[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Proposed Rules]
[Pages 14178-14180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7115]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 99N-0554]


How to Use Health Claims and Nutrient Content Claims in Food 
Labeling; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
forthcoming public meeting concerning implementation of sections 303 
and 304 of the Food and Drug Administration Modernization Act of 1997 
(FDAMA). Those provisions provide for use, in food labeling, of health 
claims and nutrient content claims based on authoritative statements 
published by certain Federal scientific bodies or the National Academy 
of Sciences (NAS) or any of its subdivisions. We are holding the 
meeting to allow you to provide information and recommendations to 
assist us in identifying appropriate approaches for implementing 
sections 303 and 304 of FDAMA. We anticipate that the discussion will 
include presentations from people whom we invite to participate as well 
as from members of the public.

DATES: We will hold the meeting on May 11, 1999, 8 a.m. to 5 p.m. 
Please register by April 27, 1999. Written comments should be submitted 
by May 11, 1999.

ADDRESSEES: The meeting will be held at the Jefferson Auditorium, U.S. 
Department of Agriculture, South Bldg., 1400 Independence Ave. SW., 
Washington, DC.
    You may submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. You may also send comments to the Dockets 
Management Branch at the following e-mail address: 
``FDAD[email protected]'' or via the FDA Website ``http://
www.fda.gov''.

FOR FURTHER INFORMATION CONTACT: Jeanne E. Latham, Center for Food 
Safety and Applied Nutrition (HFS-456), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4697, or e-mail to 
``JL[email protected]''.


SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed FDAMA (Pub. L. 105-115) 
into law. FDAMA made amendments to the Federal Food, Drug, and Cosmetic 
Act (the act). In particular, sections 304 and 303 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). These new paragraphs provide for the use in food 
labeling of nutrient content claims and health claims, respectively,

[[Page 14179]]

based on authoritative statements 120 days after a notification of the 
claim is submitted to the agency. This notification process added by 
FDAMA supplements the petition process for nutrient content and health 
claims provided by section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) 
and Secs. 101.69 and 101.70 (21 CFR 101.69 and 101.70, respectively). 
It does so by providing a less time-consuming and less burdensome 
alternative for establishing the scientific basis for such claims 
through use of authoritative statements of certain scientific bodies.
    Since the passage of FDAMA, FDA has been reviewing both the statute 
and the accompanying legislative history to determine the most 
appropriate approach for implementing these new provisions. We issued a 
guidance document in early June 1998 (Ref. 1). In this guidance, we 
focused on the submission procedures for notifications of claims, 
identified appropriate Federal scientific bodies, discussed the nature 
of authoritative statements and the scientific standard with respect to 
health claims, outlined the content of a notification and other 
statutory requirements, and indicated that we intended to propose that 
health claims based on authoritative statements be permitted for use in 
dietary supplement labeling. We published that proposed rule in the 
Federal Register of January 21, 1999 (64 FR 3250) (Ref. 2).
    Moreover, because section 403(r)(2)(G) and (r)(3)(C) of the act 
provide that authoritative statements from appropriate Federal 
scientific bodies may be the basis of nutrient content claims and 
health claims, we believed there was benefit in identifying key persons 
within each such Federal body who could provide us with information on 
authoritative statements if needed. At our request, the Secretary of 
Health and Human Services sent a letter to scientific bodies within the 
Public Health Service (Ref. 3) and to the U.S. Department of 
Agriculture (Ref. 4) requesting that they identify such a contact 
person.
    On February 23, 1998, we received a notification containing nine 
prospective claims that were identified in the notification as health 
claims (Ref. 5). We created nine separate dockets, one for each claim, 
and issued a separate interim final rule responding to each claim 
(Refs. 6 through 14). In one of these rules (Ref. 6), we included in 
the preamble our thinking about the requirements of section 
403(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D) of the act as well as 
procedures that we would use to review notifications for claims under 
those provisions.
    We received a number of comments on these nine interim final rules. 
Some comments supported the approach that we had taken and others 
opposed it. Some comments offered alternative approaches for our 
consideration. You can find these comments in Docket Nos. 98N-0419 
through 98N-0424 and 98N-0426 through 98N-0428 at our Dockets 
Management Branch (see address in section IV of this document). In 
addition, on August 13, 1998 (Ref. 15), and October 26, 1998 (Ref. 16), 
we received congressional requests for information about the nine 
interim final rules. We responded to these requests on September 16, 
1998 (Ref. 17), and December 8, 1998 (Ref. 18).
    We believe that our efforts to implement section 304(r)(2)(G), 
(r)(2)(H), (r)(3)(C), and (r)(3)(D) of the act would benefit from a 
public meeting and an open discussion of all possible approaches to 
implementing these provisions. We anticipate that this discussion will 
be most useful to us if it involves those that commented on FDA's 
tentative approach and other members of the public, as well as 
representatives of scientific bodies that may be sources of 
authoritative statements.

