On March 7, 2014, the Federal Trade Commission (“FTC”) reported that the Agency had prevailed in federal court in its action against the Wellness Support Network. In particular, the U.S. District Court for the Northern District of California entered a …
FDA Moves to Update Nutrition Facts Label for Foods
On February 27, 2014, the U.S. Food and Drug Administration’s (“FDA”) moved to update nutrition facts labels (“Nutrition Facts Panels”) on packaged foods and dietary supplements. The proposal was prompted by recent scientific findings that suggest there is a direct …
FDA Issues Statement on IOM Report on Safety of Caffeine in Foods
On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“IOM Report”) on Caffeine in Foods. Released on January 17, 2014, the IOM Report is a culmination of the recent …
FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages
On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ. Beverages …
FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids
On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured …
FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps
On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating …
U.S. Marshals Seize Dietary Supplements Containing DMAA from Georgia Company
On November 12, 2013, the U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized dietary supplements manufactured and held by Hi-Tech Pharmaceutical, Inc., located in Georgia. According to the FDA, the dietary supplements are adulterated …
FDA Acts to Ban Trans Fat in Foods
On November 7, 2013, the U.S. Food and Drug Administration (“FDA”) published an announcement, entitled “Tentative Determination Regarding Partially Hydrogenated Oils,” announcing its preliminary determination that Partially Hydrogenated Oils (“PHOs”), which are the primary source of trans fatty acids (trans …
J&J Company Pleads Guilty to Misbranding for Off-Label Marketing
On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen Pharmaceuticals, Inc. (JPI), a Johnson & Johnson company, pled guilty to misbranding the drug Risperdal (risperidone) in violation of the …
FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices
On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device Identification (UDI) system, finalizing the proposal first announced in July 2012. Our previous report of the proposed rule may be …