[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34107-34110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16459]


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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

[[Page 34108]]

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

[[Page 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

[[Page 34110]]

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