Drugs & MedicationsHealthcare PolicyPreventive Medicine



Along the same theme as some recent blogs, dietary supplements have been under close scrutiny by the Food and Drug Administration (FDA). Why? Because several manufacturers have been adding ingredients to their supplements that may actually make the supplement unsafe. 

The FDA issued warning letters accusing 10 companies of either adding new ingredients to their products without notifying the agency or adding unsafe food additives. One of these compounds, higenamine, is known to have adverse effects on the cardiovascular system. Higenamine, manufactured by two Chinese companies, was placed on an “import alert” in July 2021, and has been banned internationally. It has been used as a stimulant by athletes. 

There were six other ingredients included in the warnings but none as concerning as higenamine.  These compounds are unapproved drugs, and drug makers include them as stimulant agents. Since the manufacturer of the supplement does so with the “intent to treat, cure, mitigate or prevent disease,” including them in the formulation requires FDA approval. The companies did not seek approval, and thus were reprimanded. If the FDA’s concerns are not addressed, legal action could ensue.

Drug manufacturers are being dishonest by secretly adding these compounds to their product simply to give the user a buzz. The FDA is saying these additives have adverse effects that put the drug-maker at great risk of litigation and patients at risk of cardiac misfortune.

References: News from the Food and Drug Administration. Dietary Supplement Sellers Receive Warnings. JAMA 2022 June 21;327(23):2281.

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