Meetings: Food Advisory Committee,

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Federal Register: May 12, 1998 (Volume 63, Number 91)NoticesPage 26194-26195From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr12my98-100

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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: 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 June 15 and 16, 1998, 8 a.m. to 6 p.m.; and June 17, 1998, 8 a.m. to 1 p.m..

Location: Sheraton Reston Hotel, Grand Ballroom, 11810 Sunrise Valley Dr., Reston, VA.

Contact: Lynn A. Larsen, Center for Food Safety and Applied Nutrition (HFS-5), 202-205-4727, or Catherine M. DeRoever (HFS-22), 202-205-4251, FAX 202-205-4970, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 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: The committee will receive and undertake a scientific discussion about new data that have become available regarding the food additive olestra.

In the Federal Register of January 30, 1996 (61 FR 3118), FDA approved olestra for use as a food additive to replace conventional fats in prepackaged savory snacks. Olestra is a sucrose polyester formed with long chain fatty acids. The agency determined, based on its evaluation of the evidence in the record at that time, that there is a reasonable certainty that no harm will result from the use of olestra in savory snacks. At the time of approval, the petitioner, Proctor and Gamble Co. (P&G), agreed to perform additional studies of olestra exposure (both amounts consumed and patterns of consumption) and the effects of olestra consumption. P&G also agreed to provide FDA with access to all data and reports of those studies as such information became available. At the time of olestra's approval, FDA committed to review all data received from P&G's studies, as well as any other new data that bear on the safe use of this additive, and present such information to the committee within 30 months of the approval.

Committee discussion will focus on data gathered from passive surveillance of complaints attributed to olestra consumption; the active surveillance of populations consuming savory snacks, including olestra snacks; any additional new data that have become available that bear on the safety of olestra (such as data and information on the health significance of carotenoids); and various other studies submitted by P&G (e.g., rechallenge, home consumption, and acute consumption test). The committee will consider whether these newly developed data are consistent with the original safety decision or whether the new data contradict FDA's original determination that there is a reasonable certainty of no harm from the use of

[Page 26195]olestra in savory snacks. The committee will also discuss the bearing, if any, of these new data on the required label statement for olestra containing snacks.

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 June 5, 1998. Oral presentations from the public will be scheduled in three sessions. The approximate session schedules and the topics upon which presentations at each should be focussed are: (1) Passive surveillance and special gastrointestinal studies on June 16, 1998, 8 a.m. to 9 a.m.; (2) active surveillance and new information on carotenoids on June 16, 1998, 4 p.m. to 4:30 p.m.; and (3) labeling on June 17, 1998, 10:30 a.m. to 11 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before June 5, 1998, 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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: May 4, 1998. Michael A. Friedman, Deputy Commissioner for Operations.

FR Doc. 98-12449Filed5-11-98; 8:45 amBILLING CODE 4160-01-F

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