[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