Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59855

1 In its original health claim evaluation, FDA used

the term ‘‘folic acid’’ to describe this B vitamin.

Later, the agency decided that the broader term

‘‘folate’’ was more scientifically accurate because

that term encompasses both synthetic and naturally

occurring forms of the vitamin, whereas folic acid

refers only to the synthetic form (see 58 FR 53254

at 53257–58, and 53280, October 14, 1993).

Accordingly, this notice uses the term ‘‘folate.’’ The

two terms may be used interchangeably in food

labeling.

2Neural tube defects are birth defects of the brain

or spinal cord. Spinabifida and anencephaly are the

most common types of neural tube defects.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25700 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 91N–0101, 91N–0098, 91N–

0103, and 91N–100H]

Food Labeling; Health Claims and

Label Statements for Dietary

Supplements; Update to Strategy for

Implementation of Pearson Court

Decision

AGENCY: Food and Drug Administration,

HHS.

ACTION: :Notice.

SUMMARY: The Food and Drug

Administration (FDA) is updating its

strategy for implementation of the court

of appeals decision in Pearson v.

Shalala (Pearson). The updated

implementation strategy includes an

interim enforcement strategy for dietary

supplement health claims that do not

meet the ‘‘significant scientific

agreement’’ standard of evidence by

which the health claims regulations

require FDA to evaluate the scientific

validity of claims. It also includes

changes in the process that will be used

for reconsidering the four Pearson

health claims and for responding to

future petitions for dietary supplement

health claims. The agency is taking this

action to inform interested persons of

the latest developments in FDA’s plans

for implementation of Pearson.

FOR FURTHER INFORMATION CONTACT:

James E. Hoadley, Center for Food

Safety and Applied Nutrition (HFS–

832), 200 C St. SW., Washington, DC

20204, 202–205–5372.

SUPPLEMENTARY INFORMATION:

I. Background

After the enactment of the Nutrition

Labeling and Education Act of 1990 (the

NLEA) and the Dietary Supplement Act

of 1992, FDA issued regulations

applying the general requirements for

health claims for conventional foods to

dietary supplements (59 FR 395, January

4, 1994). Under these regulations, a

health claim is authorized for use only

if FDA determines that there is

significant scientific agreement, among

experts qualified by scientific training

and experience to evaluate such claims,

that the claim is supported by the

totality of publicly available scientific

evidence, including evidence from welldesigned studies conducted in a manner

that is consistent with generally

recognized scientific procedures and

principles § 101.14 (21 CFR 101.14).

FDA also undertook rulemaking to

consider specific health claims,

including the four health claims at issue

in the Pearson case.

In Pearson, the plaintiffs challenged

FDA’s general health claims regulation

for dietary supplements and FDA’s

decision not to authorize health claims

for four specific substance/disease

relationships: Dietary fiber and cancer,

antioxidant vitamins and cancer, omega3 fatty acids and coronary heart disease,

and the comparative claim that 0.8

milligram of folate1 in dietary

supplement form is more effective in

reducing the risk of neural tube defects2

than a lower amount in conventional

food form. Although the district court

ruled for FDA in all respects (14 F.

Supp. 2d 10 (D.D.C. 1998)), the U.S.

Court of Appeals for the D.C. Circuit

reversed the lower court’s decision (164

F.3d 650 (D.C. Cir. 1999)). The appeals

court held that, on the administrative

record compiled in the challenged

rulemakings, the First Amendment does

not permit FDA to reject health claims

that the agency determines to be

potentially misleading unless the

agency also reasonably determines that

no disclaimer would eliminate the

potential deception. Accordingly, the

court invalidated the regulations

codifying FDA’s decision not to

authorize the four health claims listed

above and directed the agency to

reconsider the four claims. The court

further held that the Administrative

Procedure Act requires FDA to clarify

the ‘‘significant scientific agreement’’

standard for authorizing health claims,

either by issuing a regulatory definition

of significant scientific agreement or by

defining it on a case-by-case basis.

