Surprise!…That Food Is Now a Drug

Section 912 of the FDA Amendments Act of 2007 added section 301(ll) to the Federal Food, Drug, and Cosmetic Act (FDC Act), which prohibits the addition to food of an approved drug, a licensed biological product, or a drug or biological product for which substantial clinical investigations have been instituted and their existence made public. From a historical perspective, this amendment marks a significant change in the regulation of food and drugs. Given the wide range of possible interpretations available to FDA as it seeks to implement § 301(ll), submission of comments to FDA is strongly encouraged.