Tianeptine in Dietary Supplements
Tianeptine is 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 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 the preceding substances. 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). Because tianeptine does not qualify as a dietary ingredient, is not an approved food additive, and is not GRAS, dietary supplements containing tianeptine are adulterated under the 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 U.S. 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.
Recent FDA Action on Dietary Supplements Labeled as Containing Tianeptine
On November 13, 2018, the FDA issued warning letters to two companies whose products marketed as dietary supplements were labeled as containing tianeptine. Both products bear claims which establish the product as a drug and they are misbranded because they do not include adequate directions for their intended use. In addition, the letters explain that even if the labeling for these products did not contain disease claims, and assuming the products meet the definition of a “dietary supplement” under the Act, the products would be considered adulterated because tianeptine is an unsafe food additive.
Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove dietary supplement products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).
The warning letters request that the companies respond within 15 business days from the date of receipt of the letter regarding the specific steps they will take to bring their products into compliance with the law.
The agency will continue to update this page in the event additional actions are taken related to tianeptine.