The U.S. Food and Drug Administration is warning consumers about potentially dangerous ingredients in products marketed for weight loss, some of which are labeled as dietary supplements. In a Dec. 22, 2008 press release, the FDA identified 28 products that it said contained “undeclared, active pharmaceutical ingredients.” On Jan. 8, the FDA issued another release in which it expanded its warning to include 41 additional products. According to the release, the pharmaceutical ingredients in question include:
• sibutramine (a controlled substance)
• rimonabant (a drug not approved for marketing in the United States)
• phenytoin (an anti-seizure medication)
• phenolphthalein (a solution used in chemical experiments and a suspected cancer- causing agent)
• bumetanide (a diuretic)
Under the U.S. Dietary Supplement Health and Education Act of 1994, manufacturers of dietary supplements are not required to get FDA approval before marketing or selling a product, but once the product is on the market, the FDA can investigate manufacturers’ claims. Under DSHEA, it is the manufacturer’s responsibility to ensure that a dietary supplement is safe and that its product label information is “truthful and not misleading,” according to the FDA’s website.
The American Herbal Products Association responded positively to the FDA’s efforts. “We applaud this good work by FDA,” said AHPA President Michael McGuffin in a release. AHPA said its mission to promote the responsible commerce of herbal products can only be accomplished when FDA and other government agencies actively enforce the law.
The release went on to state, “None of the products indentified by FDA are marketed by members of AHPA or, to the best of AHPA’s knowledge, any other trade association in the dietary supplement industry.”
The Council for Responsible Nutrition also issued a release, from President and CEO Steve Mister, that said, “It is unfortunate that some of these products have been marketed as dietary supplements. Under the law, what is in the dietary supplement bottle should be listed on the label, and products that break the law have no business being on store shelves. CRN supports the agency’s decision to demand removal of these adulterated products from the market.”
One of the most high-profile products to come under scrutiny is Nikki Haskell’s StarCaps Diet System, which was exposed last fall for containing bumetanide. Promoted as a dietary supplement, StarCaps is blamed by professional football player Grady Jackson for a failed drug test in which he tested positive for bumetanide, which is banned by the National Football League.
On Tuesday, The New York Times reported that Jackson is pursuing legal action against StarCaps and the stores where he purchased the product—including GNC and the Vitamin Shoppe. StarCaps has halted shipping of its product, and a notice on the StarCaps website says, “We've received notice of a problem with an NFL player. We have referred the matter to our counsel and are taking all necessary steps to ensure that our customers receive product that is safe and effective. We have temporarily suspended shipping of StarCaps pending the results of our investigation.”
Weight loss products will likely continue to be watched closely, according to The New York Times article, in which an FDA spokeswoman said the agency “plans to issue a longer list of brands to avoid that are spiked with drugs.”