[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
