FDA Seizes Supplements for Drug Claims

WASHINGTON—At the request of the Food and Drug Administration (FDA), U.S. Marshals seized various supplement products distributed by Fort Walton Beach, Fla.-based Advantage Nutraceuticals LLC, which the agency said failed to heed warning notices that the products are allegedly in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.Valued at approximately $55,000, the seized products included Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules.

These products are labeled as “dietary supplements” but, according to FDA, are being marketed with claims typically associated with drug products. These claims are all over the products’ labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm—www.welcometoadvantage.com and www.welcome2advantage.com. FDA (www.fda.gov) considers these products to be unapproved new drugs, stating it takes seriously its responsibility to protect Americans from dangerous unapproved drugs.

The agency reported it previously advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products’ labeling make these products subject to regulation as drugs. However, FDA contends the firm failed to take sufficient steps to bring the products into compliance, and subsequent federal inspection revealed the offending claims were still being used.