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“This type of blatant illegal activity is not only disturbing, but also disruptive, to companies in the dietary supplement industry who sell reputable products,” said CRN President and CEO Steve Mister.
A new study authored by prominent industry critic Pieter Cohen, MD, finds a number of dietary supplements contain pharmaceutical and higher doses of banned-ingredient oxilofrine, also known as methylsynephrine or p-hydroxyephedrine. The findings were published today in Drug Testing & Analysis-one week after FDA issued warning letters to seven companies for marketing products containing methylsynephrine as dietary supplements.
FDA has not approved oxilofrine as a legal dietary supplement ingredient. Many of the oxilofrine-containing products under scrutiny from both the researchers and FDA were marketed for sports and/or weight loss.
Out of 27 supplement brands labeled as containing methylsynephrine, researchers found oxilofrine in 14 of the products, ranging in dosage from 0.0003 to 75 mg per serving. If consumers followed instructions on the label of these products, they might ingest as much as 250 mg of oxilofrine per day, noted researchers. In pharmaceutical dosages, by comparison, oxilofrine is prescribed as a stimulant in dosages of 16–40 mg.
“The potential adverse health effects of inadvertently consuming up to 250 mg of oxilofrine per day, as would be possible with supplements in our study, are entirely unknown,” wrote researchers. “Human studies using lower dosages suggest that the increased demand on the heart muscles might lead to palpitations, arrhythmias, increased blood pressure, or other adverse effects.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington D.C.), expressed appreciation for the work of the study authors and hope that the findings will help isolate marketers who break the law.
“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 Mister. “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.”
Mister also noted that CRN urges FDA to use all resource at its disposal to remove products containing methylsynephrine from the market.
“This type of blatant illegal activity is not only disturbing, but also disruptive, to companies the dietary supplement industry who sell reputable products,” said Mister. “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.”
Senator McCaskill Calls for More Proactive FDA
Also today, Senator Claire McCaskill (D-MO), the ranking member of the Special Committee on Aging, expressed concern with the amount of time it has taken FDA to act against companies marketing products containing oxilofrine as dietary supplements.
“While I am pleased the FDA has moved against these manufacturers, I am alarmed by the delay between accounts of oxilofrine use in supplements and FDA action,” wrote McCaskill, in a letter to FDA Commissioner Robert Califf, dated April 7. “Also troubling is the fact that FDA has only taken action against three of the fourteen supplements listed as containing oxilofrine in the report by Dr. Cohen and his colleagues.”
Additionally, McCaskill requested FDA act more proactively on cases of banned ingredients appearing in dietary supplement products in the future, rather than respond retroactively to outside pressure.
“The close timing of this report and FDA action also demonstrates yet again that-as with the banning of ephedra in 2004-American consumers must often wait for significant external pressure to mount before FDA acts to secure the public health,” wrote McCaskill. “And I am concerned that as with BMPEA, and DMAA before it, American consumers often remain in the dark about potentially harmful ingredients like oxilofrine until FDA decides to act.”
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Cohen et al., “Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA,” Drug Testing and Analysis. Published online April 7, 2016.