FDA Adulterated Weight-Loss Supplement Actions Lack Teeth – Attorney
This article was originally published in The Tan Sheet
Executive Summary
Three recalls out of nearly 70 weight-loss supplements identified since late December as adulterated with undeclared prescription drug ingredients reflect a growing disregard for FDA's authority, says an attorney for the manufacturer of one of the recalled products
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Three recalls out of nearly 70 weight-loss supplements identified since late December as adulterated with undeclared prescription drug ingredients reflect a growing disregard for FDA's authority, says an attorney for the manufacturer of one of the recalled products. "I don't see any deterrent effect from the FDA," observed Marc Ullman, who represents Starcaps manufacturer Balanced Health Products. FDA's Center for Drug Evaluation and Research said Jan. 28 that only three of the 69 adulterated weight-loss products it has identified are recalled so far. Those products are Zen de Shou , Venom Hyperdrive 3.0 and StarCaps. On Jan. 27 the center warned consumers not to use Venom Hyperdrive 3.0, because it contains a "significant amount" of undeclared sibutramine, the active ingredient in Abbott's Meridia prescription anti-obesity drug. Sibutramine "is a potent drug that poses potential safety risks," including addiction, FDA says in its consumer alert about Hyperdrive, which is marketed by ALR Industries, a strength-training supplement company headed by Arthur L. Rea. Sibutramine is risky for people with a history of heart disease, heart failure, irregular heartbeats or stroke. In a supplement, the ingredient "may harm unsuspecting consumers" because it can increase blood pressure and heart rate substantially, Janet Woodcock, director of the Center for Drug Evaluation and Research, says in the release. On its Web site, Las Vegas-based ALR says it initiated the recall Dec. 31 after learning from FDA about the adulteration. The company says no illnesses or injuries have been linked to the product and it "has taken this voluntary action out of concern for the health and safety of our customers." Many companies do not heed FDA warnings about supplement regulation violations, Ullman said. He added that while his client, Balanced Health, is making changes to prevent adulterants from entering its supply chain, some companies are not as responsive to FDA warnings, and their actions lead more firms to knowingly violate food and drug regulations. "FDA is an enforcement agency, but without deterrence, enforcement is impossible because you can't enforce against everybody," Ullman said. In addition to selling potentially harmful products to consumers, noncompliant supplement firms create problems for the industry. Calls from Capitol Hill and consumer protection organizations for tighter regulation of supplement manufacturing almost always follow reports of adulterated products turning up in the market, often sold by firms that have little resemblance to compliant businesses. "These guys become identified with the industry, which wants to have nothing to do with them," Ullman said. When CDER warned consumers about the adulterated supplements in December, officials said the agency might file criminal charges against the manufacturers of the products (1 (Also see "FDA Warns Of Possible Criminal Charges Against Weight-Loss Product Firms" - Pink Sheet, 5 Jan, 2009.), p. 8). Most of the products contain sibutramine and either rimonabant - an anti-obesity drug not approved in the U.S. but available in Rx products sold in other countries - or the anti-seizure drug phenytoin or phenolphthalein, which was once available as a laxative but was removed from the market due to concerns about carcinogenicity. FDA contacted the firms about conducting recalls, but because of the severity of violations found in facility inspections and the inadequate responses to recall requests, the agency said it was considering additional enforcement steps, such as issuing warning letters or initiating seizures. "There is a whole spectrum of follow-up actions we could take, from warning letter to criminal sanctions, and the severity of that action depends on the thoroughness of the voluntary action by the company and concerns the agency has about the particular product," a CDER official said in an e-mail. FDA did not comment on specific enforcement plans. The agency's approach to enforcement authority, Ullman suggested, will not keep businesses from flaunting food and drug laws by intentionally marketing adulterated supplements. "There is no fear of FDA," he said. - Malcolm Spicer ([email protected]) |