that the product may
meet the total fat and cholesterol criteria for ``extra lean'' in
Sec. 317.362.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(ii) The claim may include information from paragraphs (b) (1) and
(2) of this section, which summarizes the relationship between dietary
fat and cancer and the significance of the relationship.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have cancer. The source of this information must
be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between dietary
lipids and cancer:
(i) Development of cancer depends on many factors. A diet low in
total fat may reduce the risk of some cancers.
(ii) Eating a healthful diet low in fat may help reduce the risk of
some types of cancer. Development of cancer is associated with many
factors, including a family history of the disease, cigarette smoking,
and what you eat.
(c) Sodium and high blood pressure--(1) Relationship between sodium
and hypertension (high blood pressure). (i) Hypertension, or high blood
pressure, generally means a systolic blood pressure of greater than 140
millimeters of mercury (mm Hg) or a diastolic blood pressure of greater
than 90 mm Hg. Normotension, or normal blood pressure, is a systolic
blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm
Hg. Sodium is specified here as the chemical entity or electrolyte
``sodium'' and is distinguished from sodium chloride, or salt, which is
39 percent sodium by weight.
(ii) The scientific evidence establishes that diets high in sodium
are associated with a high prevalence of hypertension or high blood
pressure and with increases in blood pressure with age, and that diets
low in sodium are associated with a low prevalence of hypertension or
high blood pressure and with a low or no increase of blood pressure
with age.
(2) Significance of sodium in relation to high blood pressure. (i)
High blood pressure is a public health concern primarily because it is
a major risk factor for mortality from coronary heart disease and
stroke. Early management of high blood pressure is a major public
health goal that can assist in reducing mortality associated with
coronary heart disease and stroke. There is a continuum of mortality
risk that increases as blood pressures rise. Individuals with high
blood pressure are at greatest risk, and individuals with moderately
high, high normal, and normal blood pressure are at steadily decreasing
risk. The scientific evidence indicates that reducing sodium intake
lowers blood pressure and associated risks in many but not all
hypertensive individuals. There is also evidence that reducing sodium
intake lowers blood pressure and associated risks in many but not all
normotensive individuals as well.
(ii) The populations at greatest risk for high blood pressure, and
those most likely to benefit from sodium reduction, include those with
family histories of high blood pressure, the elderly, males because
they develop hypertension earlier in life than females, and black males
and females. Although some population groups are at greater risk than
others, high blood pressure is a disease of public health concern for
all population groups. Sodium intake, alcohol consumption, and obesity
are identified risk factors for high blood pressure.
(iii) Sodium intakes exceed recommended levels in almost every
group in the United States. One of the major public health
recommendations relative to high blood pressure is to decrease
consumption of salt. On a population-wide basis, reducing the average
sodium intake would have a small but significant effect on reducing the
average blood pressure, and, consequently, reducing mortality from
coronary heart disease and stroke.
(iv) Sodium is an essential nutrient, and experts have recommended
a safe minimum level of 500 mg sodium per day and an upper level of
2,400 mg sodium per day, which is the Daily Reference Value for sodium.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating diets low in sodium with reduced risk of high blood
pressure may be made on the label or labeling of a meat or meat food
product described in paragraph (c)(3)(ii)(B) of this section; Provided,
That:
(1) The claim states that diets low in sodium ``may'' or ``might''
reduce the risk of high blood pressure;
(2) In specifying the disease, the claim uses the term ``high blood
pressure'';
(3) In specifying the nutrient, the claim uses the term ``sodium'';
(4) The claim does not attribute any degree of reduction in risk of
high blood pressure to diets low in sodium; and
(5) The claim indicates that development of high blood pressure
depends on many factors.
(B) Nature of the food. (1) The product shall meet the requirements
for ``low sodium'' as defined in Sec. 317.361; and
(2) The product may meet the cholesterol criterion for ``extra
lean'' as defined in Sec. 317.362.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of high blood pressure in
addition to dietary sodium consumption: Family history of high blood
pressure, growing older, alcohol consumption, and excess weight.
(ii) The claim may include information from paragraphs (c) (1) and
(2) of this section, which summarizes the relationship between dietary
sodium and high blood pressure and the significance of the
relationship.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have high blood pressure. The source of this
information must be identified, and it must be current information from
the U.S. Department of Health and Human Services.
(v) In specifying the nutrient, the claim may include the term
``salt'' in addition to the term ``sodium.''
(vi) In specifying the disease, the claim may include the term
``hypertension'' in addition to the term ``high blood pressure.''
(vii) The claim may state that individuals with high blood pressure
should consult their physicians for medical advice and treatment. If
the claim defines high or normal blood pressure, then it shall state
that individuals with high blood pressure should consult their
physicians for medical advice and treatment.
(5) Model health claims. The following are model health claims that
may be used in food labeling to describe the relationship between
dietary sodium and high blood pressure:
(i) Diets low in sodium may reduce the risk of high blood pressure,
a disease associated with many factors.
(ii) Development of hypertension or high blood pressure depends on
many factors. [This product] can be part of a low sodium, low salt diet
that might reduce the risk of hypertension or high blood pressure.
(d) Dietary saturated fat and cholesterol and risk of coronary
heart disease--(1) Relationship between dietary saturated fat and
cholesterol and risk of coronary heart disease. (i) Cardiovascular
disease means diseases of the heart and circulatory system. Coronary
heart disease is the most common and serious form of cardiovascular
disease and refers to diseases of the heart muscle and supporting blood
vessels. High blood total- and low density lipoprotein (LDL)-
cholesterol levels are major modifiable risk factors in the development
of coronary heart disease. High coronary heart disease rates occur
among people with high blood cholesterol levels of 240 mg per decaliter
(mg/dL) (6.21 millimoles per liter (mmol/L) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high
risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol.
Dietary lipids (fats) include fatty acids and cholesterol. Total fat,
commonly referred to as fat, is composed of saturated fat (fatty acids
containing no double bonds), and monounsaturated and polyunsaturated
fat (fatty acids containing one or more double bonds).
(ii) The scientific evidence establishes that diets high in
saturated fat and cholesterol are associated with increased levels of
blood total- and LDL-cholesterol and, thus, with increased risk of
coronary heart disease. Diets low in saturated fat and cholesterol are
associated with decreased levels of blood total- and LDL-cholesterol
and, thus, with decreased risk of developing coronary heart disease.
(2) Significance of the relationship between dietary saturated fat
and cholesterol and risk of coronary heart disease. (i) Coronary heart
disease is a major public health concern in the United States,
primarily because it accounts for more deaths than any other disease or
group of diseases. Early management of risk factors for coronary heart
disease is a major public health goal that can assist in reducing risk
of coronary heart disease. There is a continuum of mortality risk from
coronary heart disease that increases with increasing levels of blood
LDL-cholesterol. Individuals with high blood LDL-cholesterol are at
greatest risk. A larger number of individuals with more moderately
elevated cholesterol also have increased risk of coronary events; such
individuals comprise a substantial proportion of the adult U.S.
population. The scientific evidence indicates that reducing saturated
fat and cholesterol intakes lowers blood LDL-cholesterol and risk of
heart disease in most individuals. There is also evidence that reducing
saturated fat and cholesterol intakes in persons with blood cholesterol
levels in the normal range also reduces risk of heart disease.
(ii) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity, and lack of regular physical exercise.
(iii) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. One of the major public health
recommendations relative to coronary heart disease risk is to consume
less than 10 percent of calories from saturated fat, and an average of
30 percent or less of total calories from all fat. Recommended daily
cholesterol intakes are 300 mg or less.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific requirements--(A) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol with reduced
risk of coronary heart disease may be made on the label or labeling of
a meat or meat food product described in paragraph (d)(3)(ii)(B) of
this section; Provided, That:
(1) The claim states that diets low in saturated fat and
cholesterol ``may'' or ``might'' reduce the risk of heart disease;
(2) In specifying the disease, the claim uses the terms ``heart
disease'' or ``coronary heart disease'';
(3) In specifying the nutrient, the claim uses the terms
``saturated fat'' and ``cholesterol'' and lists both;
(4) The claim does not attribute any degree of coronary heart
disease risk reduction to diets low in saturated fat and cholesterol;
and
(5) The claim states that coronary heart disease risk depends on
many factors.
(B) Nature of the food. The product shall meet the requirements for
``low fat,'' ``low saturated fat,'' and ``low cholesterol'' as defined
in Sec. 317.362, except that the product may meet all the requirements
for ``extra lean'' in Sec. 317.362.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors in addition to saturated fat and cholesterol
about which there is general scientific agreement that they are major
risk factors for this disease: A family history of coronary heart
disease, elevated blood total- and LDL-cholesterol, excess body weight,
high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(ii) The claim may indicate that the relationship of saturated fat
and cholesterol to heart disease is through the intermediate link of
``blood cholesterol'' or ``blood total- and LDL-cholesterol.''
(iii) The claim may include information from paragraphs (d) (1) and
(2) of this section, which summarizes the relationship between dietary
saturated fat and cholesterol and risk of coronary heart disease and
the significance of the relationship.
(iv) In specifying the nutrient, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol.''
(v) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(vi) The claim may include information on the number of people in
the United States who have coronary heart disease. The source of this
information must be identified, and it must be current information from
the U.S. Department of Health and Human Services.
(vii) The claim may state that individuals with elevated blood
total- or LDL-cholesterol should consult their physicians for medical
advice and treatment. If the claim defines high or normal blood total-
or LDL-cholesterol, then it shall state that individuals with high
blood cholesterol should consult their physicians for medical advice
and treatment.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between dietary
saturated fat and cholesterol and risk of heart disease:
(i) While many factors affect heart disease, diets low in saturated
fat and cholesterol may reduce the risk of this disease.
(ii) Development of heart disease depends upon many factors, but
its risk may be reduced by diets low in saturated fat and cholesterol
and healthy lifestyles.
(iii) Development of heart disease depends on many factors,
including a family history of the disease, high blood LDL-cholesterol,
diabetes, high blood pressure, being overweight, cigarette smoking,
lack of exercise, and the type of dietary pattern. A healthful diet low
in saturated fat, total fat, and cholesterol, as part of a healthy
lifestyle, may lower blood cholesterol levels and may reduce the risk
of heart disease.
(iv) Many factors, such as family history of the disease, increased
blood total- and LDL-cholesterol levels, high blood pressure, cigarette
smoking, diabetes, and being overweight, contribute to developing heart
disease. Eating a diet low in saturated fat, cholesterol, and total fat
may help reduce the risk of heart disease.
(v) Diets low in saturated fat, cholesterol, and total fat may
reduce the risk of heart disease. Heart disease is dependent upon many
factors, including diet, a family history of the disease, elevated
blood LDL-cholesterol levels, and physical inactivity.
(e) Fiber-containing grain products, fruits, and vegetables and
cancer--(1) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (i)
Cancer is a constellation of more than 100 different diseases, each
characterized by the uncontrolled growth and spread of abnormal cells.
Cancer has many causes and stages in its development. Both genetic and
environmental risk factors may affect the risk of cancer. Risk factors
include a family history of a specific type of cancer, cigarette
smoking, alcohol consumption, overweight and obesity, ultraviolet or
ionizing radiation, exposure to cancer-causing chemicals, and dietary
factors.
(ii) The scientific evidence establishes that diets low in fat and
high in fiber-containing grain products, fruits, and vegetables are
associated with a reduced risk of some types of cancer. Although the
specific role of total dietary fiber, fiber components, and the
multiple nutrients and other substances contained in these foods are
not fully understood, many studies have shown that diets low in fat and
high in fiber-containing foods are associated with reduced risk of some
types of cancer.
(2) Significance of the relationship between consumption of diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and risk of cancer. (i) Cancer is ranked as a leading cause
of death in the United States. The overall economic costs of cancer,
including direct health care costs and losses due to morbidity and
mortality, are very high.
(ii) U.S. diets tend to be high in fat and low in grain products,
fruits, and vegetables. Studies in various parts of the world indicate
that populations who habitually consume a diet high in plant foods have
lower risks of some cancers. These diets are generally low in fat and
rich in many nutrients, including, but not limited to, dietary fiber.
Current dietary guidelines from the Federal Government and nationally
recognized health professional organizations recommend decreased
consumption of fats (less than 30 percent of calories), maintenance of
desirable body weight, and increased consumption of fruits and
vegetables (five or more servings daily), and grain products (six or
more servings daily).
