[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34092-34097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16455]
[[Page 34092]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0428]
Food Labeling: Health Claims; Antioxidant Vitamin A and Beta-
Carotene and the Risk in Adults of Atherosclerosis, Coronary Heart
Disease, and Certain Cancers
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim
final rule to prohibit the use on foods of a claim relating to the
relationship between antioxidant vitamin A and beta-carotene and the
risk in adults of atherosclerosis, coronary heart disease, and certain
cancers. This interim final rule is in response to a notification of a
health claim submitted under section 303 of the FDA Modernization Act
of 1997 (FDAMA). FDA has reviewed statements that the petitioner
submitted in that notification, and, in conformity with the
requirements of FDAMA, the agency is prohibiting the claim because the
statements submitted as the basis of the claim are not ``authoritative
statements'' of a scientific body, as required by FDAMA; therefore,
section 303 of FDAMA does not authorize use of this claim. As provided
for in section 301 of FDAMA, this interim final rule is effective
immediately upon publication.
DATES: The interim final rule is effective June 22, 1998; comments by
September 8, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Christine J. Lewis, Center for Food
Safety and Applied Nutrition (HFS-451), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4168.
SUPPLEMENTARY INFORMATION:
I. The FDA Modernization Act of 1997
On November 21, 1997, the President signed FDAMA into law (Pub. L.
105-115), which amended the Federal Food, Drug, and Cosmetic Act (the
act). Sections 303 and 304 of FDAMA amended section 403(r)(2) and
(r)(3) of the act (21 U.S.C. 343(r)(2) and (r)(3)) by adding new
paragraphs (r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D) to section
403 of the act (21 U.S.C. 343(r)(2)(G), (r)(2)(H), (r)(3)(C), and
(r)(3)(D), respectively), which provide for the use in food labeling of
nutrient content claims and health claims, respectively, based on
authoritative statements. FDAMA requires that a notification of the
prospective nutrient content claim or the prospective health claim be
submitted to FDA at least 120 days before a food bearing the claim may
be introduced into interstate commerce. FDAMA and its requirements are
discussed in more detail in ``Food Labeling: Health Claims; Antioxidant
Vitamins C and E and the Risk in Adults of Atherosclerosis, Coronary
Heart Disease, Certain Cancers, and Cataracts'' (hereinafter referred
to as ``Health Claims; Vitamins C and E''), which is published
elsewhere in this issue of the Federal Register. In particular, aspects
of the requirements for an ``authoritative statement'' that are
relevant to this rulemaking and FDA's review process for notifications
are discussed in sections I.A and I.B, respectively, of that document.
II. The Notification
Section 403(r)(2)(G) and (r)(3)(C) of the act became effective on
February 19, 1998. On February 23, 1998, the agency received a
notification from Weider Nutrition International, Inc., containing nine
prospective claims that were identified in the text of the notification
as health claims (Ref. 1). The notification included statements that
the submitter described as authoritative statements and a scientific
literature review for each claim. FDA has created nine separate
dockets, one for each of the nine claims and is issuing a separate
interim final rule responding to each claim.
This interim final rule addresses the second claim in the
notification. The notification included 11 statements that the
petitioner identified as authoritative statements on which the
following claim is based: ``Antioxidant vitamin A and beta-carotene may
reduce the risk in adults of atherosclerosis, coronary heart disease
and certain cancers. Sources of Vitamin A and beta-carotene include
red, yellow and green leafy vegetables, dairy products, and dietary
supplements.''
The first sentence of this claim will be discussed in greater
detail in section III of this document. FDA notes that this claim
describes the relationship between vitamin A and beta-carotene and a
number of different diseases and, thus, in point of fact, reflects
several prospective health claims. The second sentence, ``Sources of
Vitamin A and beta-carotene include red, yellow and green leafy
vegetables, dairy products, and dietary supplements,'' is not a health
claim. Given that the notification indicated that it was intended to be
a notification for health claims, this statement was not reviewed by
FDA. The submitter did not separately identify this statement as any
particular type of claim.
Nonetheless, as a point of information, the agency wishes to
highlight that statements that appropriately constitute nutrient
content claims are allowed on labels and in the labeling of foods and
dietary supplements. Moreover, statements that constitute dietary
guidance are also allowed provided the information is truthful and not
misleading as required by sections 403(a) and 201(n) of the act (21
U.S.C. 321(n)). These aspects of nutrient content claims and dietary
guidance are discussed in more detail in ``Health Claims; Vitamins C
and E,'' which is published elsewhere in this issue of the Federal
Register.
