Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations 58917

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 through 53258 and 53280, October 14,

1993). Accordingly, this rule 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. Spina bifida and anencephaly are

the most common types of neural tube defects.

Technical Note: Fermenters include

bioreactors, chemostats, and continuous-flow

systems.

c. Centrifugal separators capable of

the continuous separation of pathogenic

microorganisms, without the

propagation of aerosols, and having all

of the following characteristics:

c.1. A flow rate greater than 100 liters

per hour;

c.2. Components of polished stainless

steel or titanium;

c.3. Double or multiple sealing joints

within the steam containment area; and

c.4. Capable of in situ steam

sterilization in a closed state.

Technical Note: Centrifugal separators

include decanters.

d. Cross (tangential) flow filtration

equipment capable of continuous

separation of pathogenic

microorganisms, viruses, toxins, and

cell cultures without the propagation of

aerosols, having all of the following

characteristics:

d.1. Equal to or greater than 5 square

meters;

d.2. Capable of in situ sterilization.

e. Steam sterilizable freeze-drying

equipment with a condenser capacity

greater than 50 kgs of ice in 24 hours but

less than 1,000 kgs;

f. Equipment that incorporates or is

contained in P3 or P4 containment

housing, as follows:

f.1. Independently ventilated

protective full or half suits;

f.2. Class III biological safety cabinets

or isolators with similar performance

standards;

g. Chambers designed for aerosol

challenge testing with microorganisms,

viruses, or toxins and having a capacity

of 1 m3 or greater.

Dated: September 22, 2000.

R. Roger Majak,

Assistant Secretary for Export

Administration.

[FR Doc. 00–25068 Filed 10–2–00; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 91N–0101, 91N–0098, 91N–

0103, and 91N–100H]

RIN 0910–AA19

Food Labeling: Health Claims and

Labeling Statements; Dietary Fiber and

Cancer; Antioxidant Vitamins and

Cancer; Omega-3 Fatty Acids and

Coronary Heart Disease; Folate and

Neural Tube Defects; Revocation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking its

regulations codifying the agency’s

decision not to authorize the use of

health claims for four substance-disease

relationships in the labeling of foods,

including dietary supplements: Dietary

fiber and cancer, antioxidant vitamins

and cancer, omega-3 fatty acids and

coronary heart disease, and the claim

that 0.8 milligram (mg) of folate in

dietary supplement form is more

effective in reducing the risk of neural

tube defects than a lower amount in

conventional food. This action is being

taken in response to a decision of the

U.S. Court of Appeals for the D.C.

Circuit invalidating these regulations

and directing FDA to reconsider

whether to authorize the four health

claims. This action will result in the

removal of the regulations but does not

constitute FDA authorization of the four

claims. FDA is completing its

reconsideration of the claims and

expects to issue decisions on all four

claims by October 10, 2000.

DATES: This rule is effective October 3,

2000.

FOR FURTHER INFORMATION CONTACT:

James E. Hoadley, Center for Food

Safety and Applied Nutrition (HFS–

832), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5429.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 6,

1993, FDA issued final rules

announcing its decision not to authorize

the use of health claims for four

substance-disease relationships in the

labeling of conventional foods. (See 58

FR 2537 (dietary fiber and cancer); 58

FR 2622 (antioxidant vitamins and

cancer); 58 FR 2682 (omega-3 fatty acids

and coronary heart disease); and 58 FR

2606 (folic acid 1 and neural tube

defects2)). Soon after, FDA proposed in

the Federal Register of October 14, 1993

(58 FR 53296), not to authorize use of

three of the four claims in the labeling

of dietary supplements. In October

1993, after further review of evidence on

the relationship between folate and

reduced risk of neural tube defects, FDA

proposed to authorize a health claim for

this relationship (58 FR 53254, October

14, 1993); however, the agency

proposed not to allow such claims to

include a statement that folate from one

source is more effective in reducing the

risk of neural tube defects than folate

from another source. Both proposals

became final by operation of law on

December 31, 1993. (See 59 FR 395,

January 4, 1994 (dietary fiber and

cancer, antioxidant vitamins and cancer,

and omega-3 fatty acids and coronary

heart disease); 59 FR 433, January 4,

1994 (folate and neural tube defects).)

FDA’s decisions not to authorize these

four claims are codified in § 101.71(a)

(21 CFR 101.71(a)) (dietary fiber and

cancer); § 101.71(c) (antioxidant

vitamins and cancer); § 101.71(e)

(omega-3 fatty acids and coronary heart

disease); and § 101.79(c)(2)(i)(G) (21

CFR 101.79(c)(2)(i)(G)) (claims

comparing effectiveness of folate from

different sources).

Several dietary supplement marketers

and nonprofit organizations that had

submitted comments during FDA’s

health claims rulemakings filed suit in

Federal district court on constitutional

and statutory grounds seeking, among

other things, authorization to make the

following health claims for use in the

labeling of dietary supplements:

‘‘Consumption of fiber may reduce the

risk of colorectal cancer,’’

‘‘Consumption of antioxidant vitamins

may reduce the risk of certain kinds of

cancer,’’ ‘‘Consumption of omega-3 fatty

acids may reduce the risk of coronary

heart disease,’’ and ‘‘0.8 mg of folic acid

in a dietary supplement is more

effective in reducing the risk of neural

tube defects than a lower amount in

foods in common form.’’ The district

court ruled for FDA in all respects

58918 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations

(Pearson v. Shalala, 14 F. Supp. 2d 10

(D.D.C. 1998)); however, the U.S. Court

of Appeals for the D.C. Circuit reversed

the district court’s decision. The court

of appeals held the regulations

codifying FDA’s decision not to

authorize the four health claims invalid

and instructed FDA to reconsider the

four health claims (Pearson v. Shalala,

164 F.3d 650 (D.C. Cir. 1999)).

In the Nutrition Labeling and

Education Act of 1990, 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)). FDA adopted the same

procedure for health claims in dietary

supplement labeling that Congress had

prescribed for health claims in the

labeling of conventional foods (see

section 403(r)(3) and (r)(4) of the act).

