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.
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.”
Given the challenges and current regulatory limitations facing FDA in its work to police the adulteration problem, Sharfstein openly asked the industry for help during the 2010 CRN symposium.
Then, as part of its ongoing dialogue with the U.S. dietary supplement industry, the FDA held a conference call on Oct. 27 with five supplement trade associations—the United Natural Products Association (UNPA), the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA), the Natural Products Association (NPA) and the Consumer Healthcare Products Association (CHPA)—to discuss how regulators and industry can tackle this issue once and for all.
“We all have a mutual resolve to aggressively deal with this issue, and we discussed our ideas for moving forward,” said UNPA Executive Director Loren Israelsen. “The FDA communicated to us that we will see the agency’s level of enforcement around this problem increase dramatically and quickly.” Added John Gay, NPA’s executive director and CEO: “The spiking of supplements is a topic of particular concern to both the FDA and industry.” AHPA President Michael McGuffin echoed Gay's and Israelsen's sentiments regarding the seriousness of the tainted supplements issue.
Although both FDA and industry want to move quickly on stemming the tide of adulterated products and prosecuting those involved, Israelsen acknowledged that, at this time, no easy, short-term solution exists. “This is a global trade problem,” he said. “Those are very difficult to fix. Getting to the source of what is criminal activity is daunting.”
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.
Collaborating on consumer education was another item discussed between the supplement trade associations and FDA. One piece of this is ensuring the media and consumers understand that products adulterated with sibutramine, steroids and other illegal substances are not dietary supplements—they are adulterated and misbranded drugs, Israelsen said.
Manufacturers, suppliers retailers, media and consumers also need more guidance on how to spot potentially adulterated products—and then sound the alarm, Israelsen added. “My view is that a very aggressive collective effort by all of the trade organizations is necessary to quickly inform and update our retailers, manufacturers and suppliers.”
As part of this effort, UNPA plans to issue a guidance document for manufacturers and suppliers on the analytical methods required to identify adulterated or contaminated ingredients and other areas of supply chain protection. Said Israelsen: “No company can safely assume that they are not involved in this problem until they have truly qualified their supply chain.”
Working with New Hope Natural Media (NewHope360.com’s parent company), the FDA issued an e-mail alert on Oct. 7 titled, “Tainted Dietary Supplements and Foods: Responsibilities of Retailers and Distributors” (an updated version of this alert was sent on Oct. 29). In the document, the agency provided a list of items that retailers and distributors should watch for on food and supplement products, including label claims.
In this document, FDA stated that products within the sexual enhancement, weight-loss, bodybuilding and diabetes categories warranted further investigation on the part of retailers and distributors. The agency also advised proactive investigation of products that:
· Claim to be an alternative to approved drug products or legal versions of anabolic steroids;
· Claim to provide immediate sexual enhancement effects;
· Offer directions and warnings that resemble FDA-approved drug products; or
· Say “May cause positive result in performance-enhancing drug test.”
“Firms that sell dietary supplement products play an integral role in preventing tainted supplements from harming consumers and have a legal responsibility to ensure that the products they sell are not tainted,” the FDA wrote in its alert.
As Israelsen sees it, more of such education and outreach is needed for all groups touched by the spiking issue.
The issue of product adulteration and its potential fallout could impact every part of the dietary supplements sector.
Ingredient suppliers could face decreasing sales related to the sexual enhancement, weight management and bodybuilding categories. More important, however, is that all suppliers selling ingredients associated with these categories could be suspected as being potential contributors to the spiking problem. Therefore, suppliers should expect extra scrutiny from scrupulous manufacturers buying from them. Of course, in the “don’t ask, don’t tell” environment that frequently exists within the ingredient market, some manufacturers unfortunately don’t care if they are purchasing adulterated or sub-standard ingredients. But is it wise to do business with these companies? As a supplier, it is in your and the industry’s best interests to strengthen and support your relationships with responsible manufacturers.
Manufacturers operating in the weight-loss, bodybuilding and sexual enhancement categories also face additional risk, scrutiny and liability. This is where certain product-level certifications, such as the NSF Certified for Sport program, can provide credibility and value. As awareness of category-based problems continues to rise, manufacturers should expect to see larger retailers take steps to reduce their exposure in these categories. Manufacturers can differentiate their products by the actions they take in purchasing and testing and by communicating those actions downstream.
For retailers, understanding this issue is crucial. As the FDA communicated in its recent alert, the agency sees retailers as having a legal responsibility to ensure that the products they sell are not adulterated. Therefore, retailers should expect more regulatory scrutiny in all categories, especially the suspect ones. For this reason, it is more important than ever for retailers to know and understand a brand manufacturer’s commitment to quality, which can be measured in the form of certifications and trade association memberships.
In the end, all companies operating with the dietary supplement industry have a responsibility to help eradicate product adulteration or risk harming their most important constituent: consumers. As Jim Hamilton, president of the global ingredient supply company DSM Nutritional Products, said during the 2010 CRN symposium, “We have great trust with consumers, and we have to take that trust seriously.”