Why Legal Kratom May Face a Battle with Drug CompaniesTags Bureaucracy and RegulationHealth
Kratom is a natural drug based on the leaves and extractions of a plant of the same name that come from Southeast Asia. It is said to treat a variety of ailments and conditions, most notably withdrawal symptoms from heroin and other addictive drugs. It is also considered a mood and energy booster and is also used recreationally.1
The product contains compounds that can have psychotropic (mind-altering) effects, although the product is largely legal in the US. Mostly it is consumed for pain and relaxation, like cannabis.
While legal nationwide, concerns about the product have led some jurisdictions to restrict it. My state of Alabama has made it illegal and other authorities prevent local retail sales.
Concerns are in all likelihood overblown. In one study of Colorado (pop. 5.8+ million), over the period 1999–17 there were only fifteen kratom-related deaths. Of these cases, fourteen involved multiple other drugs, eight involved opiates, and only one was found to be a kratom-only death.
Based on my little anecdotal evidence, consumers find that kratom is very safe and effective. Most of them have been consuming it for a long time and consider it “no big deal.” In informal interviews, they discuss it similarly to the ways your aunt might talk about her fish oil pills or your neighbor might discuss the benefits of WD-40.
Despite some medical promise and consumer benefit, there are potential problems with the consumption of kratom. First, it has been suggested there might be possible negative interactions with everything from alcohol and coffee to some legal and illegal dangerous drugs. Identifying these interactions and providing warnings should be a priority.
Second, the market is “immature” in the sense that is relatively new and not well developed. The drug comes in many forms and is not well “standardized” for consumption in the same way as products such as aspirin. There are no large well-established producers with established practices, and there is a large volume of entry and exit in the industry, akin to some periods in the nineteenth-century patent medicine industry in the US.
Third, the product is touted as a solution to addiction withdrawal and as a way to prevent addicts from falling off the wagon. However, some experts also believe that kratom itself is addictive or at least habit forming. There is some evidence that it is habit forming, but it does not appear to be any worse than alcohol, coffee, and tobacco.
The problems of drug interactions, the chaotic nature of the market, and the consequences of addiction are answerable questions, and we will surely get some answers as time goes by. However, you cannot simply call up a health or medical expert and get an easy solution other than “don’t do drugs.” Also, you cannot expect the market to magically whip up the ultimate solutions in the very short run. Competitive markets are necessarily a process of trial and error (and success!).
However, even given these possible problems, there appear to be no problems at present, and the above concerns might better be looked at as possible improvements or opportunities in this product industry going forward.
Obviously shutting down the industry would be a colossal mistake. It would be like shutting down the early US auto industry because cars did not have airbags or shatterproof glass. Likewise, we did not shut down the personal computer and internet businesses because of problems with computer viruses, hacking, and phishing. Kratom could be an important medicinal and recreational product, but there is a bumpy road ahead politically speaking.
Despite this good situation and the fact that kratom is a generally legal product, the Food and Drug Administration (FDA) is coming under increasing pressure to restrict and possibly prohibit the product, and the agency is seen to be increasingly bending to this pressure.
The FDA 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.
There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom.2
Over the last decade the FDA has moved away from being an observer toward being much more interventionist. According to the agency itself, the “FDA has taken a number of additional actions, including:
- In September 2014, U.S. Marshals, at the FDA’s request, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
- In January 2016, U.S. Marshals, at the FDA’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro.
- In August 2016, U.S. Marshals, at the FDA’s request, seized more than 100 cases of products labeled as containing kratom and worth more than $150,000. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy.”3
The outside pressure on the FDA to intervene in these ways is certainly not coming from inside the kratom industry itself, including consumers, producers, and distributors.
No, the outside pressure includes pockets of the pharmaceutical industry who perceive kratom as an effective competitor, especially but not limited to the embattled pain medication sector. This is exactly what observers of the FDA and the pharmaceutical industry have found.4 At the same time, the pharmaceutical companies themselves want to produce and sell their own patented kratom based-products!
We have learned in the cannabis legalization movement that the opposition to legalization has been financed by the pharmaceutical, alcohol, tobacco, and private prison industries. No doubt kratom has similar enemies, and therefore, unfortunately, we should not be surprised if the FDA continues to bow to such pressure groups with more government interventions, especially given kratom’s increasing popularity.
- 1. "Kratom," WedMD, accessed Nov. 23, 2020, https://www.webmd.com/vitamins/ai/ingredientmono-1513/kratom.
- 2. "FDA and Kratom," US Food and Drug Administration (website), last modified Sept. 11, 2019, https://www.fda.gov/news-events/public-health-focus/fda-and-kratom.
- 3. Ibid.
- 4. Mike Papantonio, "Big Pharma Forces FDA to Create Kratom Hysteria, interview by Ed Schulz, RT America, 2018, Speciosa.org, accessed Nov. 23, 2020, http://speciosa.org/big-pharma-forces-fda-to-create-kratom-hysteria/.