34084 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0426]

Food Labeling: Health Claims;

Antioxidant Vitamins C and E and the

Risk in Adults of Atherosclerosis,

Coronary Heart Disease, Certain

Cancers, and Cataracts

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 antioxidant

vitamins C and E and the risk in adults

of atherosclerosis, coronary heart

disease, certain cancers, and cataracts.

This 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 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 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. These provisions of FDAMA

supplement the petition process for

nutrient content and health claims

provided by section 403(r)(4) (21 U.S.C.

343(r)(4)) and §§ 101.69 and 101.70 (21

CFR 101.69 and 101.70, respectively) by

providing an alternative for establishing

the scientific basis for such claims by

reliance 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.

The notification must contain specific

information including: (1) The exact

wording of the prospective nutrient

content claim or health claim; (2) a

concise description of the basis upon

which the petitioner relied for

determining that the requirements of

section 403(r)(2)(G)(i) of the act for

nutrient content claims or section

403(r)(3)(C)(i) for health claims have

been satisfied; (3) a copy of the

authoritative statement that serves as

the basis for the claim; and (4) a

balanced representation of the scientific

literature relating to the nutrient level

for a prospective nutrient content claim

or relating to the relationship between

the nutrient and the disease or healthrelated condition for a prospective

health claim. For a prospective nutrient

content claim, the authoritative

statement must identify the nutrient

level to which the claim refers. For a

prospective health claim, the

authoritative statement must be a

statement about the relationship

between a nutrient and a disease or

health-related condition to which the

claim refers. For both types of claims,

the authoritative statement must be

currently in effect and it must have been

published either by a scientific body of

the U.S. Government that has official

responsibility for public health

protection or research directly relating

to human nutrition (e.g., the National

Institutes of Health (NIH) or the Centers

for Disease Control and Prevention

(CDC)) or by the National Academy of

Sciences (NAS) or any of its

subdivisions (hereinafter referred to as a

‘‘scientific body’’).

Under new section 403(r)(2)(H) and

(r)(3)(D) of the act, such a claim may be

made beginning 120 days after

submission of the notification until: (1)

FDA has issued an effective regulation

that prohibits or modifies the claim; (2)

the agency has issued a regulation

finding that the requirements under

section 403(r)(2)(G) for a prospective

nutrient content claim or under section

403(r)(3)(C) for a prospective health

claim have not been met; or (3) a district

court of the United States in an

enforcement proceeding under chapter

III of the act has determined that the

requirements under section 403(r)(2)(G)

for a prospective nutrient content claim

or under section 403(r)(3)(C) for a

prospective health claim have not been

met. During the 120 days following

submission of a notification and before

the claim may appear on a food, the

agency may also notify any person who

is making the claim that the notification

did not include all of the required

information.

Section 304 of FDAMA permits

nutrient content claims based on

authoritative statements for both

conventional foods and for dietary

supplements because section 304

amended section 403(r)(2) of the act,

which provides for nutrient content

claims on both conventional foods and

dietary supplements. Section 303 of

FDAMA does not include provisions for

health claims for dietary supplements

based on authoritative statements,

however. In particular, section

403(r)(5)(D) of the act (21 U.S.C.

343(r)(5)(D)) specifies that health claims

for dietary supplements shall not be

subject to section 403(r)(3) of the act,

but rather to a procedure and standard

that FDA establishes by regulation. In

section 303 of FDAMA, Congress

amended section 403(r)(3) of the act,

which provides for procedures and

standards for health claims for

conventional foods, to allow for health

claims based on authoritative statements

for conventional foods, but Congress did

not amend section 403(r)(5)(D) of the

act.

Therefore, FDA believes that section

403(r)(3)(C) of the act authorizes use of

a health claim based on an authoritative

statement only on any conventional

food that provides an appropriate level

of the nutrient that is the subject of the

health claim, that does not exceed the

disqualifying levels identified in

§ 101.14(a)(5) (21 CFR 101.14(a)(5)), and

that otherwise complies with section

403(r)(3)(C) and all other provisions of

the act. Nevertheless, FDA has

tentatively concluded that, for health

claims authorized via the authoritative

statement procedure provided by

FDAMA, conventional foods and dietary

supplements should be subject to the

same standards and procedures. This

position is consistent with the agency’s

final rule that made dietary

supplements subject to the same general
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34085

requirements as apply to conventional

foods with respect to health claims (59

FR 395, January 4, 1994). This approach

is also consistent with the guidance of

the Commission on Dietary Supplement

Labels, which stated in its 1997 report

(Ref. 1) that the process for the approval

of health claims should remain the same

for dietary supplements and

conventional foods. Therefore, FDA

intends to issue a proposed rule to

provide for health claims based on

authoritative statements for dietary

supplements.

A. Authoritative Statements

Sections 303 and 304 of FDAMA

authorize the use of a health or nutrient

content claim based, in part, on an

‘‘authoritative statement.’’ In particular,

new section 403(r)(3)(C)(i) and

(r)(2)(G)(i) of the act states that such

claims are authorized and may be made

when ‘‘a scientific body * * * has

published an authoritative statement,

which is currently in effect.’’ For a

health claim, section 403(r)(3)(C)(i) of

the act requires that the statement must

be ‘‘about the relationship between a

nutrient and a disease or health-related

condition to which the claim refers.’’

