FDA official addresses kratom on Capitol Hill

A U.S. Food and Drug Administration official on Tuesday echoed previous remarks from his agency that kratom does not belong in dietary supplement products and suggested that enforcing against kratom and other substances that don’t belong in food is a game of whack-a-mole.  

During a Sept. 10 hearing on Capitol Hill, Rep. Kathy Castor (D-Fla.) cited an investigation on kratom published in December 2023 by the Tampa Bay Times. The newspaper found that more than 580 people in Florida died from kratom-related overdoses during the past decade, and that while most of the deaths were caused by a combination of kratom and at least one other substance, 46 people overdosed solely on the herb. 

Castor also referenced a safety alert issued by FDA in July regarding a kratom product and statements by the agency that the botanical “is not being lawfully marketed.”  

“But it just seems like we’re in this limbo where people assume, ‘OK, it’s on the shelf. It must be safe,’” the congresswoman added.  

FDA Deputy Commissioner for Human Foods Jim Jones responded that manufacturers are “exploiting either ambiguity within the system or … their product does not fit within any of the legal pathways that we have.” 

Jones noted that kratom has been the subject of several new dietary ingredient notifications to FDA for use in supplements.  

Related:FDA doubles down on kratom in dietary supplement products

“It has not met the standard for that,” the FDA official said before the Health Subcommittee of the House Committee on Energy and Commerce. “It is not allowed for use in the United States.” 

Commenting on an earlier conversation during the hearing about THC — the psychoactive ingredient in marijuana — being added to food, Jones suggested FDA needs to “figure out” how to “address the use of ingredients that are not legally allowed to be used in food and how we’re going to get our arms around those issues.” 

Castor mentioned a bill introduced in April in Congress to stop the sale of certain products — including tianeptine, or “gas station heroin” — that are marketed as dietary supplements. The new bills in the House of Representatives and Senate seek to amend the Federal Food, Drug & Cosmetic Act to introduce a “new prohibited act.”  

Jones said he was not familiar with the legislation but would be pleased to work with congressional offices.  

“As I said, I think there is a meaningful problem we have right now with ingredients … that are not legally allowed to be used in foods,” he added.  

In his exchange with Castor, Jones suggested that the kratom market “is dominated not by major players but by relatively small players.” 

Related:FDA’s Jones reiterated support for dietary supplement listing requirement

“There’s a little bit of a whack-a-mole going on where you stop it here and it pops up over here,” he said. 

During an industry conference in June, an FDA official who oversees the Office of Dietary Supplement Programs said her agency has been seizing kratom products for several years yet continues to find them in the U.S. marketplace. 

FDA’s Cara Welch, Ph.D., cited a hypothetical scenario in which FDA clears the marketplace of kratom products, then added, “And I think six months later, we would be right back where we started.” 

She said it’s “frustrating” when FDA is “explicitly clear on our position on an ingredient, and we still regularly find it.” 

Meanwhile, kratom advocates maintain FDA is out of touch with the current science.  

In a seven-page letter sent via email to FDA Commissioner Robert Califf, M.D., and dated Sept. 4, Mac Haddow of the American Kratom Association (AKA) said FDA is in receipt of “substantial scientific evidence pertaining to the safety and addiction profile of kratom that not only support the independent reviews, but also directly and substantively contradict the statements made by FDA on its ‘FDA and Kratom’ webpage.” For instance, he cited a dose-finding study on kratom conducted by FDA that "appears to contradict the agency’s public stance on kratom being inherently dangerous."

Haddow requested FDA hold a public stakeholders meeting focused on kratom products.  

“Such a meeting would provide an invaluable opportunity for the FDA to engage directly with the kratom consumers most affected by potential regulatory actions, to hear from scientific and policy experts who have studied kratom, to evaluate legal experts views on the current excesses of the FDA’s abuse of authority in regulating kratom, and to better understand the experiences of those who use kratom as part of their health regimen as evidenced by numerous peer-reviewed published articles supporting the claims by consumers that kratom is helping them improve the quality of life they experience and, in many cases, actually saving their lives,” Haddow wrote to Califf.