FDA Moves to Protect Public Safety —Agency Issues Two Warning Letters on Illegal Products Containing Tianeptine

Washington, D.C., November 20, 2018 — In response to a new notice, “FDA Takes Action on Products Marketed as Dietary Supplements Containing Tianeptine and Warns,” issued  today by the Food and Drug Administration, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:

Statement by Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs: 

“Today FDA demonstrated its continued commitment to public health and the agency’s dedication to protect consumers from illegal products falsely identified and marketed as dietary supplements. Companies selling these illegal products, labeled as containing tianeptine, are in direct violation of the federal law and are putting consumers’ health at risk. FDA knows of serious adverse events associated with tianeptine, and the agency is aware that these companies selling this ingredient are making dangerous claims, such as treating opioid use disorder (OUD). 

CRN has previously alerted consumers that there is no mainstream research supporting using a dietary supplement to treat opioid addiction, and the law does not allow marketers of dietary supplement products to make treatment claims. Dietary supplements provide benefits that promote better health and wellness, but they do not treat opioid addiction. Consumer safety and access to safe products are important to both CRN and the FDA. CRN recommends that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”