Regulatory approaches vary across the country, and Gov. Maura Healey on Thursday took a swing at restricting the sale of kratom, a leafy tropical tree native to Southeast Asia that the U.S. Food and Drug Administration has warned consumers not to use due to dangerous effects.
Kratom is often used “to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal,” according to the Food and Drug Administration.
It’s not lawfully marketed in the U.S. as a drug product, dietary supplement or food additive in conventional food, per the FDA, which says it “has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder.”
But the substance is “widely sold” in convenience stores, smoke shops and gas stations in the form of tablets, gummies and capsules, the Healey administration said, calling the products “largely unregulated” and noting they can “vary significantly in their potency and ingredients, making it difficult for consumers to know what they are purchasing or the potential health risks.”
State Public Health Commissioner Robbie Goldstein issued an emergency order temporarily placing all forms of kratom into Schedule I under state law. Schedule I drugs are those with no currently accepted medical use and a high potential for abuse, according to the U.S. Drug Enforcement Administration. Examples include heroin, LSD, ecstasy and marijuana.
The order will take effect following a 14-day notice period and remain in effect for up to one year, the Healey administration said, giving local boards of health and other municipal officials “additional authority to take enforcement action against retailers selling kratom products.”
DPH will hold an informational webinar for local public health officials to support the order’s implementation, and provide information and guidance to local boards of health, healthcare providers and substance use treatment programs about the new restrictions, health risks associated with kratom, and available treatment and recovery services, the administration said.
A U.S. Food and Drug Administration slideshow warning people about 7-hydroxymitragynine (7-OH), a compound that occurs naturally in small amounts in the plant kratom, shows products that include the substance sold in places like convenience stores and gas stations.
“Dangerous kratom products are being sold in stores across Massachusetts with little oversight, and people — including children — often have no way of knowing what they’re buying or how potent it is,” Healey said in a statement. “Customers should be able to trust that the products being sold in stores are safe. We’re taking action to protect young people and residents, give communities the tools to get dangerous products off store shelves and make sure anyone struggling with dependence can get the treatment and support they need.”
Kratom can create stimulant-like or opioid-like effects depending upon the potency, the administration said, while some products have highly concentrated or laboratory-modified compounds that can have stronger opioid-like effects.
The alkaloid 7-hydroxymitragynine (7-OH), which is naturally occurring within the kratom plant, demonstrates substantially greater mu-opioid receptor potency than kratom’s primary alkaloid constituent mitragynine, as well as other classical opioids such as morphine, according to the FDA.
The DEA filed notices of intent in early July to temporarily place 7-OH and related substances into Schedule I of the Controlled Substances Act. The DEA “believes these substances pose an imminent threat to public safety given their effects are highly unpredictable,” it wrote. The scheduling doesn’t apply to botanical kratom products that contain naturally occurring 7-OH below the specific threshold.
Once the temporary scheduling orders take effect, the manufacturing, distribution, sale and possession of covered 7-OH substances would become subject to criminal, civil and administrative provisions of the Controlled Substances Act. Health and Human Services Secretary Robert F. Kennedy commended the DEA for taking action, calling the substances “addictive and harmful” and “dangerous opioids that fuel addiction and put American lives at risk.”
The American Kratom Association calls kratom “a precious natural resource,” though the group “recognizes that every effort should be made to keep kratom risks low, and protect consumers from adulterated and contaminated kratom products.”
“With appropriate FDA consumer regulation, we can maximize the potential for kratom to be responsibly used for the improvement of health and well-being of individuals and public health in America,” the association states on its website.
The FDA says an estimated 1.7 million Americans aged 12 and older used kratom in 2021, citing the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.
Regulation varies across the country. The Rhode Island Kratom Act went into effect in April, allowing for licenses to sell and manufacture kratom products, making it illegal to sell kratom to anyone under the age 21, and requiring all kratom products to meet specific labeling and packaging standards. The law also requires that kratom products come from licensed manufacturers and retailers.
A ban of kratom and 7-OH products took effect in Kansas in July, per Hawver’s Capitol Report, which reported that the bill classified the drug as Schedule I. The National Conference of State Legislatures reported that Kansas joined Alabama, Arkansas, Indiana, Louisiana, Vermont and Wisconsin in doing so. A ban in Tennessee went into effect in July, though the Nashville Banner reported that advocates were fearful that the ban could cause an increase in overdose deaths. The National Institute on Drug Abuse reports that people use kratom to manage drug withdrawal symptoms and cravings.
Pluribus News in April reported that states including Ohio, South Dakota, Michigan, Kentucky and New Hampshire have also taken different actions related to kratom.
A graphic from the U.S. Food and Drug Administration warning about 7-hydroxymitragynine (7-OH), a compound that occurs naturally in small amounts in the plant kratom.
U.S. Federal Drug Administration
Several local boards of health within Massachusetts have already moved to prohibit the sale and distribution of kratom, including those in Hanover, Lowell, Belchertown, Dracut, Yarmouth and Chelmsford. The city of Boston was also reported in March to be considering regulation, according to GBH News.
Massachusetts lawmakers also looked to implement regulations in the House’s economic development proposal (H 5576), which defines the terms “kratom product,” “kratom retailer” and “manufacture,” and states that a kratom retailer cannot sell, distribute or sell a kratom product without a label stating the name and address of its manufacturer, an ingredient list, and “directions for its safe and effective use, including the recommended serving size.”
The language would bar kratom retailers from distributing, advertising or selling a kratom product “that is contaminated with a dangerous non-kratom substance,” that contains a level of 7-OH “in the alkaloid fraction that is greater than 2 per cent of the overall alkaloid composition of the product,” and that contains any synthetic alkaloids. Retailers wouldn’t be able to “knowingly distribute” kratom products to anyone under the age of 21,“ and would be subject to fines for violations. The bill requires the Department of Public Health to create rules and regulations for administration and enforcement of the kratom measures, including standards for accurate labeling and safety testing kratom products.
The House kratom proposal is one of many that are subject to ongoing House-Senate conference committee negotiations.
