Over the past 18 months, there have been as many as 40 lawsuits file over alleged harm done by a natural herbal (Kratom) which is currently sold at vape shops across the United States. Mitragyna speciosa, commonly known as kratom, is a tree native to Southeast Asia. It has been used for hundreds of years in various Southeast Asian countries in both recreational and medicinal settings. It was introduced into the United States in the 1980s, where it has gained popularity since the mid-2000s (Eastlack et al. 2020; Grundmann et al. 2017; Singh et al. 2017). 

In Southeast Asia, the leaves were historically used in rural communities by farmers, laborers, or fishermen as a stimulant to reduce or prevent fatigue (Grundmann 2017; Singh et al. 2017). Medicinally, kratom has been used in recent years to treat symptoms of substance abuse disorders (opium withdrawal), toothaches, cough, diarrhea, headaches, stroke symptoms, fever, sleeplessness, cholesterol issues, typhoid, stimulate appetite, hypertension, pain, diabetes, anxiety, as a wound poultice, and as a deworming agent (Ahmad et al. 2022; Eastlack et al. 2020; Gong et al. 2012; Grundmann et al. 2017; Singh et al. 2017). These effects are largely due to the properties of two alkaloids: mitragynine and 7-hydroxymitrgynine (Grundmann 2017; Singh et al. 2017; Eastlack et al. 2020). 

Researchers and various health agencies have estimated current kratom use prevalence at 1.3 to 6.1% in the U.S. (Palamar 2021; Schimmel et al. 2021; Substance Abuse and Mental Health Services Administration 2022; Swogger et al. 2022). This equates to about 5 million users. Kratom is often purchased as capsules, powders, or liquid extracts, along with the teas and juices, as previously mentioned (Prozialeck et al. 2012; Singh et al. 2016). Though less popular, kratom-containing vapes (similar to e-cigarettes) have come onto market as of early 2024, along with resins and gummies.

Kratom can be bought online and in “head” shops and gas stations across the country and is promoted as a legal psychoactive product on numerous websites (Singh et al. 2016; United States Drug Enforcement Agency (DEA) 2024). Kratom has also been marketed as an herbal dietary supplement (Singh et al. 2016). These websites post recommended doses, vendors listings, tea preparation instruction, alleged medicinal uses, and user reports of various positive effects (United States Drug Enforcement Agency (DEA) 2024).

Users of kratom in the United States have indicated similar motivations for use to Southeast Asian users, including to self-treat pain, as an opioid substitute, and for mood disorders (Eggleston et al. 2019; Smith et al. 2022). Kratom consumption is sometimes reported in addition to the use of compounds such as cannabis, vaped nicotine, and in some instances buprenorphine (Smith et al. 2022). The available data indicate that many United States kratom users are utilizing these products as an alternative to high-risk compounds linked to diverse adverse health effects. This indicates that, among certain user groups and at certain doses, the availability of kratom may contribute net benefits to public health. 

Kratom is not regulated at a Federal level in the United States. The FDA has not studied the validity of the reported effects, whether beneficial or adverse, nor has it significantly evaluated any kratom processors or distributors in the U.S. No medications, whether over-the-counter or prescribed, have been approved that contain kratom or its active alkaloids (U.S. Food and Drug Administration (FDA) 2023). 

Due to the lack of Federal regulation, states have taken it upon themselves to regulate kratom to varying degrees. As of early 2024, twenty-two different states and the District of Columbia regulate kratom, mitragynine, and/or 7-hydroxymitragynine in some capacity. Kratom components are regulated as Schedule I controlled substances in Alabama, Arkansas, Indiana, Rhode Island, Wisconsin, and Washington D.C. and “regulated drugs” in Vermont (Legislative Analysis and Public Policy Association (LAPPA) 2024). In sixteen states, the possession, sale, and/or manufacture of kratom products is regulated, in which age restrictions at either 18 or 21 are included in all, and ten of which regulate labelling (Legislative Analysis and Public Policy Association (LAPPA) 2024). 

