Enforcement

FDA Issues Final Rule on Prior Notice for Imported Food

On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the…

Company’s Operations Halted for Violating FDA Food Labeling Rules

On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of…

Marshals Seize Supplements with Undeclared Drug Ingredients

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters…

FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a…

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 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…

GlaxoSmithKline to Pay $3 Billion in Settlement with Government

On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what…

FDA Warns Makers of RockStar Coffee & Energy Products

On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the…

House Oversight Committee Finds that FDA Actions Cause Drug Shortages

On June 15, 2012, the U.S. House of Representatives Committee on Oversight and Government Reform issued a Staff Report, detailing…

Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request

On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a…