FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA
On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree…
FDA Warns Online Cigarette Retailers for Marketing Violations
In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes,…
FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis
On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit…
Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional
On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales…
FDA Actions Highlight New Authority under FSMA
On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a…
FDA Investigates Illnesses Linked to Energy Drinks and Supplements
On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of…
Jimmy Dean Initiates Recall for Failure to Declare Allergens
On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of…
FDA Warns Company for Marketing Medical Device
On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a…
FDA Targets Online Pharmacies in International Efforts
On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of…
FDA Approves MS Drug, Noting Boxed Warnings
On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured…