Synthetic Kratom: The Call for Stricter Regulations Amid Public Health Concerns

In the ever-evolving landscape of dietary supplements and herbal products, synthetic kratom has emerged as a substance of significant controversy and concern. Derived from the natural kratom leaf, synthetic variants, particularly those containing the highly potent metabolite 7-hydroxymitragynine (7OH), are pushing for tighter regulation due to their increased potency and associated health risks.

The Global Kratom Coalition has been vocal about the necessity of state-level regulations for products featuring synthetic kratom alkaloids, or their analogues, which exhibit properties far more potent than morphine. Matthew Lowe, executive director of the coalition, highlighted the distinct differences in the safety profiles of natural versus synthetic kratom products. The primary issue revolves around products marketed as derivatives of kratom that contain isolated synthetic compounds like 7OH. These compounds are not only more potent but also lack comprehensive scientific research to back their safety (Global Kratom Coalition Statement).

Scientists from reputable institutions such as the University of Florida and Johns Hopkins University have echoed these concerns. In a recent open letter, researchers urged the Food and Drug Administration (FDA) to ensure kratom products sold in the U.S. are accurately labeled to differentiate them from their adulterated synthetic counterparts. They propose that kratom products should include detailed labeling that reflects the content of mitragynine, 7-hydroxymitragynine, and total alkaloids, ensuring consumers are aware they are purchasing products free from semi-synthetic kratom-derived alkaloids.

Despite kratom’s long history and some evidence suggesting it is an Old Dietary Ingredient (ODI), the FDA maintains that kratom is a New Dietary Ingredient (NDI) for which safe use has not been adequately substantiated. This stance has led to the rejection of multiple New Dietary Ingredient Notifications for kratom, underscoring the agency’s ongoing concerns about the substance’s safety profile (FDA and Kratom). According to the National Institute on Drug Abuse, kratom can produce opioid-like effects and is used by some for managing pain, fatigue, and mental health issues, although it comes with risks of psychiatric and physiological problems (NIDA on Kratom).

The synthetic version of kratom, primarily through the metabolite 7OH, shows a higher affinity to opioid receptors, which significantly enhances its potency and risk profile. This heightened potency is a result of a synthesis process that amplifies the natural degradation of kratom leaves to produce 7OH at levels much higher than found in natural kratom.

The legislative landscape across the U.S. varies, with kratom banned in several states, though recent movements suggest some states are reconsidering their stance. In contrast, other states have enacted or are considering Kratom Consumer Protection Acts, which aim to regulate the sale and composition of kratom products, ensuring consumer safety and preventing the sale of adulterated or synthetic variants (CRS Report on Kratom).

California, for example, has seen legislative proposals such as Assembly Bill 2365, which would require kratom products to be registered with the state’s public health department. This registration process would include stipulations on the chemical composition of kratom, specific labeling requirements, and restrictions preventing sales to individuals under the age of 21. Furthermore, these products cannot contain more than 1% 7OH, aiming to curb the availability of highly potent synthetic kratom (Los Angeles Times Article).

The debate over kratom, particularly synthetic forms, underscores a complex interplay between consumer freedom, public health, and regulatory oversight. As this discussion continues, it becomes increasingly evident that informed, science-backed policies will be crucial in navigating the benefits and risks associated with kratom and its synthetic derivatives.