On March 1, 1999, the Government

filed a petition for rehearing en banc

(reconsideration by the full court of

appeals). The U.S. Court of Appeals for

the D.C. Circuit denied the petition for

rehearing on April 2, 1999 (172 F.3d 72

(D.C. Cir. 1999)).

II. Strategy for Implementation of the

Pearson Court Decision

A. The December 1999 Implementation

Strategy Notice

In the Federal Register of December 1,

1999 (64 FR 67289), FDA published a

notice entitled ‘‘Food Labeling: Health

Claims and Label Statements for Dietary

Supplements; Strategy for

Implementation of Pearson Court

Decision’’ to inform the public of the

steps FDA planned to follow to carry

out the Pearson decision. The strategy

included five components: (1) Update

the scientific evidence on the four

claims at issue in Pearson; (2) issue

guidance clarifying the ‘‘significant

scientific agreement’’ standard; (3) hold

a public meeting to solicit input on

what changes to FDA’s general health

claim regulations for dietary

supplements may be warranted in light

of the Pearson decision; (4) conduct a

rulemaking to reconsider the general

health claims regulations for dietary

supplements in light of the Pearson

decision; and (5) conduct rulemakings

on the four Pearson health claims. In

addition, the implementation strategy

notice stated that, until the rulemaking

to reconsider the general health claims

regulations for dietary supplements was

complete, FDA would deny, without

prejudice, any petition for a dietary

supplement health claim that does not

meet the significant scientific agreement

standard in § 101.14(c). The notice

further explained that, once the

rulemaking was complete, the agency

would, on its own initiative, reconsider

any petitions denied during the interim

period.

Since the December 1999 Federal

Register notice was published, FDA has

completed the first three steps in the

implementation strategy. The agency

entered into contracts with two

nongovernment firms to conduct a

literature review for the four claims to

identify relevant scientific information

that became available after the agency’s

initial 1991 to 1993 review of these

claims. FDA also published a notice in

the Federal Register of September 8,

1999 (64 FR 48841), requesting that

interested persons submit any available

scientific data concerning the substancedisease relationships that are the subject

of the four claims.

In December 1999, FDA issued a

guidance clarifying the significant

scientific agreement standard. A notice

of availability of the guidance was

published in the Federal Register of

December 22, 1999 (64 FR 71794). The

guidance is available on the Internet at

http://vm.cfsan.fda.gov/∼dms/

ssaguide.html.

59856 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices

In response to a request from several

of the Pearson plaintiffs, the agency

agreed to reopen the comment period

for scientific data on the four claims

after the agency issued its guidance on

the significant scientific agreement

standard. Accordingly, in the Federal

Register of January 26, 2000 (65 FR

4252), FDA reopened the comment

period for an additional 75 days, until

April 3, 2000.

On April 4, 2000, FDA completed the

third step in the Pearson

implementation strategy by convening a

public meeting to solicit input on

changes to the general health claims

regulations for dietary supplements in

light of the Pearson decision.

Information on the public meeting,

including the agenda and transcripts,

are available on the Internet at http://

vm.cfsan.fda.gov/dms/ds-0400.html.

B. Modifications to the December 1999

Implementation Strategy

1. Interim Enforcement Strategy for

Dietary Supplement Health Claims

In the NLEA, Congress made health

claims for dietary supplements subject

to a procedure and standard to be

established by FDA (see section

403(r)(5)(D) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

343(r)(5)(D)). By regulation, FDA

adopted the same procedure and

standard for health claims in dietary

supplement labeling that Congress had

prescribed in the NLEA for health

claims in the labeling of conventional

foods (see section 403(r)(3) and (r)(4) of

the act). The procedure requires the

evidence supporting a health claim to be

presented to FDA for review before the

claim may appear in labeling

(§§ 101.14(d) and (e), and 101.70 (21

CFR 101.70)). The standard requires a

finding of ‘‘significant scientific

agreement’’ before FDA may authorize a

health claim by regulation (§ 101.14(c)).