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific Requirements. (A) Nature of the claim. A health claim
associating diets low in fat and high in fiber-containing grain
products, fruits, and vegetables with reduced risk of cancer may be
made on the label or labeling of a meat or meat food product described
in paragraph (e)(3)(ii) (B) of this section; Provided, That:
(1) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``may'' or ``might''
reduce the risk of some cancers;
(2) In specifying the disease, the claim uses the terms ``some
types of cancer'' or ``some cancers'';
(3) The claim is limited to grain products, fruits, and vegetables
that contain dietary fiber;
(4) The claim indicates that the development of cancer depends on
many factors;
(5) The claim does not attribute any degree of cancer risk
reduction to diets low in fat and high in fiber-containing grain
products, fruits, and vegetables;
(6) In specifying the dietary fiber component of the labeled
product, the claim uses the terms ``fiber,'' ``dietary fiber,'' or
``total dietary fiber''; and
(7) The claim does not specify types of dietary fiber that may be
related to risk of cancer.
(B) Nature of the food. (1) The product shall contain a grain
product, fruit, or vegetable;
(2) The product shall meet the requirements for ``low fat'' as
defined in Sec. 317.362, except that the product may meet the total fat
and cholesterol criteria for ``extra lean'' in Sec. 317.362; and
(3) The product shall meet the requirements for a ``good source''
of fiber as defined in Sec. 317.354 prior to any nutrient addition,
except the basis for meal-type products as defined in Sec. 317.313(l)
shall be per labeled serving size.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(ii) The claim may include information from paragraphs (e) (1) and
(2) of this section, which summarizes the relationship between diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and cancer and the significance of the relationship.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have cancer. The source of this information must
be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and cancer risk:
(i) Low fat diets rich in fiber-containing grain products, fruits,
and vegetables may reduce the risk of some types of cancer, a disease
associated with many factors.
(ii) Development of cancer depends on many factors. Eating a diet
low in fat and high in grain products, fruits, and vegetables that
contain dietary fiber may reduce your risk of some cancers.
(f) Fruits, vegetables, and grain products that contain dietary
fiber, particularly soluble fiber, and risk of coronary heart disease--
(1) Relationship between diets low in saturated fat and cholesterol and
high in fruits, vegetables, and grain products that contain fiber,
particularly soluble fiber, and risk of coronary heart disease. (i)
Cardiovascular disease means diseases of the heart and circulatory
system. Coronary heart disease is the most common and serious form of
cardiovascular disease and refers to diseases of the heart muscle and
supporting blood vessels. High blood total- and low density lipoprotein
(LDL)-cholesterol levels are major modifiable risk factors in the
development of coronary heart disease. High coronary heart disease
rates occur among people with high blood cholesterol levels of 240 mg
per decaliter (mg/dL) (6.21 millimoles per liter (mmol/L) or above and
LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline
high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to
6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-
cholesterol. Dietary lipids (fats) include fatty acids and cholesterol.
Total fat, commonly referred to as fat, is composed of saturated fat
(fatty acids containing no double bonds), and monounsaturated and
polyunsaturated fat (fatty acids containing one or more double bonds).
(ii) The scientific evidence establishes that diets high in
saturated fat and cholesterol are associated with increased levels of
blood total- and LDL-cholesterol and, thus, with increased risk of
coronary heart disease. Diets low in saturated fat and cholesterol are
associated with decreased levels of blood total- and LDL-cholesterol
and, thus, with decreased risk of developing coronary heart disease.
(iii) Populations with relatively low blood cholesterol levels tend
to have dietary patterns that are not only low in total fat, especially
saturated fat and cholesterol, but are also relatively high in fruits,
vegetables, and grain products. Although the specific roles of these
plant foods are not yet fully understood, many studies have shown that
diets high in plant foods are associated with reduced risk of coronary
heart disease. These studies correlate diets rich in fruits,
vegetables, and grain products and nutrients from these diets, such as
some types of fiber, with reduced coronary heart disease risk. Persons
consuming these diets frequently have high intakes of dietary fiber,
particularly soluble fiber. Currently, there is not scientific
agreement as to whether a particular type of soluble fiber is
beneficial, or whether the observed protective effects of fruits,
vegetables, and grain products against heart disease are due to other
components, or a combination of components, in these diets, including,
but not necessarily limited to, some types of soluble fiber, other
fiber components, other characteristics of the complex carbohydrate
content of these foods, other nutrients in these foods, or displacement
of saturated fat and cholesterol from the diet.
(2) Significance of the relationship between diets low in saturated
fat and cholesterol and high in fruits, vegetables, and grain products
that contain fiber, particularly soluble fiber, and risk of coronary
heart disease. (i) Coronary heart disease is a major public health
concern in the United States, primarily because it accounts for more
deaths than any other disease or group of diseases. Early management of
risk factors for coronary heart disease is a major public health goal
that can assist in reducing risk of coronary heart disease. There is a
continuum of mortality risk from coronary heart disease that increases
with increasing levels of blood LDL-cholesterol. Individuals with high
blood LDL-cholesterol are at greatest risk. A larger number of
individuals with more moderately elevated cholesterol also have
increased risk of coronary events; such individuals comprise a
substantial proportion of the adult U.S. population. The scientific
evidence indicates that reducing saturated fat and cholesterol intakes
lowers blood LDL-cholesterol and risk of heart disease in most
individuals, including persons with blood cholesterol levels in the
normal range. Additionally, consuming diets high in fruits, vegetables,
and grain products, foods that contain soluble fiber, may be a useful
adjunct to a low saturated fat and low cholesterol diet.
(ii) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity, and lack of regular physical exercise.
(iii) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. Intakes of fiber-containing fruits,
vegetables, and grain products are about half of recommended intake
levels. One of the major public health recommendations relative to
coronary heart disease risk is to consume less than 10 percent of
calories from saturated fat, and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
300 mg or less. Recommended total dietary fiber intakes are about 25 g
daily, of which about 25 percent (about 6 g) should be soluble fiber.
(iv) Current dietary guidance recommendations encourage decreased
consumption of dietary fat, especially saturated fat and cholesterol,
and increased consumption of fiber-rich foods to help lower blood LDL-
cholesterol levels. Results of numerous studies have shown that fiber-
containing fruits, vegetables, and grain products can help lower blood
LDL-cholesterol.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol and high in
fruits, vegetables, and grain products that contain fiber, particularly
soluble fiber, with reduced risk of heart disease may be made on the
label or labeling of a meat or meat food product described in paragraph
(f)(3)(ii) (B) of this section; Provided, That:
(1) The claim states that diets low in saturated fat and
cholesterol and high in fruits, vegetables, and grain products that
contain fiber ``may'' or ``might'' reduce the risk of heart disease;
(2) In specifying the disease, the claim uses the terms ``heart
disease'' or ``coronary heart disease'';
(3) The claim is limited to those fruits, vegetables, and grains
that contain fiber;
(4) In specifying the dietary fiber, the claim uses the terms
``fiber,'' ``dietary fiber,'' ``some types of dietary fiber,'' ``some
dietary fibers,'' or ``some fibers,'' and the term ``soluble fiber''
may be used in addition to these terms;
(5) In specifying the fat component, the claim uses the terms
``saturated fat'' and ``cholesterol'';
(6) The claim indicates that development of heart disease depends
on many factors; and
(7) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets low in saturated fat and cholesterol
and high in fruits, vegetables, and grain products that contain fiber.
(B) Nature of the food. (1) The product shall contain a fruit,
vegetable, or grain product;
(2) The product shall meet the requirements for ``low fat,'' ``low
saturated fat,'' and ``low cholesterol'' as defined in Sec. 317.362,
except that the product may meet all the requirements for ``extra
lean'' in Sec. 317.362; and
(3) The product shall contain at least 0.6 g of soluble fiber per
reference amount customarily consumed prior to any nutrient addition,
except the basis for meal-type products as defined in 317.313(l) shall
be per labeled serving size.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for heart disease about which there is
general scientific agreement: A family history of coronary heart
disease, elevated blood total- and LDL-cholesterol, excess body weight,
high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(ii) The claim may indicate that the relationship of diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain fiber to heart disease is through the
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol.''
(iii) The claim may include information from paragraphs (f) (1) and
(2) of this section, which summarizes the relationship between diets
low in saturated fat and cholesterol and high in fruits, vegetables,
and grain products that contain fiber and coronary heart disease and
the significance of the relationship.
(iv) In specifying the nutrients, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol.''
(v) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(vi) The claim may include information on the number of people in
the United States who have coronary heart disease. The source of this
information shall be identified, and it shall be current information
from the U.S. Department of Health and Human Services.
(vii) The claim may state that individuals with elevated blood
total- and LDL-cholesterol should consult their physicians for medical
advice and treatment. If the claim defines high or normal blood total-
and LDL-cholesterol levels, then it shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain fiber and risk of heart disease:
(i) Diets low in saturated fat and cholesterol and rich in fruits,
vegetables, and grain products that contain some types of dietary
fiber, particularly soluble fiber, may reduce the risk of heart
disease, a disease associated with many factors.
(ii) Development of heart disease depends on many factors. Eating a
diet low in saturated fat and cholesterol and high in fruits,
vegetables, and grain products that contain fiber may lower blood
cholesterol levels and reduce your risk of heart disease.
(g) Fruits and vegetables and cancer--(1) Relationship between
substances in diets low in fat and high in fruits and vegetables and
cancer risk. (i) Cancer is a constellation of more than 100 different
diseases, each characterized by the uncontrolled growth and spread of
abnormal cells. Cancer has many causes and stages in its development.
Both genetic and environmental risk factors may affect the risk of
cancer. Risk factors include a family history of a specific type of
cancer, cigarette smoking, alcohol consumption, overweight and obesity,
ultraviolet or ionizing radiation, exposure to cancer-causing
chemicals, and dietary factors.
(ii) Although the specific roles of the numerous potentially
protective substances in plant foods are not yet understood, many
studies have shown that diets high in plant foods are associated with
reduced risk of some types of cancers. These studies correlate diets
rich in fruits and vegetables and nutrients from these diets, such as
vitamin C, vitamin A, and dietary fiber, with reduced cancer risk.
Persons consuming these diets frequently have high intakes of these
nutrients. Currently there is not scientific agreement as to whether
the observed protective effects of fruits and vegetables against cancer
are due to a combination of the nutrient components of diets rich in
fruits and vegetables, including but not necessarily limited to dietary
fiber, vitamin A as beta-carotene, and vitamin C, to displacement of
fat from such diets, or to intakes of other substances in these foods
which are not nutrients but may be protective against cancer risk.
(2) Significance of the relationship between consumption of diets
low in fat and high in fruits and vegetables and risk of cancer. (i)
Cancer is ranked as a leading cause of death in the United States. The
overall economic costs of cancer, including direct health care costs
and losses due to morbidity and mortality, are very high.
(ii) U.S. diets tend to be high in fat and low in fruits and
vegetables. Studies in various parts of the world indicate that
populations who habitually consume a diet high in plant foods have
lower risk of some cancers. These diets are generally low in fat and
rich in many nutrients, including but not limited to, dietary fiber,
vitamin A as beta-carotene, and vitamin C. Current dietary guidelines
from the Federal Government and nationally recognized health
professional organizations recommend decreased consumption of fats
(less than 30 percent of calories), maintenance of desirable body
weight, and increased consumption of fruits and vegetables (five or
more servings daily), particularly those fruits and vegetables which
contain dietary fiber, vitamin A, and vitamin C.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific Requirements. (A) Nature of the claim. A health claim
associating diets low in fat and high in fruits and vegetables with
reduced risk of cancer may be made on the label or labeling of a meat
or meat food product described in paragraph (g)(3)(ii)(B) of this
section; Provided, That:
(1) The claim states that diets low in fat and high in fruits and
vegetables ``may'' or ``might'' reduce the risk of some cancers;
(2) In specifying the disease, the claim uses the terms ``some
types of cancer'' or ``some cancers'';
(3) The claim characterizes fruits and vegetables as foods that are
low in fat and may contain vitamin A, vitamin C, and dietary fiber;
(4) The claim characterizes the product bearing the claim as
containing one or more of the following, for which the product is a
``good source'' under Sec. 317.354: Vitamin A (as beta-carotene),
vitamin C, or dietary fiber;
(5) The claim indicates that the development of cancer depends on
many factors;
(6) The claim does not attribute any degree of cancer risk
reduction to diets low in fat and high in fruits and vegetables;
(7) In specifying the fat component of the labeled product, the
claim uses the terms ``total fat'' or ``fat'';
(8) The claim does not specify types of fats or fatty acids that
may be related to cancer risk;
(9) In specifying the dietary fiber component of the labeled
product, the claim uses the terms ``fiber,'' ``dietary fiber,'' or
``total dietary fiber''; and
(7) The claim does not specify types of dietary fiber that may be
related to risk of cancer.
