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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T97-16                        Lawrence Bachorik:  (301) 827-6242
April 24, 1997                
                              Consumer Hotline:   (800) 532-4440


       Safety of Gelatin and Gelatin By-Products Reviewed


     The Food and Drug Administration's Transmissible Spongiform
Encephalopathy (TSE) Advisory Committee met April 23 and 24, 1997,
to assess whether bovine spongiform encephalopathy (BSE) poses any
risk to the safety of imported gelatin used in FDA-regulated
products.  The following may be used to answer questions.
     Since 1992, FDA has requested that manufacturers of FDA-
regulated products not use bovine-derived materials from BSE
countries.  In 1994, on the basis of the scientific information
available at that time, FDA stated that it did not object to the
use, in the manufacture of pharmaceutical grade gelatin, of bovine-
derived products from countries classified by the U.S. Department
of Agriculture as countries with BSE in their cattle population.  
     On August 17, 1994, in a letter to manufacturers, the FDA said
recommendations against the use of bovine materials from BSE
countries did not extend to gelatin.  
     The TSE Advisory Committee was asked whether, in light of
recent developments and current scientific understanding of TSE's,
the exemption for gelatin from BSE countries should continue.  The 
                               -More-
                                     Page 2, T97-16, Gelatin
advisory committee heard presentations by experts from academia,
industry, and the FDA.  The public was invited to present their
views during the open public hearing portion of the meeting.  
     After hearing the evidence, weighing newer scientific
information and thoroughly discussing the issues, the majority of
committee members concluded that the exemption of gelatin from BSE
countries should not continue.  Recognizing that current
understanding of TSEþs is incomplete, the committee noted the need
for continuing and further research on the TSE agent and the best
method of inactivating it.  
     Gelatin is manufactured primarily from the hides of swine and
the bones and hides of cattle.  During processing, these source
materials are exposed to extremely harsh conditions, including
prolonged exposure to highly acid or alkaline solutions.  Gelatin
is used in a wide variety of consumer and medical products
regulated by the FDA.  These products range from candies and
desserts to vaccines, drugs, medical devices, dietary supplements,
and cosmetics.  
     The TSE Advisory Committee was originally constituted as an Ad
Hoc Advisory Committee on Creutzfeld Jakob Disease (CJD), in 1995. 
After the March 1996 announcement of the possible association
between BSE and new variant CJD (nv-CJD) in the U.K., FDA re-
constituted the advisory committee in its current form to provide
advice on a broad array of public health and product-related issues
raised by TSE's.  
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