Unless and until FDA adopts a

regulation authorizing use of the claim,

a dietary supplement bearing the claim

is subject to regulatory action as a

misbranded food (see section

403(r)(1)(B) of the act), a misbranded

drug (see section 502(f)(1) of the act (21

U.S.C. 352(f)(1))), and as an unapproved

new drug (see section 505(a) of the act

(21 U.S.C. 355(a))). Under FDA’s current

general health claim regulations, the

agency cannot authorize use of a health

claim that does not meet the significant

scientific agreement standard.

Pending reconsideration of the

general health claim regulations in

response to Pearson, FDA is modifying

its approach to processing new health

claim petitions for dietary supplements.

Absent this modification, FDA would

have to deny all petitions that do not

meet the significant scientific standard

pending completion of the general

rulemaking. Such an approach could

lead to additional First Amendment

challenges prior to completion of the

rulemaking process.

Rather than denying all petitions that

do not meet the significant scientific

agreement standard pending completion

of the general rulemaking, FDA intends

to exercise enforcement discretion in

appropriate circumstances. Specifically,

the agency will consider exercising

enforcement discretion for a dietary

supplement health claim when the

following conditions are met: (1) The

claim is the subject of a health claim

petition that meets the requirements of

§ 101.70; (2) the scientific evidence in

support of the claim outweighs the

scientific evidence against the claim, the

claim is appropriately qualified, and all

statements in the claim are consistent

with the weight of the scientific

evidence; (3) consumer health and

safety are not threatened; and (4) the

claim meets the general requirements

for health claims in § 101.14, except for

the requirement that the evidence

supporting the claim meet the

significant scientific agreement standard

and the requirement that the claim be

made in accordance with an authorizing

regulation.

To the extent possible, FDA will

consider these criteria while it is

evaluating the petition and will state its

conclusions in a letter to the petitioner;

however, some criteria will have to be

evaluated after-the-fact, because they

involve information or circumstances

that cannot be determined from the

petition. For example, FDA will not be

able to determine whether the entire

claim appears in one place without

intervening material, as required by

§ 101.14(d)(2)(iv), until it actually sees

the claim on products in the

marketplace. Some provisions of

§ 101.14 may not be relevant to a

particular claim. The agency intends to

identify any such provisions in its letter

to the petitioner.

As discussed below, FDA will

consider exercising enforcement

discretion only if a petition to authorize

the health claim has been submitted; the

agency has filed the petition; the agency

has completed its scientific evaluation

of the claim and communicated that

evaluation by letter to the petitioner;

and the conditions previously

described, as well as any others stated

in the letter to the petitioner, are met.

2. Interim Process for Responding to

New Dietary Supplement Health Claim

Petitions and Reconsidering the Four

Pearson Health Claims

FDA intends to respond to the four

health claims at issue in the Pearson

case and, pending rulemaking to

implement Pearson, to new dietary

supplement health claim petitions that

have been filed for comprehensive

review (see § 101.70(j)(2)) in one of the

following three ways:

(1) If FDA determines that the

significant scientific agreement standard

is met, the agency will propose to

authorize the health claim. FDA will

consider using its interim final rule

authority under section 403(r)(7)(A)(iii)

of the act to allow use of the health

claim immediately upon publication of

the proposal.

(2) If FDA determines that the

significant scientific agreement standard

is not met, but that the scientific

evidence in support of the claim

outweighs the scientific evidence

against the claim and the other

threshold criteria listed above are met,

FDA will consider exercising

enforcement discretion with regard to

dietary supplements that bear the health

claim with appropriate qualifying

language. The petitioner will be notified

in writing of this intention. The letter to

the petitioner will outline the agency’s

rationale for its determination that the

evidence does not meet the significant

scientific agreement standard set forth

in § 101.14(c) and then state the

conditions under which the agency

would ordinarily expect to exercise

enforcement discretion for the claim.

