Editorial: FDA Action on Flagrant Violation

By Len Monheit

Earlier this week, FDA asked US marshals to seize dietary supplement products making drug claims, specifically, 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, Florida, valued at approximately $55,000.00. Although this is not the only recent enforcement action, but is significant from a few aspects.

First of all, the violations are quite obvious - the disease associations in one case even appearing in the product name. The other interesting aspect is FDA's history with the company:

"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."

Such blatant disregard for the regulations and the law should be punished and the company should be distanced from 'legitimate' industry. FDA's actions start this process, and hopefully other obvious enforcement actions are in the works. We know this is the tip of the iceberg

We know this is the tip of the iceberg and that both FDA and FTC could turn their sights almost anywhere to find violations.

Legitimate industry has been critical of FDA and FTC enforcement will, while recognizing, at least in the case of the FDA, inadequate resources probably mean that only the most flagrant or safety-compromising violations will be pursued.

This is not an ideal situation, but obviously the best we've currently got. Hopefully, more 'obvious' actions are in the works and hopefully industry is maintaining a constant stream of violations it observes as well.

Presumably, someone cares.

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