For a nutrient content claim, section

403(r)(2)(G)(i) of the act requires that the

statement must be one ‘‘that identifies

the nutrient level to which the claim

refers.’’

Section 403(r)(3)(C) and (r)(2)(G) of

the act further requires that:

* * * [a] statement shall be regarded as an

authoritative statement of a scientific body

described in subclause (i) only if the

statement is published by the scientific body

and shall not include the statement of an

employee of the scientific body made in the

individual capacity of the employee.

Although Congress did not explicitly

define the term ‘‘authoritative

statement,’’ section 403(r)(3)(C) and

(r)(2)(G) of the act and the legislative

history clarify several characteristics

that Congress intended an ‘‘authoritative

statement’’ to have. Most significantly,

to be the basis for a health or nutrient

content claim, a statement must: (1)

Address certain subjects, namely, for a

health claim, it must be about the

relationship between a nutrient and a

disease or health-related condition to

which the claim refers, or, for a nutrient

content claim, it must identify the

nutrient level to which the claim refers;

(2) be published by an appropriate

scientific body and represent its official

position, and may not be, for example,

a statement of individual employees of

the scientific body made in the

individual capacities of the employees;

(3) be based on a deliberative review of

the scientific evidence on the subject of

the statement and not indicate that the

scientific evidence about the subject of

the statement is preliminary or

inconclusive; and (4) be currently in

effect. The aspects of these requirements

relevant to this rulemaking, and its

companion rulemakings publishing

elsewhere in this issue of the Federal

Register, are discussed in greater detail

in section I.A.1 of this document.

1. To Be the Basis for a Health or

Nutrient Content Claim, a Statement

Must Address One of Two Subjects

For a statement to be eligible for

consideration as an ‘‘authoritative

statement,’’ it must address certain

subjects. Section 403(r)(3)(C) of the act

provides that, for a health claim, it must

be ‘‘about the relationship between a

nutrient and a disease or health-related

condition to which the claim refers.’’

Section 403(r)(2)(G) of the act provides

that, for a nutrient content claim, it

must ‘‘identify the nutrient level to

which the claim refers.’’

There are several aspects to these

requirements. First, a statement cannot

be an ‘‘authoritative statement’’ under

section 403(r)(2)(G) or (r)(3)(C) of the act

if it identifies no nutrient level or if it

is not about the relationship between a

nutrient and a disease or health-related

condition. For example, if a statement

refers to no nutrient, to no disease or

health-related condition, or to neither a

nutrient nor a disease or health-related

condition, it cannot be an authoritative

statement under section 403(r)(3)(C) of

the act. Second, if a statement is ‘‘about

the relationship between a nutrient and

a disease or health-related condition,’’

or if it ‘‘identif[ies] the nutrient level,’’

it must be about the relationship or

nutrient ‘‘to which the claim refers.’’

Moreover, the statement must be about

the relationship between a nutrient and

a disease or health-related condition in

humans or it must identify a nutrient

level for total daily consumption by

humans.

When evaluating what relationship a

statement is about, or what nutrient

level a statement identifies, it may be

necessary to consider the context in

which the statement appears. It is likely

that a submitter will identify excerpted

sentences as an ‘‘authoritative

statement.’’ The context in which these

excerpted sentences appears can be

relevant when determining the subject

of the statement. For example, sentences

immediately adjoining the excerpted

sentences or in a summary statement in

the document may clarify the disease

that is the subject of the excerpted

sentences.

Accordingly, the statutory

requirement in section 403(r)(3)(C)(ii)(II)

and (r)(2)(G)(ii)(II) of the act that a

notification include ‘‘a copy of the

statement referred to in subclause (i)

upon which [the] person [who

submitted the notification] relied in

making the claim,’’ means that the

entire document from which the

statement is excerpted should be

included in a notification. The agency

notes that submission of the entire

document is also relevant to other

determinations under section

403(r)(3)(C) and (r)(2)(G), such as

whether the scientific evidence about

the relationship or nutrient level at

issue is preliminary or inconclusive, as

discussed in section I.A.3 of this

document, and whether a health or

nutrient content claim is ‘‘stated in a

manner so that the claim is an accurate

representation of the authoritative

statement referred to in subclause (i),’’

as required by section 403(r)(3)(C)(iv)

and (r)(2)(G)(iv) of the act.

2. To Be the Basis for a Health or

Nutrient Content Claim, a Statement

Must Be Published by an Appropriate

Scientific Body and Represent the

Official Policy of That Body.

Section 403(r)(3)(C) and (r)(2)(G) of

the act requires that an ‘‘authoritative

statement’’ be ‘‘published.’’ The agency

understands the use of ‘‘published’’ in

section 403(r)(3)(C)(i) and (r)(2)(G)(i) to

mean that the statement must be

publicly available in print form (paper

or electronic).

