FDA’S Implementation of FDAAA’S Food-Related Provisions: A Work in Progress

This article, published in FDLI Update, provides an analysis of changes in the Federal Food, Drug, and Cosmetic Act (“FDCA”) brought about by the FDA Amendments Act of 2007 (“FDAAA”) that significantly affect the food industry. Title X of the FDAAA requires FDA and industry to take several actions to improve transmission of information relating to adulteration of human and pet food. Most significantly, FDAAA section 1005 added section 417 to the FDCA. Section 417 requires FDA to establish an electronic portal to which industry must submit reports about a “reportable food” (and to which federal, state, or local public health officials may also submit such reports). FDA is expected to implement the reportable food registry in Spring 2009.

Title IX of FDAAA contains section 912, which added section 301(ll) to the FDCA. Section 301(ll) prohibits the addition to food of an approved drug, a licensed biologic, or a “drug” or “biological product” for which substantial clinical investigations have been instituted and their existence made public, with certain exceptions. Depending on how it is implemented, section 301(ll) could adversely affect development of novel food and dietary ingredients.