Banned Stimulants Remain in Supplements, Despite FDA Efforts to Remove Them

MedicalResearch.com Interview with:

Pieter Cohen, M.D. Associate Professor of Medicine Cambridge Health Alliance Assistant Professor of Medicine Harvard Medical School

Dr. Cohen

Pieter Cohen, M.D
Associate Professor of Medicine
Department of Medicine
Cambridge Health Alliance
Somerville MA 02143

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Since ephedra was banned from supplements in 2004, a variety of experimental stimulants have been introduced into sports and weight loss supplements as ephedra replacements.  The FDA has made some efforts to remove these emerging stimulants from supplements, but whether FDA action to remove these stimulants has it’s intended effect is not known.

We studied the effect of FDA action to remove four experimental stimulants from supplements.

We found that the FDA public notices did not work.  The stimulants remained in supplements even years after the FDA moved to remove them.

MedicalResearch.com: What should readers take away from your report?

Response: Given the regulatory paradigm under which supplements are sold, consumers cannot trust that they will be effective or safe.  Clinicians should understand that supplements might contain hidden ingredients that have potent drug-like effects and consider the effects of supplements when patients experience unexplained symptoms.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: One of the most concerning findings was that one stimulant appeared in the supplements analyzed only after the FDA warned that it was not permitted to be sold in supplements. Future studies should investigate whether FDA announcements regarding new experimental stimulants might have the unintended consequence of firms learning about the stimulant and then adding it to their supplements.

Disclosures: Dr Cohen was subject of a civil suit brought by Hi-Tech Pharmaceuticals, a supplement company, regarding β-methylphenylethylamine;  The jury found in Dr Cohen’s favor. Dr Cohen has collaborated in research with NSF International and received research support from Consumers Union. No other disclosures were reported.

Citation:

Cohen PA, Wen A, Gerona R. Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration. JAMA Intern Med. Published online October 22, 2018. doi:10.1001/jamainternmed.2018.4846

Oct 23, 2018 @ 2:33 pm

 

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