SILVER SPRING, MD September 29, 2009 – 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 continue to push for more resources for the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) to enforce existing laws against the marketing of illegal steroids that masquerade as dietary supplements.
Hatch took the position that the Dietary Supplement Health & Education Act 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 Hatch and the subcommittee’s chair, Senator Arlen Specter (D-NY), 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, Hatch and Specter disagreed on whether premarket review should be required for dietary supplements. Specter expressed interest in such a concept while Hatch continued to emphasize the need for active enforcement of existing laws.
“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, titled “Body Building Products and Hidden Steroids: Enforcement Barriers,” provided a forum for testimony by 5 witnesses. FDA’s Michael Levy stated that 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. Levy also acknowledges the value of some supplements, specifically acknowledging the beneficial effects of phytosterols on heart health.
Additional witnesses included:
Joseph T. Rannazzisi
Drug Enforcement Administration
United States Anti Doping Agency
Daniel Fabricant, Ph.D.
National Products Association
Richard F. Kingham
Covington & Burling LLP
Written statements and more information on the hearing is available online: http://www.judiciary.senate.gov/hearings/hearing.cfm?id=4081
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and nonprescription drugs. Founded in 1982, AHPA’s mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org.