[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34115-34117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16462]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0420]
Food Labeling: Health Claims; Vitamin K and Promotion of Proper
Blood Clotting and Improvement in Bone Health in Adults
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 health claim relating to
relationships between vitamin K and the promotion of proper blood
clotting and improvement in bone health in adults. 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 the notification, and, in conformity with the requirements of
FDAMA, the agency is prohibiting the claim as a health claim because
the claim does not characterize the relationship of the nutrient
vitamin K to a disease or health-related condition, as required by
section 303 of FDAMA; therefore, section 303 of FDAMA does not
authorize use of this claim as a health claim. Although the claim is
not a health claim, it may be the type of claim permissible as a
structure/function 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.
[[Page 34116]]
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)(3) and
(r)(2) of the act by adding new paragraphs (r)(2)(G), (r)(2)(H),
(r)(3)(C), and (r)(3)(D) 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 Risks 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.
Provided certain conditions are met, section 403(r)(3)(C) of the
act authorizes the use of claims ``of the type described in
subparagraph (1)(B).'' Section 403(r)(1)(B) of the act describes claims
that ``characterize[ ] the relationship of a[ ] nutrient * * * to a
disease or health-related condition.'' Accordingly, for a claim to be
authorized as a health claim under section 403(r)(3)(C) of the act, it
must characterize the relationship of a nutrient to a disease or
health-related condition.
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 ninth claim in the
notification. The notification included one statement that the
petitioner identified as an authoritative statement on which the
following claim is based: ``In adults, vitamin K promotes proper blood
clotting and may improve bone health. Sources of Vitamin K include
spinach, cabbage, turnip greens, broccoli, tomatoes, 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 Vitamin K include spinach, cabbage, turnip greens, broccoli,
tomatoes, 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) of the act (21
U.S.C. 321(n)). 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, vitamin K promotes proper blood clotting
and may improve bone health. In considering this claim, FDA notes that
blood clotting does not constitute a disease or health-related
condition. Proper blood clotting is a normal, physiological function
and vitamin K has a well-established role in this function. Bone
health, likewise, does not itself identify a disease or health-related
condition. The formation of healthy bones is a normal developmental
process to which a number of nutrients contribute. As such, the claim
characterizes a relationship of the nutrient to normal body process and
not a relationship of the nutrient to a disease or health-related
condition, as required by section 403(r)(3)(C) of the act. Accordingly,
the subject claim about a relationship between vitamin K and the
promotion of proper blood clotting and improvement in bone health is
not authorized as a health claim under section 403(r)(3)(C) of the act
and is, therefore, prohibited as a health claim.
However, the claim submitted, if truthful and not misleading and
depending upon the context, may be of the type known as a structure/
function claim and thus eligible to appear on the label or in labeling
of products under the exception for such claims for foods in section
201(g)(1)(C) of the act or on dietary supplements under section
403(r)(6) of the act. The agency notes that the phrase ``may improve
bone health,'' if used in a labeling context that suggests disease or
abnormality of the bone, would constitute an implied health claim and
it would cease to be a permissible structure/function claim in that
context.
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 claim is not a health claim and therefore is not authorized by
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
[[Page 34117]]
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.
Prohibiting a health claim about the association between vitamin K
and blood clotting and bone health will not result in any regulatory
changes for firms and thus, will not result in any costs to firms.
Because the proposed claim may be permissible as a structure/function
claim as discussed in section III of this document, firms may still be
able to communicate the same or similar information to consumers. This
prohibition will not result in either costs or 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 related to the association between vitamin K and the
promotion of proper blood clotting and improvement in bone health has
not been authorized under existing regulations. The prohibition of this
claim as a health 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 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. 98-16462 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F
