[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