(3) If FDA determines that the

significant scientific agreement standard

is not met and that the evidence

supporting the claim is outweighed by

evidence against the claim (either

qualitatively or quantitatively), or the

substance poses a threat to health, or

that any of the other criteria listed in

section II.B.1 of this document are not

met, FDA intends to deny the petition.

The denial letter to the petitioner will:

(1) Outline the agency’s rationale for its

determination that the evidence does

not meet the significant scientific

agreement standard set forth in

§ 101.14(c); and (2) explain why FDA

believes that the scientific evidence for

the claim is outweighed by the evidence

against the claim, that the claim would

be otherwise misleading even if

qualified, or that authorizing a health

claim would pose a threat to consumer

health or safety.

This process is consistent with case

law holding that FDA has wide latitude

in matters of enforcement discretion.

Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59857

(See, e.g., Heckler v. Chaney, 470 U.S.

821 (1985); Schering v. Heckler, 779

F.2d 683 (D.C. Cir. 1985).) It is also

consistent with the Pearson decision,

which described several circumstances

in which FDA might be justified in

banning certain health claims outright

—e.g., where consumer health and

safety are threatened, or where FDA can

demonstrate that a health claim would

be misleading even if qualified (see

Pearson, 164 F.3d at 650, 657–60). For

example, the court said that FDA could

prohibit a health claim where the

evidence in support of the claim is

outweighed by evidence against the

claim, either quantitatively or

qualitatively (164 F.3d at 659 & n.10).

The agency is adopting this modified

process on an interim basis to minimize

any burden on speech pending

consumer research and rulemaking to

complete the implementation of the

Pearson decision.

3. Timing of FDA’s Decisions on Health

Claims for Dietary Supplements

FDA will complete its reconsideration

of the four Pearson claims and issue a

final decision on each of the claims

within 190 days after the close of the

comment period seeking scientific data

on the claims, i.e., by October 10, 2000.

For new health claim petitions for

dietary supplements, FDA will continue

to follow the applicable deadlines in

§ 101.70(j), as with past health claim

petitions.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25702 Filed 10–3–00; 4:29 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10011]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New Collection;

Title of Information Collection: Stages

of Change Survey for Informed Choice

in the Medicare Population;

Form No.: HCFA–10011 (OMB# 0938–

NEW);

Use: This is a survey of Medicare

beneficiaries in the first step in the

application the Transtheoretical Model

(the ‘‘stage model’’) to informed choice

in the Medicare population. The

Transtheoretical Model has been

applied and proven effective in

facilitating behavior change in a wide

range of health behaviors including

smoking cessation, mammography

screening, and safe sex. This work will

yield psychometrically sound and

externally valid measures of

beneficiaries’ readiness to make

informed choices about health plans,

and provide information to HCFA to

assist with its national educational

campaign to inform beneficiaries about

their choices. Stages of Change

measures will be administered to 560

Medicare beneficiaries and initial

enrollees. This survey research will

yield psychometrically sound measures

of beneficiaries’ readiness to make

informed choices about health plans,

and provide information to guide

HCFA’s National Medicare Education

Program (NMEP);

Frequency: Other: One-time survey;

Affected Public: Individuals or

Households;

Number of Respondents: 560;

Total Annual Responses: 560;

Total Annual Hours: 327.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Melissa Musotto, HCFA–

10011, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: September 26, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–25761 Filed 10–5–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–9044]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, OHHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Provider

Reimbursement Manual, Part 1—

Chapter 27, Section 2721, 2722 and

2725, Request for Exception to ESRD

Composite Rates and Supporting

Regulations in 42 CFR 413.170 and

413.184; Form No.: HCFA–9044 (OMB#

0938–0296); Use: Sections 2721, 2722

and 2525 of the Provider

Reimbursement Manual describe the

information ESRD facilities must submit