Latest FDLI Update Magazine Features Two Articles Written by HPM AttorneysJanuary 30, 2009
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by four Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “Imported Products – FDA Is Not Fooling Around,” was written by Dara Katcher Levy and John R. Fleder. It provides background information on FDA’s regulation of imports, discusses inconsistencies in FDA’s enforcement actions against imported articles, and analyzes FDA’s increasing use of very broad import alerts and the adverse effects that these are having on importers.
The second article, titled “FDA’s Implementation of FDAAA’s Food-Related Provisions: A Work In Progress,” was written by Ricardo Carvajal and Diane B. McColl. It discusses sections 417 and 301(ll) of the FDC Act, which were added by the FDA Amendments Act of 2007. Section 417 requires FDA to establish a reportable food registry and an electronic portal to which responsible parties must submit instances of reportable food. FDA is expected to implement the reportable food registry in Spring 2009. Section 301(ll) makes it a prohibited act to market a food to which has been added a new 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).