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

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/

Rae Guyse: Best Lawyers: Ones to Watch® in America

Excellence in the Legal Realm

In the vast and intricate tapestry of the legal world, certain individuals stand out for their expertise, passion, dedication, and the indelible mark they leave on their field. Rae Guyse, an Associate Attorney at Ritter Spencer PLLC, is one such luminary, recently shining even brighter with her recognition by the esteemed “Best Lawyers: Ones to Watch” award.

Celebrating Legal Brilliance

“Best Lawyers,” a name synonymous with excellence in the legal profession, has a storied tradition of spotlighting the crème de la crème of attorneys worldwide. Their “Ones to Watch” award is particularly special. It’s not just a nod to an attorney’s past achievements but a resounding affirmation of their potential to shape the future of law.

Delving into Rae’s Journey

Rae’s foray into the legal world, especially her focus on the cannabis and litigation practice groups, has been remarkable. In an industry rife with complexities, especially concerning the burgeoning sectors of hemp, cannabis, and alternative medicine, Rae has emerged as a beacon of knowledge and guidance.

Her academic laurels, crowned by her graduation with honors from the University of Texas School of Law in 2020, set the stage for her professional journey. But her real-world prowess, from assisting a diverse clientele ranging from dispensaries to processors, truly sets her apart. Rae’s nuanced understanding of insurance programs and innovative approach to risk management challenges make her an invaluable asset to clients and the legal community.

A Glimpse into the Future

Recognition by “Best Lawyers” is more than just an accolade; it’s a testament to Rae’s unparalleled expertise and promising legal trajectory. As regulations and landscapes evolve, especially in the dynamic world of cannabis and hemp, Rae is poised to be at the forefront, guiding, influencing, and shaping its course.

The legal community and its observers have much to look forward to, with professionals like Rae Guyse leading the charge. Her recent recognition is a personal achievement and a celebration for the entire legal fraternity, heralding the bright future ahead.

 

Chelsie Spencer: A Global Top 200 Cannabis Lawyer for 2023-2024

Chelsie Spencer: A Global Top 200 Cannabis Lawyer for 2023-2024 2

A Legal Force in Cannabis

In the ever-changing world of cannabis law, it’s essential to have knowledgeable and forward-thinking experts. Chelsie Spencer is one such expert. Recently, she earned a spot on the prestigious “Global Top 200 Cannabis Lawyers” list for 2023-2024. Let’s explore what this award means and why Chelsie is a name you should know in the cannabis legal sphere.

Forbes’ Seal of Approval

Forbes Magazine has described Chelsie as the “rare friendly face amid a cutthroat CBD hurricane.” This speaks to her unique blend of expertise and approachability in the complex world of CBD law.

Versatility in Practice

Chelsie leads the cannabis practice at Ritter Spencer PLLC, representing a diverse clientele, from dispensaries to growers and beyond. Her work isn’t just about courtrooms; it’s about shaping businesses through licensing, regulatory compliance, and other critical operational aspects.

A Trademark Authority

Beyond cannabis, Chelsie is a seasoned trademark attorney. She has an impressive track record of securing federal trademarks and managing global trademark portfolios. This dual expertise makes her a valuable asset to clients in the cannabis industry and beyond.

Accolades and Recognition

Chelsie has received national recognition, including titles like Super Lawyer in Cannabis Practice by Thomson Reuters and the Client Champion award by Martindale-Hubbell. The “Global Top 200 Cannabis Lawyer” accolade for 2023-2024 adds another layer of prestige to her already impressive resume.

Leadership and Policy Influence

Chelsie isn’t just about legal representation; she’s about shaping the industry. She serves in leadership roles in various cannabis-related organizations and has been instrumental in drafting legislation at both state and federal levels.

A Well-Deserved Honor

The “Global Top 200 Cannabis Lawyer” award for 2023-2024 is more than just a title; it recognizes Chelsie Spencer’s comprehensive expertise and influence in the cannabis legal field. As the industry continues to evolve, experts like Chelsie will undoubtedly be at the forefront, guiding it towards a more regulated and prosperous future.

The Pros and Cons of Arbitration

At the beginning of a legal dispute, parties should review the business contract to see if  an arbitration clause is included. Arbitration is a private method of legal conflict resolution where a dispute is submitted to one or more arbitrators instead of a judge.  Unlike a dispute in court, the parties select the arbitrator(s), and also pay the fees of the arbitrator(s). The arbitrator renders an arbitration award to conclude the dispute. Unless an exception applies, the arbitration award cannot be appealed, but it can be enforced in court. In Texas, you may be required to arbitrate if the contract has an arbitration clause. Organizations must understand the potential positives and negatives of the arbitration process. Read below to understand the pros and cons of legal arbitration and how the Dallas law firm of Ritter Spencer PLLC can help parties involved in a legal dispute make the right decision for their business.

Chelsie Spencer: Best Lawyers: Ones to Watch® in America

A Leader in the Legal Community

In American law’s vast and intricate landscape, it is crucial to recognize and celebrate the trailblazers who are making significant strides in their respective fields. One such legal expert is Chelsie Spencer, who has recently been honored to be included in the prestigious 2024 edition of the Best Lawyers: Ones to Watch® in America. The Best Lawyers: Ones to Watch® in America award is awarded to attorneys for outstanding professional excellence in private practice. This accolade is a testament to Chelsie’s unwavering dedication, expertise, and contributions to the legal community, particularly in the cannabis and hemp industries.

