On May 8, 2025, the United States Food and Drug Administration (FDA) issued yet another warning advising consumers not to purchase or use any tianeptine products. In doing so, FDA emphasized that though such products are being marketed as a "research chemical," a "nootropic" cognitive enhancer, or a dietary supplement, tianeptine does not have FDA approval "for any medical use, is not generally recognized as safe for use in food, and does not meet the statutory definition of a dietary ingredient."
Tianeptine, commonly referred to by federal and state agencies and legislatures as "gas station heroin," is not an FDA-approved substance, nor is it currently classified by the United States Drug Enforcement Agency (DEA) as a controlled substance under the Controlled Substances Act (CSA). Instead, products containing tianeptine are often illegally marketed as dietary supplements and are widely available at convenience stores, gas stations, smoke shops, and across the internet.
This most recent consumer warning is only a single instance of enforcement efforts, adverse event reports, recalls, and consumer safety communications that have occurred over the past several years.For example, as previously reported by Buchanan, FDA issued a warning on January 23, 2024, advising consumers not to purchase or use any tianeptine products, stating that such products may cause life-threatening interactions with other medications a consumer may be taking. Additionally, this warning described FDA's investigation, in conjunction with local and state health departments, into adverse event reports of seizures, loss of consciousness and death. Additionally, FDA has issued warning letters to manufacturers of products containing tianeptine and, in conjunction with the United States Department of Justice has brought enforcement actions against individuals and entities that distribute drugs containing tianeptine.
In the face of ongoing legislative developments and heightened enforcement measures surrounding tianeptine, the importance of being prepared for any potential changes or actions cannot be overstated.
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