III. Basis for the Action
FDA has reviewed the notification submitted in support of the
prospective claim: ``Antioxidant vitamin A and beta-carotene may reduce
the risk in adults of atherosclerosis, coronary heart disease and
certain cancers.'' The agency has determined that none of the 11
statements submitted as the basis for this claim meets the requirements
in section 403(r)(3)(C) of the act to be an ``authoritative
statement.'' Because the prospective claim is not based on an
authoritative statement, it is not appropriate for the claim to appear
on food labels and labeling. Consequently, FDA is issuing this interim
final rule to prohibit the use of this claim. A discussion of the basis
for the agency's action on the notification follows:
First, FDA determined that the components required by section
403(r)(3)(C) of the act were present in the notification submitted to
support this claim. Second, FDA determined that, as a threshold matter,
each of the 11 statements cited in support of the claim may be
attributable either to an appropriate Federal scientific body or to an
employee or employees of such a body.
The notification in support of the claim that is the subject of
this document cites statements from: (1) A report on nutrition
monitoring prepared for the Department of Health and Human Services
(DHHS) and the U.S. Department of Agriculture (USDA); (2) an electronic
version provided on the Internet of ``Nutrition and Your Health:
Dietary Guidelines for Americans,''
[[Page 34093]]
recommendations developed by a group of Federal agencies and issued
jointly by DHHS and USDA; (3) electronic versions provided on the
Internet of four quarterly reports from USDA's Agricultural Research
Service (ARS) (statement 3, 7, 9, and 11); (4) electronic versions
provided on the Internet of two interpretative summaries from USDA/ARS
Technology Transfer Information Center (statements 4 and 10); (5)
public information provided on the Internet by an institute of the
National Institutes of Health (NIH); (6) public information provided on
the Internet by USDA/ARS Beltsville Human Nutrition Research Center;
and (7) public information provided on the Internet by the National
Cancer Institute (NCI), an institute within NIH. Thus, nine statements
in the notification are attributable to either NIH or USDA/ARS. A 10th
statement is attributable to USDA and DHHS and is intended for use by
Federal agencies including NIH, the Centers for Disease Control and
Prevention (CDC), and USDA/ARS. An 11th statement from the Dietary
Guidelines for Americans is attributable to a group of Federal agencies
that included NIH, CDC, and USDA/ARS. Two of the agencies, NIH and CDC,
are highlighted in the statute as Federal scientific bodies. FDA
believes that USDA/ARS is also a scientific body of the U.S. Government
with official responsibility for public health protection or research
directly relating to human nutrition for the purposes of section
403(r)(2)(G) and (r)(3)(C) of the act. The agencies that were
identified as users of the ``Nutrition Monitoring Report'' as well as
the group that developed the dietary guidelines included Federal
agencies that are such scientific bodies, including NIH, CDC, and USDA/
ARS. Accordingly, the statements provided in the notification in
support of the claim may be attributable to appropriate Federal
scientific bodies or to their employees.
Finally, however, none of the 11 statements discussed in sections
III.A through III.K of this document was found to be an authoritative
statement.
A. Statement 1
Statement 1 reads: ``Beta-carotene and other pro-vitamin a
carotenoids can be converted to vitamin A in the body. Interest in the
carotenoids has increased in recent years because of the accumulation
of a large body of evidence that foods high in carotenoids are
protective against a variety of epithelial cancers.'' The notification
identified statement 1 as an ``authoritative statement'' for purposes
of making the claim that is the subject of this rulemaking. The
statement is found in a discussion on vitamins that is contained in
``Nutrition Monitoring in the United States--An Update Report on
Nutrition Monitoring'' that was prepared for USDA and the Public Health
Service of DHHS by the Life Sciences Research Office (SRO) of the
Federation of American Societies for Experimental Biology (FASEB) (DHHS
Publication No. (PHS) 89-1255, September 1989, 71). The notification
provided a photocopy of selected pages from the report.
The statement indicates that there is interest in the relationship
because of a growing body of evidence, but does not confirm that the
relationship is considered scientifically valid or well established.
Rather, the context suggests that further research would be worthwhile
and that the scientific evidence about the relationship is preliminary
or inconclusive, as described in section I.A.3 of ``Health Claims;
Vitamins C and E,'' which is published elsewhere in this issue of the
Federal Register.
