[Federal Register: March 5, 2003 (Volume 68, Number 43)]
[Page 10483]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Dietary Supplement Subcommittee of the Food 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: Dietary Supplement Subcommittee of the Food 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 25, 2003, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn (Ballrooms A and B), 10000 Baltimore Ave., 
College Park, MD, 301-345-6700.
    Contact Person: Constance J. Hardy, Center for Food Safety and 
Applied Nutrition (HFS-811), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-1433, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 10564. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: To be a dietary supplement as defined in section 201(ff) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(ff)), 
a product must contain at least one ``dietary ingredient.'' Section 
201(ff)(1) of the act lists those substances that are considered 
``dietary ingredients.'' Among other things, the term ``dietary 
ingredient'' includes a metabolite of any other dietary ingredient 
defined in section 201(ff)(1) of the act. The statute is ambiguous, 
however, as to what substances are, or are not, metabolites of other 
substances. The practical result of this ambiguity is that it is often 
difficult to determine whether a particular substance meets the dietary 
ingredient definition and, therefore, whether products containing the 
substance can be marketed as dietary supplements. The purpose of this 
meeting is to explore whether there are recognized scientific 
principles that would facilitate reaching a conclusion as to whether a 
particular substance is a ``metabolite'' of another substance that is a 
``dietary ingredient'' defined in the act and, therefore, is itself a 
dietary ingredient within the scope of section 201(ff)(1) of the act. 
The background material for this meeting will be posted on the Internet 
when available or 1-working day before the meeting at http://


    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by March 17, 
2003. Oral presentations from the public will be scheduled on March 25, 
2003, between approximately 11 a.m. and 3 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 20, 2003, 
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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Constance J. Hardy 
at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 27, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-5073 Filed 3-4-03; 8:45 am]