On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.” The draft guidance represents current thinking on the topic as previously discussed through the release of …
FDA Seizes Topical Creams Deemed Drugs
On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, …
FDA Halts Production at New York Cheese Company
On April 28, 2014, the U.S. Food and Drug Administration (“FDA”) prevailed in federal court in its action against Nancy Taber Richards and the company she co-founded, Trumansburg, N.Y.-based Finger Lakes Farmstead Cheese Company, LLC. In particular, the Western District …
FDA Publishes Draft Guidance on Honey Labeling
On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for Industry: Proper Labeling of Honey and Honey Products” (“Guidance”). The Guidance provides industry with guidelines on how to properly label …
FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients
On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company’s dietary supplements …
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 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 …
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 …
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 Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs
On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and …