Kratom in market and legislative limbo

During an education session at the health and nutrition tradeshow in Secaucus, NJ on "bad boy" ingredients, Collins was joined on stage by other industry experts to discuss the challenges and uncertainties surrounding kratom use and legislation.

FDA’s position​

Kratom (Mitragyna speciosa​) is a botanical native to Southeast Asia. It has been used to treat chronic pain, PTSD and is alleged to have helped some individuals wean themselves from addiction to opioid pain killers.

According to the Food and Drug Administration, “serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation."

“Kratom has been indicated to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements.”

FDA first issued an import alert on kratom in 2014. The import alert was reissued this year to update some details, including the companies on the so-called 'Red List.'

The FDA's position on the botanical is that kratom is a new dietary ingredient​ for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable health risk. While there have been multiple New Dietary Ingredient Notification (NDIN) attempts, the agency is yet to issue a letter of no objection for the botanical. It therefore considers dietary supplements and bulk dietary ingredients that consist of or contain kratom to be adulterated.

Despite FDA’s clear position on kratom, the picture is confused by a patchwork of approaches from the states. In some states, the botanical is legal, while it is banned in others.

Legislating kratom​

Rick Collins, partner at Collins, Gann, McCloskey & Barry, said there’s mixed messaging surrounding kratom, especially regarding safety.

“I'm involved in the defense of some kratom cases where there are allegations of wrongful death involving the consumption of kratom in almost every case,” he told attendees. “These wrongful deaths involve multiple substances, including multiple controlled substances as well as other drugs of abuse.”

States have stepped in to regulate where there’s failure to enforce or create legislation at the federal level, and that’s the reason the American Kratom Association drafted a Kratom Consumer Protection Act, he said.

“It was put forward by a trade group in the absence of federal regulation to try to work on the states to get them to authorize its use with certain conditions,” Collins explained. “And the conditions include restrictions on age, restrictions on labeling, not making drug claims on the product, having some sort of good manufacturing practices in place for it. But different states are adopting it in different guises.

“From both a consumer standpoint and from an industry standpoint, it's very hard to know what you can and can't do,” he added.

Consumption declining​

This is translating to the market. As we’ve seen with other problematic ingredients like hemp-derived CBD, rates of kratom use are falling, according to consulting firm Brightfield Group.   

“We can see with kratom that Americans purchasing these products is actually ticking downward very slightly,” said Bethany Gomez, managing director of the firm. “Over the past year that incidence rate went from about 3% down to about 2%.”

This may seem surprising as kratom has a long tradition of use, particularly in southeast Asia, said Gene Bruno, chief scientific officer at Nutraland USA. "We're talking hundreds of years, and it's known for its psychoactive properties. It's known for its use in self-management of pain."

Addressing perceptions that kratom users are druggies or burnouts who are not health focused, Gomez indicated that the data shows otherwise.

“We've done a segmentation on the market to really group consumers by their focus on health and wellness and receptivity to new and innovative products,” she said. "And the kratom user really concentrates in the healthiest consumer group, the most health-focused consumer group.”

Despite its history and recent expansion in the U.S. market, there’s more negative sentiment on social media regarding kratom. Gomez said the Brightfield Group tracks public posts on Instagram, TikTok and Twitter then uses AI to tag various ingredients, product types, consumer needs and dates so that the volume of conversations can be tracked and adjusted over time, including what people are saying about products.

The Brightfield Group has noticed more social media conversations around alleged addictive properties of kratom, regardless of whether those sentiments are scientifically backed, she added.