This procedure requires the evidence

supporting a health claim to be

presented to FDA for review before the

claim may appear in labeling. Unless

and until FDA adopts a regulation

authorizing 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)).

Recently, the U.S. District Court for

the District of Columbia denied the

Pearson plaintiffs’ motion for a

preliminary injunction granting them

immediate permission to make the four

health claims that FDA is reconsidering.

In their motion, the plaintiffs argued

that because the court of appeals had

invalidated the regulations codifying

FDA’s decision not to authorize the four

claims, the claims should be permitted

in dietary supplement labeling if

accompanied by disclaimers suggested

by the court of appeals. The district

court rejected this argument. The court’s

decision said in part that a preliminary

injunction was not in order because the

plaintiffs may not bypass FDA’s preclearance process for health claims.

‘‘Plaintiffs’ fatal assumption is that the

Court of Appeals’ invalidation of the

regulations allows them to now make

their health claims with disclaimers,

without any further pre-clearance by

FDA. It does not. Invalidation of the

regulations merely puts plaintiffs back

at square one, which means they must

again go through the pre-clearance

process * * *.’’ (Pearson v. Shalala, No.

Civ. A. 95–1865, 2000 WL 767584, at *2

(D.D.C. May 24, 2000)).

Thus, while FDA is revoking the

regulations codifying its original

decision not to authorize the four health

claims that were challenged in Pearson,

such claims still may not be used in

labeling pending reconsideration of

these claims by FDA. FDA expects to

complete its reconsideration of the four

claims and issue a decision on each

claim by October 10, 2000.

II. Effective Date

The Administrative Procedure Act

and FDA regulations provide that an

agency may dispense with notice-andcomment rulemaking procedures when

the agency for good cause finds that

such procedures are impracticable,

unnecessary, or contrary to the public

interest (5 U.S.C. 553(b)(3)(B);

§ 10.40(e)(1) (21 CFR 10.40(e)(1))).

Because this final rule is being issued in

response to a court order, FDA finds

that notice and comment are

unnecessary. In addition, the

Commissioner of Food and Drugs finds

good cause under 5 U.S.C. 553(d)(3) and

§ 10.40(c)(4)(ii) to make this final rule

effective upon publication.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

§ 101.71 [Amended]

2. Section 101.71 Health claims:

claims not authorized is amended by

removing paragraphs (a), (c), and (e);

and by redesignating paragraph (b) as

paragraph (a), and paragraph (d) as

paragraph (b).

§ 101.79 [Amended]

3. Section 101.79 Health claims:

Folate and neural tube defects is

amended by removing paragraph

(c)(2)(i)(G), and by redesignating

paragraph (c)(2)(i)(H) as (c)(2)(i)(G).

Dated: September 25, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25352 Filed 10–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

42 CFR Part 36

Contracts Under the Indian SelfDetermination Act; Removal of

Regulations

AGENCY: Indian Health Service, HHS.

ACTION: Final rule.

SUMMARY: The Indian Health Service

(IHS) is eliminating regulations on

contracts under the Indian SelfDetermination Act as mandated by

Executive Order 12866 to streamline the

regulatory process and enhance the

planning and coordination of new and

existing regulations.

EFFECTIVE DATE: October 3, 2000.

FOR FURTHER INFORMATION CONTACT:

Leslie M. Morris, Director, Division of

Regulatory and Legal Affairs, Indian

Health Service, Suite 450, 12300

Twinbrook Parkway, Rockville, MD

20852; telephone (301) 443–1116. (This

is not a toll-free number.)

SUPPLEMENTARY INFORMATION: On June

24, 1996, The Department of Health and

Human Services (HHS) and the

Department of the Interior (DOI) issued

joint regulations authorized by section

107 of the Indian Self-Determination

and Education Assistance Act (ISDA),

Public Law 93–638, as amended, 25

U.S.C. 450k. These joint regulations,

published in the Federal Register on

June 24, 1996, and codified at 25 CFR

part 900, replaced Department

regulations codified at 42 CFR part 36,

subpart I, ‘‘Contracts under the ISDA’’;

48 CFR section 352.280–4, ‘‘Contracts

awarded under the ISDA’’; 48 CFR

section 352.380–4, ‘‘Contracts awarded

under the ISDA’’; and 48 CFR subpart

380.4, ‘‘Contracts awarded under the

ISDA’’; because they are no longer

necessary for the Administration of the

IHS Program.

Section 107(b) of the ISDA provides

in pertinent part that ‘‘the secretary is

authorized to repeal any regulation

inconsistent with the provisions of this

act.’’ The HHS has proposed at 64 FR

1344 to revise 48 CFR, Chapter 3, to

streamline and simplify its acquisition

regulations (HHSRA) in accordance

with the directions of the National

Performance Review. In so doing, the

sections of 48 CFR liminated by the

joint rule (25 CFR part 900) issued by

the HHS and the DOI would be

removed. Therefore, the IHS proposed at

65 FR 4797 the elimination of only

Subpart I of 42 CFR part 36. No

comments were received in response to

the proposed rule. The proposed rule is

converted to a final rule without change.