The identical last sentence of section

403(r)(3)(C) and (r)(2)(G) of the act states

that:

* * * [a] statement shall be regarded as an

authoritative statement of a scientific body

described in subclause (i) only if the

statement is published by the scientific body

and shall not include the statement of an

employee of the scientific body made in the

individual capacity of the employee.

‘‘Published’’ as used in this sentence

means that the scientific body can be

considered to be the author of the

statement, in that the statement

represents the official policy of the

scientific body. Of course, the

statements of scientific bodies—indeed,

of organizations generally—are authored

by individuals. Yet statements that are

merely those of individual employees

made in the individual capacities of the

employees are not statements that have

been authored by, and so represent the

official policy of, the scientific body.

Similarly, in the case of Federal

scientific bodies with subdivisions,

such as NIH and CDC, section

403(r)(3)(C) and (r)(2)(G) indicates that

the scientific body, and not merely the

subdivision, can be considered to have

‘‘published’’ a statement within the
34086 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

meaning of those sections only if, as the

legislative history indicates, ‘‘statements

issued by entities such as NIH and CDC

reflect consensus within those

institutions’’ (H. Conf. Rept. 105–399, at

98 (1997)). Accordingly, to be

considered an ‘‘authoritative statement’’

under section 403(r)(3)(C) and (r)(2)(G),

a statement must represent the official

policy of a scientific body.

3. To Be the Basis for a Health or

Nutrient Content Claim, a Statement

Must Be Based on a Deliberative Review

of the Scientific Evidence on the Subject

of the Statement, and It Should Not

Indicate That the Scientific Evidence Is

Preliminary or Inconclusive

In section 403(r)(3)(C)(i) and

(r)(2)(G)(i) of the act, Congress required

that claims may be authorized only

when ‘‘a scientific body * * * has

published an authoritative statement,’’

not merely when a scientific body has

published a statement (emphasis

added). The use of ‘‘authoritative’’ here

indicates that a statement may not be

the basis for a health or nutrient content

claim merely because its source is a

scientific body, an authority on the

subject of the statement. A review of the

legislative history of sections 303 and

304 of FDAMA indicates that, to be

‘‘authoritative,’’ Congress intended that

a statement must be the product of a

deliberative review of the scientific

evidence on the subject of the statement.

In addition, the statement should not

indicate that the scientific evidence

about the subject of the statement is

preliminary or inconclusive.

Congress intended both that claims

based on authoritative statements

should have ‘‘a presumption of validity’’

(H. Rept. 105–306, at 16 and 17 (1997))

and that ‘‘more scientifically sound

nutrition information * * * be provided

to consumers through health and

nutrient content claims’’ based on

authoritative statements (H. Conf. Rept.

105–399, at 98 (1997) (emphasis added);

see also H. Rept. 105–306, at 16 (1997)

and S. Rept. 105–43, at 49 (1997)).

When FDA authorizes a health claim

by regulation under section 403(r)(3)(B)

of the act or establishes a Daily Value

that can serve as the basis for a nutrient

content claim, it conducts a deliberative

review of the scientific evidence about

the relationship between a nutrient and

a disease or health-related condition or

about the nutrient level at issue and

concludes that there is significant

scientific agreement about the

relationship or appropriate scientific

consensus about the nutrient level.

Congress intended that an ‘‘authoritative

statement’’ published by a scientific

body could be the basis for health and

nutrient content claims because the

‘‘authoritative statement’’ is to serve as

a presumptive surrogate for FDA’s

deliberative review of the scientific

evidence.

Congress therefore intended that an

‘‘authoritative statement’’ must be the

product of a deliberative review of the

scientific evidence on the subject of the

statement. For example, the House

Report states that:

[a]uthoritative scientific bodies, as part of

their official responsibilities for public health

protection, regularly undertake deliberative

reviews of the scientific evidence to evaluate

potential diet/disease relationships, and

issue authoritative statements concerning

such relationships.

(H. Rept. 105–306, at 16 (1997)). The

Senate Report repeats this idea, noting

that scientific bodies engage in:

* * * deliberative processes * * * in issuing

statements on matters of public health.

Important Federal public health

organizations, as part of their official

responsibilities, routinely review the

scientific evidence pertinent to diet and

disease relationships, and publish statements

developed through such reviews.

(S. Rept. 105–43, at 49 (1997)).

Moreover, only a statement that a

relationship between a nutrient and a

disease or health-related condition

exists or that identifies a level of a

nutrient—and not merely statements

about a possible relationship or level—

can serve as the basis for claims that

will provide consumers with

scientifically sound information. Only a

claim based on such a statement can be

accorded a presumption of validity.

Accordingly, a statement that

indicates, for example, that research

about a nutrient level or a relationship

between a nutrient and a disease or

health-related condition is preliminary

or inconclusive, that indicates that such

a relationship or a nutrient level is or

should be the subject of ongoing

scientific study, or that indicates the

direction for future research about such

a relationship or a nutrient level is not

‘‘authoritative.’’ When evaluating

whether a statement about a

relationship or nutrient level indicates

that the scientific evidence is

preliminary or inconclusive, the agency

intends to consider the context in which

the statement appears, as discussed in

section I.A.1 of this document. For

example, a statement of excerpted

sentences might not indicate that

research is preliminary or that there are

unresolved questions that require

additional study, but such qualifiers

could be found elsewhere in the

document.