II. Scope of Discussion

    We intend that the scope of the meeting be limited to issues 
related to implementing section 403(r)(2)(G), (r)(2)(H), (r)(3)(C), and 
(r)(3)(D) of the act. More specifically, comments to the nine interim 
final rules raised questions concerning both the need for and the 
nature of a definition for ``authoritative statement.'' We seek 
clarification of issues and approaches that relate to these questions. 
These questions focused on FDA's role in overseeing the provisions that 
allow such claims, as well as our role in relation to the Federal 
scientific bodies and NAS. In addition, we seek input about which of 
the regulatory requirements applicable to health claims and nutrient 
content claims that FDA authorizes by regulation under the petition 
process in section 403(r)(4) of the act should apply to health claims 
and nutrient content claims authorized based on authoritative 
statements. Finally, we seek input on several definitional and 
procedural issues. Based on the questions and comments that we have 
already received, we are particularly interested in discussions of the 
following questions:
1. The Scientific Basis for Claims
    a.  What is an ``authoritative statement''?
    b. Who defines ``authoritative statement''?
    c. Who decides if a particular statement is an ``authoritative 
statement''?
    d. Is the ``context'' of a statement in the publication in which it 
appears relevant to that determination? If so, how?
    e.   How does the significant scientific agreement standard apply 
to health claims based on authoritative statements?
2. Existing Regulatory Requirements
    a. What requirements of 21 CFR 101.13 and part 101, subpart D 
should we apply to nutrient content claims based on authoritative 
statements?
    b. What requirements of 21 CFR 101.14 should we apply to health 
claims based on authoritative statements?
3.  Procedural and Definitional Issues
    a.  Which agencies should we identify as scientific bodies of the 
U.S. Government with official responsibility for public health 
protection or research directly relating to human nutrition under 
section 403(r)(2)(G)(i) and (r)(3)(C)(i) of the act?
    b. Should we provide by regulation that health claims based on 
authoritative statements may be used in the labeling of dietary 
supplements?
    c. What should we require that you submit with a notification of a 
health or nutrient content claim based on an authoritative statement?
    d.  Should we require you to submit in a notification an analytical 
methodology for measuring the substance that is the subject of your 
submitted claim?
    e. What is a balanced presentation of the scientific literature 
relating to the subject to which a claim refers that is required under 
section 403(r)(2)(G)(ii)(III) and (r)(3)(C)(ii)(III) of the act?
    f. Should FDA keep notifications confidential for 120 days after 
the date of their submission or should we place them in a public docket 
upon receipt?
    g. If a notification is incomplete or does not support a claim, 
should we respond to it by letter or by issuing a regulation, and what 
should be the legal effect of letters were we to use them?

III.   Registration and Requests to Make Oral Presentation

    If you would like to attend the meeting, you must register with the 
contact person (address above) by April 27, 1999, by providing your 
name, title, business affiliation, address, telephone and fax number. 
To expedite processing, registration information may also be

[[Page 14180]]

faxed to 202-260-8957. If you need special accommodations due to 
disability, please inform the contact person when you register. If, in 
addition, you desire to make an oral presentation during the meeting, 
when you register to attend you must inform the contact person of that 
desire and submit: (1) A brief written statement of the general nature 
of the evidence or arguments that you wish to present, (2) the names 
and addresses of the persons who will give the presentation, and (3) an 
indication of the approximate time that you request to make your 
presentation. Depending upon the number of people who register to make 
presentations, we may have to limit the time allotted for each such 
presentation. We anticipate that, if time permits, those attending the 
meeting will have the opportunity to ask questions during the meeting.