(B) Nature of the food. (1) The product shall contain a fruit or
vegetable;
(2) The product shall meet the requirements for ``low fat'' as
defined in Sec. 317.362, except that the product may meet the total fat
and cholesterol criteria for ``extra lean'' in Sec. 317.362; and
(3) The product shall meet the requirements for a ``good source''
of at least one of the following: Vitamin A (as beta-carotene), vitamin
C, or dietary fiber as defined in Sec. 317.354 prior to any nutrient
addition, except the basis for meal-type products as defined in
Sec. 317.313(l) shall be per labeled serving size.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(ii) The claim may include information from paragraphs (g) (1) and
(2) of this section, which summarizes the relationship between diets
low in fat and high in fruits and vegetables and some types of cancer
and the significance of the relationship.
(iii) The claim may use the word ``beta-carotene'' in parentheses
after the term vitamin A when the vitamin A in the product bearing the
claim is beta-carotene.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have cancer. The source of this information must
be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between
substances in diets low in fat and high in fruits and vegetables and
cancer:
(i) Low fat diets rich in fruits and vegetables (foods that are low
in fat and may contain dietary fiber, vitamin A, and vitamin C) may
reduce the risk of some types of cancer, a disease associated with many
factors. Broccoli is high in vitamins A and C, and it is a good source
of dietary fiber.
(ii) Development of cancer depends on many factors. Eating a diet
low in fat and high in fruits and vegetables, foods that are low in fat
and may contain vitamin A, vitamin C and dietary fiber, may reduce your
risk of some cancers. Oranges, a food low in fat, are a good source of
fiber and vitamin C.
(h) Folate and neural tube defects--(1) Relationship between folate
and neural tube defects. (i) Neural tube defects are serious birth
defects of the brain or spinal cord that can result in infant mortality
or serious disability. The birth defects anencephaly and spina bifida
are the most common forms of neural tube defects and account for about
90 percent of these defects. These defects result from failure of
closure of the covering of the brain or spinal cord during early
embryonic development. Because the neural tube forms and closes during
early pregnancy, the defect may occur before a woman realizes that she
is pregnant.
(ii) The available data show that diets adequate in folate may
reduce the risk of neural tube defects. The strongest evidence for this
relationship comes from an intervention study by the Medical Research
Council of the United Kingdom that showed that women at risk of
recurrence of a neural tube defect pregnancy who consumed a supplement
containing 4 mg (4,000 micrograms (mcg)) folic acid daily had a reduced
risk of having a child with a neural tube defect. (Products that
contain this level of folic acid are drugs.) In addition, based on its
review of a Hungarian intervention trial that used a multivitamin and
multimineral preparation containing 800 mcg (0.8 mg) of folic acid, and
its review of the observational studies that reported use of
multivitamins containing 0 to 1,000 mcg of folic acid, FDA concluded
that most of these studies had results consistent with the conclusion
that folate, at levels attainable in usual diets, may reduce the risk
of neural tube defects.
(2) Significance of folate. (i) Neural tube defects occur in
approximately 0.6 of 1,000 live births in the United States (i.e.,
about 2,500 cases among 4 million live births annually). Neural tube
defects are believed to be caused by many factors. The single greatest
risk factor for a neural tube defect-affected pregnancy is a personal
or family history of a pregnancy affected with a such a defect.
However, about 90 percent of infants with a neural tube defect are born
to women who do not have a family history of these defects. The
available evidence shows that diets adequate in folate may reduce the
risk of neural tube defects but not of other birth defects.
(ii) Prevalence rates for neural tube defects have been reported to
vary with a wide range of factors, including genetics, geography,
socioeconomic status, maternal birth cohort, month of conception, race,
nutrition, and maternal age and reproductive history. Women with a
close relative (i.e., sibling, niece, nephew) with a neural tube
defect, those with insulin-dependent diabetes mellitus, and women with
seizure disorders who are being treated with valproic acid or
carbamazepine are at significantly increased risk compared with women
without these characteristics. Rates for neural tube defects vary
within the United States, with lower rates observed on the west coast
than on the east coast.
(iii) Based on a synthesis of the results of several observational
studies, the Public Health Service has estimated that about 50 percent
of neural tube defect-affected pregnancies in the United States (e.g.,
about 1,250) may be averted annually if all women consume adequate
amounts of folate daily (i.e., 0.4 mg) throughout their childbearing
years.
(3) Requirements. (i) All requirements set forth in Sec. 317.314
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating folate with reduced risk of neural tube defects may be made
on the label or labeling of a meat or meat food product described in
paragraph (h)(3)(ii)(B) of this section; Provided, That:
(1) In specifying the nutrient, the claim shall use the terms
``folate,'' ``folic acid,'' ``folacin,'' ``folate, a B vitamin,''
``folic acid, a B vitamin,'' or ``folacin, a B vitamin'';
(2) In specifying the health-related condition, the claim shall
identify the birth defects as ``neural tube defects'', ``birth defects,
spina bifida, or anencephaly,'' ``birth defects of the brain or spinal
cord anencephaly or spina bifida,'' or ``spina bifida or anencephaly,
birth defects of the brain or spinal cord'';
(3) The claim shall state that neural tube defects have many causes
and shall not imply that folate intake is the only recognized risk
factor for neural tube defects;
(4) In specifying the prevalence of neural tube defects among women
in the general population, the claim shall state that such birth
defects ``which, while not widespread, are extremely significant'' or
``* * * birth defects * * * that, while not widespread, are extremely
significant.'';
(5) The claim shall not attribute any specific degree of reduction
in risk of neural tube defects, including mention of the Public Health
Service estimate that 50 percent of neural tube defects may be averted
annually, to maintaining an adequate folate intake throughout the
childbearing years. The claim shall state that some women may reduce
their risk of a neural tube defect pregnancy by maintaining adequate
intakes of folic acid during their childbearing years;
(6) Claims on products that contain more than 25 percent of the
Reference Daily Intake for folate (100 mcg per serving) shall state
that 1 mg folate per day is the safe upper limit of intake (e.g.,
``Folate consumption should be limited to 1,000 mcg per day from all
sources'');
(7) The claim shall not state that a specified amount of folate
(e.g., 400 mcg in a dietary supplement) is more effective in reducing
the risk of neural tube defects than a lower amount (e.g., 100 mcg in a
breakfast cereal or from diets rich in fruit and vegetables);
(8) The claim shall identify diets adequate in folate by using
phrases such as ``* * * diets that include 2 to 4 servings per day of
fruits (including citrus fruits and juices), 3 to 5 servings of
vegetables (including dark green leafy vegetables and legumes), 6 to 11
servings of enriched grain products (such as breads, rice, and pasta)
and fortified cereals. Such diets provide many essential minerals and
vitamins, including folate. Women who do not eat well-balanced diets or
who may be concerned about their diets may choose to obtain folate from
dietary supplements.''; or ``Adequate amounts of folate, a B vitamin,
can be obtained from diets rich in fruits, including citrus fruits and
juices, vegetables, including dark green leafy vegetables and legumes,
enriched grain products, including breads, rice, and pasta, fortified
cereals, or a dietary supplement.''; or ``Adequate amounts of folate, a
B vitamin, can be obtained from diets rich in fruits, dark green leafy
vegetables and legumes, enriched grain products, fortified cereals, or
from dietary supplements.''; and
(9) The nutrition label shall include information about the amount
of folate in the labeled product. This information shall be declared
after the declaration for iron if only the levels of vitamin A, vitamin
C, calcium, and iron are provided, or in accordance with Sec. 317.309
if other optional vitamins or minerals are declared.
(B) Nature of the food. (1) The product shall meet or exceed the
requirements for a ``good source'' level of folate as defined in
Sec. 317.354, except the basis for meal-type products as defined in
Sec. 317.313(l) shall be per labeled serving size;
(2) The product may meet the cholesterol criterion for ``extra
lean'' as defined in Sec. 317.362; and
(3) The product shall not contain more than 100 percent of the
Reference Daily Intake as defined in Sec. 317.309 for vitamin A as
retinol or preformed vitamin A or vitamin D.
(4) Optional information. (i) The claim may specifically identify
risk factors for neural tube defects.
(ii) The claim may include information from paragraphs (h) (1) and
(2) of this section, which summarizes the relationship between folate
and neural tube defects and the significance of the relationship except
for information specifically prohibited from the claim.
(iii) The claim may state that women with a history of a neural
tube defect pregnancy should consult their physicians or health care
providers before becoming pregnant.
(iv) The claim may identify the Daily Value level of 400 mcg of
folate per day as the target intake goal.
(5) Model health claims. The following are examples of model health
claims that may be used in food labeling to describe the relationship
between folate and neural tube defects:
(i) Women who consume adequate amounts of folate, a B vitamin,
daily throughout their childbearing years may reduce their risk of
having a child with a neural tube birth defect. Such birth defects,
while not widespread, are very serious. They can have many causes.
Adequate amounts of folate can be obtained from diets rich in fruits,
dark green leafy vegetables and legumes, enriched grain products,
fortified cereals, or a supplement. Folate consumption should be
limited to 1,000 mcg per day from all sources.
(ii) Women who consume adequate amounts of folate daily throughout
their childbearing years may reduce their risk of having a child with a
birth defect of the brain and spinal cord. Such birth defects, while
not widespread, are very serious. They can have many causes. Adequate
amounts of folate, a B vitamin, can be obtained from diets rich in
fruits, dark green leafy vegetables and legumes, enriched grain
products, fortified cereals, or a supplement. Women who have had a
child with a spinal cord birth defect should consult a physician before
becoming pregnant. Folate consumption should be limited to 1,000 mcg
per day from all sources.
(iii) Women who take steps to ensure that their folate intake is
adequate throughout their childbearing years may reduce their risk of
having a child with a neural tube defect. Such birth defects, while not
widespread, are very serious. They can have many causes. Adequate
amounts of folate, a B vitamin, can be obtained from diets rich in
citrus fruits and juices, dark green leafy vegetables and legumes,
enriched grain products such as breads, rice, and pasta, fortified
cereals, or a supplement. Folate consumption should be limited to 1,000
mcg per day from all sources.
(iv) Women who take steps to ensure that their folate intake is at
least 400 mcg daily throughout their childbearing years may reduce
their risk of having a child with spina bifida or anencephaly, birth
defects of the brain or spinal cord that, while not widespread, are
very serious. These birth defects can have many causes. Adequate
amounts of folate, a B vitamin, can be obtained from diets rich in
fruits, including citrus fruits and juices, vegetables, including dark
green leafy vegetables and legumes, enriched grain products, including
breads, rice, and pasta, fortified cereals, or from a supplement. Women
who have had a pregnancy affected with a neural tube defect should
consult a physician before becoming pregnant. Folate consumption should
be limited to 1,000 mcg per day from all sources.
(v) Some women who consume the Daily Value of folate (400 mcg)
throughout their childbearing years may reduce their risk of having a
child affected with spina bifida or anencephaly, birth defects of the
brain or spinal cord that, while not widespread, are very serious.
These birth defects can have many causes. Women of childbearing age
should choose well-balanced diets that include 2 to 4 servings per day
of fruits (including citrus fruits and juices), 3 to 5 servings of
vegetables (including dark green leafy vegetables and legumes), 6 to 11
servings of enriched grain products (such as breads, rice, and pasta)
or fortified cereals throughout their childbearing years. Such diets
provide many essential minerals and vitamins, including folate. Women
who may be concerned about their diets may choose to obtain folate from
a supplement. Folate consumption should be limited to 1,000 mcg per day
from all sources.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
5. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 2.17, 2.55.
6. A new Sec. 381.414 would be added to read as follows:
Sec. 381.414 Health claims; general requirements.
(a) Definitions. For the purposes of this section, the following
definitions apply:
(1) Health claim means any claim made on the label or in labeling
of a poultry product that expressly or by implication, including third
party references, written statements (e.g., a brand name including a
term such as ``heart''), symbols (e.g., a heart symbol), or vignettes,
characterizes the relationship of any substance to a disease or health-
related condition. Implied health claims include those statements,
symbols, vignettes, or other forms of communication that suggest,
within the context in which they are presented, that a relationship
exists between the presence or level of a substance in the poultry
product and a disease or health-related condition.
(2) Substance means a specific food or component of a food.
(3) Nutritive value means a value in sustaining human existence by
such processes as promoting growth, replacing loss of essential
nutrients, or providing energy.
