CRN: Sports Illustrated article inaccurate, FDA now enforcing DSHEA powers

6/29/2009

WASHINGTON Sports Illustrated, May 18, 2009) for mischaracterizing the dietary supplement industry.—The Council for Responsible Nutrition last month strongly criticized an article (“What you don’t know might kill you,”

The association charged that the industry has suffered from a chronic dose of misperception around safety and regulatory requirements, in part because the Food and Drug Administration has not actively utilized enforcement powers afforded the agency under the Dietary Supplement Health and Education Act of 1994.

Steve Mister, president and CEO of CRN, noted that the Sports Illustrated article suggested that the DSHEA severely curtailed the FDA’s ability to regulate dietary supplements, shifting the safety burden of new supplement products to the FDA and eliminating any pre-market approval authority.

“Contrary to [former FDA commissioner] David Kessler’s statements [in the Sports Illustrated article], and to common misunderstandings about the law, rather than shifting the safety burden to the FDA, the DSHEA actually provided the FDA with new enforcement authority not previously available,” Mister argued. “Dietary supplements were regulated as a category of food prior to the DSHEA and continue to be regulated as a category of food today. Further, the FDA never had legal pre-market approval authority for dietary supplements; the DSHEA did not change that fact.”

Instead, Mister suggested that the FDA, under Kessler’s leadership, did not enforce the DSHEA at the time of its creation, and that the agency only recently has begun to realize the full regulatory powers afforded the FDA under the DSHEA.

“The extreme examples the article describes appear to be a product of the DSHEA, when in fact they more likely result from the FDA’s lack of enforcement of that law over the past 16 years, starting with Dr. Kessler’s decision to allow the FDA to turn its back on supplement regulation once the DSHEA—a bill he strongly opposed—was enacted,” Mister said. “It wasn’t until Dr. Mark McClellan became FDA commissioner in 2002 that the agency emerged from its fog of inertia concerning the dietary supplement industry and began to look at and use some of the additional authority provided to it by the DSHEA,” he said.

“In the past five years or so, the industry and the agency have both come a long way: with industry lobbying for [good manufacturing practices] that are supplement-specific and the FDA finally issuing these rules; with industry urging for passage of a mandatory reporting system for serious adverse events and the FDA getting the system up and running; and with the FDA taking strong enforcement action—ranging from warning letters to significant fines to product seizures against companies that manufacture unapproved drugs masquerading as dietary supplements.”

Mister also took exception to the suggestion that such performance-enhancing drugs as anabolic steroids are legal under current DSHEA regulations, and that it’s up to the Drug Enforcement Agency to track down and stop production of these supplements containing illicit ingredients. That couldn’t be further from the truth, Mister argued. “Under the DSHEA, most of these substances are not even legal dietary ingredients, i.e., they cannot be legally included in dietary supplements, period,” he said.

For starters, supplement manufacturers can’t legally go to market with a new-to-the-U.S. supplement ingredient without first filing a “new dietary ingredient” notification to the FDA. Products containing new ingredients without that NDI notification are adulterated under the law, Mister said.

Mister also noted that the Sports Illustrated article overstated the size of the sports nutrition industry, and in so doing overstated the size of the potential bad players within that industry. “[The] Sports Illustrated article…starts by referring to sports nutrition supplements as a ‘$20 billion obsession,’ portraying the industry as eight times larger than it is,” Mister said.

“The entire dietary supplement industry has U.S. sales of approximately $24 billion, with vitamin sales alone representing approximately $10 billion of the total market. But the sports nutrition supplements that are the focus of this article represent sales somewhere closer to $2.5 billion,” he said. Mister noted that the Sports Illustrated estimate did include sales figures from categories outside of dietary supplements, such as functional foods.

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