The FDA issued warning letters to Jack B Goods Outlet Store and MA Labs for illegally marketing products that contain tianeptine as dietary supplements, according to a press release. The companies make unproven, illegal claims that tianeptine treats serious conditions, such as opioid use disorder, pain and anxiety, according to the release.
The products in question include Tianaa Red, Tianaa White, Tianaa Green and Vicaine.
“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,” Scott Gottlieb, MD, commissioner of the FDA, said in the release. “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.”
In August, the CDC reported that tianeptine abuse and withdrawal mirror the clinical effects of opioids, according to the release. The CDC also reported an increase in tianeptine exposure between 2014 and 2017.
The FDA issued warning letters to Jack B Goods Outlet Store and MA Labs for illegally marketing products that contain tianeptine as dietary supplements.
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Tianeptine use may cause significant neurologic, cardiovascular and gastrointestinal symptoms, according to the FDA.
Tianeptine is labeled as an unsafe food additive and, therefore, dietary supplements containing the ingredient are adulterated under the Federal Food, Drug and Cosmetic Act, according to the release. Tianeptine is approved to treat depression in other countries, however the FDA emphasized that it has not approved tianeptine for any use.
The companies must respond to the FDA warning letters within 15 working days, according to the release. Failure to correct violations may result in seizure and injunction.
Disclosure: Gottlieb is the commissioner of the FDA.