7-OH Lawsuits Mount as DEA Classifies Certain Synthetic Kratom as Schedule I Controlled Substance

Kratom lawsuits increasingly focus on concentrated 7-OH derivatives that differ substantially from traditional botanical products.

Federal regulators have placed three highly potent kratom-related opioids into Schedule I amid concerns about addiction, respiratory depression and other serious health risks.

The U.S. Department of Justice (DOJ) issued a press release on August 25, announcing that the Drug Enforcement Administration (DEA) was temporarily placing mitragynine pseudoindoxyl (MGPI), MGM-15 and MGM-16 into Schedule I.

Schedule I is the most restrictive category under the federal Controlled Substances Act, reserved for drugs considered to have a high potential for abuse, no currently accepted medical use in the United States and a lack of accepted safety for use under medical supervision. The designation generally makes it illegal to manufacture, distribute or possess the substances outside of authorized research or other limited circumstances.

All three substances are potent opioid compounds chemically related to 7-OH, or 7-hydroxymitragynine. 7-OH is a powerful opioid-like substance that occurs naturally in kratom at trace levels but is increasingly sold in highly concentrated commercial products produced through laboratory processing or synthesis.

7-OH Risks

Kratom has traditionally been sold in relatively basic forms made from the leaves of the Mitragyna tree, including powders, capsules and teas. In recent years, however, the market has expanded to include concentrated extracts, shots, gummies and other products containing much higher levels of active compounds that produce opioid-like effects.

Many of these products are sold at gas stations, smoke shops, convenience stores and online, often alongside traditional kratom and frequently promoted as supplements or wellness products. However, the U.S. Food and Drug Administration (FDA) has not approved kratom to treat any medical condition.

One of the biggest concerns involves 7-hydroxymitragynine, or 7-OH, which occurs naturally in kratom only at very low levels. Manufacturers can now produce products containing far higher concentrations of 7-OH through processing or synthesis, creating substances that are substantially more potent than traditional botanical kratom.

As the potency of the products have increased, a series of kratom lawsuits have been filed alleging the manufacturers failed to adequately warn consumers about those risks, particularly. The claims maintain that these newer products can expose users to dangers that are substantially different from those associated with traditional botanical kratom.

Synthetic Kratom Schedule I Classification

Preclinical evidence indicates MGPI, MGM-15 and MGM-16 are potent mu-opioid receptor agonists, raising concerns about dependence, respiratory depression and other risks. MGPI and MGM-15 are already being manufactured and marketed in consumer products for their opioid effects. MGM-16 has not yet been confirmed in consumer products, but regulators are concerned it could emerge as a substitute for similar substances.

Although the DOJ characterized the three compounds as an “imminent hazard to public safety,” the emergency order applies only to MGPI, MGM-15 and MGM-16, not traditional botanical kratom or 7-OH itself.

“The emergency scheduling action subjects the manufacture, distribution and possession of these substances to the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances. It allows the federal government to respond to a rapidly developing market for products containing these manufactured opioid compounds.”

— U.S. Department of Justice

On August 26, the American Kratom Association filed a complaint (PDF) seeking to prevent the DEA from applying its new Schedule I classification of mitragynine pseudoindoxyl to traditional botanical kratom products that may contain naturally occurring or naturally formed trace amounts of the compound. The organization argued that the agency intended to target concentrated and synthetic opioid products and failed to establish a threshold distinguishing them from natural kratom.

7-OH Lawsuits

In addition to the DEA action, separate kratom lawsuits brought in federal courts nationwide allege manufacturers have failed to adequately disclose the potential for addiction, physical dependence, severe withdrawal, cardiac injuries, respiratory depression, poisoning, overdose and death. While some claims involve traditional kratom products, a distinct group of 7-OH lawsuits focuses on highly refined or concentrated formulations allegedly producing substantially stronger opioid-like effects.

Last year, Matthew Kernisky filed a proposed class action against Kama Distribution, a manufacturer of kratom-derived products, involving the sale of pseudoindoxyl and 7-OH tablets. The lawsuit alleges those refined compounds can produce far more powerful opioid effects than traditional botanical kratom.

Kernisky’s claim indicates 7-OH could be up to 10 times more potent than morphine, while pseudoindoxyl could be three to five times more potent. The filing contrasts those highly refined products with traditional botanical kratom, which contains much lower concentrations of potent opioid-like alkaloids. 

The filing alleges consumers were not adequately warned that highly refined formulations could cause addiction, physical dependence, tolerance and severe withdrawal.

Separate lawsuits argue that concentrated 7-OH and other kratom products have been misleadingly marketed as herbal remedies or dietary supplements despite producing powerful effects. Complaints brought by Noah Seri and Alejandro Mendoza earlier this year allege the kratom products they each consumed caused them to suffer addiction and cardiac injuries.

Kratom Injury Lawsuits

As additional kratom addiction lawsuits are being pursued, personal injury lawyers are reviewing potential claims for individuals who experienced serious injuries and health complications that may include:

• Addiction and physical dependence
• Severe withdrawal symptoms
• Rapid or irregular heartbeat and other cardiac injuries
• Seizures
• Liver or kidney damage
• Respiratory depression and other breathing problems
• Overdose or other kratom-related complications resulting in death

Kratom injury lawyers handle these cases on a contingency fee basis, meaning there are no upfront legal costs and attorneys are paid only if compensation is recovered through a settlement or award.

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