Letter to FDA re: Sales of Unapproved Drug Tianeptine

Three supplement bottles of tianeptine from different brands

In this letter, CSPI urges the FDA to issue warning letters and pursue enforcement action against the manufacturers, distributors, and retailers of tianeptine, an unapproved antidepressant that stimulates opioid receptors. Tianeptine is widely available for purchase in some southern U.S. states as a dietary supplement. However, tianeptine is not approved as a drug for any use, does not qualify as a dietary ingredient, is not an approved food additive, and is not generally recognized as safe (GRAS). Any dietary supplement containing tianeptine is therefore considered adulterated under the Federal Food, Drug, and Cosmetic Act, and cannot be sold in the United States.