Today, there are millions of dollars of compensation that are being sought by users of kratom for allegedly adverse health effects. Many of these cases involve fatalities that blame kratom, in part, as being responsible for illnesses or death. Alas, in the cases which we have evaluated, kratom was found in the bloodstream along with various opioids, medicinal drugs, alcohol, nicotine and other agents at substantial concentrations. Thus far, we cannot attribute kratom as being a substantial contributing factor to deaths claimed to be associated with these incidents.

How Paustenbach & Associates Can Help

Further assessment is warranted as kratom continues to increase in popularity in the U.S., and evidence is rapidly evolving concerning the plant’s potential pharmacologic benefits and toxicological profile. Personal injury litigation associated with kratom has increased in recent years and will likely continue. Scientists at Paustenbach & Associates have over 55 years of experience in conducting risk assessments, including those regarding plant-derived products.

We have offered testimony in more than 400 depositions and 30+ trials over the years where we presented our risk analyses. In the cases for which we were retained, we applied exposure science and the health risk assessment methodology embraced by the National Academies of Science to characterize the possible risks. Over the years, we have conducted more than 1,000 risk assessments (Paustenbach 2012; Paustenbach and Gibbons 2022). Please contact Grayson Abele for more information regarding our capabilities at gabele@paustenbachandassociates.com or 303-598-0998.

References

Eastlack SC, Cornett EM, Kaye AD. 2020. Kratom-Pharmacology, Clinical Implications, and Outlook: A Comprehensive Review. Pain and Therapy. 9: 55-69.

Eggleston W, Stoppacher R, Suen K, Marraffa JM, Nelson LS. 2019. Kratom Use and Toxicities in the United States. Pharmacotherapy. 39(7): 775-777.

Grundmann O. 2017. Patterns of Kratom use and health impact in the US-Results from an online survey. Drug and Alcohol Dependence. 176: 63-70.

Legislative Analysis and Public Policy Association (LAPPA). 2024. Kratom: Summary of State Laws. 

Palamar JJ. 2021. Past-Year Kratom Use in the U.S.: Estimates From a Nationally Representative Sample. American Journal of Preventive Medicine. 61(2): 240-245.

Paustenbach DJ. 2012. Evaluating the health risks to the community associated with a refinery fire in Richmond, Cal. (Unpublished). 

Paustenbach DJ, Gibbons RD. 2022. Radiological risk assessment of the Hunters Point Naval Shipyard (HPNS). Critical Reviews in Toxicology. 1-47.

Prozialeck WC, Jivan JK, Andurkar SV. 2012. Pharmacology of Kratom: An Emerging Botanical Agent with Stimulant, Analgesic and Opioid-Like Effects. Journal of Osteopathic Medicine. 112(12): 792-799.

Schimmel J, Amioka E, Rockhill K, Haynes CM, Black JC, Dart RC, Iwanicki JL. 2021. Prevalence and description of kratom (Mitragyna speciosa) use in the United States: a cross-sectional study. Addiction. 116: 176-181.

Singh D, Narayanan S, Vicknasingam B. 2016. Traditional and non-traditional uses of Mitragynine (Kratom): A survey of the literature. Brain Research Bulletin. 126: 41-46.

Singh D, Narayanan S, Vicknasingam B, Corazza O, Santacroce R, Roman-Urrestarazu A. 2017. Changing trends in the use of kratom (Mitragyna speciosa) in Southeast Asia. Human Psychopharmacology. 32: 1-6.

Smith KE, Rogers JM, Dunn KE, Grundmann O, McCurdy CR, Schriefer D, Epstein DH. 2022. Searching for a Signal: Self-Reported Kratom Dose-Effect Relationships Among a Sample of US Adults With Regular Kratom Use Histories. Frontiers in Pharmacology. 13: 

Substance Abuse and Mental Health Services Administration. 2022. Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health. 

Swogger MT, Smith KE, Garcia-Romeu A, Grundmann O, Veltri CA, Henningfield JE, Busch LY. 2022. Understanding Kratom Use: A Guide for Healthcare Providers. Frontiers in Pharmacology. 13: 1-12.

U.S. Food and Drug Administration (FDA). 2023. FDA and Kratom. U.S. Food and Drug Administration. 

United States Drug Enforcement Agency (DEA). 2024. Kratom. U.S. Department of Justice USDEA. Washington, D.C.: