[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Notices]
[Pages 26194-26195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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. 98-12449 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F