What is in this article?:
- NEJM article calls for premarket approval of supplements
- Supplement adulteration—not premarket approval—is the real issue
- Circumventing the law
The natural industry has reacted strongly to a New England Journal of Medicine article calling for FDA premarket approval of dietary supplements. Should responsible supplement manufacturers be punished because of a few rogue companies that sell adulterated products?
More About:
Dr. Pieter Cohen, a Massachusetts internist and longtime opponent of the dietary supplement industry, fired his latest salvo in an opinion piece released recently by the New England Journal of Medicine (NEJM). Dr. Cohen called for stricter regulation on the subject of New Dietary Ingredients (NDI), saying that FDA’s draft NDI guidance—seen as onerous by most industry stakeholders—does not go far enough.
In his NEJM article, Dr. Cohen calls for premarket approval for new dietary supplement products. He made a similar appeal during a guest appearance on a recent segment of the Dr. Oz Show on tainted weight loss supplements.
His pronouncements elicited a backlash from industry insiders, with Marc Ullman, a Washington D.C.-based attorney with a long history of representing dietary supplement companies, calling his argument “disingenuous.”
The tone of Cohen’s article presupposes a widespread risk to public health. He finishes the article by saying, “fundamental flaws in DSHEA, such as the lack of a preapproval review process for all supplements, will continue to limit the FDA's ability to ensure that dietary supplements are safe.”
“This product class has a remarkable record of safety,” said Michael McGuffin, president of the American Herbal Products Association. “We’ve averaged 1,200 serious adverse events with dietary supplements over the last three years.” By contrast, he said, hundreds of thousands of adverse events related to pharmaceuticals are sent in to FDA each year.
As a poster child for this supposedly dangerous situation, Cohen cites the case of a “well-respected dietary supplement company in Utah” which “recently” announced the recall of an erectile dysfunction supplement marketed under the name Zotrex. The company, which Cohen did not name, was doing business as Novacare and the recall of its product, Zotrex, which was found to be spiked with a Viagra analogue, happened in August 2010. What Dr. Cohen also did not say is that the same recall by this “well-respected” company named 20 other sexual enhancement products besides Zotrex, products with names like Stiff Nights, Size Matters, Hard Drive and Straight Up, all of which were suspected of being spiked with sulfoaildenafil.