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Since 1997 the U.S. Food and Drug Administration (FDA), with the assistance of its TSE Advisory Committee, has been monitoring the potential risk of animal based products, donated human blood, surgical instruments, medical devices, sterilization methods and other related subjects.
Following the submission of five validation studies which examined the manufacturing processes of bone gelatine (sponsored by the Gelatine Manufacturers of Europe (GME) and the European Union) the FDA decided to re-consider the safety profile of bovine bone gelatine.
At the recent Committee meeting on July 17, 2003 in Washington, the study investigators presented their studies in great detail, providing additional information about raw material sourcing and bone gelatine manufacturing processes.
The studies showed that even in the practically impossible event that raw materials were taken only from BSE infected cattle, no BSE infectivity could be detected in the final gelatine produced by all different manufacturing processes.
Strict sourcing ensures the safety of gelatine: all raw materials used come from healthy animals that are found fit for human consumption.
Following extensive discussions the members of the TSEAC concluded that:
The results of these new (GME) studies demonstrate that the gelatine manufacturing process has the capacity to reduce BSE infectivity that is sufficient to protect human health.
The FDA is the second significant worldwide body of experts to endorse the safety of bone gelatine. Previously, in March 2003 the Scientific Steering Committee (SSC) of Europe, concluded that the “risk (of bovine bone gelatine) is close to zero”.
Furthermore, the committee supported requests from the gelatine industry that the FDA amend their current “Guidance for Industry” to ensure its consistency with current European raw material sourcing procedures.
Further readings:
www.fda.gov/ohrms/dockets/ac/03/briefing/3969b1.htm
www.fda.gov/ohrms/dockets/ac/03/minutes/3969M.htm
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