Kratom Ban in Massachusetts Challenged by Retailers Over Schedule I Classification

Massachusetts kratom lawsuit challenges a statewide Schedule I ban, arguing regulators improperly treated traditional botanical kratom the same as highly concentrated and synthetic products.

Four Massachusetts retailers have filed a lawsuit seeking to block a statewide kratom ban scheduled to take effect August 28, arguing health officials exceeded their authority by temporarily classifying all forms of the substance as Schedule I controlled substances.

The complaint (PDF) was brought by Rihaan Corporation, doing business as Jay’s Smoke Shop, Bhakti LLC, V&K Smoke Shop and Ambreen & S Inc. in Massachusetts Superior Court on August 21, naming the Massachusetts Department of Public Health and Commissioner Dr. Robbie Goldstein as defendants.

The retailers claim Massachusetts law requires specific findings before a substance can be placed in Schedule I, including that it has a high potential for abuse, no currently accepted medical use and no accepted safety for use under medical supervision. They maintain Goldstein failed to make those findings.

Kratom Risks

Kratom is a psychoactive substance obtained from the leaves of the Mitragyna tree, which grows naturally in Southeast Asia. It is available in numerous forms, including powders, capsules, tablets, extracts, concentrated shots, gummies and beverages commonly sold at gas stations, smoke shops, convenience stores, wellness shops and online, where they are often promoted as dietary supplements.

However, the U.S. Food and Drug Administration (FDA) has not approved kratom for any medical purpose, and it contains compounds that interact with some of the same brain receptors targeted by opioids such as morphine and heroin.

On August 13, Goldstein issued an emergency order placing kratom into Schedule I in Massachusetts for up to one year, beginning August 28.

The order cites risks of liver toxicity, seizures, substance use disorder and overdose, particularly involving highly potent products, polysubstance use and individuals with chronic health conditions. It also points to Massachusetts death records, poison-control calls and emergency department data as evidence of the risks posed by kratom.

Under the regulation, possession or distribution of kratom by a food, retail or commercial establishment would constitute an “imminent health hazard,” potentially allowing local officials to suspend municipal licenses or permits.

The Massachusetts action comes amid growing efforts by state and federal regulators to restrict kratom and highly concentrated products containing 7-hydroxymitragynine, commonly known as 7-OH. Connecticut designated kratom and 7-OH as Schedule I controlled substances earlier this year, while a Kansas prohibition on the substances took effect July 1.

Other jurisdictions have taken a narrower approach that distinguishes traditional botanical kratom from concentrated or synthetic products. Ohio has targeted synthetic kratom-related compounds while exempting natural kratom leaf, while proposed Missouri legislation would place 7-OH above a specified concentration into Schedule I and impose restrictions on other kratom products.

Federal regulators have taken a similarly targeted approach. On August 26, the U.S. Drug Enforcement Administration temporarily placed three synthetic kratom-related compounds into Schedule I, including mitragynine pseudoindoxyl, MGM-15 and MGM-16, without scheduling the kratom plant itself

Massachusetts Kratom Ban Lawsuit

The complaint acknowledges Massachusetts could impose labeling requirements, potency limits, age restrictions and testing requirements or specifically schedule concentrated and synthetic kratom derivatives. However, the retailers argue the state cannot lawfully classify every form of kratom as Schedule I without satisfying the requirements established under Massachusetts law.

Plaintiffs maintain kratom has not been federally scheduled and that Goldstein’s findings satisfy only the state’s temporary emergency scheduling requirements, not the additional findings necessary for Schedule I classification.

The retailers say traditional products made from dried or powdered leaves contain predominantly mitragynine and only trace amounts of naturally occurring 7-OH, distinguishing them from highly concentrated 7-OH and synthetic derivatives such as mitragynine pseudoindoxyl, MGM-15 and MGM-16.

The complaint points out that Goldstein’s order associates overdose risks primarily with highly potent 7-OH or synthetic derivatives, products mixed with unknown substances and kratom combined with opioids, alcohol, benzodiazepines or sedatives. However, the regulation broadly encompasses the kratom plant, its naturally occurring alkaloids, several derivatives and essentially any product marketed or represented as kratom.

Plaintiffs maintain the evidence cited by the state does not establish that traditional botanical kratom, standing alone, caused the reported deaths or adverse events, and fails to distinguish botanical products from concentrated, synthetic, adulterated or polysubstance exposures.

“Plaintiffs do not dispute that some kratom products raise genuine public-health concerns, that some products are marketed irresponsibly, or that the Commonwealth may lawfully regulate them-through labeling requirements, potency limits, age restrictions, testing requirements, or targeted scheduling of concentrated and synthetic derivatives. Plaintiffs’ claims concern whether the Commissioner complied with the statutes that govern how the Commonwealth may declare a substance a Schedule I controlled substance, and whether the regulation he adopted is supported by the reasons he gave.”

— Rihaan Corporation et al. v. Massachusetts Department of Public Health et al.

Each plaintiff operates a Massachusetts retail business that lawfully sold kratom before the regulation. The businesses say the August 28 ban will force them to remove existing inventory from sale and cause immediate, irreparable financial harm.

The businesses also maintain that merely possessing kratom inventory could cause their establishments to be classified as “imminent health hazards,” potentially exposing municipal licenses and permits to summary suspension.

Plaintiffs seek declarations that Goldstein exceeded his authority by failing to make the findings required for Schedule I classification and by applying the imminent-health-hazard designation to all forms of kratom. They also claim the emergency regulation is arbitrary and overly broad, contains an unconstitutionally vague definition of kratom and threatens businesses with license suspensions without adequate due process.

The lawsuit asks the court to temporarily and permanently block enforcement of the regulation.

Kratom Addiction Lawsuits

Safety concerns have already contributed to a growing number of kratom lawsuits, which claim manufacturers marketed highly addictive products without adequately warning consumers about the potential for dependence, withdrawal and serious health complications.

Personal injury lawyers are reviewing potential claims for individuals who experienced kratom injuries and side effects 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 lawyers handle these claims on a contingency fee basis, meaning individuals pay no legal fees or expenses unless compensation is obtained through a settlement or award.

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