FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder
November 20, 2018 -- The U.S. Food and Drug Administration today posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.
“This action is part of a broader effort we have underway to re-examine our resources and authorities related to products marketed as dietary supplements, and outline a new policy on how we intend to more vigorously fulfill our obligations to protect consumers from dangerous products and unlawful claims. We’ll have more to say on our policy efforts very soon. 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. 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,” said FDA Commissioner Scott Gottlieb, M.D. “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. We won’t stand by and allow this to happen. These warning letters are one part of our enforcement plan and we’ll continue to take action to protect public health.”
The U.S. Centers for Disease Control and Prevention (CDC) warned in August that clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal. The CDC also reported there has been a rise in tianeptine exposure calls to U.S. poison control centers during 2014–2017, suggesting a possible emerging public health risk. Tianeptine is approved to treat depression in other countries, and taking it can have significant health effects, including neurologic, cardiovascular, and gastrointestinal signs and symptoms, with some effects mimicking opioid toxicity and withdrawal.
The FDA has issued warning letters to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs for its Vicaine product. Each of these products is marketed as a dietary supplement and declares tianeptine sodium on the label.
Generally, if a product is marketed as a dietary supplement but claims to diagnose, mitigate, treat, cure or prevent a specific disease or diseases, then it is regulated as a drug. In addition, dietary supplements containing tianeptine are adulterated under the Federal Food, Drug, and Cosmetic Act because tianeptine is an unsafe food additive and should not be present in dietary supplements. The FDA has not approved tianeptine for any use.
Examples of unproven and unlawful claims made by the products marketed by Jack B Goods Outlet Store and MA Labs include:
- “There has never been such a clear choice for pain and anxiety.”
- “Produces both Stimulatory and Opiate-like Effects”
- “Induces Euphoria…”
- “…pain-killer, euphoriant, speed-ball in a bottle, stress-reducing agent…”
- “Vicaine possesses both stimulatory and opiate-like properties with a strong dopaminergic element…”
- “Containing potent dopaminergic-stimulants and a full-opioid agonist…”
- “Tianeptine attaches to these receptors in the same way that traditional opiates do, displaying strong activity at the mu-receptor (primarily responsible for triggering euphoria), moderate activity at the delta-receptor (partially responsible for triggering euphoria)…”
According to the Substance Abuse and Mental Health Services Administration, patients receiving FDA-approved medication assisted treatments (MAT) for opioid dependence cut their risk of death from all causes in half. However, using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery, and put them at greater risk of death.
Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the Administration’s highest priorities. This work includes promoting more widespread innovation and access to opioid addiction treatments for the more than 2 million of Americans with an OUD. The FDA is taking new steps to make safe and effective MATs available to those who suffer from OUD and to reduce the stigma that is sometimes associated with use of these therapies.
The FDA has requested responses from Jack B Goods Outlet Store and MA Labs within 15 working days. The warning letters also state that failure to correct violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the Safety Reporting Portal.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Posted: November 2018