The agency notes that, even if a

statement meets the criteria to be an

‘‘authoritative statement,’’ Congress also

provided under new section

403(r)(3)(D)(i) of the act that FDA have

the authority to prohibit a health claim

based on an authoritative statement

when there is not significant scientific

agreement that there is a relationship

between the nutrient and the disease or

health-related condition in question. As

the Senate Report on the provision

explains, in an agency rulemaking to

prohibit or modify a health claim based

on an authoritative statement, ‘‘the

standards and criteria for health claims

prescribed by section 403(r)(3) and

implementing regulations, including the

significan[t] scientific agreement

standard, would be fully applicable’’ (S.

Rept. 105–43, at 51 (1997); see also H.

Rept. 105–306, at 15 (1997)).

With respect to nutrient content

claims, Congress indicated that the

agency is to determine ‘‘whether the

authoritative statement upon which the

notification is based is supported by

scientific consensus to the extent * * *

appropriate to allow the claim’’ (H.

Rept. 105–306, at 17–18 (1997)), an

evaluation that FDA would make under

section 403(r)(2)(H) of the act, after the

Federal scientific body that is the source

of a statement determines that the

statement reflects consensus within it,

as discussed in section I.A.2 of this

document.

B. Review Process

As allowed by sections 303 and 304

of FDAMA, health claims and nutrient

content claims based on authoritative

statements from Federal scientific

bodies or NAS may be made on foods

in interstate commerce as soon as 120

days after submission of a notification of

the claim to FDA. Upon receipt of a

notification, FDA intends to review the

notification to determine whether the

components specified in section

403(r)(2)(G) and (r)(3)(C) are present

within the submission packet. When

such components are missing, FDA

intends to notify the submitter by letter

identifying one or more of these

components that is absent from the

notification packet.

If the necessary components are

present, FDA intends to determine, for

a health claim, what relationship

between a nutrient and disease or

health-related condition is at issue, or,

for a nutrient content claim, what

nutrient is at issue. If, by regulation

under section 403(r)(3)(B) of the act, the

agency has already authorized a health

claim about the relationship at issue,

then the notification provisions of

section 403(r)(3)(C) of the act may not be

used to modify the existing health claim

or to authorize the prospective health

claim. Similarly, if by rulemaking the
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34087

agency has already established a Daily

Value for the nutrient at issue, then the

notification provisions of section

403(r)(2)(G) of the act may not be used

to modify the existing Daily Value.

Instead, a health claim about the

relationship at issue or a nutrient

content claim referring to the nutrient at

issue may be made when the claim is

consistent with the existing health claim

regulation or with the established Daily

Value and the authorized terms for

nutrient content claims. Furthermore, if

the prospective claim refers to a

relationship or a nutrient that is not

addressed by the statement that is

identified as the ‘‘authoritative

statement’’ on which the claim is based,

then section 403(r)(3)(C) and (r)(2)(G) of

the act does not authorize the health or

nutrient content claim at issue. In each

case, FDA intends to notify the

submitter by letter that use of the claim

is not authorized under section

403(r)(3)(C) or (r)(2)(G) of the act, as

appropriate.

If, however, a prospective claim could

be authorized based on an appropriate

authoritative statement, and if the

prospective claim refers to a

relationship or nutrient that is

addressed by the statement that is

identified in the notification as the

‘‘authoritative statement,’’ FDA then

intends to evaluate further whether the

statement is an ‘‘authoritative

statement.’’ In particular, FDA intends

to determine for a statement, as a

threshold matter, whether: (1) It may be

attributable to a scientific body or to one

or more of its employees; (2) it is

publicly available in print form (paper

or electronic); and (3) the statement

indicates that the scientific evidence

about the relationship between a

nutrient and a disease or health-related

condition or a nutrient level is

preliminary or inconclusive. With

respect to the first of these issues, FDA

notes that it can determine that a

statement from a non-Federal body or

agency—such as a state university

school of public health—is not an

‘‘authoritative statement,’’ or that a

statement from a scientist who was not

an employee of an appropriate scientific

body is not an ‘‘authoritative

statement.’’ As a general matter,

however, only a scientific body can state

whether a statement that is attributable

to it or to one or more of its employees

actually represents the official policy of

the scientific body or not, and FDA

would therefore consult with the

scientific body if necessary.

If a statement fails to meet any of

these criteria, FDA would normally

conclude that the statement is not an

authoritative statement. In any case the

agency may, and, when a statement

meets these three criteria, the agency

would normally, consult with the

scientific body to which the statement is

attributed. FDA would request that the

scientific body determine, for example,

whether the statement is currently in

effect; whether the statement represents

the official policy of the scientific body,

for example, by reflecting consensus

within that body, as opposed to being

the statement of individual employees

made in the individual capacities of

those employees; and whether the

statement is based on a deliberative

review of the scientific evidence.