(4) Disqualifying nutrient levels mean the levels of total fat,
saturated fat, cholesterol, or sodium in a poultry product above which
the product will be disqualified from making a health claim. These
levels are 13 grams (g) of fat, 4 g of saturated fat, 60 milligrams
(mg) of cholesterol, or 480 mg of sodium per reference amount
customarily consumed, per labeled serving size, and, only for foods
with reference amounts customarily consumed of 30 g or less or 2
tablespoons or less, per 50 g. For dehydrated products that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 381.409(g)(1),
of all nutrients, the per 50-g criterion refers to the prepared form.
Any one of the levels, on a per reference amount customarily consumed,
a per labeled serving size or, when applicable, a 50-g basis, will
disqualify a poultry product from making a health claim unless an
exception is provided for in Sec. 381.471, except that:
(i) The levels for a meal product as defined in Sec. 381.413(l) and
that weighs at least 6 ounces (oz), but less than 10 oz, per serving
(container) are 20 g of fat, 6 g of saturated fat, 95 mg of
cholesterol, or 720 mg of sodium per labeled serving size.
(ii) The levels for a meal product as defined in Sec. 381.413(l)
and that weighs 10 oz or more per serving (container) are 26 g of fat,
8 g of saturated fat, 120 mg of cholesterol, or 960 mg of sodium per
labeled serving size.
(5) Disease or health-related condition means damage to an organ,
part, structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health leading
to such dysfunctioning (e.g., hypertension); except that diseases
resulting from essential nutrient deficiencies (e.g., scurvy, pellagra)
are not included in this definition and, thereby, claims pertaining to
such diseases are not subject to Sec. 381.414 or Sec. 381.470.
(b) Eligibility. For a substance to be eligible for a health claim:
(1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an
identified U.S. population subgroup (e.g., the elderly) is at risk, or,
alternatively, the labeling application submitted by the proponent of
the claim otherwise explains the prevalence of the disease or health-
related condition in the U.S. population and the relevance of the claim
in context of the total daily diet and satisfies the other requirements
of this section.
(2) If the substance is to be consumed as a component of a poultry
product at decreased dietary levels, the substance must be a nutrient
that is required to be included in the label or labeling as set forth
in Sec. 381.409(b); or
(3) If the substance is to be consumed at other than decreased
dietary levels:
(i) The substance must contribute taste, aroma, or nutritive value,
or any technical effect listed in 21 CFR 170.3(o), to the food and must
retain that attribute when consumed at levels that are necessary to
justify a claim; and
(ii) The substance must be a food or a food ingredient or a
component of a food ingredient whose use at the levels necessary to
justify a claim has been demonstrated by the proponent of the claim to
be safe and lawful under the applicable food safety provisions of the
Federal Food, Drug, and Cosmetic Act and the Poultry Products
Inspection Act.
(c) Validity requirement. The Administrator will approve the use of
a health claim only when he or she determines that the claim is not
false or misleading, because it is supported by:
(1) The totality of publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles); and
(2) Significant scientific agreement among experts qualified by
scientific training and experience to evaluate such claims.
(d) General health claim labeling requirements. (1) When the
Administrator determines that a health claim meets the requirements of
paragraph (c) of this section, the Agency will notify the applicant, in
writing, and will institute rulemaking to amend the regulations to
authorize the use of that claim. If the claim pertains to a substance
not provided for in Part 381 of the regulations, the Administrator will
institute rulemaking to amend the regulations to include declaration of
the substance.
(2) When a regulation has been established in this Part providing
for a health claim, firms may make claims based on the regulation in
this Part; Provided, That:
(i) All label or labeling statements about the substance-disease
relationship that is the subject of the claim are based on, and
consistent with, the conclusions set forth in Sec. 381.471;
(ii) The claim is limited to describing the value that ingestion
(or reduced ingestion) of the substance, as part of a total dietary
pattern, may have on a particular disease or health-related condition;
(iii) The claim is otherwise complete, truthful, and not
misleading. Where factors other than dietary intake of the substance
affect the relationship between the substance and the disease or
health-related condition, such factors may be required to be addressed
in the claim by a specific provision in Sec. 381.471;
(iv) All information required to be included in the claim appears
in one place without other intervening material, except that the
principal display panel of the label or labeling may bear the reference
statement, ``See ________ for information about the relationship
between ________ and ________,'' with the blanks filled in with the
location of the labeling containing the health claim, the name of the
substance, and the disease or health-related condition (e.g., ``See
attached pamphlet for information about calcium and osteoporosis''),
with the entire claim appearing elsewhere on the other labeling;
Provided, That, where any graphic material (e.g., a heart symbol)
constituting an explicit or implied health claim appears on the label
or labeling, the reference statement or the complete claim shall appear
in immediate proximity to such graphic material;
(v) The claim enables the public to comprehend the information
provided and to understand the relative significance of such
information in the context of the total daily diet; and
(vi) If the claim is about the effects of consuming the substance
at decreased dietary levels, the level of the substance in the poultry
product is sufficiently low to justify the claim. To meet this
requirement, if a definition for use of the term ``low'' has been
established for that substance under this Part, the substance must be
present at a level that meets the requirements for use of that term,
unless a specific alternative level has been established for the
substance in Sec. 381.471. If no definition for ``low'' has been
established, the level of the substance must meet the level established
in the regulation authorizing the claim; or
(vii) If the claim is about the effects of consuming the substance
at other than decreased dietary levels, the level of the substance is
sufficiently high to justify the claim. To meet this requirement, if a
definition for use of the term ``high'' for that substance has been
established under this Part, the substance must be present at a level
that meets the requirements for use of that term, unless a specific
alternative level has been established for the substance in
Sec. 381.471. If no definition for ``high'' has been established (e.g.,
where the claim pertains to a food either as a whole food or as an
ingredient in another food), the claim must specify the daily dietary
intake necessary to achieve the claimed effect, as established in the
regulation authorizing the claim; Provided, That, where the poultry
product that bears the claim meets the requirements of paragraphs
(d)(2)(vi) or (d)(2)(vii) of this section based on its reference amount
customarily consumed, and the labeled serving size differs from that
amount, the claim shall be followed by a statement explaining that the
claim is based on the reference amount rather than the labeled serving
size (e.g., ``Diets low in sodium may reduce the risk of high blood
pressure, a disease associated with many factors. A serving of ________
ounces of this product conforms to such a diet.'')
(3) Nutrition labeling shall be provided in the label or labeling
of any poultry product for which a health claim is made in accordance
with Sec. 381.409.
(e) Prohibited health claims. No express or implied health claim
may be made on the label or in labeling for a poultry product unless:
(1) The claim is specifically provided for in Sec. 381.471; and
(2) The claim conforms to all general provisions of this section as
well as to all specific provisions in the appropriate section of
Sec. 381.471;
(3) None of the disqualifying levels identified in paragraph (a)(4)
of this section is exceeded in the poultry product, unless specific
alternative levels have been established for the substance in
Sec. 381.471; or, unless the Administrator has permitted a claim
despite the fact that a disqualifying level of a nutrient is present in
the product based on a finding that such a claim will assist consumers
in maintaining healthy dietary practices, and, in accordance with the
regulation in this Part that makes such a finding, the labeling bears a
referral statement disclosing the nutrient(s) that exceeds the
disqualifying level as follows: ``See [appropriate panel or Nutrition
Facts] for information about [nutrient requiring disclosure] and other
nutrients.'' The statement shall be in easily legible boldface print or
type, in distinct contrast to other printed or graphic matter, that is
no less than that required for net quantity of contents, except where
the size of the claim is less than two times the required size of the
net quantity of contents statement, in which case the referral
statement shall be no less than one-half the size of the claim but no
smaller than one-sixteenth of an inch.
(4) Except as provided in paragraph (e)(3) of this section, no
substance is present at an inappropriate level as determined in the
specific provision authorizing the claim in Sec. 381.471.
(5) The label does not represent or purport that the food is for
infants and toddlers less than 2 years of age, except if the claim is
specifically provided for in Sec. 381.471.
(6) Except where provided for in other regulations in this Part,
the poultry product contains 10 percent or more of the Reference Daily
Intake or the Daily Reference Value as defined in Sec. 381.409 for
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition, except the
basis for meal-type products as defined in Sec. 381.413(l) shall be per
labeled serving size prior to any nutrient addition.
(f) Applicability. The requirements of this section apply to
poultry products intended for human consumption that are offered for
sale.
7. A new Sec. 381.470 would be added to read as follows:
381.470 Labeling applications for health claims.
(a) Any interested person may submit a labeling application to FSIS
for approval of the use of a particular health claim in the labeling of
a poultry product. The labeling application shall be submitted in
quadruplicate, except that the supporting documentation may be
submitted on a computer readable disk. Contents of the disk should be
in a standard format, such as ASCII format. (Applicants interested in
submitting a disk should contact the Director, Product Assessment
Division, Regulatory Programs, FSIS, Washington, DC 20250 for details).
If any part of the material submitted is in a foreign language, it
shall be accompanied by an accurate and complete English translation.
The labeling application shall state the applicant's post office
address.
(b) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of FSIS. Such information may
include any findings, along with the basis of the findings, of an
outside panel with expertise in the subject area. However, any
reference to unpublished information furnished by a person other than
the applicant will not be considered unless use of such information is
authorized (with the understanding that such information may in whole
or in part be subject to release to the public) in a written statement
signed by the person who submitted it. Any reference to published
information shall be accompanied by reprints or easily readable copies
of such references.
(c) If nonclinical laboratory studies accompany a labeling
application, the applicant shall include, with respect to each
nonclinical study included with the application, either a statement
that the study has been conducted in compliance with the good
laboratory practice regulations as set forth in part 58 of chapter I,
title 21, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the
noncompliance.
(d) If clinical or other human investigations accompany a labeling
application, the applicant shall include, with respect to each clinical
investigation included with the application, either a statement that
the investigation was conducted in compliance with the requirements for
institutional review set forth in part 56 of chapter I, title 21, or
was not subject to such requirements in accordance with 21 CFR 56.104
or 56.105, and that it was conducted in compliance with the
requirements for informed consent set forth in part 50 of chapter I,
title 21.
(e) All data and information in a health claim labeling application
are available for public disclosure after the notice of filing of
labeling application is issued to the applicant (Sec. 381.470(j)(2)),
except that clinical investigation reports, adverse reaction reports,
product experience reports, consumer complaints, and other similar data
and information shall only be available after deletion of:
(1) Names and any information that would identify the person using
the poultry product.
(2) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(f) Labeling applications for a health claim shall be submitted to
the Director, Food Labeling Division, Regulatory Programs, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250 and shall include the following data and be submitted in the
following form:
----------------------------------------------------------------------
(Date)
Name of applicant------------------------------------------------------
Post office address----------------------------------------------------
Subject of the labeling application------------------------------------
The undersigned, __________ submits this labeling application
pursuant to 9 CFR 381.470 with respect to (statement of the
substance and its health claim).
Attached hereto, and constituting a part of this labeling
application, are the following:
A. Preliminary requirements. A complete explanation of how the
substance conforms to the requirements of Sec. 381.414(b). For
labeling applications where the subject substance is a food
ingredient or a component of a food ingredient, the applicant should
compile a comprehensive list of the specific ingredients that will
be added to the poultry product to supply the substance in the
poultry product bearing the health claim. For each such ingredient
listed, the applicant should state how the ingredient complies with
the requirements of Sec. 381.414(b)(3)(ii), e.g., that its use is
generally recognized as safe (GRAS), listed as a food additive, or
authorized by a prior sanction issued by FSIS, and what the basis is
for the GRAS claim, the food additive status, or prior sanctioned
status.
B. Summary of scientific data. The summary of scientific data
provides the basis upon which authorizing a health claim can be
justified as providing the health benefit. The summary must
establish that, based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner which is consistent with generally recognized
scientific procedures and principles), there is significant
scientific agreement among experts qualified by scientific training
and experience to evaluate such claims, that the claim is supported
by such evidence.
The summary shall state what public health benefit will derive
from use of the claim as proposed. If the claim is intended for a
specific group within the population, the summary shall specifically
address nutritional needs of such group and shall include scientific
data showing how the claim is likely to assist in meeting such
needs.
The summary shall concentrate on the findings of appropriate
review articles, National Institutes of Health consensus development
conferences, and other appropriate resource materials. Issues
addressed in the summary shall include answers to such questions as:
1. Is there an optimum level of the particular substance to be
consumed beyond which no benefit would be expected?
2. Is there any level at which an adverse effect from the
substance or from poultry products containing the substance occurs
for any segment of the population?
3. Are there certain populations that must receive special
consideration?
4. What other nutritional or health factors (both positive and
negative) are important to consider when consuming the substance?
In addition, the summary of scientific data shall include a
detailed analysis of the potential effect of the use of the proposed
claim on food consumption, specifically any change due to
significant alterations in eating habits and corresponding changes
in nutrient intake resulting from such changes in food consumption.
