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

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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 include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label. After testing a variety of different Zi Xiu Tang Bee Pollen dietary supplements, the FDA has discovered that each product contained at least one of the listed unnamed drug ingredients: Phenolphthalein - A substance that is associated with cancer and is not a current…
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FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids

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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 for Blunt Force Nutrition in North Carolina and is sold in retail stores, gyms, and on the internet. The FDA alleges that despite being labeled as a dietary supplement, Mass Destruction contains synthetic anabolic steroids, which makes it an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDA’s announcement may be found here.…
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FDA Investigates Illnesses Linked to Energy Drinks and Supplements

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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 in this area, including its evaluation of adverse event reports. According to the FDA, it is currently in the process of determining whether there is an actual cause-and-effect relationship between the consumption of energy drinks and energy supplements and these medical problems. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers, packers and distributors of all dietary supplement products…
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FDA Approves MS Drug, Noting Boxed Warnings

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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. The full announcement of the approval may be accessed here. As noted in the FDA’s announcement, Aubagio contains a Boxed Warning intended to alert prescribers and patients of certain risks, including liver problems and birth defects. Accordingly, prescribers are warned to refrain from prescribing Aubagio to patients who have existing liver problems. In addition, prescribers are required to verify that…
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