Oct 02 2009
Senate Hearing on Dietary Supplements Issue Puts More Pressure on FDA
The recent crackdowns on dietary supplements distributors prompted the Congress to conduct an investigation to get more insights and determine if new laws should be passed to solve the problem. Some manufacturers and retailers of nutritional supplement products were accused of selling products containing anabolic steroids or steroid like substances. The hearing which was held last September 29 was requested by Senator Arlen Specter, the chair of the Subcommittee on Crime and Drugs of the U.S. Senate Judiciary Committee. It was entitled “Body Building Products and Hidden Steroids: Enforcement Barriers.” Representatives from the different lead agencies of the government as well as representatives of the supplements industry were present during the hearing. Michael Levy, director of new drugs and labeling compliance of the FDA and Travis Tygart, chairman of the US Anti-Doping Agency were some of the resource person. Also present in the hearing is Senator Orrin Hatch, the author of the Dietary Supplement Health and Education Act of 1994.
The two senators asked the federal agencies to enforce existing laws like the DSHE Act of 1994 and the 2004 Anabolic Steroid Act. They feel that these laws are enough to control the proliferation of dietary supplements tainted with anabolic steroids. The agencies should be proactive in handling the problems in the supplements industry like conducting audits, researches, and adding more steroid precursors to their existing banned list. The senators also found out that funding and manpower is not a problem with these agencies.
Michael Levy told the senators that the FDA is having a difficult time figuring out exactly what products are on the market. “Once those products are on the market, it’s not easy to figure out exactly what’s in those products. The only way to truly do that is to test them in a lab, which is a cost- and resource-intensive type of activity,” he said. The existing law allowed manufacturers to sell supplements without a pre-market approval which is a temptation to some companies to add illicit substances into their products. Levy also said that marketing a steroid product as a ‘dietary supplement’ conveys to the consumer a false sense of safety and legitimacy for these potentially harmful products.
Travis Tygart also called for stricter regulations of the industry. He said that it is very easy for young athletes to purchase supplements online. In the Union Tribune report, Tygart admitted that dietary supplements tainted with steroids can still be purchased even on Amazon. FDA’s action is a significant step in controlling dangerous supplements which are out in the market but regulating the supplements industry is a better option according to the USADA head.
Industry representative, on the other hand, had a different stand on the issue. Daniel Fabricant, Ph.D., interim CEO of the Natural Products Association (NPA) said that tougher enforcement and prosecution to the full extent of the law are the best ways to stop those responsible for selling dietary supplements with steroids. “The barriers to enforcement are simple: money, manpower and will,” he said. Fabricant asked FDA, DEA and other concerned agencies to work together so that the sale of illegal steroids and adulterated dietary supplements could be stop.
The Council for Responsible Nutrition (CRN) also issued a statement that they do not condone illegal practices and also urged the FDA and DEA to use their authority to crack down on anabolic steroids that put athletes and young people at risk. CRN also said that product which contains anabolic steroids are not considered as dietary 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- they are illegal, unapproved new drugs,” the head of CRN, Steve Mister said.
The FDA will be facing a tough battle in implementing tighter controls on the supplement products which is multi-billion dollar industry. Those who will be affected are mostly companies producing and selling bodybuilding supplements. Anabolic steroids are popular in bodybuilding and other physical sports. Prohormones which are precursors to steroids already caused many athletes to be banned by their respective sports organizations.
This article does not mention Senator Hatch’s connection with the supplement lobby. It also does not mention the fact that he did his best during that October 2009 hearing to make the FDA all but impotent. What this article does not say says more about the author and the source. When I watched this hearing I was unaware at the time of the senator’s connection, and noticed a real bias against the FDA testimony. It did not bother him that thousands of people had to sicken or die from these products before the FDA is allowed to aggressively test them and then the only recourse was to “ask” the company to stop distributing the offending product. Hatch has a real conflict of interest here. He should not be present at any hearings involving these products. His son Scott is a named partner and registered lobbyist at Walker, Martin & Hatch LLC. In 2003, the Los Angeles Times quoted Senator Hatch as saying that the firm was formed with his “personal encouragement” and that he saw no conflict of interest in championing issues that helped his son’s clients. You could tell where his sympathy was just by watching the hearing.
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