Adverse Events – FDA Compliance Made Easy

FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

Adverse Events, Dietary Supplements, Enforcement, FDAFDA

On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company’s dietary supplements …

FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids

Adverse Events, dietary ingredients, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Warning LettersFDA

On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured …

FDA Investigates Illnesses Linked to Energy Drinks and Supplements

Adverse Events, Beverages, Dietary Supplements, Energy Drinks, FDA, FoodFDA

On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts …

FDA Approves MS Drug, Noting Boxed Warnings

Adverse Events, Boxed Warnings, Drugs, FDA, LabelingFDA

On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. …