USDA AND FDA EXERCISE TIGHT CONTROL ON ANIMAL TISSUES IN DIETARY SUPPLEMENTS

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WASHINGTON, D.C., July 27, 2000—Animal tissues have long been a traditional source of some dietary supplement ingredients, ranging from liver powders to digestive enzymes. Today (and for at least the past decade), the U.S. Department of Agriculture (USDA) exercises tight control to assure that all meat products imported into the United States are safe and that no beef products are imported from countries with a history of BSE (bovine spongiform encephalopathy). The Food and Drug Administration (FDA) enforces similar requirements through import alerts and detention of products from BSE countries. In fact, most beef products used in dietary supplements are derived from herds raised in the United States. Imported beef products come from non-BSE countries such as Canada, Argentina and Australia, and non-beef sources (such as pork) are also used.

"A letter to the New England Journal of Medicine (July 27, 2000) falsely impugns the safety of glandular products marketed in the United States, makes inaccurate statements about FDA¼s regulatory authority under the Dietary Supplement Health and Education Act (DSHEA), and misleads the public," said John Cordaro, President and C.E.O. of the Council for Responsible Nutrition. It is unfortunate that a respected medical journal would print such a flawed letter. The letter specifically charges that FDA does not have authority to prevent the use of animal ingredients from BSE countries in dietary supplements. This is incorrect. In fact, FDA¼s "import alert" #17-04 (revised January 24, 2000) specifically asserts that, with respect to dietary supplements, bovine (cattle) byproducts from BSE countries are to be considered adulterated under section 402(a) of the Food, Drug and Cosmetic Act. This section of the Act has proven to be an effective tool for safeguarding the food supply for almost 100 years, and it was not altered by DSHEA.

With regard to labeling, the law requires all ingredients of dietary supplements to be listed on the label, so consumers can be fully informed, and those who wish to avoid certain ingredients can do so. Glandular products are typically labeled as such (featuring the word "glandular"), and their labeling usually provides a listing of the specific organs included in the product. Far from wishing to obscure their glandular content, manufacturers promote these products on the basis of these ingredients. Nevertheless, glandular dietary supplements represent a specialty niche in the market and do not account for a substantial fraction of dietary supplement sales. Only a tiny proportion of products in the marketplace contain glandular ingredients. However, consumers who value these products can use them in confidence, because they are safeguarded by USDA and FDA enforcement actions that protect against the import or use of animal tissues from countries affected by BSE.