Last week’s Senate subcommittee hearing on steroid-spiked products masquerading as sports supplements has the U.S. dietary supplement industry once again clamoring for better enforcement of current supplement laws rather than the introduction of new legislation. The Dietary Supplement Health and Education Act (DSHEA) “is there and in place—it just needs to be enforced accurately,” Keri Marshall, ND, medical director for Gaia Herbs, told Nutrition Business Journal. “What is most important is for FDA to enforce the new GMP guidelines,” added Don Summerfield, vice president of integrative medicine at Pharmaca Integrative Pharmacy. “That is going to take the industry a long ways in terms of cleaning up some of the issues around product quality.”
With the healthcare reform debate still raging, Congress has much on its plate these days that supersedes the importance of creating new dietary supplement legislation. Still, some believe the tide could move in that direction. “Washington is a tricky place to predict, but there certainly does seem to be more pressure than in recent memory to revisit the regulatory scheme applicable to supplements to see if there is a way to do it better,” Ivan Wasserman, an attorney with the Washington, D.C.-based law firm Manatt, Phelps & Phillips, told NBJ. “Whether anything will actually happen depends on many factors, including more pressing priorities, but it seems like we may be at a tipping point and any additional high-profile news stories, particularly any that involve safety concerns, could be what tips the situation from debate to action.”
Senator Arlen Specter, the Pennsylvania democrat who chaired the September 29 Senate subcommittee hearing, questioned during the meeting whether government pre-market approval of dietary supplements was necessary to protect consumers from dangerous steroid-spiked products. Specter’s remarks followed testimony from Travis Tygart, CEO of the U.S. Anti-Doping Agency, who told the subcommittee that the FDA needs to know—before dietary supplement products are allowed to be sold—which companies are making dietary supplements, what products they are making and what the ingredients in those products are, according to Tygart’s written testimony. This, Tygart argued, would help guard against “the more general problem of dietary supplements that contain substances that are not disclosed on the product label.”
Also testifying during the hearing were Michael Levy, director of the division of new drugs and labeling compliance at the FDA; Joseph Rannazzisi, deputy assistant administrator of the Office of Diversion Control at the Drug Enforcement Administration (DEA); Daniel Fabricant, interim executive director and CEO of the Natural Products Association (NPA); and Richard Kingman, a partner in the law firm Covington & Burling LLP.
During his testimony, Levy detailed the steps the agency has taken to protect consumers from potentially dangerous products, including issuing 28 warning letters to firms that were illegally marketing products containing steroids. “Despite these actions, FDA’s ability to solve this problem is limited,” Levy noted in his written testimony. “Because FDA generally does not receive information on these products prior to marketing, FDA generally cannot identify violative products before they enter the marketplace. After products enter the market, we must undertake a painstaking investigative and analytical process to show that they are violative. Currently, the agency struggles to provide effective civil and criminal deterrents to prevent unscrupulous firms from fraudulently marketing these products, and we are unable to effectively prevent the importation of many violative products. These gaps make it very challenging to interrupt the sale of these dangerous products.”
Sen. Specter was perhaps toughest during the hearing on the DEA, which he questioned vigorously regarding its slow action to classify anabolic steroids as schedule III controlled substances. Such classification would subject anabolic steroids to strict manufacturing and documentation requirements that would help prevent their inclusion in products sold over the counter to consumers.
Following the hearing, the Council for Responsible Nutrition (CRN) was quick to point out that the products being scrutinized by lawmakers are illegal and unapproved new drugs not supplements. “Rogue products that contain anabolic steroids are not dietary supplements, regardless of how the bad actors who manufacture and market these products might position them,” CRN President and CEO Steve Mister said in a statement. “Responsible supplement companies do not condone these practices, and urge the Food and Drug Administration and the Drug Enforcement Administration to use the ample authority already granted to these agencies to crack down on anabolic steroids that put athletes and young people at risk.”
Congress has given the DEA special power under the Controlled Substances Act to regulate anabolic steroids, Mister added. “Just because a rogue manufacturer may misrepresent the product as a dietary supplement does not undermine the DEA’s legal authority to pursue these illicit substances,” he said. “Under the Dietary Supplement Health and Education Act (DSHEA), it is also illegal for supplements to contain drugs or undeclared substances, and FDA has the regulatory authority under existing law to take action against companies manufacturing and marketing unapproved drugs masquerading as dietary supplements. FDA can remove these products from the marketplace if they pose an imminent threat to public health or if there is a significant or unreasonable risk of injury or illness associated with use of the products.”
Nutrition Business Journal’s September issue is devoted to the $20.8 billion U.S. sports nutrition & weight-loss market and explores the sales and potential regulatory impact recent negative news could have on the U.S dietary supplement industry. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue go to NBJ’s subscription page. NBJ will also host a Web seminar on the U.S. sports nutrition & weight-loss industry on October 27, 2009. Learn more or register for the Webinar via the NBJ Website.