Section 912 May Impede Research on Nutritional Supplements

Newly proposed Section 912 of the FDA Amendments Act (FDAAA), entitled “Prohibition Against Foods to Which Drugs or Biologics Are Added,” creates the new §301(ll), which addresses the regulation of foods containing substances that have undergone clinical trials, but not without a high dose of controversy. The section prohibits the interstate transport of food products if they contain “an approved drug or biological product for which substantial clinical investigations have been instituted and the existence of those clinical investigation have been made public, unless the food was marketed first.” Although it was most likely intended to prevent ingredients prohibited in dietary supplements from making an appearance in functional foods, the lack of clarity in Section 912 has the food,...