What is in this article?:
- FDA, industry partner to tackle tainted supplements issue
- FDA crackdown
- FDA needs industry collaboration
- GMPs can help
- Education and communication
- Retailer responsibility
- What this means for you: supplier, manufacturer and retailer
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.
From the inclusion of trace levels of performance-enhancing drugs to the deliberate addition of substances designed to erroneously test as a higher-cost ingredient, the adulteration of dietary supplement products has been a persistent problem over the last decade. Along with threatening consumer safety, each adulteration event erodes the credibility of legitimate supplement industry players—even though the perpetrators of these events are typically unscrupulous individuals who operate just outside the radar of both industry and the U.S. Food and Drug Administration (FDA).
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—and one that has triggered a cascade of negative news headlines. For example, when Meridia (the prescription drug brand name for sibutramine) was pulled from the market in early October due to the increased heart attack and stroke risk linked to the product, the Wall Street Journal’s Health Blog ran this headline: “Meridia Is Gone, But Sibutramine May Remain… In Dietary Supplements.”
Not surprisingly, FDA concern over this issue is growing dramatically. During the Council for Responsible Nutrition’s 2010 Symposium for the Dietary Supplement Industry in late September, Dr. Joshua Sharfstein, principal deputy commissioner of the FDA, told attendees that the deliberate adulteration of supplements with sibutramine, anabolic steroids and other illegal substance is the agency’s greatest concern related to dietary supplements today. “Over the past several years, FDA has found hundreds of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals,” Sharfstein said.