Pioneering the CBD and Cannabis Legal Landscape

Chelsie’s reputation in the cannabis industry speaks for itself. Forbes Magazine’s portrayal of her as a “trusted ally amidst the tumultuous CBD (cannabidiol) storms” captures the essence of her role in this rapidly evolving industry. Leading the cannabis practice at Ritter Spencer PLLC, Chelsie’s clientele spans a broad spectrum, from local dispensaries to national manufacturers.  She is deeply involved in transactional aspects, focusing on licensing, regulatory compliance, and other business intricacies. Furthermore, she is a recognized voice in the industry, frequently sharing insights and forecasts at national symposiums.

Beyond Cannabis: Trademark Mastery

While Chelsie’s achievements in the cannabis sector are noteworthy, her expertise doesn’t end there. She’s also a formidable force in the world of trademarks. With a track record of securing federal trademarks and managing global trademark strategies, she’s carved a niche in this domain. Her work involves not just the registration of trademarks but also navigating the complex waters of transactional challenges, making her services invaluable to businesses across various sectors.

A Tapestry of Achievements and Recognitions

The Best Lawyers: Ones to Watch® in America honor is a milestone in Chelsie’s career, but it’s just one of many. She’s previously been spotlighted as a Super Lawyer in the Cannabis practice by Thomson Reuters and has clinched the Client Champion honor from Martindale-Hubbell. Additionally, her leadership roles, notably as the President of the Texas Hemp Legal Fund and Vice President of the Texas Cannabis Council’s Board of Directors, speaks to her commitment to the industry and her desire to shape its future.

In law, where change is the only constant, professionals like Chelsie Spencer are invaluable. They don’t just adapt to change; they drive it. Her recognition as one of the Best Lawyers: Ones to Watch® in America is not just a personal achievement; it’s an affirmation of her contributions to the broader legal community. As the legal landscape continues to evolve, with new challenges and opportunities emerging, it’s heartening to know that experts like Chelsie are at the forefront, guiding, influencing, and shaping its future.

 

 

How to Open a Dispensary in Texas

Although recreational marijuana has not yet been legalized in Texas, Texas currently has a limited medical marijuana program established by the Texas Compassionate Use Act in 2015. The Texas Department of Safety (“DPS”) administers the Compassionate Use Program (“CUP”), including all licensing processes for dispensing organizations. In early 2023, DPS opened the full application process for dispensing organization licenses for the first time since licenses were initially awarded in 2017. The application window closed on April 28, 2023. Currently, only three dispensing organizations have been granted licenses by DPS to cultivate, process, and dispense low-THC cannabis to qualifying patients in Texas: Compassionate Cultivation, Fluent, and Surterra Texas. An announcement on the award of new licenses has not yet been made, and DPS has not confirmed how many licenses it expects to award. Pursuant to the Compassionate Use Act, DPS may only issue the number of licenses necessary to ensure reasonable statewide access to and availability of low-THC cannabis for patients registered in the compassionate-use registry.

Texas is a vertically integrated state, meaning that all dispensing organizations must cultivate, process, package, and dispense the medical marijuana from a single location. Currently, only low-THC cannabis is approved for dispensation under CUP, currently limited to 1% THC by dry weight. The program also has restrictions regarding qualifying conditions and does not include certain conditions, such as chronic pain. Applicants must also follow all other administrative and statutory rules of the Texas Administrative Code (“TAC”) Chapter 12, and Texas Health and Safety Code Chapter 487.

All applicants must pay a non-refundable application fee of $7,356.00 dollars. If approved, licensed dispensing organizations must pay a new licensing fee of $488,520.00 for a two (2) year period. A biennial renewal license costs $318,511.00. Dispensing organizations must also pay fees per employee to register them with DPS. Entry costs for Texas are very high compared to other states.

Limited Liability Partnership and Series LLC Explained

Limited liability partnerships and limited liability companies are two common ways to classify small businesses. While the two are similar in name, they are structurally different regarding management requirements, liability protections, tax benefits, and more. 

It is vital for small business owners to thoroughly comprehend the structural differences between LLPs, LLCs, and sub-LLCs to correctly establish their company from a legal, tax, and management perspective. Working with business litigation attorneys like Ritter Spencer can ensure business owners understand varying legal structures thoroughly. Read below to learn more about LLPs, LLCs, and sub-LLcs.

Everything You Need to Know About The Cannabis Regulators Association

As the cannabis industry continues to experience an influx of financial opportunities, scientific studies, and legislative changes, states are coming together to share institutional knowledge and regulatory best practices. In November 2020, cannabis regulators from various states formed the Cannabis Regulators Association to provide federal lawmakers and administrative agencies with the resources needed to regulate cannabis. Since then, the national organization has made strides in cannabis-based education nationwide. Read below to learn more about the Association and how it benefits the cannabis industry. 

When to Hire a Real Estate Attorney

Buying a home is a significant investment and involves a series of complex transactions between a buyer and seller. Both parties must survey and sign several contractual agreements to legally transfer property from one entity to another. However, it is common for buyers and sellers to need the help of an expert to navigate their closing documents. Real estate litigation attorneys work to review documents and contracts related to property sales, making the closing process easier for all parties involved. Read below to learn when to hire a real estate attorney and how Ritter Spencer can advise individuals and businesses through real estate litigation.