If the statement is found to be issued

by an appropriate scientific body and

determined to be an ‘‘authoritative

statement’’ under section 403(r)(2)(G) or

(r)(3)(C) of the act, the agency intends to

review the wording of the claim to

determine if it is in accordance with

section 403(r)(3)(C)(iv) or (r)(2)(G)(iv) of

the act. These provisions of the act

require that the claim be stated in a

manner so that it is an accurate

representation of the authoritative

statement and so that the claim enables

the public to comprehend the

information provided in the claim and

to understand the relative significance

of such information in the context of a

total daily diet.

For health claims, FDA also intends to

consider the requirement of section

403(r)(3)(C)(iii) of the act that there be

compliance with, for example, sections

403(a) and 201(n) of the act (21 U.S.C.

321(n)), which require that the claim be

truthful and not misleading, including

compliance as appropriate with existing

§ 101.14. FDA would also determine

whether there is significant scientific

agreement concerning the authoritative

statement, as provided for under new

section 403(r)(3)(D)(i) of the act. For

nutrient content claims, FDA intends to

consider the requirements of section

403(r)(2)(G)(iii) of the act that there be

compliance with, for example, section

403(r)(2)(A)(i) of the act, which requires

that nutrient content claims use the

terms defined in FDA’s regulations, and

sections 403(a) and 201(n) of the act,

including compliance as appropriate

with existing § 101.13 (21 CFR 101.13).

If, after this review, FDA has no

objections to the claim, then the statute

provides that the claim may be used on

food labels 120 days after submission of

a complete notification.

By contrast, if the statement is not

from an appropriate scientific body or is

found not to be an ‘‘authoritative

statement’’ from a Federal scientific

body or NAS (or any of its

subdivisions), the agency intends to

determine that the notification does not

meet the requirements of section

403(r)(3)(C) or (r)(2)(G) of the act in that

the submitter has not submitted a

statement from a Federal scientific body

or NAS, or an authoritative statement

from such a body. The agency may

notify the submitter of this

determination, and its basis, by letter.

Alternatively, the agency may issue an

interim final rule to prohibit the claim.

Generally, the agency would notify

the submitter by letter when, for

example, the notification is deficient on

its face, and the agency would use the

rulemaking process when substantial

scientific or legal questions are

presented by the notification. The

agency intends to elaborate further on

these issues in implementing

regulations. The agency has chosen to

respond with nine interim rules

publishing in this issue of the Federal

Register to a notification for nine claims

to specify the approach used by the

agency to review this notification in the

absence of implementing regulations,

and to provide opportunity for public

comment. In the future, the agency

anticipates that it may respond to

similar notifications by letter. Whether

FDA sends a letter or acts by rulemaking

to prohibit a claim, the agency may

begin an enforcement action under the

act in a U. S. district court if such a

claim is used in food labeling.

The agency notes that, when it sends

such a letter or acts by regulation to

prohibit the use of a claim, a person

nonetheless may submit in the future a

notification that bases the claim on a

statement that meets the requirements of

section 403(r)(3)(C) or (r)(2)(G) of the

act. If there is no authoritative statement

that may serve as a basis for the claim,

an interested person may petition the

agency under section 403(r)(4) of the act

and § 101.70 to authorize the health

claim by regulation under section

403(r)(3)(B) of the act. For a nutrient

content claim, an interested person may

submit a citizen petition under 21 CFR

10.30 that requests the agency to

establish the Daily Value to which the

claim would refer.

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. 2). 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
34088 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

the nine claims and is issuing a separate

interim final rule responding to each

claim.

This interim final rule addresses the

first claim in the notification. The

notification included six statements that

the petitioner identified as authoritative

statements on which the following

claim is based: ‘‘Antioxidant vitamins C

and E may reduce the risk in adults of

atherosclerosis, coronary heart disease,

certain cancers, and cataracts. Sources

of Vitamin C and E include fruits,

vegetables, and dietary supplements.’’

The first sentence of this claim will be

discussed in greater detail in section III

of this document. FDA notes that this

claim describes the relationship

between vitamins C and E and a number

of different diseases and, thus, in point

of fact, reflects several prospective

health claims. The second sentence,

‘‘Sources of Vitamin C and E include

fruits, vegetables, 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.

With respect to nutrient content

claims, FDA concluded in comment 152

of its final rule for nutrient content

claims (58 FR 2302 at 2345, January 6,

1993) that the term ‘‘source’’ alone

merely connotes that a nutrient is

present and does not provide consumers

with meaningful information about the

level of the nutrient. Therefore, FDA did

not define the term ‘‘source,’’ although

it did define several other terms that

include the word ‘‘source.’’ For

example, a food is defined as a ‘‘good

source’’ of a nutrient if it contains 10 to

19 percent of the Reference Daily Intake

(RDI) for that nutrient per reference

amount customarily consumed

(§ 101.54(c) (21 CFR 101.54(c))), or as an

‘‘excellent source’’ if it contains 20

percent or more of a nutrient’s RDI per

reference amount customarily

consumed (§ 101.54(b)). In addition,

‘‘trivial source’’ is defined as a synonym

for ‘‘free’’ and ‘‘low source’’ as a

synonym for ‘‘low’’ (see, for example, 21

CFR 101.61(b)(1) and (b)(4)).

