FDA Issues Warnings to Certain Marketers of Products Labeled as Dietary Supplements for Making Unproven Claims

The FDA today posted warning letters issued to 2 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.

Warning letters have been issued by the FDA 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.

According to FDA Commissioner Scott Gottlieb, MD, the agency’s action is part of a broader effort underway that is re-examining the FDA’s resources and authorities related to products marketed as dietary supplements. The effort underway also aims to outline a new policy on how the FDA will more vigorously fulfill its 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 Gottlieb, in a prepared statement. “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 CDC warned in August that clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal. According to the FDA, the CDC also reported there has been a rise in tianeptine exposure calls to United States 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.

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.

Reference

FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder [news release]. Silver Spring, MD; November 20, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626349.htm. Accessed November 20, 2018.