IV. Comments

    You may, by May 11, 1999, submit written comments to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. You may also send comments to the 
Dockets Management Branch at the following e-mail address: 
``FDAD[email protected]'' or via the FDA Website ``http://
www.fda.gov''. You should annotate and organize your comments to 
identify the specific issues to which they refer. You must submit two 
copies of any comments, identified with the docket number found in 
brackets in the heading of this document, except that you may submit 
only one copy if you are an individual. You may see received comments 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Transcripts

    You may request transcripts of the meeting in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
working days after the meeting at a cost of 10 cents per page. You may 
also examine the transcript of the meeting after May 21, 1999, at the 
Dockets Management Branch (address above) between 9 a.m. and 4 p.m., 
Monday through Friday, as well as on the FDA Website ``http://
www.fda.gov''.

VI. References

    We have placed the following references on display in the Dockets 
Management Branch (address above). You may see them at that office 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. ``Guidance for Industry: Notification of a Health Claim or 
Nutrient Content Claim Based on an Authoritative Statement of a 
Scientific Body,'' June 11, 1998.
    2. Food Labeling: Use on Dietary Supplements of Health Claims 
Based on Authoritative Statements (64 FR 3250, January 21, 1999).
    3. Memorandum from Donna E. Shalala, DHHS, to scientific bodies 
within the Public Health Service, March 17, 1998.
    4. Memorandum from Donna E. Shalala, DHHS, to The Honorable Dan 
Glickman, USDA, March 17, 1998.
    5. 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.
    6. Food Labeling: Health Claims; Interim Final Rule; Antioxidant 
Vitamins C and E and the Risk in Adults of Atherosclerosis, Coronary 
Heart Disease, Certain Cancers, and Cataracts (63 FR 34084, June 22, 
1998).
    7. Food Labeling: Health Claims; Interim Final Rule; Antioxidant 
Vitamin A and Beta-Carotene and the Risk in Adults of 
Atherosclerosis, Coronary Heart Disease, and Certain Cancers (63 FR 
34092, June 22, 1998).
    8. Food Labeling: Health Claims; Interim Final Rule; B-Complex 
Vitamins, Lowered Homocysteine Levels, and the Risk in Adults of 
Cardiovascular Disease (63 FR 34097, June 22, 1998).
    9. Food Labeling: Health Claims; Interim Final Rule; Calcium 
Consumption by Adolescents and Adults, Bone Density and The Risk of 
Fractures (63 FR 34101, June 22, 1998).
    10. Food Labeling: Health Claims; Interim Final Rule; Chromium 
and the Risk in Adults of Hyperglycemia and the Effects of Glucose 
Intolerance (63 FR 34104, June 22, 1998).
    11. Food Labeling: Health Claims; Interim Final Rule; Omega-3 
Fatty Acids and the Risk in Adults of Cardiovascular Disease (63 FR 
34107, June 22, 1998).
    12. Food Labeling: Health Claims; Interim Final Rule; Garlic, 
Reduction of Serum Cholesterol, and the Risk of Cardiovascular 
Disease in Adults (63 FR 34110, June 22, 1998).
    13. Food Labeling: Health Claims; Interim Final Rule; Zinc and 
the Body's Ability to Fight Infection and Heal Wounds in Adults (63 
FR 34112, June 22, 1998).
    14. Food Labeling: Health Claims; Interim Final Rule; Vitamin K 
and Promotion of Proper Blood Clotting and Improvement in Bone 
Health in Adults (63 FR 34115, June 22, 1998).
    15. Letter of August 13, 1998, to Michael A. Friedman, FDA, from 
The Honorable Dan Burton, House of Representatives, regarding the 
nine interim final rules that FDA published in the Federal Register 
of June 22, 1998.
    16. Letter of October 26, 1998, to Jane Henney, FDA, from The 
Honorable Dan Burton, House of Representatives, regarding the nine 
interim final rules that FDA published in the Federal Register of 
June 22, 1998.
    17. Letter of September 16, 1998, to The Honorable Dan Burton, 
House of Representatives, from Diane E. Thompson, FDA, regarding the 
nine interim final rules that FDA published in the Federal Register 
of June 22, 1998.
    18. Letter of December 8, 1998, to The Honorable Dan Burton, 
House of Representatives, from Diane E. Thompson, FDA, regarding the 
nine interim final rules that FDA published in the Federal Register 
of June 22, 1998.

    Dated: March 18, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-7115 Filed 3-23-99; 8:45 am]
BILLING CODE 4160-01-F