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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.
GMPs can help
FDA and the supplement trade associations used the Oct. 27 meeting to, one, voice their mutual interest in solving what all believe is a serious issue; and, two, to brainstorm—but not yet commit to—actions that need to be taken. “No promises were made as to what specific solutions would be pursued,” Israelsen said.
The group discussed the tools the FDA has withing the current regulatory framework that could help protect supplement companies from unknowingly purchasing adulterated ingredients. One such tool is section 111 of the supplement Good Manufacturing Practices (GMPs), which states that if a company has “reasonable anticipation” that a contaminant could be present in a raw material, it must establish a procedure to prevent contamination.
According to Israelsen, the trade associations and FDA discussed on Oct. 27 the idea of using GMP section 111 to require the establishment of a contamination-prevention procedure all supplement products that make certain weight-management, muscle-building or male enhancement claims. “If you buy, sell or manufacturer ingredients or products that make claims in these three areas, it is [UNPA’s] view that you have an affirmative duty to prevent ingredient contamination,” Israelsen said. “We believe this is necessary to protect consumers and our companies from becoming unwittingly involved in product adulteration.”
Such a procedure could include testing in-bound materials for the presence of known spiking agents and known analogs. Certainly, such testing comes at a cost to companies. According to James Neal-Kababick, the director of Flora Research Laboratories (an FDA and DEA registered and inspected lab), his company typically charges just under $500 to test a single ingredient lot for sibutramine and other contaminants found in weight-loss supplements. Such testing could be regarded as cost prohibitive for a small manufacturer, but the reality is that using an adulterated ingredient could result in even heftier costs down the road, Israelsen noted. “Vigilance is required until we have a better way of doing this.”
Although such a solution might not immediately zero in on the “crooks” at the center of the adulteration problem, Israelsen said he believes it would “create a defensive perimeter to help protect companies from spiked ingredients.”
Of course, those manufacturers who sell lots of sports nutrition and weight-loss products have the most to gain from such a “defensive perimeter,” Israelsen added. “My hope is that they will be the companies that want to make the most significant short-term and long-term investments in building a fire wall against spiking.”
According to Nutrition Business Journal estimates, sales of pill-form sports supplements (which would include the types of muscle-building products identified by FDA) grew 8% to $160 million in 2009. Sales of weight-loss supplements fell 4% to $1.6 billion last year, while sales of sexual health supplemetns (which would include products targeted to male sexual performance) were relatively flat at $480 million in 2009.