FDA Takes Action Against Products Marketed as Supplements that Contain Active Drug Ingredients

December 22, 2010 2:14 PM

In response to numerous complaints of injury and following hundreds of consumer alerts, FDA has taken action against the manufacture and sales of products marketed as dietary supplements that contain the active ingredients found in FDA-approved drugs. On December 15, 2010, FDA sent a letter to dietary supplement manufacturers stressing the dangers to public health from dietary supplements marketed as weight loss, body-building, or sexual enhancement products, that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients, or compounds such as synthetic steroids that do not qualify as dietary ingredients. Consumers who take such products, sometimes unaware that the active ingredients are present, may experience serious side effects or drug interactions with other products they are taking. FDA reminded manufacturers of relevant regulations related to the manufacture of dietary supplements, and actions that have been taken to protect consumers from illegally manufactured, unsafe products. The letter also advised manufacturers, distributors, and importers of the responsibility to protect the supply chain from adulterated and/or misbranded drugs.

Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research stated in an FDA press release that “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”