Disease Claims – Page 3 – FDA Compliance Made Easy

Marshals Seize Supplements with Undeclared Drug Ingredients

CGMP, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Seizure, Warning LettersFDA

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be …

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

Disease Claims, Drugs, Enforcement, FDA, FTC, Labeling, Substantiation, Warning LettersFDA, FTC

On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler …

FDA Warns Company for Marketing Medical Device

510(k), Disease Claims, FDA, Labeling, Medical Devices, PMA, Warning LettersFDA

On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to …

FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

Dietary Supplements, Disease Claims, Drugs, Food, Labeling, Structure-Function Claims, Warning LettersFDA

On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and …