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The agency has received reports of serious health problems associated with use of the products, which are marketed as dietary supplements and contain an unsafe food additive called tianeptine.
The warning letters were sent to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White and Tianaa Green products and to MA Labs for its Vicaine product.
Tianeptine is approved to treat depression in other countries, but the FDA has not approved tianeptine for any use. Tianeptine can pose a number of health risks, including neurologic, cardiovascular and gastrointestinal problems, and can mimic opioid toxicity and withdrawal, according to the FDA.
In August, the U.S. Centers for Disease Control and Prevention said tianeptine exposure calls to U.S. poison control centers rose from 2014 to 2017, suggesting a possible emerging public health risk, the FDA said.
FDA-approved medication-assisted treatment for opioid addiction can reduce by half a patient's risk of death from all causes, but the use of unproven treatments can increase their risk of death.
"In this case, these companies are preying on vulnerable patients who may be seeking alternative treatments to serious medical conditions like opioid use disorder. They're also selling products with known safety issues," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
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