Industry trades to Sen. Durbin: Tianeptine isn’t a dietary supplement

Trade associations in separate letters to U.S. Sen. Dick Durbin (D-Ill.) underscored their members do not sell tianeptine, that the substance nicknamed “gas station heroin” does not belong in dietary supplements and that the Food and Drug Administration should use its authorities to remove these products from the market. 

“We can persuade. We can encourage. We can inform. But we can’t regulate,” United Natural Products Alliance (UNPA) President Loren Israelsen told Natural Products Insider in an interview. “I think the senator needs to be talking to FDA and the folks where these products are sold. It boils down to that for me.” 

UNPA was one of four trade groups to write separately to Durbin in response to the senator’s outreach to the groups. The other trades included the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and Consumer Healthcare Products Association (CHPA). 

Most of the trade group letters obtained by Natural Products Insider were written to the senator in April.

Israelsen advised Durbin that tianeptine is predominantly sold at gas stations, smoke shops, truck stops and what he characterized as “the darker corners of the internet.” 

“These are not sales venues that responsible dietary supplement companies use,” Israelsen wrote to the senator in a letter dated March 21. “We hope your office will be in contact with the relevant trade associations that represent or own gas stations, smoke shops, truck stops, etc. We believe they are the principal parties that could quickly stop the sale of tianeptine from outlets they own or control.” 

Related:FDA still receiving reports related to ‘gas station heroin’

Steve Mister, president and CEO of CRN, said his trade organization has taken several actions to remove tianeptine from commerce, including writing to the American Petroleum and Convenience Store Association, National Association of Convenience Stores and National Association of Truck Stop Owners. CRN also wrote a letter to Maryland Gov. Wes Moore, expressing support for the “Tianeptine Consumer Protection Act” introduced in the state legislature. And in a column published by Natural Products Insider, Mister fought back against the narrative that dangerous products like tianeptine aren’t the industry’s problem. 

FDA has identified cases in which people have suffered serious harmful effects — including confusion, coma and death — from abusing or misusing tianeptine by itself or with other drugs. Additional adverse effects have included agitation, drowsiness, high blood pressure, nausea, rapid heartbeat, slowed or stopped breathing, sweating and vomiting.

Related:Sen. Durbin to reintroduce Dietary Supplement Listing Act

Since it’s not a legal dietary ingredient, tianeptine “has no place in dietary supplements whatsoever,” Mister wrote to Durbin. 

“A company that markets this ingredient is breaking the law and putting lives in danger,” he added. “While tianeptine is not a legitimate dietary supplement, we recognize that it has been inappropriately labeled as one and, as such, have been working to encourage the Food and Drug Administration (FDA), the Department of Defense (DoD) and state governments to use their regulatory authority to remove this product from the market.” 

AHPA President Michael McGuffin and Director of Regulatory Affairs Robert Marriott also noted tianeptine has no place in dietary supplement products. 

“AHPA members and other members of the lawful dietary supplement trade do not market products containing tianeptine, which FDA has repeatedly stated does not qualify as an ingredient eligible for use in dietary supplements (as a dietary ingredient or otherwise)," McGuffin and Marriott stated in their letter to Durbin. “We share your concern about these unlawful drug products and urge the agency to promptly use its robust authorities to remove them from the market.” 

In his letter to Durbin, CHPA President and CEO Scott Melville focused, in part, on the senator’s support for regulatory modernization of dietary supplement products. Amid concerns over tianeptine, Durbin announced in March that he intended to reintroduce a bill this year that would require a listing of dietary supplement products with FDA. 

“CHPA agrees that recent reports about the presence of the adulterant tianeptine being found in products fraudulently marketed by unscrupulous companies as dietary supplements underscore the need for key regulatory modernizations to protect consumers, increase trust in the industry and eliminate bad actors from the marketplace,” Melville wrote. “Some of the key regulatory priorities that would enhance the agency’s ability to identify and more quickly remove illegal products from the market include: mandatory product listing; increasing inspection capacity; and clarifying FDA’s authority to better facilitate enforcement against unlawfully marketed products.” 

As Natural Products Insider previously reported, FDA is continuing to receive adverse event reports following consumers’ exposure to products containing tianeptine. The agency has announced that some tianeptine products have been recalled.  

Asked in the interview what else he would like FDA to do, UNPA’s Israelsen supported action by the U.S. Department of Justice. 

“I know it’s resource-intensive, but to me, this is the kind of case where [FDA] ought to get the Department of Justice involved and really go after one or more of the key players here,” he said. “Send a very clear message that if you traffic in this kind of product where people die [and] get injured, somebody’s going to go to jail—one or more. 

“Short of that, quite honestly when the perceived risk of getting caught and punished is so low, people will do this if there’s money to be made,” Israelsen continued. "[It’s the] oldest story in the book.”