34110 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 omega-3 fatty

acids 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 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.

Dated: June 16, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–16459 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

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.

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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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 wellknown 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.
34112 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0421]

Food Labeling: Health Claims; Zinc

and the Body’s Ability to Fight

Infection and Heal Wounds in Adults

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim final rule.

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 zinc and the

body’s ability to fight infection and heal

wounds in adults. This 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