Enforcement
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…
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…
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…