The latter item shall specifically address the effect on the intake
of nutrients that have beneficial and negative consequences in the
total diet.
If the claim is intended for a significant subpopulation within
the general U.S. population, the analysis shall specifically address
the dietary practices of such group, and shall include data
sufficient to demonstrate that the dietary analysis is
representative of such group (e.g., adolescents or the elderly).
If appropriate, the labeling application shall explain the
prevalence of the disease or health-related condition in the U.S.
population or subpopulation and the relevance of the claim in the
context of the total daily diet.
Also, the summary shall demonstrate that the substance that is
the subject of the proposed claim conforms to the definition of the
term ``substance'' in Sec. 381.414(a)(2).
C. Analytical data. Analytical data that show the amount of the
substance that is present in representative poultry products that
would be candidates to bear the claim should be obtained from
representative samples using methods in accordance with
Sec. 381.409(h). If no USDA or AOAC methods are available, the
applicant shall submit the assay method used, and data establishing
the validity of the method for assaying the substance in the poultry
product. The validation data shall include a statistical analysis of
the analytical and product variability.
D. Model health claim. One or more model health claims that
represent label statements that may be used on a label or in
labeling for a poultry product to characterize the relationship
between the substance to a disease or health-related condition that
is justified by the summary of scientific data provided in section B
of the labeling application. The model health claim shall include:
1. A brief capsulized statement of the relevant conclusions of
the summary, and
2. A statement of how this substance helps the consumer to
attain a total dietary pattern or goal associated with the health
benefit that is provided.
E. Supporting Documentation. The labeling application shall
include the following attachments:
1. Copies of any computer literature searches done by the
applicant (e.g., Medline).
2. Copies of articles cited in the literature searches and other
information as follows:
a. All information relied upon for the support of the health
claim, including copies of publications or other information cited
in review articles and used to perform meta-analyses.
b. All information concerning adverse consequences to any
segment of the population (e.g., sensitivity to the substance).
c. All information pertaining to the U.S. population.
F. The applicant is required to submit either a claim for
categorical exclusion under 21 CFR 25.24 or an environmental
assessment under 21 CFR 25.31.
Yours very truly,
Applicant--------------------------------------------------------------
By---------------------------------------------------------------------
(Indicate authority)
(g) The data specified under the several lettered headings should
be submitted on separate pages or sets of pages, suitably identified.
If such data have already been submitted with an earlier application
from the applicant or any other final labeling application, the present
labeling application may incorporate it by specific reference to the
earlier application.
(h) The labeling application shall include a statement signed by
the person responsible for the labeling application that, to the best
of his or her knowledge, it is a representative and balanced submission
that includes unfavorable information, as well as favorable
information, known to him or her to be pertinent to the evaluation of
the proposed health claim.
(i) The labeling application shall be signed by the applicant or by
his or her attorney or agent, or, if a corporation, by its responsible
officer or agent.
(j) FSIS action on the labeling application. (1) Upon receipt of
the labeling application and supporting documentation, the applicant
shall be notified, in writing, of the date on which the labeling
application was received. Such notice shall inform the applicant that
the labeling application is undergoing FSIS review and that the
applicant shall subsequently be notified of FSIS's decision to consider
for further review or deny the labeling application.
(2) Upon review of the labeling application and supporting
documentation, FSIS shall notify the applicant, in writing, that the
labeling application is either being considered for further review or
that it has been summarily denied by the Administrator. FSIS shall deny
a labeling application without reviewing the information contained in
subsection B of this part, Summary of Scientific Data, if the
information in subsection A of this part, Preliminary Requirements, is
inadequate to explain how the substance conforms to the requirements of
Sec. 381.414(b).
(3) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why FSIS has determined that the proposed health
claim is false or misleading. The notification letter shall inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed health claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(4) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register
a proposed rule to amend the regulations to authorize the use of the
health claim. The proposal shall also summarize the labeling
application, including where the supporting documentation can be
reviewed. The Administrator's proposed rule shall seek comment from
consumers, the industry, consumer and industry groups, medical and
scientific professionals, and other interested persons on the labeling
application and the use of the proposed health claim. After public
comment has been received and reviewed by FSIS, the Administrator shall
make a determination on whether the proposed health claim shall be
approved for use on the labeling of poultry products.
(i) If the claim is denied by the Administrator following the
review of the public comments, FSIS shall notify the applicant, in
writing, of the basis for the denial, including the reason why the
claim on the labeling was determined by FSIS to be false or misleading.
The notification letter shall also inform the applicant that the
applicant may submit a written statement by way of answer to the
notification, and that the applicant shall have the right to request a
hearing with respect to the merits or validity of the Administrator's
decision to deny the use of the proposed health claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall thereafter be conducted in
accordance with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, FSIS shall notify the applicant, in
writing, and shall also publish in the Federal Register a final rule
amending the regulations to authorize the use of the claim.
8. A new section 381.471 would be added to read as follows:
Sec. 381.471 Health claims.
(a) Calcium and osteoporosis--(1) Relationship between calcium and
osteoporosis An inadequate calcium intake contributes to low peak bone
mass and has been identified as one of the many risk factors in the
development of osteoporosis. Peak bone mass is the total quantity of
bone present at maturity, and experts believe that it has the greatest
bearing on whether or not a person will be at risk of developing
osteoporosis and related bone fractures later in life. Another factor
that influences total bone mass susceptibility to osteoporosis is the
rate of bone loss after skeletal maturity. An adequate intake of
calcium is thought to exert a positive effect during adolescence and
early adulthood in optimizing the amount of bone that is laid down.
However, the upper limit of peak bone mass is genetically determined.
The mechanism through which an adequate calcium intake and optimal peak
bone mass reduce the risk of osteoporosis is thought to be as follows.
All persons lose bone with age. Hence those with higher bone mass at
maturity take longer to reach the critically reduced mass at which
bones can fracture easily. The rate of bone loss after skeletal
maturity also influences the amount of bone present at old age and can
influence an individual's risk of developing osteoporosis. Maintenance
of an adequate intake of calcium later in life is thought to be
important in reducing the rate of bone loss particularly in the elderly
and in women during the first decade following menopause.
(2) Significance of calcium. Calcium intake is not the only
recognized risk factor in the development of osteoporosis, a
multifactorial bone disease. Other factors including a person's sex,
race, hormonal status, family history, body stature, level of exercise,
general diet, and specific life style choices such as smoking and
excess alcohol consumption affect the risk of osteoporosis.
(i) Heredity and being female are two key factors identifying those
individuals at risk for the development of osteoporosis. Hereditary
risk factors include race: Notably, Caucasians and Asians are
characterized by low peak bone mass at maturity. Caucasian women,
particularly those of northern European ancestry, experience the
highest incidence of osteoporosis-related bone fracture. American women
of African heritage are characterized by the highest peak bone mass and
lowest incidence osteoporotic fracture, despite the fact that they have
low calcium intake.
(ii) Maintenance of an adequate intake of calcium throughout life
is particularly important for a subpopulation of individuals at
greatest risk of developing osteoporosis and for whom adequate dietary
calcium intake may have the most important beneficial effects on bone
health. This target subpopulation includes adolescent and young adult
Caucasian and Asian American women.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating calcium with reduced risk of osteoporosis may be made on
the label or labeling of a poultry product described in paragraph
(a)(3)(ii) (B) of this section; Provided, That:
(1) The claim makes clear that adequate calcium intake throughout
life is not the only recognized risk factor in this multifactorial bone
disease by listing specific factors, including a sex, race, and age
that place persons at risk of developing osteoporosis and stating that
an adequate level of exercise and a healthful diet are also needed;
(2) The claim does not state or imply that the risk of osteoporosis
is equally applicable to the general United States population. The
claim shall identify the populations at particular risk for the
development of osteoporosis. These populations include white (or the
term ``Caucasian'') women and Asian women in their bone forming years
(approximately 11 to 35 years of age or the phrase ``during teen years
or early adult years'' may be used). The claim may also include
menopausal (or the term ``middle-aged'') women, persons with a family
history of disease, and elderly (or ``older'') men and women as being
at risk;
(3) The claim states that adequate calcium intake throughout life
is linked to reduced risk of osteoporosis through the mechanism of
optimizing peak bone mass during adolescence and early adulthood. The
phrase ``build and maintain good bone health'' may be used to convey
the concept of optimizing peak bone mass. When reference is made to
persons with a family history of the disease, menopausal women, and
elderly men and women, the claim may also state that adequate calcium
intake is linked to reduced risk of osteoporosis through the mechanism
of slowing the rate of the bone loss;
(4) The claim does not attribute any degree of reduction in risk of
osteoporosis to maintaining an adequate calcium intake throughout life;
and
(5) The claim states that a total dietary intake greater than 200
percent of the Recommended Daily Intake (2,000 mg of calcium) has no
further known benefit to bone health. This requirement does not apply
to poultry products that contain less than 40 percent of the
Recommended Daily Intake of 1,000 mg of calcium per day or 400 mg of
calcium per reference amount customarily consumed as defined in
Sec. 381.412(b), except the basis for meal-type products as defined in
Sec. 381.413(l) shall be per labeled serving size.
(B) Nature of the food. (1) The product shall meet or exceed the
requirements for a ``high'' level of calcium as defined in
Sec. 381.454, except the basis for meal-type products as defined in
Sec. 381.413(l) shall be per labeled serving size;
(2) The product shall not contain more phosphorus than calcium on a
weight-per-weight basis; and
(3) The product may meet the cholesterol criterion for ``extra
lean'' as defined in Sec. 381.462.
(4) Optional information. (i) The claim may include information
from paragraphs (a) (1) and (2) of this section, which summarizes the
relationship between calcium and osteoporosis and the significance of
the relationship.
(ii) The claim may include information on the number of people in
the United States who have osteoporosis. The source of this information
must be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between calcium and
osteoporosis:
(i) Regular exercise and a healthy diet with enough calcium helps
teens and young adult white and Asian women maintain good bone health
and may reduce their high risk of osteoporosis later in life.
(ii) [FOR FOODS EXCEPTIONALLY HIGH IN CALCIUM] Regular exercise and
a healthy diet with enough calcium helps teens and young adult white
and Asian women maintain good bone health and may reduce their high
risk of osteoporosis later in life. Adequate calcium intake is
important, but daily intakes above about 2,000 mg are not likely to
provide any additional benefit.
(b) Dietary lipids and cancer--(1) Relationship between lipids and
cancer. (i) Cancer is a constellation of more than 100 different
diseases, each characterized by the uncontrolled growth and spread of
abnormal cells. Cancer has many causes and stages in its development.
Both genetic and environmental risk factors may affect the risk of
cancer. Risk factors include a family history of a specific type of
cancer, cigarette smoking, alcohol consumption, overweight and obesity,
ultraviolet or ionizing radiation, exposure to cancer-causing
chemicals, and dietary factors.
(ii) Among dietary factors, the strongest positive association has
been found between total fat intake and risk of some types of cancer.
Based on the totality of the publicly available scientific evidence,
there is significant scientific agreement among experts, qualified by
training and experience to evaluate such evidence, that diets high in
total fat are associated with an increased cancer risk. Research to
date, although not conclusive, demonstrates that the total amount of
fats, rather than any specific type of fat, is positively associated
with cancer risk. The mechanism by which total fat affects cancer has
not yet been established.
(iii) A question that has been the subject of considerable research
is whether the effect of fat on cancer is site-specific. Neither human
nor animal studies are consistent in the association of fat intake with
specific cancer sites.
(iv) Another question that has been raised is whether the
association of total fat intake to cancer risk is independently
associated with energy intakes, or whether the association of fat with
cancer risk is the result of the higher energy (caloric) intake
normally associated with high fat intake. FSIS has concluded that
evidence from both animal and human studies indicates that total fat
intake alone, independent of energy intake, is associated with cancer
risk.
(2) Significance of the relationship between fat intake and risk of
cancer. (i) Cancer is ranked as a leading cause of death in the United
States. The overall economic costs of cancer, including direct health
care costs and losses due to morbidity and mortality, are very high.
