Kratom Industry in Texas – New Wellness Trend, or Legal Question Mark?

Kratom (Mitragyna speciosa) is a plant native to Southeast Asia that has been used in traditional medicine and cultural practices[1] for centuries. It has become increasing popular in Texas (like the rest of the Western world) over the past several years, and is most commonly sold as a powder, tea, or in capsules. Kratom products can be found online, at smoke and vape shops, and at gas stations across the state.  Botanical vendors, often selling both kratom and kava products, are popping up all over Texas, selling kratom infused elixers that tout a range of wellness benefits depending on the different strain of the plant being used: for example, “white vein” kratom, is known for uplifting and energizing effects while red vein kratom is known for its pain relieving and relaxation effects. Kratom has gained popularity over the years in wellness communities, often discussed as a an alternative for chronic pain relief, and a social alternative to alcohol (though, the FDA has cracked down on kratom companies that market products with medical claims). The U.S. kratom industry is estimated to be worth over $1.3 billion, with an estimated 15 million consumers based on a 2021 estimate.[3]

However, there has also been public concern and national headlines calling into question the safety of kratom. The DEA has listed kratom as a Drug and Chemical of Concern[4]. The FDA has not approved any prescription or over-the-counter drug products containing kratom, and the agency has been quite vocal about its concerns regarding the safety of kratom.[5] NPR recently reported on several recent lawsuits targeting kratom that were filed after a series of kratom overdoses.[6]

When kratom is consumed, the compounds in the plant bind to opioid receptors in the brain, mimicking the effect of traditional opioids – which also gives it its pain-relieving effects.[7] While low doses of kratom most often result in a mild euphoric effect, acting as a natural stimulant and pain reliever, high doses can lead to adverse effects. However, rates of addiction and overdose are much lower than other opioid drugs, and there is some scientific evidence supporting kratom’s effectiveness as a treatment for opioid addiction.[8]  There has also been concern about the lack of regulations around kratom products allowing manufacturers to add dangerous additives to products with little consequence.

The attorneys at Ritter Spencer have represented kratom clients across the nation and in Texas for many years. Our team is experienced in navigating federal issues impacting kratom, such as FDA issues impacting import, and Texas kratom regulations. Texas recently joined several states across the nation in passing kratom regulations.

LEGAL STATUS OF KRATOM IN TEXAS

Kratom has not been scheduled federally, however, products containing kratom are subject to United States Food and Drug Administration (“FDA”) oversight and compliance with applicable Food and Drug Cosmetic Act (“FD&C Act”) regulations.

While kratom has been largely unregulated in Texas, Texas passed the Texas Kratom Consumer Health and Safety Protection Act (the “Act”) in May 2023.  The Act becomes effective on September 1, 2023. The Act prohibits the sale of kratom to anyone under the age of 18 in Texas and puts in place standards to increase the safety of available products.  The Act will require kratom product labels to include direction on product use and the recommended serving size, and prohibits any kratom product that: is contaminated with any “dangerous non-kratom substance affecting the quality or strength of the product…”; is ”contaminated with a “poisonous or otherwise deleterious non-kratom substance”; has a level of 7-hydroxymitragynine in an alkaloid fraction greater than two percent of overall alkaloid composition; or that contains any synthetic alkaloid. [9] Violating the chapter will result in a $250 for first violations, $500 for a second violation, and $1000 for each subsequent violation. The Act does not define what will qualify as a “dangerous,” “poisonous,” or “deleterious” substance.

Recently, there have been a number of seizures of kratom products across the nation by the FDA.  In May 2023, the FDA seized more of than $3 million worth of kratom products in Oklahoma from Botanic Tonics.[10] And in July, the FDA reissued an import alert for kratom[11] allowing for the detention of supplements and bulk dietary ingredients containing kratom, which it identifies as an unapproved drug”. The FDA has issued similar import alerts for kratom since 2012. Under the FDA’s view, there is an absence of history of use or other evidence of the safety of kratom as a dietary ingredient. Kratom products intended for use as a dietary supplement may be refused admission at a port of entry. Specifically, advertising products containing kratom in conjunction with medical claims regarding diagnosis, cure, treatment, mitigation, or prevention of disease places the product under section 201(g) of the FD&C Act. Because the FDA’s stance is that kratom has not been recognized as safe and effective for diagnosis, treatment, mitigation, cure or prevention, the product qualifies as a “new drug” under FD&C Act § 321(p). Under FD&C Act §§ 331(d) and 355(a), “new drugs” are prohibited from introduction into commerce absent prior FDA approval. This reveals the tension between the FDA and kratom manufacturers and distributors. The FDA has issued numerous warning letters to kratom companies that are making claims related to pain treatment, palliative treatments, blood pressure treatment, and others.[12]

While it is uncertain if and when federal regulations will be put in place for kratom, it wouldn’t be a surprising development. The DEA issued a temporary ban of kratom and urged that it be placed on Schedule I of the Controlled Substances Act back in 2016.[13] The ban was delayed indefinitely after public outcry, particularly by kratom industry associations.[14] However, as the popularity of the product continues to grow, we continue to follow federal and state developments.

It is important for your Texas kratom business to ensure that it is compliant with the new Texas kratom regulations. There are also special considerations for risk management in kratom product labeling, claims formulations, and  other kratom business considerations. The kratom lawyers at Ritter Spencer PLLC have worked in the kratom industry for years and are experienced in navigating the complex regulatory landscape governing kratom products.

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Rae Guyse is an associate attorney with Ritter Spencer PLLC who handles matters in alternative and psychedelic medicine in addition to cannabis and hemp regulatory matters. Chelsie Spencer, a founding principal with Ritter Spencer PLLC, represents kratom companies and other companies in the alternative substance industries in all areas of compliance. The lawyers at Ritter Spencer are prepared to advise your kratom business in all facets of the industry, including regulatory and compliance issues. Contact Ritter Spencer or give us a call at 214.295.5070 for more information.

[1] The History of Kratom: Origins, Cultural Significance, and Traditional Use – Programming Insider

[3] https://drive.google.com/file/d/1ChyAKfdOrWzckau9kKwWti1F47D0WjUO/view

[4] Drug Fact Sheet: Kratom (dea.gov)

[5] FDA and Kratom | FDA

[6] Kratom at the center of a spate of wrongful death lawsuits : NPR

[7] Is Kratom an Opioid or a Narcotic? No! (cfah.org)

[8] Wilson, L. L., Chakraborty, S., Eans, S. O., Cirino, T. J., Stacy, H. M., Simons, C. A., … & McLaughlin, J. P. (2021). Kratom alkaloids, natural and semi-synthetic, show less physical dependence and ameliorate opioid withdrawal. Cellular and molecular neurobiology, 41(5), 1131-1143

[9] 87(R) HB 1097 – Introduced version (texas.gov)

[10] FDA seizes $3 million worth of kratom (naturalproductsinsider.com)

[11] Import Alert 54-15 (fda.gov)

[12] https://www.natlawreview.com/article/fda-issues-warning-letters-to-companies-illegally-selling-unapproved-misbranded#:~:text=On%20June%2025%2C%20FDA%20issued%20warning%20letters%20to,treat%20or%20cure%20opioid%20addiction%20and%20withdrawal%20symptoms.

[13] https://www.federalregister.gov/documents/2016/08/31/2016-20803/schedules-of-controlled-substances-temporary-placement-of-mitragynine-and-7-hydroxymitragynine-into

[14] https://kratomguides.com/dea-kratom-ban-update-2019/