[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34104-34107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0424]
Food Labeling: Health Claims; Chromium and the Risk in Adults of
Hyperglycemia and the Effects of Glucose Intolerance
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 chromium and the risk in adults of hyperglycemia
and the effects of glucose intolerance. 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 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 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)), 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 a companion
document in this issue of the Federal Register (see ``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''). 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 fifth claim in the
notification. The notification included three statements
[[Page 34105]]
that the petitioner identified as authoritative statements on which the
following claim is based: ``In adults, chromium may reduce the risk of
hyperglycemia and the effects of glucose intolerance. Sources of
chromium include whole grains, brewer's yeast, cheese, and dietary
supplements.''
The first sentence of this claim will be discussed in greater
detail in section III of this document. The agency notes that this
claim describes the relationship between chromium and two diseases or
health-related conditions, and thus reflects two prospective health
claims. The second sentence, ``Sources of chromium include whole
grains, brewer's yeast, cheese, 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 section 403(a) and 201(n) (21 U.S.C. 321(n))
of the act. 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: ``In adults, chromium may reduce the risk of
hyperglycemia and the effects of glucose intolerance.'' The agency has
determined that none of the three 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 three 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: (1) Two statements from quarterly reports from the
U.S. Department of Agriculture's (USDA) Agricultural Research Service
(ARS) from electronic versions provided on the Internet; and (2) one
statement from a report issued by the U.S. Surgeon General. Thus, the
statements in the notification are attributable to USDA's ARS or to the
Surgeon General. FDA believes that USDA/ARS and the Surgeon General,
who is housed within the U.S. Department of Health and Human Services
(DHHS), are scientific bodies 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. 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 three statements discussed in
sections III.A through C of this document was found to be an
authoritative statement.
A. Statement 1
Statement 1 reads: ``Chromium supplements--in two different
formulations--lowered blood pressure in rats bred to spontaneously
develop hypertension * * * the supplements, chromium picolinate and
chromium nicotinate, also reduced the formation of damaging free
radicals in the animals' tissues, indicating that chromium can act as
an antioxidant * * * chromium is essential for insulin to operate
efficiently and has been shown to reduce diabetic symptoms and restore
glucose tolerance in studies of humans and animals.'' 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 Human Nutrition (quarterly reports of selected
research projects, 3d quarter 1997) issued by USDA's ARS and provided
on the Internet (``http://www.ars.usda.gov/is/qtr/q397/hn397.htm''
accessed on 11/26/97). 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: ``Chromium supplements--in two
different formulations--lowered blood pressure in rats bred to
spontaneously develop hypertension.'' The paragraph, which describes
the nature and outcome of one ARS study and which refers to previous
studies, is attributed to Richard A. Anderson of the Beltsville Human
Nutrition Research Center, Beltsville, MD.
The agency notes that the statement focuses first on hypertension
in rats, then on the formation of free radicals in rats. The third
component of the statement suggests that chromium has an effect in
reducing diabetic symptoms and restoration of glucose tolerance in
humans as well as animals.
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. 2). 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)(3)(C) of the
act because it is not based on a deliberative review of the scientific
evidence, 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.
B. Statement 2
Statement 2 reads: ``In a 20-week ARS study, rats that daily
consumed more than 2,000 times the estimated safe limit of chromium for
people showed no sign of toxicity * * * [the findings] bring into
question the relevance of a study done 2 years ago * * * that reported
DNA damage.''
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 found in Human Nutrition (quarterly
reports of selected research projects, 3d quarter 1997) (see discussion
of statement 1 in section III.A of this document), which is issued by
USDA's ARS and provided on the Internet (``http://www.ars.usda.gov/is/
qtr/q397/hn397.htm'' accessed on 11/26/97) in a description of research
entitled: ``There's good news for people concerned about the safety of
taking chromium supplements.'' The paragraph describes the nature and
outcome of one ARS study on rats and
[[Page 34106]]
is attributed to Richard A. Anderson of the Beltsville Human Nutrition
Research Center.
FDA concludes that the statement focuses on levels of intake
considered safe in rats and does not identify a relationship between a
nutrient and a disease or health-related condition in humans, 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.
Thus, this statement is not an ``authoritative statement'' under
section 403(r)(3)(C) of the act because it is not about the
relationship between a nutrient and a disease or health-related
condition.
C. Statement 3
Statement 3 reads: ``Scientists must often draw inferences about
the relationships between dietary factors and disease from animal
studies or human metabolic and population studies that approach issues
indirectly.'' 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 a discussion
on the nature of scientific evidence contained in ``The Surgeon
General's Report on Nutrition and Health--Summary and Recommendations''
that was published by the Public Health Service (PHS) of DHHS (1988).
FDA concludes that the statement focuses on a general principle of
scientific inference and is not about the relationship between a
nutrient and a disease or health-related condition. Thus, this
statement is not an ``authoritative statement'' under section
403(r)(3)(C) of the act.
In summary, FDA has concluded that the notification does not
include any authoritative statement 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 chromium and the risk in
adults of hyperglycemia and the effects of glucose intolerance 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) of the act and 21 CFR 10.70 to authorize a health
claim or claims by regulation under section 403(r)(3)(B) of the act.
IV. Issuance of an Interim Final Rule, Immediate Effective Date,
and Opportunity for Public Comment
For the reasons described in this section, 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. 105-399, at 98
(1997)).
As described 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 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 chromium and the risk in adults of hyperglycemia
and the effects of glucose intolerance 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 related to the association between chromium and the
risk in adults of hyperglycemia and the effects of glucose intolerance
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)
[[Page 34107]]
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 relating to the relationship between chromium and
the risk in adults of hyperglycemia and the effects of glucose
intolerance 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 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. Letter to Christine Lewis, CFSAN, FDA, from Eileen Kennedy,
USDA, May 7, 1998.
Dated: June 16, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-16458 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F
