Senate Hearing Examines DSHEA vs. Pre-market Approval

Senate Hearing Examines DSHEA vs. Pre-market Approval

On September 29, the Senate Judiciary’s Subcommittee on Crime and Drugs held a hearing presided over by subcommittee chairman Senator Arlen Specter (D-PA) and ranking member Senator Orrin Hatch (R-UT) concerning hidden steroids in bodybuilding supplements. Sen. Specter, putting forth the idea that supplements should be pre-approved at the federal level before entering the market, has sparked an industry-wide stir.

Generated in part by a recent claim by Philadelphia Phillies pitcher J.C. Romero that he failed a drug test because a supplement he had been taking contained unlisted steroids, the hearing included testimony from the US Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), US Anti-Doping Agency (USADA), the Natural Products Association (NPA) and more. Some placed blame on the Dietary Supplement Health and Education Act of 1994 (DSHEA), calling for more government intervention in the dietary supplement industry. Others called on Congress to fund FDA with the resources it needs to do its job in a quick and effective fashion.

“Because FDA generally does not receive information on these products prior to marketing, FDA generally cannot identify violative products before they enter the marketplace,” testified Michael Levy, director of FDA’s new drugs and labeling compliance division. “After the products enter the market, we must undertake a painstaking investigation and analytical process to show that they are violative. FDA’s ability to solve the problem is limited.”

And while Sen. Specter raised the possibility of introducing a legal requirement for supplement makers to receive government approval before products hit the market, American Herbal Products Association (AHPA) President Michael McGuffin strongly disagreed. “Companies that are willing to ignore current laws would also ignore any new law,” he said, in support of DSHEA. “Enforcement is a better answer.”

Indeed, United Natural Products Alliance (UNPA) Executive Director Loren Israelsen cited the FDA as “chronically underfunded and understaffed,” arguing that the focus should be on improving the regulation already in place.

“Enforcement tools available to FDA include seizure of products, and fines and criminal sanctions against companies that ignore the law,” agreed Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “FDA just needs the resources and the political will to use them.”

“The hearing ended up as well as can be expected for the industry,” said Marc Ullman, industry attorney. “Dan Fabricant of NPA and Richard Kingham, Esq. of Covington & Burling did a superb job of explaining that this situation had nothing to do with DSHEA, but that it actually was caused by a lack of will and/or resources at FDA to enforce the law as written. Neither Mr. Levy nor the representative from USADA were able to explain how requiring all supplements to undergo a premarket approval process would make people who already ignore such a requirement comply.”

Still, Ullman believes that DSHEA is in jeopardy. “Not only because I think that this issue will not go away, but because I am concerned that overall lack of enforcement by FDA has created an atmosphere where frauds/charlatans feel that there is next to no risk in entering the supplement field and selling their illegal products,” he said, noting that the reaction would be not to blame the FDA, but to push for DSHEA’s rollback. “It is imperative that stakeholders take this threat seriously and support their trade associations and get involved with their representatives in Washington.”