The agency notes that the report was prepared under a DHHS contract
by LSRO/FASEB, an organization that is neither a Federal Government
agency nor affiliated with the National Academy of Sciences (NAS).
Contractual activities involved in the preparation of the report were
overseen by several Federal agencies that participate in the National
Nutrition Monitoring System (NNMS). The report provides an independent
expert panel's review of the dietary and nutritional status of the U.S.
population, as well as the factors that determine status, based on
information available through the NNMS; the report is an advisory
document for the Government agencies. A disclaimer that appears on the
inside front cover of the report, which was not included in the
notification, states that, although the report was printed and
distributed as part of a series of reports from the NNMS, ``the
interpretations contained in this report do not necessarily express the
views or policies of the U.S. Government and its constituent agencies''
(Ref. 2). Additionally, as noted in the foreword of the report (page
vii), representatives of participating Federal Government agencies
``reviewed final drafts of the report for technical accuracy and
satisfaction of the scope of work'' (Ref. 2).
Given this disclaimer and the statement from the foreword, the
component of the submitter's notification that provided ``a concise
description of the basis upon which [the submitter] relied for
determining that the requirements of [403(r)(3)(C)(i)] have been
satisfied'' (as required by 403(r)(3)(C)(ii)(I) of the act) needed to
address why this statement was in fact an authoritative statement. It
did not. The disclaimer indicates that Federal Government agencies
cannot be considered to have ``published'' the report in the sense that
it represents official policy of the agencies, as discussed in section
I.A.2 of ``Health Claims; Vitamins C and E,'' which is published
elsewhere in this issue of the Federal Register. The foreword of the
report indicates that it may involve a deliberative review of the
scientific evidence about the dietary and nutritional status of the
U.S. population, but that it does not involve a deliberative review of
the scientific evidence about diet/disease relationships. Further, the
foreword indicates that the Federal agencies did not themselves conduct
a deliberative review of the scientific evidence necessary for the
statements in the report to be ``authoritative statements,'' as
described in section I.A.3 of ``Health Claims; Vitamins C and E,''
which is published elsewhere in this issue of the Federal Register, but
rather only a review for technical accuracy of a final draft of the
report itself.
FDA concludes that the statement is not an ``authoritative
statement'' because it indicates that the scientific evidence is
preliminary or inconclusive, that it does not reflect the official
policy of an appropriate scientific body, and that no appropriate
scientific body has conducted a deliberative review of the scientific
evidence.
B. Statement 2
Statement 2 reads: ``The antioxidant nutrients found in plant foods
(e.g., vitamin C, carotenoids, vitamin E, and certain minerals) are
presently of great interest to scientists and the public because of
their potentially beneficial role in reducing the risk of cancer and
certain other chronic diseases.'' The notification identified statement
2 as an ``authoritative statement'' for purposes of making the claim
that is the subject of this rulemaking. The statement is from an
electronic version of ``Nutrition and Your Health: Dietary Guidelines
for Americans'' (Home and Garden Bulletin No. 232, Fourth Ed., 1995),
hereinafter referred to as the ``dietary guidelines,'' issued jointly
by DHHS and USDA and provided on the Internet (``http:www.usda.gov/fcs/
library/0102-1.txt'' accessed on 12/5/97). The submitted material
consists of selected pages reprinted from the Internet information,
which identifies the seven dietary guidelines and gives background
[[Page 34094]]
information on the use of, and reasons for, the guidelines. The dietary
guidelines reflect the findings of a panel of scientists concerning the
dietary recommendations to be made to the U.S. population, and the
guidelines are based on a deliberative review of the scientific
evidence about the nutrient/disease relationships that the guidelines
address. The subject statement is found within the discussion that
accompanies the recommendation to ``Choose a diet with plenty of grain
products, vegetables, and fruits.''
The statement indicates that a relationship between antioxidant
nutrients and cancer and other chronic disease is ``of great interest''
because of a ``potentially beneficial role.'' The statement points to
the need for future research and suggests that whether a relationship
exists should be the subject of scientific study, but does not indicate
that there exists a scientifically sound relationship that should be
accorded a presumption of validity. This assessment is further
supported by the fact that the subject of the dietary guideline is the
dietary importance of grain products, vegetables, and fruits, not the
specific impact of antioxidant nutrients, vitamin A and beta-carotene,
per se. FDA notes that, consistent with the dietary guidelines, the
agency has authorized a health claim for the relationship between
cancer and fruits and vegetables that contain vitamins A (as beta-
carotene) as well as vitamin C and dietary fiber (21 CFR 101.78).
