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On January 23, 2024, the United States Food and Drug Administration (FDA) issued a warning 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 the Agency’s investigation into adverse event reports of seizures, loss of consciousness and death in conjunction with local and state health departments.

What Is Tianeptine?

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 marketed as dietary supplements and are widely available at convenience stores, gas stations, smoke shops, and across the internet.

FDA Warnings and Enforcement Actions

FDA’s recent consumer warning is not the Agency’s first action involving products containing tianeptine. Since at least 2018, FDA has made clear that it considers tianeptine to be a substance that does not meet the statutory definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. § 321(ff)(1)] and therefore is an unsafe food additive or unapproved drug. For example, FDA has issued Warning Letters to manufacturers of products containing tianeptine stating such products are unapproved and adulterated drugs. FDA has also sent letters to various retailers urging them to stop selling tianeptine-containing products to the public.

In addition to these efforts made by FDA to reduce the distribution of products containing tianeptine, the United Stated Department of Justice, in conjunction with the FDA’s Office of Criminal Investigations and the U.S. Postal Inspection Service, has brought enforcement actions against individuals and entities that distribute drugs containing tianeptine.

Legislative efforts regarding tianeptine have also recently arisen. In fact, on January 25, 2024, United States Representative Jimmy Panetta (D-Calif.) and United States Representative August Pfluger (R-Texas) announced bipartisan legislation — the Scheduling Tianeptine and Analogues Now to Defend Against Emerging Opioids Act (“STAND Against Emerging Opioids Act”) — that would classify tianeptine as a Schedule III controlled substance under the CSA. Should the STAND Against Emerging Opioids Act be enacted, sales of tianeptine would be illegal unless prescribed to prevent misuse and abuse, much like codeine and ketamine.

Additionally, in a letter to FDA Commissioner Dr. Robert Califf dated January 18, 2024, various members of the United States Congress requested information on FDA’s actions to address concerns related to tianeptine. These members urged FDA “to take immediate action to research and provide guidance on tianeptine use.”

The Need for Partnering with Experienced Counsel

As the United States Government continues to address concerns with tianeptine, it is imperative to be prepared for any potential changes or actions. Buchanan’s White Collar Practice Group, led by George Karavetsos, Former Director of FDA’s Office of Criminal Investigations, and Buchanan’s Life Sciences Industry Group are poised to assist individuals or entities impacted by these developments.