Manufacturers of over-the-counter (OTC) medications often move to dismiss consumer class actions based on federal preemption.  The Federal Food, Drug, and Cosmetic Act (FDCA) contains an express preemption clause that forbids states from enforcing laws relating to OTC drugs that are “different from or in addition to, or that [are] otherwise not identical with, a requirement under” the FDCA.  21 U.S.C. § 379r(a).  (Section 379r also contains a savings clause that exempts product liability actions from its preemptive scope.  See id. § 379r(e).)  Similar preemption provisions exist for food and cosmetics.  Id. §§ 343-1(a), 379s(a).  Although most courts have interpreted the FDCA’s express preemption provisions broadly, a minority have limited their application.  As discussed below, the minority view involves distinguishable circumstances and is inconsistent with the FDCA’s statutory text.

Continue Reading A Closer Look: Express Federal Preemption for OTC Medications Subject to Monographs