Bovine-Derived Materials; Agency Letters to Manufacturers of FDA- Regulated Products

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The Food and Drug Administration (FDA) is publishing the texts of four letters it recently issued to manufacturers of FDA-regulated products requesting that bovine-derived materials from certain cattle not be used in the manufacture of FDA-regulated products intended for humans or animals. FDA believes that bovine spongiform encephalopathy (BSE), a neurological disease of bovine animals, is a concern in the manufacture of FDA-regulated products. FDA believes that precautionary measures will reduce potential risk of exposure to, or transmission of, the agents that cause BSE in cattle. FDA is publishing the texts of the four letters at the end of this document in addition to mailing them directly to manufacturers.