FDA plans to contact supplement manufacturers regarding bovine ingredient tracking.

FDA TO ASSESS BOVINE-DERIVED INGREDIENT TRACKING IN DIETARY SUPPLEMENT INDUSTRY by soon contacting individual supplement companies. FDA said it plans to request information regarding voluntary compliance with a 1994 Federal Register notice concerning bovine-derived ingredient safety.

Published in response to concern about possible contamination with bovine spongiform encephalopathy (BSE) -- or "mad cow disease" -- the 1994 notice urged manufacturers to develop "plans for ensuring with a high degree of certainty" that bovine-derived materials from BSE-affected countries are not used in manufacturing ("The Tan Sheet" Aug. 29, 1994, p. 14).

Recent media coverage has suggested that FDA is in the process of developing regulations regarding the use of bovine-derived ingredients. However, the agency has clarified that no formal rulemaking on the topic is in the works.

Consumer concern -- and a slew of media coverage -- about products containing bovine-derived ingredients comes in the wake of a recent statement by British officials that BSE, a transmissible, "uniformly fatal" neurological disease in cows, may be linked to Creutzfeldt-Jacob disease in humans through consumption of contaminated beef. The theory, however, is unconfirmed.

Bovine-derived ingredients are used in some dietary supplements such as athletes' vitality formulas and treatments to lessen the symptoms of menopause. Bovine-derived gelatin is used commonly in drug and supplement capsule encasements.

In an April 3 release, the Council for Responsible Nutrition asserted that, despite media reports suggesting "that some `mad cow' parts may escape the USDA safety net" and be used in the manufacture of supplements, "this is not the case."

The dietary supplement trade association said the industry "is in full compliance with all applicable regulations and procedures" to ensure that infected bovine products are not used in supplement manufacturing.