From a regulatory standpoint, America’s dietary supplement industry has endured a hellacious year.
In January, few industry execs were closely tracking the activities of state attorneys general. Then New York Attorney General Eric Schneiderman announced a supplement investigation that accused major U.S. retailers of a colossal fraud: hawking products that contained an abundance of contaminants, but few, if any, of the advertised herbs. The scathing accusations were plastered on the front page of The New York Times and culminated in newspaper editorials that derided the regulatory framework governing the dietary supplement industry.
Industry leaders immediately blasted Schneiderman’s DNA testing methodology as unreliable. The last 11 months have highlighted a new reality heading into 2016: Compliance with federal regulations alone isn’t sufficient to stave off enforcement actions from government agencies.
The states are scrupulously patrolling dietary supplement labels and the actual ingredients in those products. Look no further than Schneiderman’s investigation into herbal supplements and his subsequent devil’s claw probe. The latter investigation underscores the states’ inquiries are likely to be broader than probes launched by FDA, whose primary mission is to protect the public health from unsafe products.
In 2016, state regulators are likely to ramp up their enforcement activities against dietary supplements. Schneiderman’s future probes may follow the narrative contained in devil’s claw cease-and-desist letters that were delivered in September to 13 marketers. According to New York authorities, the products contained inferior plant material than the one advertised (devil’s claw).
Industry leaders predict Schneiderman will launch investigations into additional herbal products that are said to be mislabeled, possibly based on findings from the New York Botanical Garden. That is the same organization whose research formed the basis for the devil’s claw letters.
Among products that have been studied by the New York Botanical Garden in recent years: black cohosh, saw palmetto and Ginkgo biloba supplements. Using DNA barcoding, researchers found a number of products failed to contain the labeled herbs.
Attorneys general, who are charged with protecting consumers from deceptive trade practices, are likely to find such research alarming. A number of states—not just New York—already view the industry with skepticism.
In October, as was widely reported, Oregon Attorney General Ellen Rosenblum sued GNC, a giant retailer that consumers commonly associate with the US$37 billion dietary supplement industry. And during a recent meeting convened by the National Association of Attorneys General in St. Louis, critics from the Center for Science in the Public Interest (CSPI) and Harvard Medical School weighed in on the industry.
“The questions were canned, pre-asked and were designed basically to say, 'Why are you doing what you are doing?'," said United Natural Products Alliance (UNPA) President Loren Israelsen, who attended the panel on dietary supplements and commented on it during a UNPA conference held in Salt Lake City in early November. “‘You are a bad industry’ ... it was a very painful 60 minutes. Very painful 60 minutes."
"The impression left among the AGs," Israelsen continued, “was this is an industry that doesn't really care about quality, safety, product integrity."
As dietary supplement marketers head into the New Year, they should take those words to heart. Shattering frosty perceptions of the natural products industry is going to require a different mindset and strategy than a scathing condemnation of an attorney general, his beloved DNA technology and the fact that he hasn’t released all the testing data.
Welcome 2016 as an opportunity for a metamorphosis. Dietary supplement companies should consider measures to improve their business practices well in advance of receiving a subpoena or a cease-and-desist letter from an AG. Adopting DNA technology is just one of a number of measures that could help validate what industry trade organizations have long held: that the majority of natural products not only contain the advertised ingredients, they are effective and safe.
It is through proactive measures and collaborative efforts that the industry can begin to counteract the growing skepticism of the states and answer in the affirmative a critical question that Schneiderman raised in his initial probe: whether consumers who buy dietary supplements are getting what they are paying for.