Information regarding the agency’s

position on nutrient content claims is

included in the preamble to the

proposed and final rules for nutrient

content claims (56 FR 60421, November

27, 1991, and 58 FR 2302, January 6,

1993) and in the agency guidance

document, ‘‘Food Labeling—Questions

and Answers—Volume I—For Guidance

to Facilitate the Process of Developing

or Revising Labels for Foods Other than

Dietary Supplements’’ (Ref. 3).

As for statements that constitute

dietary guidance, such label information

must be truthful and not misleading as

discussed in section II.D.6 of the

preamble to the final rule for general

requirements for health claims (58 FR

2478 at 2487, January 6, 1993) and in

the agency guidance document, ‘‘Food

Labeling—Questions and Answers—

Volume II—A Guide for Restaurants and

Other Retail Establishments’’ (Ref. 4).

The agency notes that in the case of the

subject sentence, not all fruits,

vegetables, and dietary supplements

contain significant amounts of vitamins

C and E, and therefore if the statement

were intended to reflect dietary

guidance it cannot be considered to be

truthful and not misleading. In addition,

to be truthful and not misleading when

used on a particular food’s labeling, that

food must contain significant amounts

of vitamins C and E.

III. Basis for the Action

FDA has reviewed the notification

submitted in support of the prospective

claim: ‘‘Antioxidant vitamins C and E

may reduce the risk in adults of

atherosclerosis, coronary heart disease,

certain cancers, and cataracts.’’ The

agency has determined that none of the

six 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

six 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 statements from: (1) A

published article authored by two

employees of CDC; (2) public

information provided on the Internet by

an institute of NIH; (3) an electronic

version provided on the Internet of

‘‘Nutrition and Your Health: Dietary

Guidelines for Americans,’’ (Home and

Garden Bulletin No. 232, Fourth

Edition, 1995) (hereinafter, referred to as

‘‘the dietary guidelines’’)

recommendations developed by a group

of Federal agencies and issued jointly by

the Department of Health and Human

Services (DHHS) and the United States

Department of Agriculture (USDA); (4)

public information provided on the

Internet by CDC’s Office of Women’s

Health; (5) a NIH press release provided

on the Internet; and (6) an electronic

version provided on the Internet of a

quarterly report from USDA’s

Agricultural Research Service (ARS).

Thus, the statements in the notification

are attributable to NIH, CDC, and

USDA/ARS, as well as a group of

Federal agencies that included NIH,

CDC, and USDA/ARS. Two of the

scientific bodies identified, NIH and

CDC, are highlighted in the statute as

Federal scientific bodies. FDA believes

that USDA/ARS is also 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. The group that developed the

dietary guidelines included Federal

agencies that are such scientific bodies.

Accordingly, the statements provided in

the notification in support of the claim

may be attributable to appropriate

Federal scientific bodies or to their

employees.

Finally, however, none of the six

statements discussed in A. through F. of

this section of this document was found

to be an authoritative statement.

A. Statement 1

Statement 1 reads: ‘‘Antioxidant

micronutrients, especially carotenes,

vitamin C, and vitamin E, appear to play

many important roles in protecting the

body against cancer. They block the

formation of chemical carcinogens in

the stomach, protect DNA and lipid

membranes from oxidative damage, and

enhance immune function.’’ The

notification identified Statement 1 as an

‘‘authoritative statement’’ for purposes

of making the claim that is the subject

of this rulemaking. The statement is

found in the conclusion section of an

article published in The Annual Review

of Nutrition (12:139–59:1992), entitled:

‘‘Dietary Carotenes, Vitamin C, and

Vitamin E as Protective Antioxidants in
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34089

Human Cancers,’’ and authored by two

persons, T. Byers and G. Perry, who are

identified in the article as employees of

CDC at the time of publication of the

article. The Annual Review of Nutrition

is published periodically by Annual

Reviews, Inc., in Palo Alto, CA. Editors

for each volume serve as reviewers for

the various articles included in the

volume and contributors are asked to

submit articles for consideration for

publication. The subject article is 20

pages of a review of the literature that

includes a section on the theoretical

roles of dietary oxidants in cancer

prevention and focuses on the outcomes

of laboratory animal research and

epidemiologic studies conducted since

1987. The subject statement appears in

the conclusion section of the paper. The

agency notes that the next sentence in

the conclusion section states:

‘‘Nevertheless, many important

questions need to be answered before

either micronutrient supplements or

food fortification can be recommended

as a cancer prevention strategy to the

general population.’’

The noted qualifying sentence, as well

as the wording of the statement itself

(i.e., ‘‘appear to play’’), suggests that the

scientific evidence about the

relationship in question is preliminary

or inconclusive, as discussed in section

I.A.3 of this document.

FDA asked CDC whether the

statement is an ‘‘authoritative

statement’’ under FDAMA. CDC

responded to FDA that the statement is

not an authoritative statement of CDC

because it does not reflect consensus

within CDC and was not published by

CDC (Ref. 5). CDC indicated that the

article was authored by individual

employees made in the individual

capacity of those employees. Therefore,

FDA has concluded that the statement is

not an ‘‘authoritative statement’’ under

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

the statement was not published by CDC

and is instead the statement of

individual employees of CDC made in

their individual capacities, as discussed

in section I.A.2 of this document.