(ii) U.S. diets tend to be high in fat and high in calories. The
average U.S. diet is estimated to contain 36 to 37 percent of calories
from total fat. Current dietary guidelines from the Federal Government
and nationally recognized health professional organizations recommend
that dietary fat intake be reduced to a level of 30 percent or less of
energy (calories) from total fat. In order to reduce intake of total
fat, individuals should choose diets which are high in vegetables,
fruits, and grain products (particularly whole grain products), choose
lean cuts of meats, fish, and poultry, substitute low-fat dairy
products for higher fat products, and use fats and oils sparingly.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating diets low in fat with reduced risk of cancer may be made on
the label or labeling of a poultry product described in paragraph
(b)(3)(ii)(B) of this section; Provided, That:
(1) The claim states that diets low in fat ``may'' or ``might''
reduce the risk of some cancers;
(2) In specifying the disease, the claim uses the terms ``some
types of cancer'' or ``some cancers'';
(3) In specifying the nutrient, the claim uses the terms ``total
fat'' or ``fat'';
(4) The claim does not specify types of fat or fatty acids that may
be related to the risk of cancer;
(5) The claim does not attribute any degree of cancer risk
reduction to diets low in fat; and
(6) The claim indicates that the development of cancer depends on
many factors.
(B) Nature of the food. The product shall meet the requirements for
``low fat'' as defined in Sec. 381.462, except that the product may
meet the total fat and cholesterol criteria for ``extra lean'' in
Sec. 381.462.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(ii) The claim may include information from paragraphs (b) (1) and
(2) of this section, which summarizes the relationship between dietary
fat and cancer and the significance of the relationship.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have cancer. The source of this information must
be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between dietary
lipids and cancer:
(i) Development of cancer depends on many factors. A diet low in
total fat may reduce the risk of some cancers.
(ii) Eating a healthful diet low in fat may help reduce the risk of
some types of cancer. Development of cancer is associated with many
factors, including a family history of the disease, cigarette smoking,
and what you eat.
(c) Sodium and high blood pressure--(1) Relationship between sodium
and hypertension (high blood pressure). (i) Hypertension, or high blood
pressure, generally means a systolic blood pressure of greater than 140
millimeters of mercury (mm Hg) or a diastolic blood pressure of greater
than 90 mm Hg. Normotension, or normal blood pressure, is a systolic
blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm
Hg. Sodium is specified here as the chemical entity or electrolyte
``sodium'' and is distinguished from sodium chloride, or salt, which is
39 percent sodium by weight.
(ii) The scientific evidence establishes that diets high in sodium
are associated with a high prevalence of hypertension or high blood
pressure and with increases in blood pressure with age, and that diets
low in sodium are associated with a low prevalence of hypertension or
high blood pressure and with a low or no increase of blood pressure
with age.
(2) Significance of sodium in relation to high blood pressure. (i)
High blood pressure is a public health concern primarily because it is
a major risk factor for mortality from coronary heart disease and
stroke. Early management of high blood pressure is a major public
health goal that can assist in reducing mortality associated with
coronary heart disease and stroke. There is a continuum of mortality
risk that increases as blood pressures rise. Individuals with high
blood pressure are at greatest risk, and individuals with moderately
high, high normal, and normal blood pressure are at steadily decreasing
risk. The scientific evidence indicates that reducing sodium intake
lowers blood pressure and associated risks in many but not all
hypertensive individuals. There is also evidence that reducing sodium
intake lowers blood pressure and associated risks in many but not all
normotensive individuals as well.
(ii) The populations at greatest risk for high blood pressure, and
those most likely to benefit from sodium reduction, include those with
family histories of high blood pressure, the elderly, males because
they develop hypertension earlier in life than females, and black males
and females. Although some population groups are at greater risk than
others, high blood pressure is a disease of public health concern for
all population groups. Sodium intake, alcohol consumption, and obesity
are identified risk factors for high blood pressure.
(iii) Sodium intakes exceed recommended levels in almost every
group in the United States. One of the major public health
recommendations relative to high blood pressure is to decrease
consumption of salt. On a population-wide basis, reducing the average
sodium intake would have a small but significant effect on reducing the
average blood pressure, and, consequently, reducing mortality from
coronary heart disease and stroke.
(iv) Sodium is an essential nutrient, and experts have recommended
a safe minimum level of 500 mg sodium per day and an upper level of
2,400 mg sodium per day, which is the Daily Reference Value for sodium.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating diets low in sodium with reduced risk of high blood
pressure may be made on the label or labeling of a poultry product
described in paragraph (c)(3)(ii)(B) of this section; Provided, That:
(1) The claim states that diets low in sodium ``may'' or ``might''
reduce the risk of high blood pressure;
(2) In specifying the disease, the claim uses the term ``high blood
pressure'';
(3) In specifying the nutrient, the claim uses the term ``sodium'';
(4) The claim does not attribute any degree of reduction in risk of
high blood pressure to diets low in sodium; and
(5) The claim indicates that development of high blood pressure
depends on many factors.
(B) Nature of the food. (1) The product shall meet the requirements
for ``low sodium'' as defined in Sec. 381.461; and
(2) The product may meet the cholesterol criterion for ``extra
lean'' as defined in Sec. 381.462.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of high blood pressure in
addition to dietary sodium consumption: Family history of high blood
pressure, growing older, alcohol consumption, and excess weight.
(ii) The claim may include information from paragraphs (c) (1) and
(2) of this section, which summarizes the relationship between dietary
sodium and high blood pressure and the significance of the
relationship.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have high blood pressure. The source of this
information must be identified, and it must be current information from
the U.S. Department of Health and Human Services.
(v) In specifying the nutrient, the claim may include the term
``salt'' in addition to the term ``sodium.''
(vi) In specifying the disease, the claim may include the term
``hypertension'' in addition to the term ``high blood pressure.''
(vii) The claim may state that individuals with high blood pressure
should consult their physicians for medical advice and treatment. If
the claim defines high or normal blood pressure, then it shall state
that individuals with high blood pressure should consult their
physicians for medical advice and treatment.
(5) Model health claims. The following are model health claims that
may be used in food labeling to describe the relationship between
dietary sodium and high blood pressure:
(i) Diets low in sodium may reduce the risk of high blood pressure,
a disease associated with many factors.
(ii) Development of hypertension or high blood pressure depends on
many factors. [This product] can be part of a low sodium, low salt diet
that might reduce the risk of hypertension or high blood pressure.
(d) Dietary saturated fat and cholesterol and risk of coronary
heart disease--(1) Relationship between dietary saturated fat and
cholesterol and risk of coronary heart disease. (i) Cardiovascular
disease means diseases of the heart and circulatory system. Coronary
heart disease is the most common and serious form of cardiovascular
disease and refers to diseases of the heart muscle and supporting blood
vessels. High blood total- and low density lipoprotein (LDL)-
cholesterol levels are major modifiable risk factors in the development
of coronary heart disease. High coronary heart disease rates occur
among people with high blood cholesterol levels of 240 mg per decaliter
(mg/dL) (6.21 millimoles per liter (mmol/L) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high
risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol.
Dietary lipids (fats) include fatty acids and cholesterol. Total fat,
commonly referred to as fat, is composed of saturated fat (fatty acids
containing no double bonds), and monounsaturated and polyunsaturated
fat (fatty acids containing one or more double bonds).
(ii) The scientific evidence establishes that diets high in
saturated fat and cholesterol are associated with increased levels of
blood total- and LDL-cholesterol and, thus, with increased risk of
coronary heart disease. Diets low in saturated fat and cholesterol are
associated with decreased levels of blood total- and LDL-cholesterol
and, thus, with decreased risk of developing coronary heart disease.
(2) Significance of the relationship between dietary saturated fat
and cholesterol and risk of coronary heart disease. (i) Coronary heart
disease is a major public health concern in the United States,
primarily because it accounts for more deaths than any other disease or
group of diseases. Early management of risk factors for coronary heart
disease is a major public health goal that can assist in reducing risk
of coronary heart disease. There is a continuum of mortality risk from
coronary heart disease that increases with increasing levels of blood
LDL-cholesterol. Individuals with high blood LDL-cholesterol are at
greatest risk. A larger number of individuals with more moderately
elevated cholesterol also have increased risk of coronary events; such
individuals comprise a substantial proportion of the adult U.S.
population. The scientific evidence indicates that reducing saturated
fat and cholesterol intakes lowers blood LDL-cholesterol and risk of
heart disease in most individuals. There is also evidence that reducing
saturated fat and cholesterol intakes in persons with blood cholesterol
levels in the normal range also reduces risk of heart disease.
(ii) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity, and lack of regular physical exercise.
(iii) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. One of the major public health
recommendations relative to coronary heart disease risk is to consume
less than 10 percent of calories from saturated fat, and an average of
30 percent or less of total calories from all fat. Recommended daily
cholesterol intakes are 300 mg or less.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific requirements--(A) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol with reduced
risk of coronary heart disease may be made on the label or labeling of
a poultry product described in paragraph (d)(3)(ii)(B) of this section;
Provided, That:
(1) The claim states that diets low in saturated fat and
cholesterol ``may'' or ``might'' reduce the risk of heart disease;
(2) In specifying the disease, the claim uses the terms ``heart
disease'' or ``coronary heart disease'';
(3) In specifying the nutrient, the claim uses the terms
``saturated fat'' and ``cholesterol'' and lists both;
(4) The claim does not attribute any degree of coronary heart
disease risk reduction to diets low in saturated fat and cholesterol;
and
(5) The claim states that coronary heart disease risk depends on
many factors.
(B) Nature of the food. The product shall meet the requirements for
``low fat,'' ``low saturated fat,'' and ``low cholesterol'' as defined
in Sec. 381.462, except that the product may meet all the requirements
for ``extra lean'' in Sec. 381.462.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors in addition to saturated fat and cholesterol
about which there is general scientific agreement that they are major
risk factors for this disease: A family history of coronary heart
disease, elevated blood total- and LDL-cholesterol, excess body weight,
high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(ii) The claim may indicate that the relationship of saturated fat
and cholesterol to heart disease is through the intermediate link of
``blood cholesterol'' or ``blood total- and LDL-cholesterol.''
(iii) The claim may include information from paragraphs (d) (1) and
(2) of this section, which summarizes the relationship between dietary
saturated fat and cholesterol and risk of coronary heart disease and
the significance of the relationship.
(iv) In specifying the nutrient, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol.''
(v) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(vi) The claim may include information on the number of people in
the United States who have coronary heart disease. The source of this
information must be identified, and it must be current information from
the U.S. Department of Health and Human Services.
(vii) The claim may state that individuals with elevated blood
total- or LDL-cholesterol should consult their physicians for medical
advice and treatment. If the claim defines high or normal blood total-
or LDL-cholesterol, then it shall state that individuals with high
blood cholesterol should consult their physicians for medical advice
and treatment.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between dietary
saturated fat and cholesterol and risk of heart disease:
(i) While many factors affect heart disease, diets low in saturated
fat and cholesterol may reduce the risk of this disease.
(ii) Development of heart disease depends upon many factors, but
its risk may be reduced by diets low in saturated fat and cholesterol
and healthy lifestyles.
(iii) Development of heart disease depends on many factors,
including a family history of the disease, high blood LDL-cholesterol,
diabetes, high blood pressure, being overweight, cigarette smoking,
lack of exercise, and the type of dietary pattern. A healthful diet low
in saturated fat, total fat, and cholesterol, as part of a healthy
lifestyle, may lower blood cholesterol levels and may reduce the risk
of heart disease.
(iv) Many factors, such as family history of the disease, increased
blood total- and LDL-cholesterol levels, high blood pressure, cigarette
smoking, diabetes, and being overweight, contribute to developing heart
disease. Eating a diet low in saturated fat, cholesterol, and total fat
may help reduce the risk of heart disease.
(v) Diets low in saturated fat, cholesterol, and total fat may
reduce the risk of heart disease. Heart disease is dependent upon many
factors, including diet, a family history of the disease, elevated
blood LDL-cholesterol levels, and physical inactivity.
(e) Fiber-containing grain products, fruits, and vegetables and
cancer--(1) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (i)
Cancer is a constellation of more than 100 different diseases, each
characterized by the uncontrolled growth and spread of abnormal cells.
Cancer has many causes and stages in its development. Both genetic and
environmental risk factors may affect the risk of cancer. Risk factors
include a family history of a specific type of cancer, cigarette
smoking, alcohol consumption, overweight and obesity, ultraviolet or
ionizing radiation, exposure to cancer-causing chemicals, and dietary
factors.
(ii) The scientific evidence establishes that diets low in fat and
high in fiber-containing grain products, fruits, and vegetables are
associated with a reduced risk of some types of cancer. Although the
specific role of total dietary fiber, fiber components, and the
multiple nutrients and other substances contained in these foods are
not fully understood, many studies have shown that diets low in fat and
high in fiber-containing foods are associated with reduced risk of some
types of cancer.
(2) Significance of the relationship between consumption of diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and risk of cancer. (i) Cancer is ranked as a leading cause
of death in the United States. The overall economic costs of cancer,
including direct health care costs and losses due to morbidity and
mortality, are very high.
