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With the surfacing of more sibutramine-tainted weight-loss supplements over the last several months, the adulteration issue has become a more persistent and dangerous problem for the U.S. dietary supplement industry. On Oct. 27, the FDA and the U.S. supplement trade associations convened to discuss what can be done to address what the agency says is the biggest safety issue facing dietary supplements.
Although the spiking problem is not new, the recall of the prescription form of sibutramine and the growth in the black market trade of this weight-loss ingredient, as well as adulteration problems associated with sports and erectile dysfunction-related supplements, have triggered increased regulatory action on the part of FDA.
Just this year, the agency brought misdemeanor charges against several people selling sexual enhancement supplements tainted with active pharmaceutical ingredients. VMG Global faces a felony conviction and fines for selling supplements laced with anabolic steroids. “The challenge here is not with companies that are responsible; it’s with companies that are not responsible—[but are] putting the reputation of your products on the line,” Sharfstein noted during his CRN presentation.
As Sharfstein explained, adulterated supplement products are entering the U.S. market in two ways: 1) via products manufactured abroad and typically marketed in small units via the Internet or mail-order distribution; and 2) as raw materials shipped to domestic contract manufacturers and sold in the United States as multiple finished products. The key product categories affected by adulteration are weight management, male sexual enhancement and muscle building. “Everyone in the supply chain is responsible under the law for ensuring their firm is not selling tainted supplements,” Sharfstein said. “Be especially careful with products in the high-risk categories. These are very attractive to spike.”