On this basis, FDA has concluded that the statement is not an
``authoritative statement'' under section 403(r)(3)(C) of the act
because the statement indicates that the scientific evidence about the
relationship in question is preliminary or inconclusive, as discussed
in section I.A.3 of the Federal Register ``Health Claims; Vitamins C
and E,'' which is published elsewhere in this issue of the Federal
Register.
The dietary guidelines is the product of a periodic review by a
group of Federal agencies, the most recent review having been completed
in 1995. FDA did not attempt to reconvene this group of Federal
agencies to consult with it about whether the statement is an
authoritative statement because, as discussed previously, the wording
and context of the statement show that it is not an authoritative
statement under section 403(r)(3)(C) of the act.
C. Statement 3
Statement 3 reads: ``If the findings hold up in further research,
eating more vegetables rich in beta-carotene and related carotenoids-
lutein and lycopene-may help people ward off a cold or flu as well as
protect from cancer * * *. The findings also suggest that carotenoid-
rich vegetables also stimulate the immune system.'' The notification
identified statement 3 as an ``authoritative statement'' for purposes
of making the claim that is the subject of this rulemaking. The
statement is found in Human Nutrition (quarterly reports of selected
research projects, 4th quarter 1996) issued by the USDA's ARS and
provided on the Internet (``http://www.ars.usda.gov/is/qtr/q496/
hn496.htm'' accessed on 12/3/97). Human Nutrition is a periodic
compilation of brief (one paragraph) descriptions of ongoing research
being conducted within the various ARS facilities. The subject
statement (submitted to the agency as a hardcopy reprint from the
Internet) appears in a description of research entitled: ``Daily
servings of dark green and deep yellow vegetables and tomatoes boost
immune response, a preliminary study suggests.'' The paragraph
describes the nature and outcome of one ARS study and is attributed to
Tim R. Kramer and Beverly Clevidence of the USDA Beltsville Human
Nutrition Research Center in Beltsville, MD. The agency notes that the
research is identified as a ``preliminary study.''
The context of the paragraph, as well as the wording of the
statement (i.e., ``if the findings hold up''), suggests that the
statement is based on preliminary research and that further study is
needed. As such, the statement appears to indicate that the scientific
evidence about the relationship is preliminary or inconclusive.
The agency asked USDA whether the statement is an ``authoritative
statement'' under FDAMA. USDA responded to FDA that the statement is
not an authoritative statement of USDA because it was not based upon a
deliberative review of the scientific evidence regarding a relationship
between the nutrient and the disease in question (Ref. 3). USDA
explained that the ARS quarterly reports describe progress on
individual projects without a deliberative review of all relevant
scientific evidence. Therefore, FDA has concluded that the statement is
not an ``authoritative statement'' under section 403(r)(C)(3) of the
act because it is not based on a deliberative review of the scientific
evidence.
D. Statement 4
Statement 4 reads: ``This research involving cells provides data
which supports the general hypothesis that beta-carotene and lutein
protect cells by serving as antioxidants.'' The notification identified
statement 4 as an ``authoritative statement'' for purposes of making
the claim that is the subject of this rulemaking. The statement is
found in a one paragraph interpretative summary of a research report
from Technology Transfer Information Center, TEKTRAN of USDA/ARS
entitled ``Beta-carotene and Lutein Protect the Plasma Membrane of
HEPG2 Human Liver Cells Against Oxidant-induced Damage,'' and provided
on the Internet (``http://www.nalusda.gov/ttic/tektran/data/000006/92/
0000069264.html'' accessed on 12/3/97) (ARS Report Number 69264). It
describes the nature and outcome of one study, which is attributed to
Keith J. Martin, Mark L. Failla, and James C. Smith, Jr.
The statement is not ``about the relationship between a nutrient
and a disease or health-related condition'' because no disease is
identified in the statement. Therefore, FDA has concluded that the
statement does not address a disease or health-related condition and
therefore is not an ``authoritative statement'' under section
403(r)(C)(3) of the act, as described in section I.A.1 of ``Health
Claims; Vitamins C and E,'' which is published elsewhere in this issue
of the Federal Register.
E. Statement 5
Statement 5 reads: ``[Antioxidants] may help prevent disease.
