WASHINGTON, D.C. (WPVI) -- The Food and Drug Administration today sent warning letters to two companies illegally marketing dietary supplements containing the unapproved antidepressant tianeptine (Stablon).
The companies claim it can relieve opioid addiction, pain, and anxiety.
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.
The agency says the products contain tianeptine, are marketed as dietary supplements, and make several "unproven and unlawful" claims.
The FDA cited these claims:
"There has never been such a clear choice for pain and anxiety."
"Produces both stimulatory and opiate-like effects"
"...pain-killer, euphoriant, speed-ball in a bottle, stress-reducing agent..."
FDA Commissioner Scott Gottlieb, MD, said taking these supplements may prevent opioid addicts from getting approved treatments, raising their risk of deaths.
The FDA has received reports of serious adverse events associated with the use of dietary supplements containing tianeptine, which is currently not approved in the United States for any use.
Tianeptine use can cause significant neurologic, cardiovascular, and gastrointestinal symptoms, with some effects mimicking opioid toxicity and withdrawal, the FDA said.
Last summer, the US Centers for Disease Control and Prevention (CDC) reported an increase in calls to poison control centers regarding tianeptine exposure, suggesting a possible emerging public health risk.
In a statement, Gottlieb said, "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.,"
The FDA has requested responses from Jack B Goods Outlet Store and MA Labs within 15 working days of receipt of the warning letter, which was dated November 7.
FDA officials urge healthcare professionals to report any adverse events tied to these products to MedWatch.
FDA Warns Sellers of Illegal Tianeptine Supplements
Claims to help opioid addiction, pain, anxiety disputed
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