Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34115

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 zinc and, in adults, the body’s

ability to fight infection and heal

wounds 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 zinc and, in

adults, the body’s ability to fight

infection and heal wounds 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 zinc and, in

adults, the body’s ability to fight

infection and heal wounds 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.

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–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. 98–16461 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

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.

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.
34116 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 healthrelated 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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