From cancer-causing dyes posing as costly eye-health botanicals to sexual enhancement remedies spiked with dangerous drugs, adulterated ingredients are making their way into the U.S. dietary supplement market. More than a quarter of finished products and as much as 85% of certain problem ingredients, such as billberry, have been adulterated in some way, according to research by third-party testing companies. And the problem, say industry experts, is escalating for some ingredients — despite the rollout of the U.S. Food and Drug Administration's (FDA's) good manufacturing practice (GMP) rules, which were designed to identify and eliminate problem or suspect dietary supplement ingredients.
“You would assume that with the increased regulation, the new GMPs, and all of the press about these types of problems, that fear would be driving people not to do it. But at this point, the number of incidents we are seeing is going up, not down,” Frank Jaksch, CEO of third-party testing company ChromaDex Inc., told Nutrition Business Journal.
In the wake of the melamine pet food and infant formula scandals of 2007 and 2008, and a host of other high-profile food and supplement recalls, the FDA in May 2009 held a meeting and issued a call for comments to determine how widespread “economically motivated adulteration” (EMA) is in the industries it regulates and what can be done to prevent it. Although the agency has yet to make any conclusions public, the dietary supplement industry has responded robustly, with the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN) calling for more clear regulations, greater enforcement of quality-control laws, and better communication between FDA and industry when a known ingredient adulteration has occurred. Meanwhile, third-party testers and supplement company CEOs are chiming in loudly, blaming a culture in which ingredients are chosen for price, not quality; substandard tests are passed off as definitive; and accountability is usurped by finger pointing.
Although the dietary supplement industry has yet to suffer a widespread and deadly adulteration like the recent melamine debacle, many believe it is just a matter of time. And given the current mood in Congress to crack-down on industries and products it believes threaten consumer safety, one such case could be just the motivation legislators need to introduce stricter dietary supplement regulation.
“We've reached a tipping point and it's a big concern,” Jaksch said. “People are asking: ‘What is it going to take to fix this problem?’”
4 ways to avoid adulteration
Acknowledge the problem. “Economic adulteration has been going on since the beginning of time, but now we are starting to see adulterants move from being benign to actually causing harm,” Shao said. “It has changed the game. When it starts hurting people, the issue must be taken more seriously by everyone.”
Deal only with suppliers you trust, and ask them to do the same. Under the new GMP rules for dietary supplements, which were enacted in 2007, the onus lies on the finished product manufacturer to ensure that incoming ingredients are what they say they are. (Dietary ingredient suppliers, meanwhile, are subject to less-stringent food GMPs.) “It is unfortunate that the FDA entirely put the burden for ingredient safety and quality on the manufacturers, but the agency has made it very clear that we are responsible for policing our suppliers,” said Travis Borchardt, vice president of regulatory affairs and quality control at Enzymatic Therapy.
Invest in quality testing that uses standardized, up-to-date methods.“The adulterators are becoming more sophisticated. They are coming up with ways to trick the tests,” said William Obermeyer, vice president of research for third-party testing company Consumerlab.com. In fact, Obermeyer estimated that one-quarter of the finished products his company tests have been adulterated in some way.
Be leery of bargain-basement prices. “When things sound too good, there is a reason for it,” said Al Czap, president of Idaho-based supplement manufacturer Thorne Research Inc., whose company buys its botanicals, such as gingko biloba, from Italy-based Indena and uses ChromaDex for testing. “We have stuff that we could buy for 30 percent less from a different supplier, but would we do it? No. You get what you pay for.”