(ii) U.S. diets tend to be high in fat and low in grain products,
fruits, and vegetables. Studies in various parts of the world indicate
that populations who habitually consume a diet high in plant foods have
lower risks of some cancers. These diets are generally low in fat and
rich in many nutrients, including, but not limited to, dietary fiber.
Current dietary guidelines from the Federal Government and nationally
recognized health professional organizations recommend decreased
consumption of fats (less than 30 percent of calories), maintenance of
desirable body weight, and increased consumption of fruits and
vegetables (five or more servings daily), and grain products (six or
more servings daily).
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific Requirements. (A) Nature of the claim. A health claim
associating diets low in fat and high in fiber-containing grain
products, fruits, and vegetables with reduced risk of cancer may be
made on the label or labeling of a poultry product described in
paragraph (e)(3)(ii) (B) of this section; Provided, That:
(1) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``may'' or ``might''
reduce the risk of some cancers;
(2) In specifying the disease, the claim uses the terms ``some
types of cancer'' or ``some cancers'';
(3) The claim is limited to grain products, fruits, and vegetables
that contain dietary fiber;
(4) The claim indicates that the development of cancer depends on
many factors;
(5) The claim does not attribute any degree of cancer risk
reduction to diets low in fat and high in fiber-containing grain
products, fruits, and vegetables;
(6) In specifying the dietary fiber component of the labeled
product, the claim uses the terms ``fiber,'' ``dietary fiber,'' or
``total dietary fiber''; and
(7) The claim does not specify types of dietary fiber that may be
related to risk of cancer.
(B) Nature of the food. (1) The product shall contain a grain
product, fruit, or vegetable;
(2) The product shall meet the requirements for ``low fat'' as
defined in Sec. 381.462, except that the product may meet the total fat
and cholesterol criteria for ``extra lean'' in Sec. 381.462; and
(3) The product shall meet the requirements for a ``good source''
of fiber as defined in Sec. 381.454 prior to any nutrient addition,
except the basis for meal-type products as defined in Sec. 381.413(l)
shall be per labeled serving size.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(ii) The claim may include information from paragraphs (e)(1) and
(2) of this section, which summarizes the relationship between diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and cancer and the significance of the relationship.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have cancer. The source of this information must
be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and cancer risk:
(i) Low fat diets rich in fiber-containing grain products, fruits,
and vegetables may reduce the risk of some types of cancer, a disease
associated with many factors.
(ii) Development of cancer depends on many factors. Eating a diet
low in fat and high in grain products, fruits, and vegetables that
contain dietary fiber may reduce your risk of some cancers.
(f) Fruits, vegetables, and grain products that contain dietary
fiber, particularly soluble fiber, and risk of coronary heart disease--
(1) Relationship between diets low in saturated fat and cholesterol and
high in fruits, vegetables, and grain products that contain fiber,
particularly soluble fiber, and risk of coronary heart disease. (i)
Cardiovascular disease means diseases of the heart and circulatory
system. Coronary heart disease is the most common and serious form of
cardiovascular disease and refers to diseases of the heart muscle and
supporting blood vessels. High blood total- and low density lipoprotein
(LDL)-cholesterol levels are major modifiable risk factors in the
development of coronary heart disease. High coronary heart disease
rates occur among people with high blood cholesterol levels of 240 mg
per decaliter (mg/dL) (6.21 millimoles per liter (mmol/L) or above and
LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline
high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to
6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-
cholesterol. Dietary lipids (fats) include fatty acids and cholesterol.
Total fat, commonly referred to as fat, is composed of saturated fat
(fatty acids containing no double bonds), and monounsaturated and
polyunsaturated fat (fatty acids containing one or more double bonds).
(ii) The scientific evidence establishes that diets high in
saturated fat and cholesterol are associated with increased levels of
blood total- and LDL-cholesterol and, thus, with increased risk of
coronary heart disease. Diets low in saturated fat and cholesterol are
associated with decreased levels of blood total- and LDL-cholesterol
and, thus, with decreased risk of developing coronary heart disease.
(iii) Populations with relatively low blood cholesterol levels tend
to have dietary patterns that are not only low in total fat, especially
saturated fat and cholesterol, but are also relatively high in fruits,
vegetables, and grain products. Although the specific roles of these
plant foods are not yet fully understood, many studies have shown that
diets high in plant foods are associated with reduced risk of coronary
heart disease. These studies correlate diets rich in fruits,
vegetables, and grain products and nutrients from these diets, such as
some types of fiber, with reduced coronary heart disease risk. Persons
consuming these diets frequently have high intakes of dietary fiber,
particularly soluble fiber. Currently, there is not scientific
agreement as to whether a particular type of soluble fiber is
beneficial, or whether the observed protective effects of fruits,
vegetables, and grain products against heart disease are due to other
components, or a combination of components, in these diets, including,
but not necessarily limited to, some types of soluble fiber, other
fiber components, other characteristics of the complex carbohydrate
content of these foods, other nutrients in these foods, or displacement
of saturated fat and cholesterol from the diet.
(2) Significance of the relationship between diets low in saturated
fat and cholesterol and high in fruits, vegetables, and grain products
that contain fiber, particularly soluble fiber, and risk of coronary
heart disease. (i) Coronary heart disease is a major public health
concern in the United States, primarily because it accounts for more
deaths than any other disease or group of diseases. Early management of
risk factors for coronary heart disease is a major public health goal
that can assist in reducing risk of coronary heart disease. There is a
continuum of mortality risk from coronary heart disease that increases
with increasing levels of blood LDL-cholesterol. Individuals with high
blood LDL-cholesterol are at greatest risk. A larger number of
individuals with more moderately elevated cholesterol also have
increased risk of coronary events; such individuals comprise a
substantial proportion of the adult U.S. population. The scientific
evidence indicates that reducing saturated fat and cholesterol intakes
lowers blood LDL-cholesterol and risk of heart disease in most
individuals, including persons with blood cholesterol levels in the
normal range. Additionally, consuming diets high in fruits, vegetables,
and grain products, foods that contain soluble fiber, may be a useful
adjunct to a low saturated fat and low cholesterol diet.
(ii) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity, and lack of regular physical exercise.
(iii) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. Intakes of fiber-containing fruits,
vegetables, and grain products are about half of recommended intake
levels. One of the major public health recommendations relative to
coronary heart disease risk is to consume less than 10 percent of
calories from saturated fat, and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
300 mg or less. Recommended total dietary fiber intakes are about 25 g
daily, of which about 25 percent (about 6 g) should be soluble fiber.
(iv) Current dietary guidance recommendations encourage decreased
consumption of dietary fat, especially saturated fat and cholesterol,
and increased consumption of fiber-rich foods to help lower blood LDL-
cholesterol levels. Results of numerous studies have shown that fiber-
containing fruits, vegetables, and grain products can help lower blood
LDL-cholesterol.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol and high in
fruits, vegetables, and grain products that contain fiber, particularly
soluble fiber, with reduced risk of heart disease may be made on the
label or labeling of a poultry product described in paragraph
(f)(3)(ii)(B) of this section; Provided, That:
(1) The claim states that diets low in saturated fat and
cholesterol and high in fruits, vegetables, and grain products that
contain fiber ``may'' or ``might'' reduce the risk of heart disease;
(2) In specifying the disease, the claim uses the terms ``heart
disease'' or ``coronary heart disease'';
(3) The claim is limited to those fruits, vegetables, and grains
that contain fiber;
(4) In specifying the dietary fiber, the claim uses the terms
``fiber,'' ``dietary fiber,'' ``some types of dietary fiber,'' ``some
dietary fibers,'' or ``some fibers,'' and the term ``soluble fiber''
may be used in addition to these terms;
(5) In specifying the fat component, the claim uses the terms
``saturated fat'' and ``cholesterol'';
(6) The claim indicates that development of heart disease depends
on many factors; and
(7) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets low in saturated fat and cholesterol
and high in fruits, vegetables, and grain products that contain fiber.
(B) Nature of the food. (1) The product shall contain a fruit,
vegetable, or grain product;
(2) The product shall meet the requirements for ``low fat,'' ``low
saturated fat,'' and ``low cholesterol'' as defined in Sec. 381.462,
except that the product may meet all the requirements for ``extra
lean'' in Sec. 381.462; and
(3) The product shall contain at least 0.6 g of soluble fiber per
reference amount customarily consumed prior to any nutrient addition,
except the basis for meal-type products as defined in 381.413(l) shall
be per labeled serving size.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for heart disease about which there is
general scientific agreement: A family history of coronary heart
disease, elevated blood total- and LDL-cholesterol, excess body weight,
high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(ii) The claim may indicate that the relationship of diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain fiber to heart disease is through the
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol.''
(iii) The claim may include information from paragraphs (f)(1) and
(2) of this section, which summarizes the relationship between diets
low in saturated fat and cholesterol and high in fruits, vegetables,
and grain products that contain fiber and coronary heart disease and
the significance of the relationship.
(iv) In specifying the nutrients, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol.''
(v) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(vi) The claim may include information on the number of people in
the United States who have coronary heart disease. The source of this
information shall be identified, and it shall be current information
from the U.S. Department of Health and Human Services.
(vii) The claim may state that individuals with elevated blood
total- and LDL-cholesterol should consult their physicians for medical
advice and treatment. If the claim defines high or normal blood total-
and LDL-cholesterol levels, then it shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(5) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain fiber and risk of heart disease:
(i) Diets low in saturated fat and cholesterol and rich in fruits,
vegetables, and grain products that contain some types of dietary
fiber, particularly soluble fiber, may reduce the risk of heart
disease, a disease associated with many factors.
(ii) Development of heart disease depends on many factors. Eating a
diet low in saturated fat and cholesterol and high in fruits,
vegetables, and grain products that contain fiber may lower blood
cholesterol levels and reduce your risk of heart disease.
(g) Fruits and vegetables and cancer--(1) Relationship between
substances in diets low in fat and high in fruits and vegetables and
cancer risk. (i) Cancer is a constellation of more than 100 different
diseases, each characterized by the uncontrolled growth and spread of
abnormal cells. Cancer has many causes and stages in its development.
Both genetic and environmental risk factors may affect the risk of
cancer. Risk factors include a family history of a specific type of
cancer, cigarette smoking, alcohol consumption, overweight and obesity,
ultraviolet or ionizing radiation, exposure to cancer-causing
chemicals, and dietary factors.
(ii) Although the specific roles of the numerous potentially
protective substances in plant foods are not yet understood, many
studies have shown that diets high in plant foods are associated with
reduced risk of some types of cancers. These studies correlate diets
rich in fruits and vegetables and nutrients from these diets, such as
vitamin C, vitamin A, and dietary fiber, with reduced cancer risk.
Persons consuming these diets frequently have high intakes of these
nutrients. Currently there is not scientific agreement as to whether
the observed protective effects of fruits and vegetables against cancer
are due to a combination of the nutrient components of diets rich in
fruits and vegetables, including but not necessarily limited to dietary
fiber, vitamin A as beta-carotene, and vitamin C, to displacement of
fat from such diets, or to intakes of other substances in these foods
which are not nutrients but may be protective against cancer risk.
(2) Significance of the relationship between consumption of diets
low in fat and high in fruits and vegetables and risk of cancer. (i)
Cancer is ranked as a leading cause of death in the United States. The
overall economic costs of cancer, including direct health care costs
and losses due to morbidity and mortality, are very high.
(ii) U.S. diets tend to be high in fat and low in fruits and
vegetables. Studies in various parts of the world indicate that
populations who habitually consume a diet high in plant foods have
lower risk of some cancers. These diets are generally low in fat and
rich in many nutrients, including but not limited to, dietary fiber,
vitamin A as beta-carotene, and vitamin C. Current dietary guidelines
from the Federal Government and nationally recognized health
professional organizations recommend decreased consumption of fats
(less than 30 percent of calories), maintenance of desirable body
weight, and increased consumption of fruits and vegetables (five or
more servings daily), particularly those fruits and vegetables which
contain dietary fiber, vitamin A, and vitamin C.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific Requirements. (A) Nature of the claim. A health claim
associating diets low in fat and high in fruits and vegetables with
reduced risk of cancer may be made on the label or labeling of a
poultry product described in paragraph (g)(3)(ii)(B) of this section;
Provided, That:
(1) The claim states that diets low in fat and high in fruits and
vegetables ``may'' or ``might'' reduce the risk of some cancers;
(2) In specifying the disease, the claim uses the terms ``some
types of cancer'' or ``some cancers'';
(3) The claim characterizes fruits and vegetables as foods that are
low in fat and may contain vitamin A, vitamin C, and dietary fiber;
(4) The claim characterizes the product bearing the claim as
containing one or more of the following, for which the product is a
``good source'' under Sec. 381.454: Vitamin A (as beta-carotene),
vitamin C, or dietary fiber;
(5) The claim indicates that the development of cancer depends on
many factors;
(6) The claim does not attribute any degree of cancer risk
reduction to diets low in fat and high in fruits and vegetables;
(7) In specifying the fat component of the labeled product, the
claim uses the terms ``total fat'' or ``fat'';
(8) The claim does not specify types of fats or fatty acids that
may be related to cancer risk;
(9) In specifying the dietary fiber component of the labeled
product, the claim uses the terms ``fiber,'' ``dietary fiber,'' or
``total dietary fiber''; and
(10) The claim does not specify types of dietary fiber that may be
related to risk of cancer.
