[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34097-34101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16456]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0427]
Food Labeling: Health Claims; B-Complex Vitamins, Lowered
Homocysteine Levels, 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 B-complex vitamins (folic acid, vitamin
B6, vitamin B12), lowering elevated serum
homocysteine levels, 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
[[Page 34098]]
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 (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 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 third claim in the
notification. The notification included four statements that the
submitter identified as authoritative statements on which the following
claim is based: ``B-complex vitamins-Folic Acid, Vitamin B6,
Vitamin B12--may reduce the risk in adults of cardiovascular
disease by lowering elevated serum homocysteine levels, one of the many
factors implicated in that disease. Sources of B-complex vitamins
include whole and enriched grains, green leafy vegetables, fish, dry
beans, red meat, and dietary supplements.''
The first sentence of this claim will be discussed in greater
detail section III of this document. The second sentence, ``Sources of
B-complex vitamins include whole and enriched grains, green leafy
vegetables, fish, dry beans, red meat, 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 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: ``B-complex vitamins--Folic Acid, Vitamin
B6, Vitamin B12--may reduce the risk in adults of
cardiovascular disease by lowering elevated serum homocysteine levels,
one of the many factors implicated in that disease.'' The agency has
determined that none of the four 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 four 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 four statements from quarterly reports from the
U.S. Department of Agriculture's (USDA) Agricultural Research Service
(ARS) from electronic versions provided on the Internet. Thus, the
statements in the notification are all attributable to USDA's ARS. FDA
believes that USDA/ARS is 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 an appropriate Federal scientific body or to its
employees.
Finally, however, none of the four statements discussed in sections
III.A through III.D of this document was found to be an authoritative
statement.
A. Statement 1
Statement 1 reads: ``A research team's new evidence confirms
earlier data that elevated levels of the amino acid homocysteine
increase the odds for significant narrowing of the arteries * * * The
Analysis also Showed that Insufficient Levels of Folate and, to a
Lesser Extent, Vitamin B6 contribute to increased risk of
artery narrowing. Like a see-saw, homocysteine levels go up as the
vitamins go down, and vice versa.'' The notification identified
Statement 1
[[Page 34099]]
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, 1st quarter
1995) issued by the USDA's ARS and provided on the Internet (``http://
www.ars.usda.gov/is/qtr/q195/hn195.htm'' accessed on 12/4/97). 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: ``Eating green vegetables, citric and other foods
rich in folate (folic acid) may help keep the arteries open, reducing
heart disease and stroke risks.'' The paragraph describes the nature
and outcome of one ARS study and is attributed to Jacob Selhub and Paul
Jaques of the Jean Mayer USDA Human Nutrition Research Center on Aging
at Tufts.
FDA 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 in ``Health Claims; Vitamins C
and E,'' which is published elsewhere in this issue of the Federal
Register.
B. Statement 2
Statement 2 reads: ``When people don't have enough of these
[vitamin B12 and folate] vitamins to metabolize homocysteine
it accumulates in the blood and damages the vessels.'' 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, 4th Quarter 1996) (see discussion of statement 1 in
section III.A of this document), which is issued by the USDA's ARS and
provided on the Internet (``http://www.ars.usda.gov/is/qtr/q496/
hn496.htm accessed'' on 12/3/97) in a description of research entitled:
``One or two alcoholic drinks a day can interfere with people's B
vitamin levels, according to a study of 41 men and women.'' The
paragraph describes the nature and outcome of one ARS study and is
attributed to Judith Hallfrisch of the USDA Beltsville Human Nutrition
Research Center on Aging.
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). 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.
C. Statement 3
Statement 3 reads: `` [T]he body needs [folate] to convert
homocysteine into a nontoxic amino acid and thus prevent damage to
blood vessels * * * Supplement users had the lowest homocysteine levels
but not much lower than frequent consumers of fruits, vegetables and
cereal.'' 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 Human Nutrition (quarterly
reports of selected research projects, 4th Quarter 1996) (see
discussion of statement 1 in section III.A of this document), which is
issued by the USDA's ARS and provided on the Internet (``http://
www.ars.usda.gov/is/qtr/q496/hn496.htm'' accessed on 12/3/97) in a
description of research entitled: ``Eating more fruits, vegetables, and
cold cereal fortified with folic acid--a form of folate--should
significantly reduce the risk of heart disease and stroke that comes
from having high blood levels of homocysteine, a new study shows.'' The
paragraph describes the nature and outcome of one ARS study and is
attributed to Katherine L. Tucker of the Jean Mayer USDA Human
Nutrition Research Center on Aging at Tufts, Boston, MA.
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). 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.
D. Statement 4
Statement 4 reads: ``Research has linked high homocysteine levels
to increased risk of heart disease and stroke.'' The notification
identified Statement 4 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 1995) (see discussion of Statement 1 in
section III.A of this document), which is issued by the USDA's ARS and
provided on the Internet (``http://www.ars.usda.gov/is/qtr/q395/
hn395.htm'' accessed on 12/3/97) in a description of research entitled
``Measuring blood levels of the amino acid homocysteine only after an
overnight fast could miss nearly half of the people with elevated
levels.'' The paragraph describes the nature and outcome of one ARS
study and is attributed to Andrew G. Bostom and Jacob Selhub of the
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts,
Boston, MA.
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). 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 any authoritative statement published by a scientific body of
the U.S. Government as required by section 403(r)(3)(C) of the act.
Accordingly, the subject claim relating to the relationship between B-
complex vitamins (folic acid, vitamin B6, vitamin
B12), lowering elevated serum homocysteine levels, 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
[[Page 34100]]
agency under section 403(r)(4) of the act and 21 CFR 101.70 to
authorize a health claim 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) of the act.
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 B-complex vitamins (folic acid, vitamin
B6, vitamin B12), lowering elevated serum
homocysteine levels, 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 B-complex
vitamins (folic acid, vitamin B6, vitamin B12),
lowering elevated serum homocysteine levels, 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 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 B-complex
vitamins (folic acid, vitamin B6, vitamin B12),
lowering elevated serum homocysteine levels, 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 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.
[[Page 34101]]
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. 98-16456 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F