Updated 1:57 PM EST, Thursday January 25, 2024

Washington, DC—With recent media coverage highlighting the growing concern over fake supplements that contain tianeptine, as well as documented cases of adverse effects and increased calls to poison control centers related to tianeptine exposure, the Council for Responsible Nutrition (CRN) has issued a warning to consumers: Do not purchase or use products containing tianeptine. The association cautioned: "These products are often illegally marketed as dietary supplements and can pose significant health risks."

Outlining the issue with tianeptine, CRN reported:

  • Tianeptine is not recognized by the U.S. Food and Drug Administration (FDA) for any use in dietary supplements. Products sold in the U.S. that contain it violate federal regulations. 
  • FDA and the Centers for Disease Control and Prevention (CDC) have previously issued warnings about the severe health risks associated with tianeptine, including its potential for abuse and adverse neurological, cardiovascular, and gastrointestinal reactions. 

Where are products that contain tianeptine sold?

Some gas stations, convenience stores, and online marketplaces may sell products are often misleadingly labeled as dietary supplements, health products, or using other benign-sounding descriptions, CRN said. Consumers should be vigilant and avoid any products that list tianeptine as an ingredient or make unverified health claims. 

Dietary supplements should be purchased from reputable sources, CRN stressed, such as the reputable companies the association represents. Additionally, consumers should consult healthcare professionals before starting any new supplement regimen, or to purchase .

CRN also urged consumers to report any adverse events or health issues related to the use of tianeptine-containing products to the FDA's MedWatch program. And for more information on safe supplement use, consumers can use CRN's resource: Consumer tips for selecting supplements | Council for Responsible Nutrition (crnusa.org).

FDA Issues New Warning

On January 23, FDA warned consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks. The agency said it is has continued to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death. FDA said: "These products may interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments.

FDA added that Neptune Resources, LLC, has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets to the consumer level. Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately, FDA said, adding that it sent a letter to convenience store, gas station and other organizations urging retailers to stop selling the products, as well as any other tianeptine-containing products.

Related: GAO Report on Prenatal Supplements "Strikes an Unnecessarily Alarmist Note"

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