Antioxidants fight harmful molecules called oxygen free radicals, which
are created by the body as cells go about their normal business of
producing energy * * *. [S]ome studies show that antioxidants may help
prevent heart disease, some cancers, cataracts, and other health
problems that are more common as people get older.'' The notification
identified statement 5 as an ``authoritative statement'' for purposes
of making the claim that is the subject of this rulemaking. The
statement is found within an information piece entitled: ``Life
Extension: Science or Fiction?'' that is provided on the Internet by
the Administration on Aging and which includes statements from the
``Age Page'' of the National Institute on Aging (an Institute of the
NIH) (``http://www.aoa.dhhs.gov/aoa/pages/agepages/lifextsn.html''
accessed on 12/2/97). This electronically available information
(submitted to the agency as a hardcopy reprint from the Internet
information) is dated 1994, is approximately two standard printed pages
in length, and is described as being intended to inform the reader
about chemicals being studied that may play a role in aging and what
scientists have learned about them so far. Topics
[[Page 34095]]
covered include: Antioxidants, DNA, DHEA, and other hormones. Ten tips
for healthy aging are also included. The section on antioxidants is 14
sentences in length and includes the 3 sentences identified as the
subject statement. The agency notes that the last sentence of the
antioxidant section is: ``More research is needed before specific
recommendations can be made.''
FDA asked NIH whether the statement is an ``authoritative
statement'' under FDAMA. NIH responded to FDA that the statement is not
an authoritative statement of NIH because it was prepared by an
individual from the National Institute on Aging and is not based on a
deliberative review of scientific evidence regarding the nutrient-
disease relationship in question (Ref. 4). Therefore, FDA has concluded
that the statement is not an ``authoritative statement'' under section
403(r)(3)(C) of the act because it is not based on a deliberative
review of the scientific evidence.
F. Statement 6
Statement 6 reads: ``As potent antioxidants, [lutein and lycopene]
are thought to contribute to the lower rates of heart disease, cancer
and other diseases of aging among populations that eat a lot of fruits
and vegetables.'' The notification identified statement 6 as an
``authoritative statement'' for purposes of making the claim that is
the subject of this rulemaking. The statement is found within an
information piece, ``BHNRC Success Stories,'' provided on the Internet
by USDA/ARS Beltsville Human Nutrition Research Center and entitled:
``Carotenoids Show Their Real Colors'' (``http://www.barc.usda.gov/
bhnrc/success.htm'' accessed on 12/4/97). This electronically available
information (submitted to the agency as a hardcopy reprint from the
Internet information) is undated. The section on carotenoids is three
brief paragraphs in length and describes the nature and outcome of a
single ARS study attributed to Tim Kramer and Beverly Clevidence. The
same study was also referenced in ARS's Human Nutrition quarterly
report as noted in the discussion of statement 3 in section III.C of
this document.
The context of the section, as well as the wording of the statement
(i.e., ``are thought''), suggests that the statement is based on
preliminary research and that further study is needed. As such, the
statement appears to indicate that the scientific evidence about the
relationship is preliminary or inconclusive.
The agency asked USDA whether the statement is an ``authoritative
statement'' under FDAMA. USDA responded to FDA that the statement is
not an authoritative statement of USDA because it was not based upon a
deliberative review of the scientific evidence regarding a relationship
between the nutrient and the disease in question (Ref. 3). USDA
explained that the ARS ``BHNRC Success Stories'' describe progress on
individual projects without a deliberative review of all relevant
scientific evidence. Therefore, FDA has concluded that the statement is
not an ``authoritative statement'' under section 403(r)(C)(3) of the
act because it is not based on a deliberative review of the scientific
evidence.
G. Statement 7
Statement 7 reads: ``Researchers also found more evidence
suggesting that carotenes act as antioxidants to protect the body from
harmful oxidation. Antioxidants are thought to help prevent heart
attack, stroke and cancer. During the low-carotene stints, researchers
recorded several biochemical signs of oxidative damage.'' The
notification identified statement 7 as an ``authoritative statement''
for purposes of making the claim that is the subject of this
rulemaking. The statement is found in Human Nutrition (quarterly
reports of selected research projects, 4th quarter 1996) (see
discussion of statement 3 in section III.C of this document), which is
issued by the USDA's ARS and provided on the Internet (``http://
www.ars.usda.gov/is/qtr/q496/hn496.htm'' accessed on 12/3/97) in a
description of research entitled: ``Do carotenoids--the bright red,
yellow and orange pigments in fruits and vegetables--warrant a
Recommended Dietary Allowance?'' The paragraph describes the nature and
outcome of two ARS studies and is attributed to Betty Burri of the
Western Human Nutrition Research Center in San Francisco, CA. The
agency notes that the final sentence states: ``Further ARS studies will
try to shed more light on whether a specific minimum daily intake of
carotenoids is important for good health.''
