Doses of Banned Stimulant Oxilofrine Found in Dietary Supplements Sold in The US

It has never been approved for use in the US as a prescription drug or as a dietary supplement.

Several athletes have been banned from sport for testing positive for oxilofrine, and have claimed that they inadvertently consumed oxilofrine in sports supplements.

 

According to the research, published online in Drug Testing and Analysis, consumption of supplements containing oxilofrine may also pose serious health risks. For example, one brand of supplements containing oxilofrine has been linked to serious adverse events including vomiting, agitation, and cardiac arrest.

 

“We designed our study to determine the presence and quantity of oxilofrine in dietary supplements sold in the US,” Pieter A. Cohen, assistant professor at the Department of Medicine, Harvard Medical School, and lead author of the study explained.
“The presence of oxilofrine was confirmed using a reference standard. We analyzed 27 brands of supplements labelled as containing a synonym of oxilofrine (‘methylsynephrine’) and found that oxilofrine was present in 14 different brands (52%) at dosages ranging from 0.0003 to 75 mg per individual serving.”

 

“Of the supplements containing oxilofrine, 43% (6/14) contained pharmaceutical or greater dosages of oxilofrine. Following instructions on the label, consumers could ingest as much as 250 mg of oxilofrine per day. The drug oxilofrine was found in pharmacological and greater dosages in supplements labelled as containing methylsynephrine.”

 

In response to this study, the Council for Responsible Nutrition (CRN) – the leading trade association for the dietary supplement and functional food industry – noted their concern: “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,” said Steve Mister, president and CEO. 

 

“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, the CRN commended the US Food and Drug Association (FDA) for taking enforcement action against a select number of companies illegally marketing this product.

Mister continued: “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.”