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Senator Hatch pushes for greater enforcement of dietary supplements.

As the ranking member at a hearing before the Senate Committee on the Judiciary, Crime and Drugs Subcommittee, Senator Orrin Hatch (R-UT) renewed his commitment to pushing for more resources for FDA and the Drug Enforcement Agency (DEA) to enforce existing laws against the marketing of illegal steroids that masquerade as dietary supplements.

Sen. Hatch took the position that the Dietary Supplement Health & Education Act (DSHEA) of 1994 and the Anabolic Steroid Control Act of 2004 provide FDA and DEA with sufficient authority to bring strong enforcement actions, including criminal charges, against companies that ignore current laws when they sell products that contain illegal or undeclared steroids. Both Sen. Hatch and the subcommittee's chair, Senator Arlen Specter (D-PA), however, suggested a willingness to consider revisions to the latter law if changes are needed to speed up the process whereby "designer" steroids can be classified by DEA as controlled substances.

On the other hand, Senators Hatch and Specter disagreed on whether pre-market review should be required for dietary supplements. Sen. Specter expressed interest in such a concept while Sen. Hatch continued to emphasize the need for active enforcement of existing laws.

The American Herbal Products Association (AHPA), Silver Spring, MD, has urged FDA to step up enforcement against illegal synthetic steroid products, in much the same way the agency applied its enforcement program regarding fraudulent 2009 H1N1 products. "AHPA has long expressed its support for providing adequate resources to ensure that the laws now in place are properly enforced," said AHPA president Michael McGuffin. "Both consumers and law-abiding supplement companies are harmed when scofflaws go unchecked and unpunished, but there is no reason to think that a change in the law would in any way change unlawful behavior," he added. "Companies that are willing to ignore current laws would also ignore any new law. Enforcement is a better answer."

The hearing, entitled "Body Building Products and Hidden Steroids: Enforcement Barriers," provided a forum for testimony by five witnesses--FDA's Michael Levy; Joseph Rannazzisi, DEA; Travis Tygart United States Anti Doping Agency (USADA); Daniel Fabricant, PhD, Natural Products Association; and Richard Kingham, Covington & Burling LLP.

FDA's Mr. Levy stated, in accordance with the agency's position, that the presence of a steroid in a dietary supplement presents "several possible enforcement outcomes," and that such a product may be an unapproved new drug, an adulterated dietary supplement because it contains an unsafe food additive, or adulterated if the steroid is a new dietary ingredient unless notification is submitted to FDA at least 75 days before marketing. Mr. Levy also acknowledged the value of some supplements, specifically the beneficial effects of phytosterols on heart health.

In a letter to FDA, Mr. McGuffin states: "AHPA is concerned that the net impression left by FDA's testimony before the Senate is that the agency cannot presently take effective enforcement action with respect to synthetic steroids that are illegally marketed as dietary supplements. AHPA disagrees, and believes that FDA has all of the authority it needs to shut down the marketers of any such product. We are suggesting that the agency can do so efficiently by adapting its successful program for enforcing against fraudulent H1N1 products."
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Title Annotation:Top Of The News
Publication:Nutraceuticals World
Date:Nov 1, 2009
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