The Food and Drug Administration (FDA) has taken enforcement action against three New Jersey-based sports supplement manufacturers after inspectors uncovered dead rodents, urine and feces on bags of product. FDA investigators inspected the companies’ facilities on three separate occasions between 2007 and 2009 and cited the companies for failure to comply with current Good Manufacturing Practices (GMPs) each time. On July 1, the U.S. Department of Justice filed for a permanent injunction against Quality Formulation Laboratories Inc., American Sports Nutrition Inc. and Sports Nutrition International LLC for GMP failures. Mohamed Desoky, who is in charge of operations for all three companies, also faces injunction.
The FDA contacted Desoky as early as July 2007 with a warning letter informing him of labeling violations and adulterated product. At the time, Quality Formulation Labs was cited for manufacturing protein powders that did not contain the form of protein it claimed to on the label. Powders being manufactured by the company were deemed adulterated after inspectors found products labeled as egg protein that actually contained whey protein—a change in formulation that was not reflected on product labels. Similarly, the company did not disclose the presence of milk protein in a product, which resulted in several allergic reactions reported by consumers, according to the FDA warning letter. The complaint also noted that the company failed to clean processing equipment between batches and control allergens in the facility.
In a July 10, 2009, press release, the FDA indicated that the companies promised to correct their GMP violations, but failed to do so. “This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”
An FDA spokesperson confirmed to Nutrition Business Journal that Desoky’s companies violated existing food GMPs and not the newer dietary supplement GMPs, which were rolled out to the largest supplement manufacturers in June 2008. Given the extent of the companies’ violations, it’s unlikely that they would have been compliant with the newer GMPs had they been subject to those regulations.
United Natural Products Alliance (UNPA) Executive Director Loren Israelsen told NBJ that dietary supplement companies have an obligation to the industry to become GMP compliant. “[Companies] seek the least expensive source of anything—labor, goods, services. There are intense competitive forces and some try to compete with the cheapest goods. That’s how the melamine and peanut problems happened,” said Israelsen. “It’s in our interest as an industry to get [GMP compliance] right, [otherwise] the headline [will read], ‘Supplements Kill People,’ and that is really bad for business.”
The FDA began enforcing dietary supplement GMP regulations for mid-size firms with more than 20 and fewer than 500 full-time employees on June 25, 2009. FDA Supervisory Investigator Ricki Chase, speaking at a GMP mock inspection seminar hosted by UNPA in May, noted that inspections will become routine and more frequent for dietary supplement manufacturers under the new GMPs. Although it is not known exactly how many companies may be subject to an inspection this year, many in the industry feel that there will be a marked increase in the number of companies inspected. According to Chase, the FDA recently made a number of new hires to assist with dietary supplement GMP enforcement.
NBJ subscribers can read more about GMP compliance, including 11 Tips for Ensuring a Smooth FDA Inspection, in our 2009 U.S. Nutrition Industry Overview issue, which should hit mailboxes this week. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue.
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