Food Labeling: Health Claims; Omega-3 Fatty Acids and the Risk in Adults of Cardiovascular Disease

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N-0419]

Food Labeling: Health Claims; Omega-3 Fatty Acids and the Risk in

Adults of Cardiovascular Disease

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 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

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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

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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

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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]

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