The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are required to receive premarket approval from the Food and Drug Administration (“FDA”).  The MDA also allows the FDA to condition a grant of premarket approval on a requirement that a device meet certain performance standards. The establishment of a performance standard is a formal process that requires publication in the Federal Register and providing interested parties with an opportunity to comment.  The MDA expressly preempts state medical device regulations that are “different from, or in addition to, any [federal] requirement.”


Continue Reading Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices

Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions.

In the AcneApp case, the defendants claimed that their apps could treat

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed

The Food and Drug Administration (FDA) is expected to issue guidance and possibly regulations regarding use of social media. These policies will only be enforceable on marketers of prescription drugs and restricted medical devices; however, industry can expect that the rationale and policy behind the guidance and regulations will apply across the board to consumer

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves

On May 19, 2010, the Federal Trade Commission (FTC) approved a final settlement order with the Indoor Tanning Association charging that the association exaggerated the health benefits of indoor tanning and misrepresented that indoor tanning increases the risk of skin cancer. The settlement bars the Association from making misrepresentations about the health and safety of indoor tanning and requires that future advertisements from the association that make health or safety claims be accompanied by clear and prominent disclosures about the risks of indoor tanning. The Indoor Tanning Association represents tanning facilities and suppliers of tanning equipment.

Continue Reading Settlement with Indoor Tanning Association Regarding Claims Characterizing Disease Risks for Tanning and Vitamin D Supplements