[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