Much as it has done with products marketed as supplements for bird flu, ebola and other public health scares, FDA has issued warning letters to two companies for marketing dietary supplements containing a chemical claimed to treat opioid use disorder and associated pain and anxiety. The agency said it took action after receiving reports of serious adverse events (SAEs) associated with the use of products containing tianeptine.
FDA reviewed the respective websites for Henderson, Nevada-based MA Labs and Ridgeland, Mississippi-based Jack B Goods Outlet Store, finding unapproved opioid-related drug claims for products marketed as dietary supplements and containing tianeptine, which the agency said is not a legal dietary supplement.
MA Labs claimed its Vicaine product produces “stimulatory and opiate-like effects,” contains “potent dopaminergic-stimulants and a full-opioid agonist,” and is a “Prohedonic Opioid-Stimulant Complex.”
“Even if your Vicaine product did not have claims that make it an unapproved new drug and misbranded drug, Vicaine would be an adulterated dietary supplement … because it contains an unsafe food additive,” explained FDA, in its warning letter to MA Labs. “Non-dietary ingredients intended for use in dietary supplements, such as the tianeptine used in your dietary supplement product, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods.”
Similarly, FDA found Jack B Goods made claims that implied its Tianaa Red, Tianaa White, and Tianaa Green products were a solution for opioid cravings and “a clear choice for pain and anxiety.” The company also claimed the Tianaa products were a good alternative to kratom for opioid cravings.
In a press statement highlighting the warnings, FDA noted the U.S. Centers for Disease Control and Prevention (CDC) warned the public in August about the clinical effects of tianeptine abuse and that withdrawal can mimic opioid toxicity and withdrawal. According to CDC, tianeptine exposure calls to U.S. poison control centers rose between 2014 and 2017, suggesting a possible emerging public health risk. FDA noted tianeptine is approved to treat depression in other countries, but taking it can have significant health effects, including neurologic, cardiovascular and gastrointestinal (GI) signs and symptoms. The agency said in some cases, tianeptine’s effects can mimic opioid toxicity and withdrawal.
While the warning letters targeted tianeptine and illegal opioid-related claims for products marketed as dietary supplements, the agency’s press announcement was as much a declaration of its renewed investment in going after rogue companies trying to take advantage of the dietary supplement market.
“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 Scott Gottlieb, M.D., FDA commissioner, who promised more details on the policy 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,” he said. “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.”
Gottlieb said in the case of the opioid warning letters, these and potentially other companies are preying on vulnerable patients who may be searching for alternative treatments to serious medical conditions. “They’re also selling products with known safety issues,” he added. “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 Council for Responsible Nutrition (CRN) issued immediate support for FDA’s enforcement actions against tianeptine.
“Today 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,” said Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, in a statement. “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 [SAEs] 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 alerted consumers in December 2017 dietary supplements do not treat opioid addiction and such treatment claims for dietary supplements are illegal. It noted a lack of mainstream research supporting the use of dietary supplements to treat opioid addiction.
MacKay emphasized consumer safety and access to safe products are important to both CRN and 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,” he advised.