Food Labeling: Health Claims; Vitamin K and Promotion of Proper Blood Clotting and Improvement in Bone Health in Adults

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.

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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