Labeling

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 Warning Letters to Online Cigarette Companies

In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many…

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…

Food Seasonings Recalled Due to Undeclared Allergens

On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound…

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…

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…

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…

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 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…