Kratom sees impressive sales growth despite its regulatory status and stigma

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A controversial ingredient that warrants examination, kratom is among the best-selling functional ingredients on the market while not legally a dietary ingredient. Based on data from SPINS from the 52 weeks ending October 6, 2024, kratom has landed in the 25 top-selling functional ingredients for the mainstream multi-outlet channel with $441,408,984 in sales, increasing 21.9% since the previous year.

Kratom is made from the leaves of a tropical tree (Mitragyna speciosa) native to Southeast Asia and has a number of perceived benefits. According to Nick Avé, general manager of Zamnesia, an online retailer that sells the ingredient, “Kratom has been around for a long time and has been used by people for a variety of reasons, like boosting energy or unwinding. Many folks say it helps them focus better and improves their mood.”

“What truly speaks to kratom’s validity is its longstanding role in daily life across Southeast Asia,” adds Ali Garawi, co-founder, CEO and CFO of Dialed Moods, which manufactures finished products from kratom. “For centuries, laborers and farmers have relied on kratom to combat fatigue and enhance stamina during long, physically demanding workdays. This consistent use by millions of people over generations underscores its effectiveness as a natural energy and mood booster.”

Despite the wealth of anecdotal evidence, our understanding of the ingredient’s effects and mechanisms is still limited. “Science is still working to catch up because of challenges with regulations and funding,” says Avé. “We’re big on responsible use and are pushing for more scientific research to better understand what kratom can offer.”

One reason for kratom consumption that is highly controversial and draws the scrutiny of the U.S. Food and Drug Administration (FDA) is the self-treatment of opioid use disorder and opioid withdrawal.¹ The two main chemical compounds in kratom are mitragynine and 7-OH-mitragynine, which FDA says bind to the same receptors in the brain as opioid drug, giving the ingredient “opioid properties,” according to a 2018 statement² from then FDA commissioner Scott Gottlieb, MD. In that statement, the commissioner underscored kratom’s potential for abuse, informed by the agency’s Public Health Assessment via Structural Evaluation (PHASE) methodology, which is a tool that simulates, using 3D computer technology, “how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain.” Results of the PHASE model on kratom “predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors…[confirming] that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors.”

The PHASE model “also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.”

This data, as well as a reported 44 deaths associated with kratom consumption have been used by FDA to justify an ongoing import alert, and the agency has even recommended that the Drug Enforcement Agency (DEA) place kratom under Schedule I of the Controlled Substances Act, which has not come to fruition. That said, there is research that contradicts FDA’s assertion that kratom is a dangerous ingredient with opioid properties that is life-threatening to users. A policy report³ from the American Kratom Association (AKA) cites research that indicates that the alkaloids in kratom “adopt a binding pose at the mu-opioid receptor that is distinct from that of classical opioids” and does not result in significant respiratory depression.⁴ Furthermore, assertions made by FDA that kratom is responsible for a reported 44 deaths fail to elucidate that many of the reported adverse events they cite involve multiple illicit or prescribed substances, and it is therefore difficult to conclude that kratom is the actual cause of death. There is, however, the real danger of adulteration of kratom products, which have caused people to die. One notable example was the death of nine people from consumption of a kratom product that was subsequently found to be adulterated with O-desmethyltramadol, an active metabolite of the commonly prescribed analgesic tramadol.⁵

“The root of the issue lies in the absence of regulatory oversight, which has allowed unethical operators to prioritize profit over safety,” says Garawi. “Bad actors have developed highly concentrated or synthetic versions of naturally occurring compounds like 7-hydroxy-mitragynine (7-MIT), which exists in the plant at negligible levels. By producing synthetic products with dangerously high concentrations, they’ve fueled misconceptions and tarnished kratom’s reputation.”

This highlights the importance of vetting suppliers and cGMP standards in manufacture of kratom products. Being able to accurately trace the raw materials and verify authenticity is also crucial. “We prioritize brands that engage in sustainable harvesting practices from Southeast Asian farms, particularly in Indonesia, Thailand, and Malaysia. The vendors we work with establish strong relationships with local farmers, ensuring that the leaves are harvested at peak alkaloid levels, which directly affects the potency and effectiveness of the product,” explains Avé. Third-party testing also ensures that the materials are free from heavy metals, pesticides and microbes. Additionally, Zamnesia only works with suppliers who are members of AKA.