B. Statement 2

Statement 2 reads: ‘‘[Antioxidants]

may help prevent disease. Antioxidants

fight harmful molecules called oxygen

free radicals, which are created by the

body as cells go about their normal

business of producing energy * * *

[Some] studies show that antioxidants

may help prevent heart disease, some

cancers, cataracts, that are more

common as people get older.’’ 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 within an information piece

entitled ‘‘Life Extension: Science or

Fiction?’’ that is provided on the

Internet by the Administration on Aging

and which includes statements from the

‘‘Age Page’’ of the National Institute on

Aging (an Institute of NIH) (‘‘http://

www.aoa.dhhs.gov/aoa/pages/agepages/

lifextsn.html’’ accessed on 12/2/97).

This electronically available

information (submitted to the agency as

a hardcopy reprint from the Internet

information) is dated 1994, is

approximately two standard printed

pages in length, and is described as

being intended to inform the reader

about chemicals being studied that may

play a role in aging and what scientists

have learned about them so far. Topics

covered include antioxidants,

deoxyribonucleic acid (DNA),

dehydroepiandrosterone (DHEA), and

other hormones. Ten tips for healthy

aging are also included. The section on

antioxidants is 14 sentences in length

and includes the three sentences

identified as the subject statement. The

agency notes that the last sentence of

the antioxidant section is: ‘‘More

research is needed before specific

recommendations can be made.’’

FDA asked NIH whether the statement

is an ‘‘authoritative statement’’ under

FDAMA. NIH responded to FDA that

the statement is not an authoritative

statement of NIH because it was

prepared by an individual from the

National Institute on Aging and is not

based on a deliberative review of the

scientific evidence regarding the

nutrient-disease relationship in question

(Ref. 6). 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 of this document.

C. Statement 3

Statement 3 reads: ‘‘The antioxidant

nutrients found in plant foods (e.g.,

vitamin C, carotenoids, vitamin E, and

certain minerals) are presently of great

interest to scientists and the public

because of their potentially beneficial

role in reducing the risk of cancer and

certain other chronic diseases.’’ 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

from an electronic version of the dietary

guidelines issued jointly by DHHS and

USDA and provided on the Internet

(‘‘http:www.usda.gov/fcs/library/0102–

1.txt’’ accessed on 12/5/97). The

submitted material consists of selected

pages reprinted from the Internet

information, which identifies the seven

dietary guidelines and gives background

information on the use of, and reasons

for, the guidelines. The dietary

guidelines reflect the findings of a panel

of scientists concerning the dietary

recommendations to be made to the U.S.

population, and the guidelines are based

on a deliberative review of the scientific

evidence about the nutrient/disease

relationships that the guidelines

address. The subject statement is found

within the discussion that accompanies

the recommendation to ‘‘Choose a diet

with plenty of grain products,

vegetables, and fruits.’’

The statement indicates that a

relationship between antioxidant

nutrients and cancer and other chronic

disease is ‘‘of great interest’’ because of

a ‘‘potentially beneficial role.’’ The

statement points to the need for future

research and suggests that whether a

relationship exists should be the subject

of scientific study, but does not indicate

that there exists a scientifically sound

relationship that should be accorded a

presumption of validity. This

assessment is further supported by the

fact that the subject of the dietary

guidelines recommendation that the text

is intended to clarify is the dietary

importance of grain products,

vegetables, and fruits, not the specific

impact of antioxidant nutrients,

vitamins C and E, per se. FDA notes

that, consistent with the dietary

guidelines, the agency has authorized a

health claim for the relationship

between cancer and fruits and

vegetables that contain vitamin C (as

well as vitamin A (as beta-carotene) and

dietary fiber) (21 CFR 101.78).

On this basis, FDA has concluded that

the statement is not an ‘‘authoritative

statement’’ under section 403(r)(3)(C) of

the act because the statement indicates

that the scientific evidence about the

relationship in question is preliminary

or inconclusive, as discussed in section

I.A.3 of this document.

The dietary guidelines is the product

of a periodic review by a group of

Federal agencies, the most recent review

having been completed in 1995. FDA

did not attempt to reconvene this group

of Federal agencies to consult with it

about whether the statement is an

authoritative statement because, as

discussed previously, the wording and

context of the statement show that it is

not an authoritative statement under

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

D. Statement 4

Statement 4 reads: ‘‘A diet high in

fiber, high in antioxidants, and low in

fat may play an important role in
34090 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

preventing the development of

atherosclerosis, coronary heart disease,

and some cancers.’’ 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 information on ‘‘Health in

Later Years’’ provided on the Internet by

CDC’s Office of Women’s Health in a

section entitled: ‘‘Health Problems

among Older Women,’’ and is included

in the subsection ‘‘Improving Health

and Quality of Life’’ (‘‘http://

www.cdc.gov/od/owh/whily.htm’’

accessed on 11/26/97). This

electronically available information

(submitted to the agency as a hardcopy

reprint from the Internet information) is

not dated, is approximately three

standard printed pages in length, and

covers the topics of coronary heart

disease, cancer, stroke, and other

diseases.