(B) Nature of the food. (1) The product shall contain a fruit or
vegetable;
(2) The product shall meet the requirements for ``low fat'' as
defined in Sec. 381.462, except that the product may meet the total fat
and cholesterol criteria for ``extra lean'' in Sec. 381.462; and
(3) The product shall meet the requirements for a ``good source''
of at least one of the following: Vitamin A (as beta-carotene), vitamin
C, or dietary fiber as defined in Sec. 381.454 prior to any nutrient
addition, except the basis for meal-type products as defined in
Sec. 381.413(l) shall be per labeled serving size.
(4) Optional information. (i) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(ii) The claim may include information from paragraphs (g) (1) and
(2) of this section, which summarizes the relationship between diets
low in fat and high in fruits and vegetables and some types of cancer
and the significance of the relationship.
(iii) The claim may use the word ``beta-carotene'' in parentheses
after the term vitamin A when the vitamin A in the product bearing the
claim is beta-carotene.
(iii) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans.''
(iv) The claim may include information on the number of people in
the United States who have cancer. The source of this information must
be identified, and it must be current information from the U.S.
Department of Health and Human Services.
(5) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between
substances in diets low in fat and high in fruits and vegetables and
cancer:
(i) Low fat diets rich in fruits and vegetables (foods that are low
in fat and may contain dietary fiber, vitamin A, and vitamin C) may
reduce the risk of some types of cancer, a disease associated with many
factors. Broccoli is high in vitamins A and C, and it is a good source
of dietary fiber.
(ii) Development of cancer depends on many factors. Eating a diet
low in fat and high in fruits and vegetables, foods that are low in fat
and may contain vitamin A, vitamin C and dietary fiber, may reduce your
risk of some cancers. Oranges, a food low in fat, are a good source of
fiber and vitamin C.
(h) Folate and neural tube defects--(1) Relationship between folate
and neural tube defects. (i) Neural tube defects are serious birth
defects of the brain or spinal cord that can result in infant mortality
or serious disability. The birth defects anencephaly and spina bifida
are the most common forms of neural tube defects and account for about
90 percent of these defects. These defects result from failure of
closure of the covering of the brain or spinal cord during early
embryonic development. Because the neural tube forms and closes during
early pregnancy, the defect may occur before a woman realizes that she
is pregnant.
(ii) The available data show that diets adequate in folate may
reduce the risk of neural tube defects. The strongest evidence for this
relationship comes from an intervention study by the Medical Research
Council of the United Kingdom that showed that women at risk of
recurrence of a neural tube defect pregnancy who consumed a supplement
containing 4 mg (4,000 micrograms (mcg)) folic acid daily had a reduced
risk of having a child with a neural tube defect. (Products that
contain this level of folic acid are drugs.) In addition, based on its
review of a Hungarian intervention trial that used a multivitamin and
multimineral preparation containing 800 mcg (0.8 mg) of folic acid, and
its review of the observational studies that reported use of
multivitamins containing 0 to 1,000 mcg of folic acid, FDA concluded
that most of these studies had results consistent with the conclusion
that folate, at levels attainable in usual diets, may reduce the risk
of neural tube defects.
(2) Significance of folate. (i) Neural tube defects occur in
approximately 0.6 of 1,000 live births in the United States (i.e.,
about 2,500 cases among 4 million live births annually). Neural tube
defects are believed to be caused by many factors. The single greatest
risk factor for a neural tube defect-affected pregnancy is a personal
or family history of a pregnancy affected with such a defect. However,
about 90 percent of infants with a neural tube defect are born to women
who do not have a family history of these defects. The available
evidence shows that diets adequate in folate may reduce the risk of
neural tube defects but not of other birth defects.
(ii) Prevalence rates for neural tube defects have been reported to
vary with a wide range of factors, including genetics, geography,
socioeconomic status, maternal birth cohort, month of conception, race,
nutrition, and maternal age and reproductive history. Women with a
close relative (i.e., sibling, niece, nephew) with a neural tube
defect, those with insulin-dependent diabetes mellitus, and women with
seizure disorders who are being treated with valproic acid or
carbamazepine are at significantly increased risk compared with women
without these characteristics. Rates for neural tube defects vary
within the United States, with lower rates observed on the west coast
than on the east coast.
(iii) Based on a synthesis of the results of several observational
studies, the Public Health Service has estimated that about 50 percent
of neural tube defect-affected pregnancies in the United States (e.g.,
about 1,250) may be averted annually if all women consume adequate
amounts of folate daily (i.e., 0.4 mg) throughout their childbearing
years.
(3) Requirements. (i) All requirements set forth in Sec. 381.414
shall be met.
(ii) Specific requirements. (A) Nature of the claim. A health claim
associating folate with reduced risk of neural tube defects may be made
on the label or labeling of a poultry product described in paragraph
(h)(3)(ii)(B) of this section; Provided, That:
(1) In specifying the nutrient, the claim shall use the terms
``folate,'' ``folic acid,'' ``folacin,'' ``folate, a B vitamin,''
``folic acid, a B vitamin,'' or ``folacin, a B vitamin'';
(2) In specifying the health-related condition, the claim shall
identify the birth defects as ``neural tube defects,'' ``birth defects,
spina bifida, or anencephaly,'' ``birth defects of the brain or spinal
cord anencephaly or spina bifida,'' or ``spina bifida or anencephaly,
birth defects of the brain or spinal cord'';
(3) The claim shall state that neural tube defects have many causes
and shall not imply that folate intake is the only recognized risk
factor for neural tube defects;
(4) In specifying the prevalence of neural tube defects among women
in the general population, the claim shall state that such birth
defects ``which, while not widespread, are extremely significant'' or
``* * * birth defects * * * that, while not widespread, are extremely
significant.'';
(5) The claim shall not attribute any specific degree of reduction
in risk of neural tube defects, including mention of the Public Health
Service estimate that 50 percent of neural tube defects may be averted
annually, to maintaining an adequate folate intake throughout the
childbearing years. The claim shall state that some women may reduce
their risk of a neural tube defect pregnancy by maintaining adequate
intakes of folic acid during their childbearing years;
(6) Claims on products that contain more than 25 percent of the
Reference Daily Intake for folate (100 mcg per serving) shall state
that 1 mg folate per day is the safe upper limit of intake (e.g.,
``Folate consumption should be limited to 1,000 mcg per day from all
sources'');
(7) The claim shall not state that a specified amount of folate
(e.g., 400 mcg in a dietary supplement) is more effective in reducing
the risk of neural tube defects than a lower amount (e.g., 100 mcg in a
breakfast cereal or from diets rich in fruit and vegetables);
(8) The claim shall identify diets adequate in folate by using
phrases such as ``* * * diets that include 2 to 4 servings per day of
fruits (including citrus fruits and juices), 3 to 5 servings of
vegetables (including dark green leafy vegetables and legumes), 6 to 11
servings of enriched grain products (such as breads, rice, and pasta)
and fortified cereals. Such diets provide many essential minerals and
vitamins, including folate. Women who do not eat well-balanced diets or
who may be concerned about their diets may choose to obtain folate from
dietary supplements.''; or ``Adequate amounts of folate, a B vitamin,
can be obtained from diets rich in fruits, including citrus fruits and
juices, vegetables, including dark green leafy vegetables and legumes,
enriched grain products, including breads, rice, and pasta, fortified
cereals, or a dietary supplement.''; or ``Adequate amounts of folate, a
B vitamin, can be obtained from diets rich in fruits, dark green leafy
vegetables and legumes, enriched grain products, fortified cereals, or
from dietary supplements.''; and
(9) The nutrition label shall include information about the amount
of folate in the labeled product. This information shall be declared
after the declaration for iron if only the levels of vitamin A, vitamin
C, calcium, and iron are provided, or in accordance with Sec. 381.409
if other optional vitamins or minerals are declared.
(B) Nature of the food. (1) The product shall meet or exceed the
requirements for a ``good source'' level of folate as defined in
Sec. 381.454, except the basis for meal-type products as defined in
Sec. 381.413(l) shall be per labeled serving size;
(2) The product may meet the cholesterol criterion for ``extra
lean'' as defined in Sec. 381.462; and
(3) The product shall not contain more than 100 percent of the
Reference Daily Intake as defined in Sec. 381.409 for vitamin A as
retinol or preformed vitamin A or vitamin D.
(4) Optional information. (i) The claim may specifically identify
risk factors for neural tube defects.
(ii) The claim may include information from paragraphs (h) (1) and
(2) of this section, which summarizes the relationship between folate
and neural tube defects and the significance of the relationship except
for information specifically prohibited from the claim.
(iii) The claim may state that women with a history of a neural
tube defect pregnancy should consult their physicians or health care
providers before becoming pregnant.
(iv) The claim may identify the Daily Value level of 400 mcg of
folate per day as the target intake goal.
(5) Model health claims. The following are examples of model health
claims that may be used in food labeling to describe the relationship
between folate and neural tube defects:
(i) Women who consume adequate amounts of folate, a B vitamin,
daily throughout their childbearing years may reduce their risk of
having a child with a neural tube birth defect. Such birth defects,
while not widespread, are very serious. They can have many causes.
Adequate amounts of folate can be obtained from diets rich in fruits,
dark green leafy vegetables and legumes, enriched grain products,
fortified cereals, or a supplement. Folate consumption should be
limited to 1,000 mcg per day from all sources.
(ii) Women who consume adequate amounts of folate daily throughout
their childbearing years may reduce their risk of having a child with a
birth defect of the brain and spinal cord. Such birth defects, while
not widespread, are very serious. They can have many causes. Adequate
amounts of folate, a B vitamin, can be obtained from diets rich in
fruits, dark green leafy vegetables and legumes, enriched grain
products, fortified cereals, or a supplement. Women who have had a
child with a spinal cord birth defect should consult a physician before
becoming pregnant. Folate consumption should be limited to 1,000 mcg
per day from all sources.
(iii) Women who take steps to ensure that their folate intake is
adequate throughout their childbearing years may reduce their risk of
having a child with a neural tube defect. Such birth defects, while not
widespread, are very serious. They can have many causes. Adequate
amounts of folate, a B vitamin, can be obtained from diets rich in
citrus fruits and juices, dark green leafy vegetables and legumes,
enriched grain products such as breads, rice, and pasta, fortified
cereals, or a supplement. Folate consumption should be limited to 1,000
mcg per day from all sources.
(iv) Women who take steps to ensure that their folate intake is at
least 400 mcg daily throughout their childbearing years may reduce
their risk of having a child with spina bifida or anencephaly, birth
defects of the brain or spinal cord that, while not widespread, are
very serious. These birth defects can have many causes. Adequate
amounts of folate, a B vitamin, can be obtained from diets rich in
fruits, including citrus fruits and juices, vegetables, including dark
green leafy vegetables and legumes, enriched grain products, including
breads, rice, and pasta, fortified cereals, or from a supplement. Women
who have had a pregnancy affected with a neural tube defect should
consult a physician before becoming pregnant. Folate consumption should
be limited to 1,000 mcg per day from all sources.
(v) Some women who consume the Daily Value of folate (400 mcg)
throughout their childbearing years may reduce their risk of having a
child affected with spina bifida or anencephaly, birth defects of the
brain or spinal cord that, while not widespread, are very serious.
These birth defects can have many causes. Women of childbearing age
should choose well-balanced diets that include 2 to 4 servings per day
of fruits (including citrus fruits and juices), 3 to 5 servings of
vegetables (including dark green leafy vegetables and legumes), 6 to 11
servings of enriched grain products (such as breads, rice, and pasta)
or fortified cereals throughout their childbearing years. Such diets
provide many essential minerals and vitamins, including folate. Women
who may be concerned about their diets may choose to obtain folate from
a supplement. Folate consumption should be limited to 1,000 mcg per day
from all sources.
Done at Washington, DC, on: May 16, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-12466 Filed 5-24-94; 8:45 am]
BILLING CODE 3410-DM-P
