[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34110-34112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16460]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0422]
Food Labeling: Health Claims; Garlic, Reduction of Serum
Cholesterol, and the Risk of Cardiovascular Disease in Adults
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 garlic, decreased serum cholesterol, and the risk
in adults of cardiovascular disease. 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 the
statement that the petitioner submitted in that notification, and, in
conformity with the requirements of FDAMA, the agency is prohibiting
the claim because the statement submitted as the basis of the claim is
not an ``authoritative statement'' 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), 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 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 seventh claim in the
notification. The
[[Page 34111]]
notification included one statement that the petitioner identified as
an authoritative statement on which the following claim is based: ``In
adults, garlic may reduce serum cholesterol and the risk of
cardiovascular disease.'' This claim will be discussed in greater
detail in section III of this document.
III. Basis for the Action
FDA has reviewed the notification submitted in support of the
prospective claim: ``In adults, garlic may reduce serum cholesterol and
the risk of cardiovascular disease.'' The agency has determined that
the one statement submitted as a basis for this claim does not meet 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,
the statement 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 a statement from a U.S. Department of Agriculture
(USDA) press release provided on the Internet that refers to USDA's
Agricultural Research Service (ARS) for further information. Thus, the
statement in the notification is attributable to USDA's ARS. FDA
believes that USDA/ARS is 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). Accordingly, the statement provided in the
notification in support of the claim may be attributable to an
appropriate Federal scientific body or to its employees.
Finally, however, the statement discussed in this section of this
document was not found to be an authoritative statement.
Statement
The statement reads: ``Garlic is well-known for its medicinal
benefits: Lowering blood cholesterol, fighting off infections and
boosting the immune system.'' The notification identified the statement
as an ``authoritative statement'' for purposes of making the claim that
is the subject of this rulemaking. The statement is contained in a
press release from USDA, dated February 7, 1995, entitled: ``Nation's
First Garlic from True Seed Produced by USDA Scientist'' (Release No.
0102.95), which was provided on the Internet (``http://www.usda.gov/
news/releases/1995/02/0102'' accessed on 12/16/97). The press release
(submitted to the agency as a hardcopy reprint from the Internet) is
attributed to Linda Cooke and Maria Bynum (affiliation unknown), but
refers editors to Philip W. Simon at ARS for details. The press release
summarizes the development of the first garlic seeds and is
approximately two standard printed pages in length. The subject
sentence is included in a description of garlic and its uses.
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 informational pieces such as press releases 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 discussed in section I.A.3 of
``Health Claims; Vitamins C and E,'' which is published elsewhere in
this issue of the Federal Register.
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 garlic, decreased serum
cholesterol, and the risk in adults of cardiovascular disease 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 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
a claim, an interested person may petition the agency under section
403(r)(4) of the act and 21 CFR 101.70 to authorize a health claim 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 of the 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. 105-399, at 98
(1997)).
As described in section III of this document, FDA has determined
that the statement submitted in support of the prospective health claim
does not meet the requirements for an authoritative statement 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.
[[Page 34112]]
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 garlic, decreased serum cholesterol, and the risk
in adults of cardiovascular disease 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 garlic,
decreased serum cholesterol, and the risk in adults of cardiovascular
disease 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 relating to the relationship between garlic,
decreased serum cholesterol, and the risk in adults of cardiovascular
disease 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
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. 98-16460 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F