Friday, September 15, 2006

09/15/06 - "promotes and markets... for serious disease conditions"



The FDA issued the following press release last week:


"At the request of ...(FDA), on September 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules... valued at approximately $55,000.00."

[Note the following claim that the NEW drug and misbranding provisions apply to dietary supplements as well as to drugs, when the DS is being promoted, in FDA's opinion, as a "drug."]

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

"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 various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. ..."

"[Company's] labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures."

[And now, what to expect.]

"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' labeling 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."


Note that "sufficient steps to come into compliance..." was the issue. This case appears to be another example of "guilty until proven innocent" in that no independent third party determined that the steps the company took were "sufficient." The companies that will survive in what is becoming a much stricter regulatory climate are those that are ready to react quickly. Oh, and if you are one of those companies trying to take "sufficient steps," not keeping a large inventory in your main plant is probably a good idea too.

You need to pay attention to your site claims on a continuing basis, and that is what the Vitamin Lawyer Oversight Seal program is all about. See: for details.

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