63256 Federal Register / Vol. 65, No. 205 / Monday, October 23, 2000 / Notices

Respondents No. of

respondents

No. of

responses/

respondent

Avg.

burden per

response

(in hours)

Total

burden

(in hours)

Total Burden ............................................................................................................. 169.4

Dated: October 17, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–27118 Filed 10–20–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N 0044]

Statements Made for Dietary

Supplements Concerning the Effect of

the Product on the Structure or

Function of the Body; Availability of

Citizen Petitions for Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of three

petitions submitted by Hyman Phelps &

McNamara (HP&M), the American

Herbal Products Association (AHPA),

and jointly by the Council for

Responsible Nutrition (CRN) and the

Consumer Healthcare Products

Association (CHPA). The petitions

requested, among other things, that

dietary supplements be permitted to

make claims about effects on the

structure or function of the body that are

derived from nutritive value without

being subject to the disclaimer and

notification requirements of the Federal

Food, Drug, and Cosmetic Act (the act).

DATES: Submit written comments on the

petitions by December 22, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA 305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Electronic

comments may be submitted via the

Internet at www.accessdata.fda.gov/

scripts/oc/dockets/comments/

commentdocket.cfm or via e-mail:

fdadockets@oc.fda.gov. All comments

should be identified with the docket

number found in brackets in the

heading of this document. The petitions

are available for review at the Dockets

Management Branch (address above) or

electronically on the agency’s website at

http//www.fda.gov/ohrms/dockets/

dockets.htm. You may also request

copies of the petitions from the Dockets

Management Branch.

FOR FURTHER INFORMATION CONTACT:

Rhonda Rhoda Kane, Office of

Nutritional Products, Labeling, and

Dietary Supplements, Center for Food

Safety and Applied Nutrition (HFS 821),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–4168.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 6,

2000 (65 FR 1000), in the preamble to

its final rule entitled ‘‘Regulations on

Statements Made for Dietary

Supplements Concerning the Effect of

the Product on the Structure or

Function of the Body,’’ FDA stated that

dietary supplements bearing structure/

function claims must comply with the

notice, disclaimer, and other

requirements of section 403(r)(6) of the

act (21 U.S.C. 343(r)(6)). More

specifically, the agency stated:

Section 403(r)(6) of the act, by its

terms, applies to dietary supplements.

The other possible source of authority to

make structure/function claims on

dietary supplements is section

201(g)(1)(C) of the act, which provides

that ‘‘articles (other than food) intended

to affect the structure or any function of

the body of man or other animals’’ are

drugs. Under this provision, foods may

make claims to affect the structure or

function of the body without being

regulated as drugs. By its terms,

however, section 201(g)(1)(C) of the act

exempts a dietary supplement that bears

a structure/function claim from drug

regulation only if it is also a food. The

last sentence of section 201(ff) of the act

provides, ‘‘Except for purposes of

section 201(g), a dietary supplement

shall be deemed to be a food within the

meaning of this Act.’’ The clear import

of this language is that dietary

supplements are not foods under section

201(g) of the act and therefore cannot

qualify for the ‘‘(other than food)’’

exception to the drug definition in

section 201(g)(1)(C). As a result, dietary

supplements that use structure/function

claims may do so only under section

403(r)(6) of the act and are therefore

subject to the disclaimer, notification,

and other requirements in that section

and in FDA’s implementing regulation.

65 FR 1000 at 1033.

The preamble acknowledged that this

conclusion reverses a position stated in

the Federal Register of September 23,

1997 (62 FR 49859), in the final rule

entitled ‘‘Food Labeling; Requirements

for Nutrient Content Claims, Health

Claims, and Statements of Nutritional

Support for Dietary Supplements.’’ The

preamble to that rule stated that a

dietary supplement could bear a

structure/function claim under the

‘‘(other than food)’’ exception to the

drug definition in section 201(g)(1)(C) of

the act (21 U.S.C. 321(g)(1)(C)), provided

that the claim was truthful,

nonmisleading, and derived from

nutritive value (see 62 FR 49859 at

49860, 49863, and 49864). The reversal

was based on reconsideration of the

plain language of section 201(ff) of the

act.

II. The Citizen Petitions

On February 4, 2000, HP&M filed a

petition requesting, among other things,

that the agency reconsider and revoke

its ‘‘pronouncement’’ in the January 6,

2000, final rule that all structure/

function claims in the labeling of

dietary supplements must use the

section 403(r)(6) of the act disclaimer

and notification procedures. The

petition further requests that FDA

reinstate its previous position that a

structure/function claim in the labeling

of a dietary supplement product need

not comply with the disclaimer and

notification requirements if the claim is

truthful, nonmisleading, and derived

from nutritive value.

Citing United States v. Ten Cartons

***Ener-B Vitamin B 12, 72 F.3d 285,

287 (2d Cir. 1995), HP&M argues that

section 201(g)(1)(C) of the act must be

applied without reference to section

201(ff) of the act. In sum, HP&M states

that the effect of section 201(ff) of the

act ‘‘is merely that a dietary supplement

will not ‘‘automatically qualify as

food.’’’ HP&M further argues that

whether or not a particular dietary

supplement qualifies as food is

determined by Nutrilab, Inc. v.

