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FDA hasn't forgotten about adulterated supplements

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Another steroid-spiked supplement case puts another arrow in FDA's quiver. Although FDA's NDI Guidance recently has hogged the spotlight, perhaps a priority shift for supplement companies is in order.

On Nov. 3, two supplement companies—sports nutrition marketer Advanced Muscle Science, a subsidiary of DCD, and contract manufacturer R&D Holdings—pled guilty to distributing steroids packaged as dietary supplements. An FDA investigation revealed that DCD’s Dienedrone and Liquidrone, as well as R&D’s Orafindrol 50, Microdrol and Methyldrostanolone products used anabolic steroids or steroid analogs as active ingredients. Sentencing is set for January 2012, with recommendations that DCD pay a fine of $125,000 and that R&D pay $21,000.

According to a release from the Department of Justice, the companies distributed their products across state lines, through “a large Internet-based retailer that has its headquarters in Meridian, Idaho.”

In December of last year, before he resigned as FDA commissioner, Joshua Sharfstein spoke to the press about FDA’s intent to clean up the “dirty” supplement areas—bodybuilding, weight loss and sexual enhancement—and curb the sale of steroids and illegal drugs as supplements. It would appear that that lip service now has legs, with the focus of FDA’s ire seemingly centered on that large Idaho-based online retailer. In May, for example, California-based Tribravus Enterprises pled guilty in a U.S. District Court in Idaho to a similar adulteration indictment.

Meanwhile, as these adulteration cases roll on, a time-bomb lies in wait in the pre-workout market. The oft-maligned 1,3 DMAA—called out by many scientists as a synthetic drug and not, in fact, a geranium extract—is still sold in popular pre-workout products like Jack3d from USPlabs. (Jack3d remains a top seller through online retail.) Should chemists reveal 1,3 DMAA to actually be a drug and not derived from a natural source, some supplement sellers would be best off reformulating their pre-workouts tout de suite.

FDA has made it clear that if industry can’t police itself in these problem categories, the agency’s prepared to step in. Beyond industry’s caterwauling on FDA’s heavy-handed NDI guidance, supplement companies continue to fail GMP audits and get hit with adulteration suits. It seems like a priority shift is in need.

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