Washington, D.C., April 7, 2016—In response to a new study, “Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA,” published online today in Drug Testing and Analysis, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Steve Mister, president and CEO, CRN:
“The findings of Dr. Pieter Cohen’s latest study are particularly troubling to responsible marketers of dietary supplements because they demonstrate once again that rogue companies will ignore the laws designed to protect consumers. Oxilofrine is not a legitimate dietary ingredient, and its marketers have not complied with the legal requirements for bringing a new dietary ingredient to market so it cannot legally be sold in dietary supplements. Oxilofrine, also referred to as methylsynephrine, has not met the legal requirements for demonstrating a reasonable expectation of safety, and thus it raises questions about the potential health risks to consumers who might use these products.
We appreciate the work that Dr. Cohen and the co-authors of this new study have done, and we hope this will result in isolating fringe players that recklessly break the law. As the authors acknowledge, ‘the US law regulating supplements does not permit dietary supplements to contain unapproved pharmaceutical drugs such as oxilofrine.’
Earlier this week, CRN commended FDA for taking enforcement action against a select number of companies illegally marketing this product. We urge FDA to use all the resources at its disposal to take action to sanction these companies—and others—to remove the products from the marketplace. We urge consumers to follow FDA’s advice and not use any products marketed as supplements that contain methylsynephrine, oxilofrine, or p-hydroxyephedrine.
This type of blatant illegal activity is not only disturbing, but also disruptive, to companies in the dietary supplement industry who sell reputable products. When rogue companies use the supplement space to peddle illegal products, like we have in this situation, the legitimate companies have their reputations damaged—and worst of all, consumers are put at risk. In addition to implementing self-regulatory initiatives, we are part of a coalition that lobbies for FDA to receive additional resources in order to fully enforce the law. We are committed to doing what we can to help to support both the agency’s and industry’s efforts to protect consumers.”