DEFYING THE FDA: KRATOM ADVOCATES FIGHT FOR SAFE AND REGULATED USE

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In a string of victories in state houses across America, kratom advocates have started to gain momentum toward sensible regulation for the first time in years, since the Food and Drug Administration led a campaign to try and ban the plant.

Now the FDA is coming back with its counter punch.

New guidance from the federal agency renews claims that kratom should be avoided by consumers, citing no approved medicinal uses by the FDA. The action comes after a flurry of states approved regulated kratom markets as a food and dietary ingredient, and has advocates worried about whether the FDA’s position limits its ability to operate in good faith when it comes to the future of kratom research.

The guidance from the FDA came with an update to the agency’s page titled “FDA and Kratom” which now has a “Content current” date of 6/2/2023. It’s a small tweak in terms of content available on the web but shows that the FDA’s stance on kratom remains consistent with the resistance the regulatory agency has shown to kratom for the past 10 years.

Most recently, the FDA seized around $3 million worth of kratom from an Oklahoma-based distributor, and at the time the underlying logic of the agency’s action was much of the same language as appears in the most recent warning. A spokesperson for the FDA at the time told NBC News that “the agency has received concerning reports about the safety of kratom” and concluded, “We are not aware of any evidence that would meet the agency’s standard for approval of kratom as a drug.”

Per Oklahoma state law, a “kratom product” is defined as a food product and is only allowed to be sold and marketed as such. The FDA has a different set of regulations and processes surrounding dietary ingredients but refuses to acknowledge kratom as such due to the wording of the Dietary Supplement Health and Education Act of 1994.

Although the FDA does not recognize kratom as a supplement that was being sold at that time, kratom is a plant that has been consumed for “hundreds of years” per the National Institute on Drug Abuse. The NIDA also acknowledges that fatal overdose from kratom is “extremely rare” and directly contrasts the number of kratom-linked deaths (11) with the 200,000 deaths from opioids during the same period of study.

That risk of adulteration and illicit materials being added to kratom products is why states like Oklahoma have been passing versions of laws known as Kratom Consumer Protection Acts, which seek to establish access to safe, regulated kratom products. Oklahoma’s law passed in 2020.

As part of the warning itself, the FDA has included a list of examples with each update, yet the examples have remained static since a failed push to schedule kratom in 2016.

In addition to the Oklahoma seizure, the FDA also lists actions taken in 2014 and 2016 in which $5 million, $400,000, and $150,000 of products were taken in the three actions listed. Those shipments were seized under the authority of import alerts that the FDA issued in 2012 and 2014, and haven’t updated since.

While there are many examples of the FDAs action and stance against kratom, what is lacking is actual scientific evidence or data to back up the claims made in the warning. As has been included in most of the materials issued by the FDA, the most recent warning includes that the agency “is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

Kratom is not an opioid. Some of the ways that kratom affects the body are similar to opioids and activate similar pathways in the brain. At the same time, prevailing scientific research has started to show the ways that kratom is different from opioids, highlighting scientific-based reasoning behind why kratom should be treated differently from opioids.

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That’s a point that the American Kratom Association has been trying to address in its advocacy work across the country. Since the FDA attempted to encourage states to schedule kratom, the AKA has been working to establish the opposite–regulated kratom markets. More specifically, the AKA has helped 11 states create a framework for defining and regulating kratom as a food ingredient, with some states opting for a more in-depth version that includes laws against shoddy manufacturing standards.

In the six states that have scheduled kratom, the AKA has worked with five of them to advance discussions and policy proposals to reverse the bans. On the federal level, the AKA worked with lawmakers on both sides of the aisle to introduce what it called “groundbreaking” legislation in the form of a proposed “Federal Clarity for Kratom Consumers Act.”

In that bill, federal lawmakers sought to limit the FDA's hand in restricting access to kratom and encourage research and transparency on the prevailing science around the plant. Although the FDA has pledged to evaluate all available data on kratom, advocates have argued that the agency’s actions and position on kratom restrict the research it claims to be evaluating. During a webinar early this year hosted by the AKA, leading researchers spoke about how even the government struggles to obtain pure kratom for research purposes, in large part due to FDA restrictions.

After the FDA updated its warning on kratom, the AKA responded with a statement renewing its questions about the intentions of the federal agency.

The statement read: “How exactly are they encouraging more research? And with $8.4 billion–why isn't the FDA performing more research? Why isn't the FDA working close(ly) with NIDA to help further kratom research?”