The U.S. Food and Drug Administration (FDA) on Nov. 20 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," said FDA Commissioner Scott Gottlieb, MD. "We’ll have more to say on our policy efforts very soon," he added. "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. 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 (Mississippi) for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs (Nevada) 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.
In response, Duffy MacKay, ND, senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN), noted that:
“… FDA demonstrated its continued commitment to public health and the agency’s dedication to protect consumers from illegal products falsely identified and marketed as dietary supplements. Companies selling these illegal products, labeled as containing tianeptine, are in direct violation of the federal law and are putting consumers’ health at risk. FDA knows of serious adverse events associated with tianeptine, and the agency is aware that these companies selling this ingredient are making dangerous claims, such as treating opioid use disorder (OUD).
"CRN has previously alerted consumers that there is no mainstream research supporting using a dietary supplement to treat opioid addiction, and the law does not allow marketers of dietary supplement products to make treatment claims. Dietary supplements provide benefits that promote better health and wellness, but they do not treat opioid addiction. Consumer safety and access to safe products are important to both CRN and the FDA. CRN recommends that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”
To read FDA’s original release, visit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626349.htm.