NEJM article calls for premarket approval of supplements

NEJM article calls for premarket approval of supplements

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?

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. 

Supplement adulteration—not premarket approval—is the real issue

“It is utterly disingenuous to try to confuse the issue by pointing to the actions of rogue companies and then say this is why the whole regulatory framework for the industry needs to be addressed,” said Ullman, who is a partner in the firm Ullman, Shapiro & Ullman.

McGuffin said the product that Cohen cites is “no more representative of products in the dietary supplement category than somebody who practices medicine without a license is representative of the medical community.”

FDA has long identified sexual enhancement as one of the problem categories for spiking, along with weight loss and sports performance. There have been frequent warnings by FDA about products found to be spiked with undeclared pharmaceuticals in the form of Viagra knock-offs in the ED category, sibutramine in weight loss and steroids and pharmaceutical stimulants in the sports category. Barriers to entry in the industry are small, and the agility afforded by Internet sales sites help many bad actors stay one step ahead of regulators.

It is a problem that has been on FDA’s radar for a number of years. In January 2011, Dr. Joshua Sharfstein, who was then deputy director of FDA, told newhope360, “Over the past several years, FDA has found hundreds of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals. The challenge here is not with companies that are responsible; it’s with companies that are not responsible [but are] putting the reputation of your products on the line."

Industry observers agree that Dr. Cohen’s call for a hard line by FDA on its draft NDI guidance would do nothing to address these concerns. 

“The issue here should be what can we do to prevent criminals from adulterating their dietary supplements,” Ullman said.

Circumventing the law

Cohen cites what he characterizes as shortcomings in the evidence of safety called for in the draft NDI guidance. He said that the number and complexity of tests mandated for new ingredients in the guidance do not go far enough and should be expanded.

“What Dr. Cohen is recommending is that we transfer inappropriately to the Food and Drug Administration the authority that the Congress has to change laws, because all of what he is recommending does not fit the current law,” McGuffin said.

Ullman said Dr. Cohen’s statements attack a fundamental aspect of DSHEA. “This comes down to one of the fundamental concerns of the supplement industry and that is health freedom. The more restrictions, the less access, the fewer supplements—the more consumers are dependent on people like Dr. Cohen,” he said.

DSHEA, Ullman said, was meant to allow people “to make their own health decisions and not rely on people like Dr. Cohen to make their decisions for them.”

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