“We stick to cGMP standards to make sure our products are safe, consistent and high-quality,” adds Avé. “We regularly audit our suppliers and processes to stay on track. In addition to the testing and certifications, we give our customers detailed product info, show where we source our product, and provide clear usage guidelines. A key part of this is providing quality educational content on our website. This shows that we’re all about building trust and that we’re committed to doing whatever it takes to keep that trust strong.”

Dialed Moods also adheres to cGMP standards. “Each batch [of kratom] undergoes a strict testing process: once received, the kratom is quarantined and tested by accredited third-party laboratories for potential contaminants,” explains Garawi. “After passing this rigorous testing, the batch undergoes our purification, blending, and final testing phase. We ensure precise formulations and dosing to meet cGMP standards, delivering a consistent, clean product every time. Additionally, all testing results—from raw materials to finished product—are available on our website for transparency and customer peace of mind.”

While some retailers and manufacturers value the health and safety of their customers, many are indifferent. Couple that with the fact that kratom is not legally a dietary supplement ingredient, it can be difficult for consumers to find or identify high quality kratom products. So far, FDA has denied six new dietary ingredient notifications, and while legislation has been introduced, namely the Kratom Consumer Protection Act, to create a regulatory framework for the ingredient, there is little indication that the ingredient will earn legitimacy anytime soon.That said, kratom products continue to sell, and sell well.

Its success is similar to that of hemp-derived CBD and other cannabinoids. Now, synthetically derived cannabinoids like delta-8 and delta-10 THC that have intoxicating properties are being sold in liquor stores as an alternative to alcohol. Kratom fills a similar need. Speculating on what’s driving the growth of kratom, Scott Dicker, market insights director of SPINS says, “I think there is this desire for euphoric ingredients. We know people are drinking less alcohol, for example, [but] what are they replacing with it? As people look to replace something like an alcoholic beverage with an ingredient that will still give them kind of an altered feeling…I think the demand for these euphorics will continue to grow…I don’t know if this ingredient necessarily will be the winner or have continued staying power as people enter the category…but the category will continue to grow in my opinion.”

If consumer demand for kratom continues to grow and products continue to proliferate, federal regulators may not have much choice but to exercise enforcement discretion on the ingredient, like it does with hemp-derived CBD. On the state level, while six states have outright banned kratom when there was indication that it would be scheduled by DEA, Mac Haddow, senior fellow on public policy for AKA, tells Nutritional Outlook that five out of the six states that have banned kratom are in the process of changing the bans to take a regulatory approach. So, the tide may be turning. In the meantime, great care must be taken to ensure safety and quality of kratom ingredients to protect consumers. It’s hard to say whether kratom’s reputation can be repaired and the ingredient be accepted more broadly. While cannabinoids have seen acceptance, it may be more of an uphill battle for kratom.

“In my opinion, CBD has had a smoother ride gaining acceptance and being backed by research after it was taken off the Controlled Substances Act,” says Avé. “Kratom, though, is still not as well understood and gets a lot more scrutiny,”

“The lack of regulation exposed the industry to a lot of bad actors and led to harmful practices and a tarnished reputation,” adds Garawi. “There has been a lack of understanding by the general public and fearmongering from critics. There needs to be more research and regulation to combat these anxieties, as overcoming these hurdles will take time and education.”

References

1. FDA and Kratom. U.S. Food and Drug Administration.https://www.fda.gov/news-events/public-health-focus/fda-and-kratom (accessed 2025-01-21)
2. Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse. U.S. Food and Drug Administration. February 6, 2018. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-scientific-evidence-presence-opioid-compounds (accessed 2025-01-21)
3. Babin, J. The FDA Kratom Death Data: Exaggerated Claims, Discredited Research, and Distorted Data Fail to Meet the Evidentiary Standard for Placing Kratom as a Schedule I Controlled Substance. American Kratom Association. 2018, 1.https://www.courthousenews.com/wp-content/uploads/2022/01/kratom-deaths-babin.pdf
4. Kruegel, A.C.; Gassaway, M.M.; Kapoor, A.; Varadi, A.; Majumdar, S.; Filizola, M.; Javitch, J.A.; Sames, D. Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids: Mitragynine as an Atypical Molecular Framework for Opioid Receptor Modulators. Journal of American Chemical Society. 2016, 138 (21), 6754–6764 DOI: 10.1021/jacs.6b00360
5. Kronstrand, R.; Roman, M.; Thelander, G.; Eriksson, A. Unintentional fatal intoxications with mitragynine and O-desmethyltramadol from the herbal blend Krypton. J Anal Toxicol. 2011, 35 (3), 242-247. DOI: 10.1093/anatox/35.4.242