Schweiker, 713 F.2d 335 (7th Cir. 1983).

That case held that a product is a food

if it is used primarily for ‘‘taste, aroma

or nutritive value.’’ Nutrilab, 713 F.2d at

338. For example, the petition argues

Federal Register / Vol. 65, No. 205 / Monday, October 23, 2000 / Notices 63257

that calcium would qualify as a food

since it is an essential mineral nutrient.

HP&M articulates several other

grounds for the action requested in the

petition. HP&M also argues that the

requirements of section 403(r)(6) of the

act apply only to structure/function

claims that fall within the health claims

definition 21 CFR 101.14(a)(1).

Moreover, HP&M argues that FDA’s

change in interpretation is not entitled

to deference because it was issued more

than 5 years after the Dietary

Supplement Health and Education Act

(DSHEA) was passed and, therefore, is

not a ‘‘contemporaneous construction’’

of the statute. The petition also asserts

that Congress intended DSHEA to

reduce FDA requirements for dietary

supplements. HP&M believes that FDA’s

new position is inconsistent with

congressional intent since it imposes

regulatory burdens that did not exist

before DSHEA. Finally, the petition also

raises an administrative law argument

that FDA’s reversal is effectively a

substantive rule that must comply with

the notice and comment rulemaking

procedures of the Administrative

Procedure Act in 5 U.S.C. 553.

Petitions filed by AHPA and jointly

by CRN and CHPA on February 7, 2000,

also requested a reversal of FDA’s

position on this issue. These petitions

made arguments similar to those made

by the HP&M petition.

III. Questions

The agency is interested in receiving

comments on all three petitions.

Moreover, there are several specific

questions on which FDA would like

comment.

1. The outcome of a reversal of FDA’s

position would be that dietary

supplements that qualify for the ‘‘(other

than food)’’ exception would not have to

accompany the structure/function claim

with a disclaimer while dietary

supplements that do not qualify would.

Would consumer confusion result from

this outcome?

2. The outcome of maintaining the

current position would be that dietary

supplements making a structure/

function claim would have to bear a

disclaimer while conventional foods

making the same claim would not. Is it

better to have an inconsistency between

dietary supplements and conventional

foods or between dietary supplements

that qualify for the ‘‘(other than food)’’

exception and dietary supplements that

do not?

3. If FDA were to reverse its position

as requested by the petitions, the agency

would be notified of some structure/

function claims for dietary supplements,

but not others. Therefore, the agency

would not be aware of all the structure/

function claims in the marketplace,

including some that might be in fact

disease claims rather than legitimate

structure/function claims. To determine

whether a dietary supplement could

legitimately bear a structure/function

claim without a disclaimer, FDA would

have to investigate whether the claim

was based on the nutritive value of the

supplement. What would be the impact

of this situation on enforcement?

IV. Comments

You may submit to the Dockets

Management Branch (address above)

written or electronic comments by

December 22, 2000. Electronic

comments may be submitted via the

Internet to: www.accessdata.fda.gov/

scripts/oc/dockets/comments/

commentdocket.cfm or via e-mail:

fdadockets@oc.fda.gov. Groups or

organizations must submit two copies of

any comments. Individuals may submit

one copy of their comments. Identify

your written comments by placing the

docket number at the top of your

comment(s). If you base your comments

on scientific evidence or data, please

submit copies of the specific

information along with your comments.

Any comments submitted will be filed

under the docket number identified in

brackets in the heading of this

document. The petition and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27083 Filed 10–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Devices Dispute Resolution

Panel of the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Medical Devices

Dispute Resolution Panel of the Medical

Devices Advisory Committee.

General Function of the Panel: To

provide advice and recommendations to

the agency on scientific disputes

between the Center for Devices and

Radiological Health and sponsors,

applicants, and manufacturers.

Date and Time: The meeting will be

held on October 31, 2000, 1 p.m. to 4

p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Les S. Weinstein,

Center for Devices and Radiological

Health (HFZ–5), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, e-mail:

lsw@cdrh.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 10232.

Please call the Information Line for upto-date information on this meeting.

Agenda: The members of the newly

established Medical Devices Dispute

Resolution Panel will be introduced to

the public and will hear presentations

by FDA staff on the purpose of the panel

and its role in dispute resolution.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues regarding

resolving scientific disputes concerning

medical devices and on the role of this

panel. Written submissions may be

made to the contact person by October

25, 2000. Oral presentations from the

public will be scheduled between

approximately 2 p.m. and 4 p.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before October 25, 2000,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

October 31, 2000, Medical Devices

Dispute Resolution Panel of the Medical

Devices Advisory Committee meeting.

Because the agency believes there is

some urgency to bring this issue to

public discussion and qualified

members of the Medical Devices

Dispute Resolution Panel of the Medical

Devices Advisory Committee were

available at this time, the Commissioner

of Food and Drugs concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).