Kratom Regulation in California: A Balancing Act Between Consumer Safety and Access

California is taking significant steps towards regulating kratom, a controversial herbal substance that has gained popularity among millions of Americans. Assemblymember Matt Haney’s proposed bill AB 2365 aims to establish comprehensive safety standards and consumer protections for kratom products, potentially setting a precedent for national regulation.

Kratom, derived from the leaves of Mitragyna speciosa, a tropical tree native to Southeast Asia, has been used for centuries in traditional medicine. In recent years, it has gained traction in the United States, with an estimated 1.7 million Americans aged 12 and older using kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health. Users often turn to kratom for self-treatment of conditions such as pain, anxiety, depression, and opioid withdrawal.

However, the rapid rise in kratom’s popularity has outpaced regulatory frameworks, leaving consumers vulnerable to potential risks associated with unregulated products. The Food and Drug Administration (FDA) has warned against kratom use, citing concerns about liver toxicity, seizures, and substance use disorder. The agency has also highlighted the lack of FDA-approved uses for kratom and its components.

California’s proposed legislation seeks to address these concerns by adding kratom products to the Sherman Food, Drug, and Cosmetic Law. The bill would require processors of kratom products to register with the State Department of Public Health and adhere to specific standards for alkaloid content, labeling, and packaging. Importantly, it would prohibit the sale of kratom to individuals under 21 years of age and ban products that might be attractive to children or inhalable kratom products.

Dr. Christopher R. McCurdy, a professor at the University of Florida College of Pharmacy and a leading kratom researcher, emphasizes the importance of such regulation. “The unregulated nature of kratom products has led to a concerning trend of increasingly potent and potentially hazardous extracts,” he notes. While raw kratom leaves typically contain around 2% mitragynine, the primary active ingredient, some modern extracts boast concentrations exceeding 40%.

The American Kratom Association (AKA), a prominent advocacy group, has been at the forefront of pushing for responsible regulation. The organization supports the implementation of Kratom Consumer Protection Acts (KCPA) across various states, aiming to ensure product safety while maintaining access for consumers. To date, 11 states have passed versions of the KCPA, including Arizona, Colorado, Florida, and Utah.

However, the regulatory landscape remains complex and often contradictory. While some states move towards regulation, others have banned kratom outright. The FDA maintains that kratom is not lawfully marketed in the U.S. as a dietary supplement or food additive, creating a challenging environment for both consumers and industry stakeholders.

The debate surrounding kratom’s safety and efficacy continues in scientific circles. Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA), has called for more research into kratom’s potential benefits, particularly in pain management and the treatment of opioid use disorder. This stance contrasts with the FDA’s more cautionary approach, highlighting the need for comprehensive, evidence-based policy-making.

California’s proposed legislation attempts to strike a balance between these competing perspectives. By requiring product registration, standardized labeling, and age restrictions, the bill aims to protect consumers while acknowledging the substance’s widespread use. The bill would also allow kratom processors operating in good faith to continue manufacturing and selling products until April 1, 2025, providing a transition period for the industry to adapt to new regulations.

Critics of stringent regulation argue that overly restrictive policies could drive the kratom market underground, potentially exposing consumers to greater risks. Advocates for kratom, like Sacramento resident Dijon Evans, credit the substance with significant pain relief and improved quality of life. Such testimonials underscore the complex nature of the kratom debate and the need for nuanced policy approaches.

The proposed California legislation also raises questions about the interplay between state and federal regulations. While states like California move forward with their own regulatory frameworks, the lack of federal guidance creates a patchwork of policies across the country. This situation poses challenges for consumers, manufacturers, and law enforcement alike.

Michele Scasserra, LCSW, LCADC, CCS, director of Substance Use Counseling Services at Blake Recovery Center, highlights another concern: “The growing and widespread availability of kratom is also of great concern. Depending on the state, those who are 18 or 21 can buy the substance in local smoke shops, online and even in convenience stores.” This easy accessibility, combined with varying age restrictions and product standards across states, further complicates regulatory efforts.

As California moves forward with its regulatory efforts, the state’s approach could serve as a model for other jurisdictions grappling with similar issues. The bill’s focus on product safety, clear labeling, and age restrictions addresses many of the concerns raised by health professionals and regulatory bodies. However, it also recognizes the reality of kratom’s widespread use and the potential benefits reported by many consumers.

The path forward for kratom regulation in California and beyond will likely require ongoing collaboration between lawmakers, health professionals, researchers, and consumer advocates. As more scientific data becomes available, policies may need to evolve to reflect the most current understanding of kratom’s risks and benefits.

In conclusion, California’s proposed kratom regulation represents a significant step towards addressing the complex issues surrounding this controversial substance. By attempting to balance consumer safety with access, the legislation could pave the way for a more standardized approach to kratom regulation nationwide. As the debate continues, it is clear that evidence-based policies, continued research, and open dialogue between all stakeholders will be crucial in shaping the future of kratom use and regulation in the United States.