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  1. CFSAN Constituent Updates

FDA Takes Action on Products Marketed as Dietary Supplements Containing Tianeptine and Warns Consumers

Constituent Update

November 20, 2018

On November 20, 2018, the U.S. Food and Drug Administration (FDA) issued Warning Letters to two companies whose products marketed as dietary supplements were labeled as containing tianeptine.

The FDA is aware of serious adverse events that are associated with tianeptine. Consumers may inadvertently find themselves addicted to tianeptine and should avoid all products containing this ingredient, especially those claiming to treat opioid use disorder (OUD). In addition to potential adverse events, 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. We know that patients receiving FDA-approved medication-assisted treatment (MAT) cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.

Under the Federal Food, Drug, and Cosmetic Act, dietary supplements must contain at least one “dietary ingredient” but can also contain non-dietary ingredients, subject to applicable requirements. “Dietary ingredient” is defined as 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. Tianeptine does not meet the definition on a dietary ingredient. 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. In addition, the products that were the subject of these Warning Letters are considered to be drugs under the Act because they are marketed with claims to cure, mitigate, treat or prevent a disease, including opioid use disorder (OUD). These products are not approved for such uses.

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