The context of the paragraph, as well as the wording of the
statement (i.e., ``are thought''), suggests that the statement is based
on preliminary research and that further study is needed. As such, the
statement appears to indicate that the scientific evidence about the
relationship is preliminary or inconclusive.
The agency asked USDA whether the statement is an ``authoritative
statement'' under FDAMA. USDA responded to FDA that the statement is
not an authoritative statement of USDA because it was not based upon a
deliberative review of the scientific evidence regarding a relationship
between the nutrient and the disease in question (Ref. 3). Therefore,
FDA has concluded that the statement is not an ``authoritative
statement'' under section 403(r)(C)(3) of the act because it is not
based on a deliberative review of the scientific evidence.
H. Statement 8
Statement 8 reads: ``[H]igh dietary carotene and possibly vitamins
C and E and folate are associated with reduced risk for cervical
cancer.'' The notification identified statement 8 as an ``authoritative
statement'' for purposes of making the claim that is the subject of
this rulemaking. The statement is found in information provided on the
Internet by the NCI, an institute of NIH, in an article entitled:
``Prevention of Cervical Cancer'' and disseminated as part of ``PDQ--
Detection & Prevention--Health Professionals'' (PDQ stands for
physicians data query) (``http://cancernet.nci.nih.gov/clinpdq/
screening/Prevention__of__cervical__ cancer__Physician.html'' accessed
on 12/1/97). This electronically available information (submitted as a
hardcopy reprint from the Internet information) is undated,
approximately nine standard printed pages in length, and is described
as intended for use by doctors and other health care professionals. The
subject sentence is one of several sentences summarizing research on
the intake of micronutrients and the risk of squamous intraepithelial
lesion (SIL) and cervical cancer.
FDA asked NIH whether this was an ``authoritative statement'' under
FDAMA. NIH responded that the statement was not an authoritative
statement of NIH and does not reflect consensus within NIH (Ref. 4).
NIH explained that the evidence was reviewed by an editorial board for
PDQ, and the majority of the members are not Federal employees. The
statements contained in PDQ were reported by NIH to be ``state of the
art'' educational statements developed by an editorial board that
assesses the levels of scientific evidence supporting the statements.
In this instance, the scientific evidence for the nutrient-disease
relationship was not considered to be strong since it was based on
observational studies. NIH reiterated that the statement is not the
product of consensus process within the NCI and the statement has not
undergone formal review and clearance by the Director of the National
Institutes of Health.
Therefore, FDA has concluded that the statement is not an
``authoritative statement'' under section 403(r)(C)(3) of
[[Page 34096]]
the act because it does not reflect consensus within NIH, as discussed
in section I.A.2 of ``Health Claims: Vitamin C and E,'' which is
published elsewhere in this issue of the Federal Register.
I. Statement 9
Statement 9 reads: ``[B]eta carotene or vitamin A supplements have
reversed pre-cancerous conditions in people's mouths.'' The
notification identified statement 9 as an ``authoritative statement''
for purposes of making the claim that is the subject of this
rulemaking. The statement is found in Human Nutrition (quarterly
reports of selected research projects, 3rd quarter 1995) (see
discussion of statement 3 in section III.C of this document), which is
issued by the USDA's ARS and provided on the Internet (``http://
www.ars.usda.gov/is/qtr/q395/hn395.htm'' accessed on 12/3/97) in a
description of research entitled: ``A daily dose of blue-green algae
Spirulina may help prevent cancer of the mouth, a study shows.'' The
paragraph describes the nature and outcome of an ARS study and is
attributed to Padmanabhan P. Nair of the Beltsville Human Nutrition
Research Center, Beltsville, MD.
The agency asked USDA whether the statement is an ``authoritative
statement'' under FDAMA. USDA responded to FDA that the statement is
not an authoritative statement of USDA because it was not based upon a
deliberative review of the scientific evidence regarding a relationship
between the nutrient and the disease in question (Ref. 3). Therefore,
FDA has concluded that the statement is not an ``authoritative
statement'' under section 403(r)(C)(3) of the act because it is not
based on a deliberative review of the scientific evidence.
J. Statement 10
Statement 10 reads: ``Carotenoids or other plant components appear
to boost the immune system.'' The notification identified statement 10
as an ``authoritative statement'' for purposes of making the claim that
is the subject of this rulemaking. The statement is found in a one-
paragraph interpretative summary of a research report from Technology
Transfer Information Center, TEKTRAN of USDA/ARS entitled:
``Consumption of Carotenoid-Rich Vegetables Increases T-Lymphocyte
Proliferation and Plasma Levels of Carotenoid Oxidation Products'' and
provided on the Internet (``http://www.nalusda.gov/ttic/tektran/data/
000007/41/0000074185.html'' accessed on 12/3/97) (ARS Report Number
74185). It describes the nature and outcome of one study, which is
attributed to ten researchers, the first author being Beverly
Clevidence.
FDA finds that the statement is not ``about the relationship
between a nutrient and a disease or health-related condition'' because
no disease is identified in the statement. Therefore, FDA has concluded
that the statement does not address a disease or health-related
condition and therefore is not an ``authoritative statement'' under
section 403(r)(C)(3) of the act.
K. Statement 11
Statement 11 reads: ``A wealth of epidemiological evidence has
linked a high intake of green leafy and deep yellow vegetables--both
rich in beta- carotene--with lower rates of many types of cancer * * *.
Men over 65 who took a 50-milligram beta-carotene supplement every
other day during the 12-year study had natural killer cells that were
more active than their counterparts who got a placebo. Natural killer
cells--or NK cells--are the immune system's sentinels, ever on watch
for viruses and cancer cells.'' The notification identified statement
11 as an ``authoritative statement'' for purposes of making the claim
that is the subject of this rulemaking. The statement is found in Human
Nutrition (quarterly reports of selected research projects, 4th quarter
1996) (see discussion of statement 3 in section III.C of this
document), which is issued by the USDA's ARS and provided on the
Internet (``http://www.ars.usda.gov/is/qtr/q496/hn496.htm'' accessed on
12/3/97) in a description of research entitled: ``Older people who get
plenty of beta carotene may have a better chance of preventing virus
infections or a cancerous growth.'' The paragraph describes the nature
and outcome of a study and is attributed to Simin Nikbin Meydani of the
USDA Human Nutrition Research Center on Aging at Tufts, Boston, MA.
The agency asked USDA whether the statement is an ``authoritative
statement'' under FDAMA. USDA responded to FDA that the statement is
not an authoritative statement of USDA because it was not based upon a
deliberative review of the scientific evidence regarding a relationship
between the nutrient and the disease in question (Ref. 3). Therefore,
FDA has concluded that the statement is not an ``authoritative
statement'' under section 403(r)(C)(3) of the act because it is not
based on a deliberative review of the scientific evidence.
In summary, FDA has concluded that the notification does not
include any authoritative statements published by a scientific body as
required by section 403(r)(3)(C) of the act. Accordingly, the subject
claim relating to the relationship between antioxidant vitamin A and
beta-carotene and the risk in adults of atherosclerosis, coronary heart
disease, and certain cancers is not authorized under section
403(r)(3)(C) of the act and is, therefore, prohibited. The agency notes
that, at any future time, a notification may be submitted to the agency
that bases such a claim or claims on a statement that meets the
requirements of section 403(r)(3)(C) of the act. If there is no
authoritative statement that may serve as a basis for such claims, an
interested person may petition the agency under section 403(r)(4) and
21 CFR 10.70 to authorize the health claim or claims by regulation
under section 403(r)(3)(B).
IV. Issuance of an Interim Final Rule, Immediate Effective Date,
and Opportunity for Public Comment
For the reasons described in this section of this document, FDA is
issuing this rule as an interim final rule, effective immediately, with
an opportunity for public comment. New section 403(r)(7)(B) of the act,
added by section 301 of FDAMA, provides that FDA ``may make proposed
regulations issued under [section 403(r)] effective upon publication
pending consideration of public comment and publication of a final
regulation'' if the agency ``determines that such action is necessary *
* * to enable [FDA] to act promptly to ban or modify a claim'' under
section 403(r) of the act. For purposes of judicial review, ``[s]uch
proposed regulations shall be deemed final agency action.'' The
legislative history indicates that the agency should issue rules under
this authority as interim final rules (H. Conf. Rept. No. 105-399, at
98 (1997)).
