Several e-Network blood bankers have expressed concern over the use by donors of Dietary Supplements, since some of these supplements might contain non-US bovine source materials. To read some of these concerns and how they might affect donor deferral strategies, read the ADDENDA in the e-Network discussion "Deferral of a whole blood donor over CJD concerns because of a bovine jaw/dental implant". Please note that the FDA regulates dietary supplements under a different set of regulations than those "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Visit the following FDA site to learn about their oversight of the Dietary Supplements industry.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator