FDA issues another kratom warning following death

The Food and Drug Administration on Friday reiterated its position that kratom — a botanical native to Southeast Asia and reportedly used by millions of Americans — cannot be lawfully marketed as a dietary supplement or added to conventional food in a consumer advisory warning about a product linked to serious adverse events, including death.

FDA disclosed recently receiving an adverse event report of an individual who died after using OPMS (Optimized Plant Mediated Solutions) Black Liquid Kratom, whose product label indicates the presence of two kratom alkaloids, mitragynine and 7-hydroxymitragyine (7-OH mitragynine).

“This is one of many reports of serious adverse events individuals have reported experiencing after consuming OPMS Black Liquid Kratom,” FDA stated in the consumer advisory. “Other reported adverse health effects include withdrawal symptoms, addiction, digestive issues, restless leg syndrome, skin problems, aggressive behavior, increased anxiety, lack of energy and inability to focus.”

Gwendolyn Payton, an attorney who represents the owner of the OPMS Black trademark, described FDA’s statement as “disappointing” in an emailed statement.

“It was a surprise given the safety record of this product and the fact that no one from the agency ever reached out to us for information before issuing this warning,” Payton said. “We would have been very glad to work with the agency and provide information had we known they had any questions or concern. We are going to challenge this warning and are confident that once the agency receives correct information on this product and the science surrounding it, the agency will change its position. We look forward to an opportunity to share more information with the agency about OPMS Black.”

Related:FDA doubles down on kratom in dietary supplement products

Talis Abolins is of counsel to mctlaw, a law firm that has wrongful death lawsuits pending against OPMS and other defendants in the kratom space.

He described the FDA advisory as “the latest reminder of what many in the kratom industry know too well: Kratom is an adulterated new dietary ingredient under federal law. As such, kratom remains unlawful to import, and unfit for human consumption.”

“For consumers, the use of kratom is hazardous, but it is not a crime. But it is a crime for those who import and sell kratom in interstate commerce, particularly where kratom is sold as a ‘safe' alternative for the treatment of medical conditions,” Abolins added in an email. “In 2023, a group of independent scientists confirmed that kratom is 63 times more deadly than other natural products sold over the counter. Sadly, the OPMS fatality referenced in the FDA advisory is one of thousands where kratom was the sole and/or contributing cause of death.”

Related:Kratom groups, researchers sound alarm over 7-hydroxymitragynine products

The study referenced above by Abolins was led by researchers from the University of Pittsburgh School of Pharmacy. The study examined kratom-associated adverse drug reactions reported to FDA from January 2004 to September 2021, comparing them to other natural products and drugs.

“The observed/reported number of kratom‐related accidental death reports was 63‐fold greater than expected,” the authors wrote. “There were eight strong signals related to addiction or drug withdrawal. An excess proportion of ADR reports were about kratom‐related drug complaints, toxicity to various agents and seizures. Although further research is needed to assess the safety of kratom, clinicians and consumers should be aware that real‐world evidence points to potential safety threats.”

Kratom advocates dispute that the botanical itself generally is the main cause or contributor to deaths and other serious adverse events, pointing to consumers’ concurrent use of other drugs along with kratom, adulterated products and other factors.

In a 2023 news release criticizing FDA’s failure to properly regulate kratom, American Kratom Association (AKA) Senior Fellow on Public Policy Mac Haddow said, “The safety and addiction profile of pure, unadulterated kratom is well documented by science and there is no known level of kratom use that would cause any fatality unless it is irresponsibly consumed, adulterated with a toxic drug, or used … concurrently with a deadly drug substance.”

FDA, however, continues to advise consumers not to use kratom due to what it describes as “the risk of serious adverse events, including liver toxicity, seizures and substance use disorder.”

Despite the marketing of kratom products as drugs with therapeutic benefits, FDA has not approved any prescription or OTC drug products containing kratom or its compounds, mitragynine and 7-OH mitragynine, FDA stated in the July 26 advisory. The agency also raised “serious safety concerns with the use of kratom in dietary supplements and conventional foods,” adding the botanical cannot be lawfully added to conventional food or marketed as a dietary supplement.

During an industry conference last month in New York, FDA’s dietary supplement director noted the agency has been seizing kratom products for many years but continues to find them in the U.S. marketplace.

“We have invested a lot of resources into” attempting to make plain “FDA’s position on kratom in dietary supplements,” said Cara Welch, Ph.D., director of FDA’s Office of Dietary Supplement Programs (ODSP). “And unfortunately, we’re still seeing it out there.”

Welch 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.”