FDA asked CDC whether this

statement is an ‘‘authoritative

statement’’ under FDAMA. CDC

responded that the statement is not an

authoritative statement of CDC because,

although it is a statement from CDC, it

is not based upon a deliberative review

of the scientific evidence regarding the

nutrient-disease relationship in

question; rather, it is a statement from

an educational fact sheet developed by

CDC’s Office of Women’s Health to

convey information to the public (Ref.

5). Therefore, FDA has concluded that

the statement is not an ‘‘authoritative

statement’’ under section 403(r)(3)(C) of

the act because the statement is not

based on a deliberative review of the

scientific evidence.

E. Statement 5

Statement 5 reads: ‘‘[It] is likely that

certain antioxidants, such as vitamins C

and E, may destroy the oxygen radicals,

retard molecular damage, and perhaps

slow the rate of aging.’’ The notification

identified Statement 5 as an

‘‘authoritative statement’’ for purposes

of making the claim that is the subject

of this rulemaking. The statement is

contained in an undated press release

from the National Institute on Aging at

NIH, which was provided on the

Internet (‘‘http://www.nih.gov/nia/new/

press/agingcau.htm’’ accessed on 12/1/

97). The press release (submitted to the

agency as a hardcopy reprint from the

Internet) states that it is a synopsis of a

recent publication entitled: ‘‘Aging—

Causes and Defenses,’’ which had been

authored by R. Martin, D. Danger, and

N. Holbrook and published in The

Annual Review of Medicine

(44:419,429:1993). The press release

indicates that it is providing a synopsis

of the publication but does not clarify if

the authors are associated with, or are

staff of, NIH. The Annual Review of

Medicine is published periodically by

Annual Reviews, Inc., in Palo Alto, CA.

Editors for each volume serve as

reviewers for the various articles

included in the volume and contributors

are asked to submit articles to be

considered for publication.

The statement is not ‘‘about the

relationship between a nutrient and a

disease or health-related condition’’

because aging, the absence of oxygen

radicals, and the presence of molecular

damage are not diseases or healthrelated conditions. FDA has therefore

concluded that the statement does not

address a disease or health-related

condition and therefore, as discussed in

section I.A.1 of this document, is not an

‘‘authoritative statement’’ under section

403(r)(3)(C) of the act.

F. Statement 6

Statement 6 reads: ‘‘Antioxidants are

thought to help prevent heart attack,

stroke and cancer.’’ The notification

identified Statement 6 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) 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).

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: ‘‘Do

carotenoids—the bright red, yellow and

orange pigments in fruits and

vegetables—warrant a Recommended

Dietary Allowance?’’ The paragraph

describes the nature and outcome of two

ARS studies and is attributed to Betty J.

Burr at the USDA Western Human

Nutrition Research Center in San

Francisco. The agency notes that the last

sentence of the paragraph is: ‘‘Further

ARS studies will try to shed more light

on whether a specific minimum daily

intake of carotenoids is important for

good health.’’

The context of the paragraph, as well

as the wording of the statement (i.e.,

‘‘are thought’’), suggests that the

scientific evidence about the

relationship in question is preliminary

or inconclusive.

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. 7). 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.

In summary, FDA has concluded that

the notification does not include any

authoritative statement published by a

scientific body as required by section

403(r)(3)(C) of the act. Accordingly, the

subject claim relating to the relationship

between antioxidant vitamins C and E

and the risk in adults of atherosclerosis,

coronary heart disease, certain cancers,

and cataracts 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 or claims 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 claims, an

interested person may petition the

agency under section 403(r)(4) of the act

and § 101.70 to authorize the health

claim or claims 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 of this document, 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 (21 U.S.C.

343(r)(7)(B)), 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)).
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34091

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).

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 antioxidant vitamins C and E

and the risk in adults of atherosclerosis,

coronary heart disease, certain cancers,

and cataracts 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

vitamins C and E and the risk in adults

of atherosclerosis, coronary heart

disease, certain cancers, and cataracts

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 antioxidant

vitamins C and E and the risk in adults

of atherosclerosis, coronary heart

disease, certain cancers, and cataracts

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. Commission on Dietary Supplement

Labels, ‘‘Report of the Commission on

Dietary Supplement Labels,’’ November

1997, p. vii.

2. 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.

3. ‘‘Food Labeling—Questions and

Answers—Volume I—For Guidance to

Facilitate the Process of Developing or

Revising Labels for Foods Other than Dietary

Supplements,’’ August 1993, Questions C1–

C54.

4. ‘‘Food Labeling—Questions and

Answers—Volume II—A Guide for

Restaurants and Other Retail

Establishments,’’ August 1995, Questions

R117–R127.

5. Letter to Christine J. Lewis, CFSAN,

FDA, from Dixie E. Snider, CDC, April 21,

1998.

6. Letter to Christine Lewis, CFSAN, FDA,

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

7. 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. 98–16454 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F