Food Labeling: Health Claims; Garlic, Reduction of Serum Cholesterol, and the Risk of Cardiovascular Disease in Adults

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