34104 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

osteoporosis provided that the food is

eligible for the claim and the claim is

consistent with the current regulations.

The prospective claim relating to the

relationship between calcium and bone

disease, specifically, increased bone

density and the risk of fractures, is not

consistent with the existing claim, and

would misbrand any food on which it

is used. Because firms can highlight the

relationship between calcium and

osteoporosis, that this prospective claim

would misbrand foods does not create

any lost opportunities for firms.

Therefore, this interim final rule results

in neither costs nor benefits.

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 calcium and

osteoporosis is authorized under

existing regulations. This interim final

rule results in no regulatory changes for

firms, and therefore, this interim final

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 the 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. Reference

The following reference has 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.

Dated: June 16, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–16457 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–0424]

Food Labeling: Health Claims;

Chromium and the Risk in Adults of

Hyperglycemia and the Effects of

Glucose Intolerance

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 chromium and the

risk in adults of hyperglycemia and the

effects of glucose intolerance. 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 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)), 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

fifth claim in the notification. The

notification included three statements
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34105

that the petitioner identified as

authoritative statements on which the

following claim is based: ‘‘In adults,

chromium may reduce the risk of

hyperglycemia and the effects of glucose

intolerance. Sources of chromium

include whole grains, brewer’s yeast,

cheese, and dietary supplements.’’

The first sentence of this claim will be

discussed in greater detail in section III

of this document. The agency notes that

this claim describes the relationship

between chromium and two diseases or

health-related conditions, and thus

reflects two prospective health claims.

The second sentence, ‘‘Sources of

chromium include whole grains,

brewer’s yeast, cheese, and dietary

supplements,’’ is not a health claim.

Given that the notification indicated

that it was 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 section 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, chromium may reduce

the risk of hyperglycemia and the effects

of glucose intolerance.’’ The agency has

determined that none of the three

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

three 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: (1) Two statements

from quarterly reports from the U.S.

Department of Agriculture’s (USDA)

Agricultural Research Service (ARS)

from electronic versions provided on

the Internet; and (2) one statement from

a report issued by the U.S. Surgeon

General. Thus, the statements in the

notification are attributable to USDA’s

ARS or to the Surgeon General. FDA

believes that USDA/ARS and the

Surgeon General, who is housed within

the U.S. Department of Health and

Human Services (DHHS), are scientific

bodies 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, none of the three

statements discussed in sections III.A

through C of this document was found

to be an authoritative statement.

A. Statement 1

Statement 1 reads: ‘‘Chromium

supplements—in two different

formulations—lowered blood pressure

in rats bred to spontaneously develop

hypertension * * * the supplements,

chromium picolinate and chromium

nicotinate, also reduced the formation of

damaging free radicals in the animals’

tissues, indicating that chromium can

act as an antioxidant * * * chromium

is essential for insulin to operate

efficiently and has been shown to

reduce diabetic symptoms and restore

glucose tolerance in studies of humans

and animals.’’ 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 Human Nutrition (quarterly

reports of selected research projects, 3d

quarter 1997) issued by USDA’s ARS

and provided on the Internet (‘‘http://

www.ars.usda.gov/is/qtr/q397/

hn397.htm’’ accessed on 11/26/97).

Human Nutrition is a periodic

compilation of brief (one paragraph)

descriptions of ongoing research being

conducted within the various ARS

facilities. The subject statement

(submitted to the agency as a hardcopy

reprint from the Internet) appears in a

description of research entitled:

‘‘Chromium supplements—in two

different formulations—lowered blood

pressure in rats bred to spontaneously

develop hypertension.’’ The paragraph,

which describes the nature and outcome

of one ARS study and which refers to

previous studies, is attributed to

Richard A. Anderson of the Beltsville

Human Nutrition Research Center,

Beltsville, MD.

The agency notes that the statement

focuses first on hypertension in rats,

then on the formation of free radicals in

rats. The third component of the

statement suggests that chromium has

an effect in reducing diabetic symptoms

and restoration of glucose tolerance in

humans as well as animals.

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

the ARS Quarterly Reports 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 described in

section I.A.3 of ‘‘Health Claims;

Vitamins C and E,’’ which is published

elsewhere in this issue of the Federal

Register.

B. Statement 2

Statement 2 reads: ‘‘In a 20-week ARS

study, rats that daily consumed more

than 2,000 times the estimated safe limit

of chromium for people showed no sign

of toxicity * * * [the findings] bring

into question the relevance of a study

done 2 years ago * * * that reported

DNA damage.’’

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 found in Human Nutrition

(quarterly reports of selected research

projects, 3d quarter 1997) (see

discussion of statement 1 in section

III.A of this document), which is issued

by USDA’s ARS and provided on the

Internet (‘‘http://www.ars.usda.gov/is/

qtr/q397/hn397.htm’’ accessed on 11/

26/97) in a description of research

entitled: ‘‘There’s good news for people

concerned about the safety of taking

chromium supplements.’’ The

paragraph describes the nature and

outcome of one ARS study on rats and
34106 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

is attributed to Richard A. Anderson of

the Beltsville Human Nutrition Research

Center.

FDA concludes that the statement

focuses on levels of intake considered

safe in rats and does not identify a

relationship between a nutrient and a

disease or health-related condition in

humans, as described in section I.A.1 of

‘‘Health Claims; Vitamins C and E,’’

which is published elsewhere in this

issue of the Federal Register. Thus, this

statement is not an ‘‘authoritative

statement’’ under section 403(r)(3)(C) of

the act because it is not about the

relationship between a nutrient and a

disease or health-related condition.

C. Statement 3

Statement 3 reads: ‘‘Scientists must

often draw inferences about the

relationships between dietary factors

and disease from animal studies or

human metabolic and population

studies that approach issues indirectly.’’

The notification identified Statement 3

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

the nature of scientific evidence

contained in ‘‘The Surgeon General’s

Report on Nutrition and Health—

Summary and Recommendations’’ that

was published by the Public Health

Service (PHS) of DHHS (1988).

FDA concludes that the statement

focuses on a general principle of

scientific inference and is not about the

relationship between a nutrient and a

disease or health-related condition.

Thus, this statement is not an

‘‘authoritative statement’’ under section

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

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 chromium and the risk in

adults of hyperglycemia and the effects

of glucose intolerance 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 or claims

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 claims, 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 or claims 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, 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

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)(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.

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 chromium and the risk in

adults of hyperglycemia and the effects

of glucose intolerance 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 related to the

association 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 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)
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