FDA considers tianeptine to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive.
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), dietary supplements must contain at least one “dietary ingredient” but can also contain non-dietary ingredients, subject to applicable requirements. A “dietary ingredient” is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. Non-dietary ingredients intended for use in dietary supplements must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS), unless they meet one of the other listed exceptions to the food additive definition. Because tianeptine does not qualify as a dietary ingredient, is not an approved food additive, is not GRAS, and does not meet any of the other listed exceptions to the dietary supplement definition, it is an unsafe food additive, and dietary supplements containing tianeptine are adulterated under the FD&C Act.
Tianeptine is used as a prescription drug in some European, Asian, and Latin American countries, but it is not approved as a drug in the United States. The FDA is aware of several serious adverse event reports associated with tianeptine.
Tianeptine is also known as:
- Tianeptine sulfate
- Tianeptine sodium powder
- Tianna Green
- Tianna Red
- Tianna White
Consumers may inadvertently find themselves addicted to tianeptine and should avoid all products containing tianeptine, especially those claiming to treat opioid use disorder (OUD). Reliance on products with unsubstantiated claims may delay those who suffer from OUD from entering recovery and may put them at greater risk of overdose and death. Consumers with OUD should consult their healthcare provider for treatment options.
- Constituent Update (November 2018)
- Warning Letter to MA Labs LLC (November 2018)
- Warning Letter to Jack B Goods Outlet Store (November 2018)
- Consumer Update (February 2022)
This webpage describes FDA’s views and recent actions with regard to an ingredient used in products marketed as dietary supplements. If you have evidence that calls FDA’s views into question, we invite you to submit it, along with your reasoning, to FDA at ODSP@fda.hhs.gov.
This page is not intended to provide a complete list of all FDA actions and communications with regard to this ingredient and its use in products marketed as dietary supplements.