As described previously in section III of this document, FDA has
determined that the statements submitted in support of the prospective
health claim do not meet the requirements for authoritative statements
in section 403(r)(3)(C) of the act. FDA has determined that it is
necessary to act promptly to prohibit the claim's use under section
403(r)(3)(C) of the act, and, accordingly, is issuing this interim
final rule to ban its use under section 403(r)(3)(C).
FDA invites public comment on this interim final rule. The agency
will consider modifications to this interim final rule based on
comments made during the comment period. Interested persons may, on or
before September 8, 1998, submit to the Dockets Management Branch
(address above) written comments regarding this interim
[[Page 34097]]
final rule. Comments must be received by that date. Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
V. Environmental Impact
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Analysis of Economic Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of this interim final rule under
Executive Order 12866. Executive Order 12866 directs Federal agencies
to assess the costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). According to Executive Order 12866, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million; adversely affecting in a material way a sector of the economy,
competition, or jobs; or if it raises novel legal or policy issues. FDA
finds that this interim final rule is not a significant regulatory
action as defined by Executive Order 12866. In addition, it has been
determined that this interim final rule is not a major rule for the
purpose of congressional review.
If in the future FDA authorizes health claims relating to the
relationship between antioxidant vitamin A and beta-carotene and the
risk in adults of atherosclerosis, coronary heart disease, and certain
cancers after finding that there is significant scientific agreement
about these relationships, the cost to consumers of prohibiting this
claim at this time would be the cost of having kept, in the interim,
information from appearing in food labeling that would ultimately be
shown to be scientifically valid, truthful, and not misleading. At this
time, the benefit to consumers of prohibiting this claim is that a
claim that has not been shown to be scientifically valid will not
appear in food labeling. Accordingly, consumers will be able generally
to have confidence when they read food labeling that any diet/disease
relationship information in that labeling has been shown to be
scientifically valid.
A health claim relating to the relationship between antioxidant
vitamin A and beta-carotene and the risk in adults of atherosclerosis,
coronary heart disease, and certain cancers has not been authorized
under existing regulations. The prohibition of this claim in this
interim final rule results in no regulatory changes for firms, and
therefore no costs to firms are attributable to this interim final
rule.
B. Small Entity Analysis
FDA has examined the impacts of this interim final rule under the
Regulatory Flexibility Act. The Regulatory Flexibility Act (5 U.S.C.
601-612) requires Federal agencies to consider alternatives that would
minimize the economic impact of their regulations on small businesses
and other small entities. In compliance with the Regulatory Flexibility
Act, FDA finds that this interim final rule will not have a significant
impact on a substantial number of small entities.
A health claim related to the relationship between antioxidant
vitamin A and beta-carotene and the risk in adults of atherosclerosis,
coronary heart disease, and certain cancers has not been authorized
under existing regulations. The prohibition of this claim in this
interim final rule results in no regulatory changes for firms, and
therefore this interim final rule will not result in a significant
increase in costs to any small entity. Therefore, this interim final
rule will not have a significant economic impact on a substantial
number of small entities. Accordingly, under the Regulatory Flexibility
Act (5 U.S.C. 601-612), the agency certifies that this interim final
rule will not have a significant economic impact on a substantial
number of small entities.
C. Unfunded Mandates Reform Act of 1995
FDA has examined the impacts of this interim final rule under the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This
interim final rule does not trigger the requirement for a written
statement under section 202(a) of UMRA because it does not impose a
mandate that results in an expenditure of $100 million or more by
State, local, and tribal governments in the aggregate, or by the
private sector, in any 1 year.
VII. The Paperwork Reduction Act of 1995
This interim final rule contains no collections of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
VIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Notification to Donna E. Shalala, DHHS, from Jonathan W.
Emord et al., Emord & Associates, P. C., Counsel for Weider
Nutrition International, Inc., February 23, 1998.
2. LSRO, FASEB, ``Nutrition Monitoring in the United States--An
Update Report on Nutrition Monitoring,'' prepared for USDA and DHHS,
DHHS Pub. No. (PHS) 89-1255, PHS, DHHS, U.S. Government Printing
Office, Washington, DC, inside front cover and pp. iii to vii,
September, 1989.
3. Letter to Christine Lewis, CFSAN, FDA, from Eileen Kennedy,
USDA, May 7, 1998.
4. Letter to Christine Lewis, CFSAN, FDA, from William R.
Harlan, NIH, April 30, 1998.
Dated: June 16, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-16455 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F
