PHOENIX Former presidential candidate Sen. John McCain, R-Ariz., together with Sen. Byron Dorgan, D-N.D., on Wednesday introduced the Dietary Supplement Safety Act of 2010, a bill that would impose greater restrictions on the entire dietary supplement industry, in part because of the insinuation often made that supplements may contain banned performance-enhancing ingredients.
“Like many of you, I am looking forward to watching the Super Bowl this Sunday and the Winter Olympics later this month,” McCain said. “However, a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy.”
The Council of Responsible Nutrition responded expressed its belief on what the legislation would do to the dietary supplement industry and consumers.
“CRN looks forward to the opportunity to study the legislation and find common ground with the sponsors and supporters of this legislation,” stated Steve Mister, CRN president and CEO. “Where specific provisions are extensions of positions we have already supported and lobbied for, we applaud more voices joining with ours.”
The legislation would require dietary supplement manufactures to register with the Food and Drug Administration and fully disclose all ingredients and provides the agency with mandatory recall authority if a product is found to be unsafe or harmful. However, the act also would require supplement companies to report all adverse event reports, which is more restrictive than the serious adverse event report requirement in place now.
“We do not believe that requiring manufacturers to report all adverse events — not just serious adverse events — would do anything to protect consumers,” countered Mister, because such a requirement would overburden the FDA without affording any greater consumer protection. “FDA itself has stated that this would overburden the Agency and would not help protect consumers,” he noted.
The “dietary supplement” referenced by McCain is the Nikki Haskell’s StarCaps weight-loss supplement, distributed by Balanced Health Products, which was sold in specialty outlets GNC, Vitamin Shoppe and Great Earth Vitamin Stores according to the StarCaps Web site at the time those NFL players were suspended. StarCaps contained bumetanide, a prescription-only diuretic, making it an illegal, adulterated drug. The NFL banned diuretics because they can be used as masking agents for steroids. Balanced Health recalled all StarCaps products in conjunction with the FDA in December 2008.