[Federal Register: March 5, 2003 (Volume 68, Number 43)][Notices][Page 10483]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr05mr03-67]-----------------------------------------------------------------------DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationDietary Supplement Subcommittee of the Food Advisory Committee;Notice of MeetingAGENCY: Food and Drug Administration, HHS.ACTION: Notice.-----------------------------------------------------------------------This notice announces a forthcoming meeting of a public advisorycommittee of the Food and Drug Administration (FDA). The meeting willbe open to the public.Name of Committee: Dietary Supplement Subcommittee of the FoodAdvisory Committee.General Function of the Committee: To provide advice andrecommendations to the agency on FDA's regulatory issues.Date and Time: The meeting will be held on March 25, 2003, from 8a.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 andApplied Nutrition (HFS-811), Food and Drug Administration, 5100 PaintBranch Pkwy., College Park, MD 20740, 301-436-1433, or FDA AdvisoryCommittee Information Line, 1-800-741-8138 (301-443-0572 in theWashington, DC area), code 10564. Please call the Information Line forup-to-date information on this meeting.Agenda: To be a dietary supplement as defined in section 201(ff) ofthe Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(ff)),a product must contain at least one ``dietary ingredient.'' Section201(ff)(1) of the act lists those substances that are considered``dietary ingredients.'' Among other things, the term ``dietaryingredient'' includes a metabolite of any other dietary ingredientdefined in section 201(ff)(1) of the act. The statute is ambiguous,however, as to what substances are, or are not, metabolites of othersubstances. The practical result of this ambiguity is that it is oftendifficult to determine whether a particular substance meets the dietaryingredient definition and, therefore, whether products containing thesubstance can be marketed as dietary supplements. The purpose of thismeeting is to explore whether there are recognized scientificprinciples that would facilitate reaching a conclusion as to whether aparticular substance is a ``metabolite'' of another substance that is a``dietary ingredient'' defined in the act and, therefore, is itself adietary ingredient within the scope of section 201(ff)(1) of the act.The background material for this meeting will be posted on the Internetwhen available or 1-working day before the meeting atwww.cfsan.fda.gov/~lrd/vidtel.html.Procedure: Interested persons may present data, information, orviews, 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 eachpresentation may be limited. Those desiring to make formal oralpresentations should notify the contact person before March 20, 2003,and submit a brief statement of the general nature of the evidence orarguments they wish to present, the names and addresses of proposedparticipants, and an indication of the approximate time requested tomake their presentation.Persons attending FDA's advisory committee meetings are advisedthat the agency is not responsible for providing access to electricaloutlets.FDA welcomes the attendance of the public at its advisory committeemeetings and will make every effort to accommodate persons withphysical disabilities or special needs. If you require specialaccommodations due to a disability, please contact Constance J. Hardyat least 7 days in advance of the meeting.Notice of this meeting is given under the Federal AdvisoryCommittee 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]
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