FDA cracks down on tianeptine claims

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FDA cracks down on tianeptine claims

The Food and Drug Administration last week issued warning letters to two companies that the agency said were illegally marketing products containing tianeptine as dietary supplements. The FDA said the companies were illegally claiming tianeptine would treat opioid use disorder, pain and anxiety, among other claims, and that the action followed reports of adverse event caused by products with the ingredient.

Scott Gottlieb, the FDA commissioner, said the letters — to Jack B Goods Outlet Store for Tianaa Red, Tianaa White and Tianna Green products, and to MA Labs for Vicaine — were part of a larger effort the agency is undertaking to focus on safety and weed out potentially harmful products making untested claims.

“The bottom line is this: we’ve seen growing instances where profiteers are pushing potentially dangerous compounds — often with unproven drug claims and crossing the line when it comes to what defines a dietary supplement,” Gottlieb said. “These potentially illegal activities put the entire dietary supplement industry at risk by confusing consumers, harming patients and tainting good dietary supplement products by associating them with the activities of bad actors.”

The Council for Responsible Nutrition lauded the move from the FDA.

“[The] 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,” CRN senior vice president of scientific and regulatory affairs Duffy MacKay said. “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.”

CRN noted that it had previously alerted consumers that there is no research to support using a supplement to treat opioid addiction, and it is illegal for supplement makers to market products with such claims.

“Consumer safety and access to safe products are important to both CRN and the FDA,” MacKay said. “CRN recommends that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”