Senate hearing criticizes lack of supplement regulation by FDA, DEA

WASHINGTON —The Senate Subcommittee on Crime and Drugs held a hearing—Body Building Products and Hidden Steroids: Enforcement Barriers—late last month, during which both the Food and Drug Administration and the Drug Enforcement Agency were soundly criticized for not doing more to regulate either the dietary supplement market or those illicit players fielding steroids illegally sold as supplements.

“[For example], ephedra was sold as a dietary supplement, banned by the FDA in 2004, but the ban occurred 10 years after the FDA issued its first advisory and only after the FDA had received thousands of reports of adverse effects, including deaths,” Sen. Arlen Specter, D-Pa., chairman of the subcommittee, said. “What possible explanation is there for that kind of delay?”

The hearing ended before the FDA representative had an opportunity to respond, but those criticisms emphasized the thought that neither agency is doing enough to enforce laws already on the books, whether for reasons of inadequate resources in the case of the FDA, or Byzantine administrative procedures in declaring a product a banned substance in the case of the DEA.

Along with those criticisms, however, came the question as to whether or not current dietary supplement regulations had enough teeth to effectively deter criminals selling steroids masquerading as supplements. The proposed regulatory addition is premarket approval of all new dietary supplements, which if ever actually implemented, would chill any new supplement products in the almost $6 billion mass-channel business (according to the latest Nielsen Co. figures) from reaching the market, noted Sen. Orrin Hatch, R-Utah.

Hatch defended current supplement regulations, which he helped draft some 15 years ago. “We all recognize that there are bad actors in the supplement industry,” he said. “These individuals should be subject to swift punishment by the FDA.… Their products should be removed from the market immediately, and the full weight of the law should be brought down on these bad actors.”

Part of the controversy surrounding steroids and supplements is the commonly held belief by many outside of the industry that supplements spiked with steroids are readily available to consumers wherever dietary supplements are sold, including such specialty retailers as GNC or even mainstream pharmacies. “Experience has shown that there are many of these body-building supplements that are sold over the counter, which may contain steroids or steroid-like substances,” Specter said during his opening remarks.

Despite criticisms around lack of enforcement action, the FDA did recently issue a warning letter to a company selling a steroid product. “Although the body-building products containing these synthetic steroids were marketed as dietary supplements, [these] were not dietary supplements,” testified Michael Levy, FDA’s director of the division of new drugs and labeling compliance. “Rather, there were unapproved and misbranded drugs that had not been reviewed by FDA for safety and effectiveness.”

Another poorly understood factor among critics of the sports nutrition industry is the assumed ease associated with selling an adulterated supplement into larger retailers. “All it takes to cash in on the storefront steroid craze is a credit card to import raw products from China or India where most of the raw ingredients come from, the ability to pour powders into a bottle…and a printer to create shiny, glossy labels,” testified Travis Tygart, CEO of the U.S. Anti-Doping Agency. “We could agree in this room right now to create a new steroid product [and] have it on the shelves in a matter of weeks.”

Lacking from that broad assumption is any appreciation for the sheer amount of product necessary to populate the shelves of a mass retailer, the upfront costs associated with actually gaining distribution or the difficulty any new supplier has in breaking through to mass retail.

All of these factors help push many of these steroid pushers online, where the costs associated with posting a product outside of legitimate online retailers are considerably less.