Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34097

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 antioxidant vitamin A and

beta-carotene and the risk in adults of

atherosclerosis, coronary heart disease,

and certain cancers 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 antioxidant

vitamin A and beta-carotene and the

risk in adults of atherosclerosis,

coronary heart disease, and certain

cancers 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 related to the

relationship between antioxidant

vitamin A and beta-carotene and the

risk in adults of atherosclerosis,

coronary heart disease, and certain

cancers 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 interim final

rule will not result in a significant

increase in costs to any small entity.

Therefore, this interim final 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 to vii, September, 1989.

3. Letter to Christine Lewis, CFSAN, FDA,

from Eileen Kennedy, USDA, May 7, 1998.

4. Letter to Christine Lewis, CFSAN, FDA,

from William R. Harlan, NIH, April 30, 1998.

Dated: June 16, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–16455 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–0427]

Food Labeling: Health Claims; BComplex Vitamins, Lowered

Homocysteine Levels, and the Risk in

Adults of Cardiovascular Disease

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 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
34098 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 Bcomplex 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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 Bcomplex 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
34100 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0423]

Food Labeling: Health Claims; Calcium

Consumption by Adolescents and

Adults, Bone Density and The Risk of

Fractures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing this

interim final rule to prohibit the use on

foods of a claim relating to the

relationship between calcium, bone

density, and the risk of fractures. 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 is prohibiting the claim because

section 303 of FDAMA does not apply

when FDA has an existing regulation

authorizing a health claim about the

relationship between the nutrient and

the disease or health-related condition

at issue. A health claim concerning the

relationship between calcium and

osteoporosis is already authorized. 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. Submit written

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 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

published elsewhere 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

fourth claim in the notification. The

notification included five statements

that the petitioner identified as

authoritative statements on which the

following claim is based: ‘‘Calcium

consumption by adolescents and adults

increases bone density and may

decrease the risk of fractures. Sources of

calcium include dairy products,

broccoli, spinach, and dietary

supplements.’’

As discussed in greater detail in

section III of this document, FDA has

determined that the claim in the first

sentence addresses the same

relationship as provided for by an

existing authorized health claim,

specifically § 101.72 (21 CFR 101.72),

‘‘Health claims: calcium and

osteoporosis.’’ The second sentence,

‘‘Sources of calcium include dairy

products, broccoli, spinach, 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

A. Section 303 of FDAMA as it Relates

to Existing Authorized Health Claims

The claim at issue in this rulemaking

raises the question of the relationship of

the notification process established in

section 403(r)(3)(C) of the act to the

health claims authorization process

provided by section 403(r)(4) and

(r)(3)(B). In particular, when FDA has

issued a regulation under section

403(r)(3)(B) of the act that authorizes

claims that characterize the relationship

of a nutrient to a disease or healthrelated condition, may the notification

process of section 403(r)(3)(C) be used to

make a health claim about the same

relationship, thereby effectively

modifying the claims already authorized

by regulation?

Section 403(r)(3)(C) of the act, as

added by section 303 of FDAMA,

provides that a health claim ‘‘which is

not authorized by the Secretary in a

regulation promulgated in accordance

with [section 403(r)(3)(B)], shall be

authorized and may be made’’ if the

requirements of section 403(r)(3)(C) of

the act are met. When discussing the

effect of section 303 of FDAMA, the

Senate Report states: ‘‘Once FDA

regulations governing health claims