The Food and Drug Administration unveiled some new tools designed to help makers of dietary supplements police their own industry. The latest efforts include an FDA guidance letter addressed to manufacturers and distributors, as well as improved methods of reporting abuses to the agency. For consumers there’s a new RSS feed that allows the FDA to reach them more quickly with warnings about unapproved supplements.
“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.”
During a teleconference announcing the additional measures, the FDA was joined by representatives of the supplement industry, including the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, the Consumer Healthcare Products Association and the American Herbal Products Association.
The hope is that the FDA letter will be “widely distributed” and eventually end up in the hands of unscrupulous manufacturers, who seem to be focusing — like email spam — on three main health and lifestyle issues: weight loss, sexual performance and body building.
With weight loss, the FDA has noticed an alarming number of products containing Sibutramine, the active ingredient in a drug recently pulled from the market on suspicion it causes heart attacks and strokes. The drugs found in the performance-enhancing supplements are just as dangerous, capable of causing liver failure and death.
In the area of sexual performance, the supplements contain the active ingredient or an analog found in legitimate prescription medications like Viagra and Levitra.
“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs.”
Of course, the problem is that many of these illegal supplement companies operate overseas and deliver direct to the consumer via the mail. Levy noted that some of the suspect products are labeled only in a foreign language or marketed through mass e-mails. With these folks, a much larger effort will be needed that includes whatever the foreign counterpart of the FDA is in any particular country.
That said, there are still enough illegitimate brands based right here in the United States, and found in small shops and other corner stores. They’re the ones who will most likely feel the hardest impact by this latest move by regulators — and the industry itself.
[Photo credit: FDA]