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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0419]

Food Labeling: Health Claims; Omega3 Fatty Acids and the Risk in Adults of

Cardiovascular Disease

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 omega-3 fatty

acids 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 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

interim final 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 (21 U.S.C. 343(r)(2) and (r)(3)) 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 ‘‘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’’, which is published elsewhere

in this issue of the Federal Register. 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

sixth claim in the notification. The

notification included two statements

that the petitioner identified as

authoritative statements on which the

following claim is based: ‘‘In adults,

Omega-3 Fatty Acids may reduce the

risk of cardiovascular disease. Sources

of Omega-3 Fatty Acids include fish,

seafood, flaxseed, soybeans, and dietary

supplements.’’

The first sentence of this claim will be

discussed in greater detail in section III

of this document. The second sentence,

‘‘Sources of Omega-3 Fatty Acids

include fish, seafood, flaxseed,

soybeans, and dietary supplements,’’ is

not a health claim. Given that the

notification indicated that it was
34108 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 sections 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, Omega-3 Fatty Acids

may reduce the risk of cardiovascular

disease.’’ The agency has determined

that neither of the two 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

two 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 statements from: (1) A

report on nutrition monitoring prepared

for the Department of Health and

Human Services (DHHS) and the U.S.

Department of Agriculture (USDA); and

(2) a USDA’s Agriculture Research

Service (ARS) press release provided on

the Internet. Thus, one statement in the

notification is attributable to USDA and

DHHS and is intended for use by

Federal agencies including the National

Institutes of Health (NIH), the Centers

for Disease Control and Prevention

(CDC), and USDA/ARS. The second

statement is attributable to USDA/ARS.

NIH and CDC are highlighted in the

statute as scientific bodies. FDA

believes that USDA/ARS is also 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) 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, neither of the two

statements discussed in section III.A

and III.B of this document was found to

be an authoritative statement.

A. Statement 1

Statement 1 reads: ‘‘Intake of

particular polyunsaturated fats, the

omega-3 fatty acids, may offer some

protection against the development of

clinical manifestations of

atherosclerosis by decreasing platelet

aggregation and clotting activity and

preventing arterial thrombosis.’’ 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 a discussion on coronary heart

disease that is contained in ‘‘Nutrition

Monitoring in the United States—An

Update Report on Nutrition Monitoring’’

that was prepared for USDA and the

Public Health Service of DHHS by the

Life Sciences Research Office (LSRO) of

the Federation of American Societies for

Experimental Biology (FASEB) (DHHS

Publication No. (PHS) 89–1255,

September 1989, 71). The notification

provided a photocopy of selected pages

from the report.

The wording and context of the

statement indicates that arterial

thrombosis as affected by omega-3 fatty

acids is a preliminary, albeit promising,

relationship, and does not yet constitute

an established relationship between

omega-3 fatty acids and heart disease.

As such, the statement appears to

indicate that the scientific evidence

about the relationship is preliminary or

inconclusive 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.

The agency notes that the report was

prepared under a DHHS contract by

LSRO/FASEB, an organization that is

neither a Federal Government agency

nor affiliated with the National

Academy of Sciences. Contractual

activities involved in the preparation of

the report were overseen by several

Federal agencies that participate in the

National Nutrition Monitoring System

(NNMS). The report provides an

independent expert panel’s review of

the dietary and nutritional status of the

U.S. population, as well as the factors

that determine status, based on

information available through the

NNMS; the report is an advisory

document for the Government agencies.

A disclaimer that appears on the inside

front cover of the report, which was not

included in the notification, states that,

although the report was printed and

distributed as part of a series of reports

from the NNMS, ‘‘the interpretations

contained in this report do not

necessarily express the views or policies

of the U.S. Government and its

constituent agencies’’ (Ref. 2).

Additionally, as noted in the foreword

of the report (page vii), representatives

of participating Federal Government

agencies ‘‘reviewed final drafts of the

report for technical accuracy and

satisfaction of the scope of work’’ (Ref.

2).

Given this disclaimer and the

statement from the foreword, the

component of the submitter’s

notification that provided ‘‘a concise

description of the basis upon which [the

submitter] relied for determining that

the requirements of [403(r)(3)(C)(i)] have

been satisfied’’ (as required by

403(r)(3)(C)(ii)(I) of the act) needed to

address why this statement was in fact

an authoritative statement. It did not.

The disclaimer indicates that Federal

Government agencies cannot be

considered to have ‘‘published’’ the

report in the sense that it represents

official policy of the agencies, as

discussed in section I.A.2 of ‘‘Health

Claims; Vitamins C and E,’’ which is

published elsewhere in this issue of the

Federal Register. The foreword of the

report indicates that it may involve a

deliberative review of the scientific

evidence about the dietary and

nutritional status of the U.S. population,

but that it does not involve a

deliberative review of the scientific

evidence about diet/disease

relationships. Further, the foreword

indicates that the Federal agencies did

not themselves conduct a deliberative

review of the scientific evidence

necessary for the statements in the

report to be ‘‘authoritative statements,’’

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, but rather only a

review for technical accuracy of a final

draft of the report itself.

FDA concludes that the statement is

not an ‘‘authoritative statement’’

because it indicates that the scientific

evidence is preliminary or inconclusive,

that it does not reflect the official policy
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34109

of an appropriate scientific body, and

that no appropriate scientific body has

conducted a deliberative review of the

scientific evidence.

B. Statement 2

Statement 2 reads: ‘‘In new soybean

oil varieties developed by the USDA’s

Agriculture Research Service palmitic

acid is replaced with oleic acid, which

has some health benefits. In addition,

omega-3 and omega-6 fatty acids, which

can actually lower cholesterol levels, are

at 7 and 60 percent respectively—

essentially the same as regular

soybeans.’’ 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 contained

in a press release from USDA’s ARS,

dated November 26, 1996, entitled:

‘‘New Soybeans Halve Saturated Fat,

Keep Nutrition,’’ which was provided

on the Internet (‘‘http://

www.ars.usda.gov/is/pr/

soyfat1196.htm’’ accessed on 12/4/97).

The press release (submitted to the

agency as a hardcopy reprint from the

Internet) is attributed to Jill Lee of ARS

and suggests that Joseph W. Burton

(USDA/ARS, Raleigh, NC) or James R.

Wilcox (USDA/ARS, West Lafayette, IN)

be contacted for details. It is

approximately two standard printed

pages in length and the subject sentence

is one of several sentences that

summarize the nutritional differences

between two new varieties of soybeans

compared with regular soybeans.

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. 3). 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.

In summary, FDA has concluded that

the notification does not include

authoritative statements published by

any scientific body as required by

section 403(r)(3)(C) of the act.

Accordingly, the subject claim relating

to the relationship between omega-3

fatty acids 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 10.70 to authorize a health

claim by regulation under section

403(r)(3)(B).

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. No.

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)(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 omega-3 fatty acids 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 omega-3 fatty

acids and the risk in adults of
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