FDA Asks U.S. Marshals to Seize Dietary Supplements

PharmaManufacturing.com
09/06/2006

At the request of the U.S. Food & Drug Administration (FDA), on Sept. 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules distributed by Advantage Nutraceuticals L.L.C. of Fort Walton Beach, Fla. The products were valued at approximately $55,000.

The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.

Advantage Nutraceuticals' Coral Max capsules.

Although these products are labeled as "dietary supplements," they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including marketing literature, an audio tape, and two websites owned and used by the firm (see www.welcometoadvantage.com and www.welcome2advantage.com.) The FDA advises consumers to consult with their physician if they are taking these products.

Advantage Nutraceuticals' labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures.

FDA considers these products to be unapproved new drugs, and the agency takes seriously its responsibility to protect Americans from dangerous unapproved drugs. Before a new drug product may be legally marketed, it must be shown to be safe and effective and approved by FDA. Drug product labeling must also include adequate directions for use, which the seized products' labeling does not provide.

Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labels make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made.