US Justice Department: Schedules Kratom Derivatives, Cites Opioid Risk

• The US Justice Department has temporarily banned three potent kratom derivatives: mitragynine pseudoindoxyl (MGPI), MGM-15, and MGM-16, classifying them as controlled substances.
• Attorney General Todd Blanche stated the ban targets "deliberately manufactured and concentrated opioid products," not traditional botanical kratom.
• The Department of Justice will use enforcement discretion for incidental trace amounts of MGPI found in otherwise botanical kratom products, acknowledging scientific questions about its natural occurrence.
• MGPI has been found to be up to 20 times stronger than morphine, and the kratom industry is divided between "pure leaf" advocates and those promoting chemically enhanced products.
• Kratom importation has been banned since 2017, but once smuggled, it is legal to sell and use in most states, contributing to a complex regulatory environment.

The federal government's decision to classify these specific Kratom derivatives as controlled substances underscores growing concerns about public safety and the unregulated market for these powerful compounds.

The US Justice Department recently announced a temporary prohibition on three potent opioid derivatives derived from the kratom plant, prompting a complex reaction across the industry. Attorney General Todd Blanche confirmed the scheduling of mitragynine pseudoindoxyl (MGPI), MGM-15, and MGM-16 as controlled substances, emphasizing that this action specifically targets "deliberately manufactured and concentrated opioid products" rather than traditional botanical kratom. This move aims to prevent these dangerous compounds from becoming a broader public health threat.

Despite the new ban, the Department of Justice indicated it would exercise enforcement discretion in specific circumstances. Attorney General Blanche clarified that while MGPI's status as a controlled substance remains unchanged, the Department will not pursue enforcement actions when incidental trace amounts of MGPI are detected in products otherwise classified as botanical kratom. This nuance acknowledges ongoing scientific and analytical questions regarding whether processing, storage, or testing conditions might lead to the presence of trace MGPI in natural products, even though published scientific literature has not established MGPI as a naturally occurring kratom alkaloid.

Kratom, a tree indigenous to Southeast Asia, has leaves that produce a mild psychoactive effect when consumed, either by eating them directly or brewing them into a tea. Proponents of the botanical claim it offers benefits such as pain relief and assistance in managing opioid withdrawal symptoms. However, this lightly regulated substance is also associated with addiction, and heavy usage has been linked to severe health issues, including seizures and fatalities. The industry, which estimates its user base at over 15 million individuals, has recently faced numerous wrongful death lawsuits, while researchers continue to investigate the plant's properties.

Although the importation of kratom has been prohibited since 2017, once it crosses the border, its sale and use are permissible in most U.S. states. For the past decade, industry lobbyists have actively sought to persuade the Food and Drug Administration (FDA) to classify kratom as a food product. This recent federal action by the US Justice Department schedules Kratom derivatives, adding a new layer to the complex regulatory environment surrounding the plant.

The kratom industry has become increasingly fractured, dividing into two primary factions. One traditional segment advocates for "pure leaf" products, including liquid tinctures, which they assert are natural and therefore safe. In contrast, a newer group promotes chemically refined or altered products that offer enhanced potency and often improved taste. These more potent offerings typically incorporate at least one of the three newly scheduled substances—MGPI, MGM-15, or MGM-16—or 7-hydroxymitragynine (7-OH), a powerful analogue that occurs naturally in kratom at low concentrations.

These groups pushing for stronger formulations have actively campaigned for the legality of these potent alkaloids. For instance, the 7-HOPE Alliance, an organization supporting 7-hydroxymitragynine, convened an online meeting on August 26 to mobilize its supporters. Their objective was to encourage a renewed flood of testimony to the FDA, advocating for 7-OH's continued legality before the agency potentially moves to schedule that compound as well. Meanwhile, traditional kratom leaf lobbyists, such as Mac Haddow of the American Kratom Association, have publicly criticized these newer market entrants, labeling them as detrimental actors within the kratom community. Haddow's organization lauded the Justice Department's scheduling announcement, specifically highlighting its commitment to leave "natural leaf" kratom products untouched, stating that this distinction is crucial for policymakers.

The federal government's decision to classify these specific Kratom derivatives as controlled substances underscores growing concerns about public safety and the unregulated market for these powerful compounds. MGPI, for example, has been identified as being up to 20 times more potent than morphine, a strength also observed in certain kratom strains. This significant potency, coupled with the plant's potential for addiction and severe health consequences, highlights the risks associated with chemically manipulated products.

While the American Kratom Association celebrated the distinction between natural leaf and chemically altered products, recent developments in a Texas wrongful death lawsuit have introduced complexities that challenge this clear separation. This ongoing legal scrutiny, combined with the Justice Department's nuanced policy on enforcement discretion for trace amounts of MGPI, means that the landscape for kratom products remains dynamic. Businesses operating in this sector must carefully navigate product formulations and marketing claims to ensure compliance with the evolving federal regulations and mitigate potential legal exposure.

Lawyers and compliance officers must advise clients in the Kratom industry on the new federal classification of specific derivatives (MGPI, MGM-15, MGM-16) as controlled substances, ensuring product formulations and marketing comply with the ban. They should also understand the nuances of enforcement discretion for incidental trace amounts of MGPI in botanical products to mitigate legal exposure.

Source: Original reporting via Courthouse News