Kratom Restrictions Recommended Over Addictive Properties of Synthetic 7-OH: FDA

Oversight would only target synthetic 7-OH compounds, not products naturally derived from kratom leaves.

Federal regulators are urging that synthetic 7-hydroxymitragynine (7-OH), a compound derived from the kratom plant, be added to the federal drug schedule due to its high abuse potential.

In a press release issued on July 29, the U.S. Food and Drug Administration (FDA) announced it would recommend 7-OH be added to the federal drug schedule in accordance with the Controlled Substances Act (CSA).

The Controlled Substances Act places certain substances into one of five schedule levels, depending on the medical use, potential for abuse and safety of the specific substance.

Kratom is a plant native to Southeast Asia, commonly consumed as a tea or in supplement form. Although it is not currently classified as a controlled substance under federal law, growing evidence suggests it can be as addictive as opioids like heroin, morphine or oxycodone.

The risk is especially high when kratom is refined into a more potent compound called 7-OH, which binds to the brain’s opioid receptors to produce a euphoric effect. Over time, users may need increasing amounts to achieve the same results, leading to a cycle of dependence.

As a result of the compound’s addictive nature, numerous lawsuits have been filed in state and federal courts, alleging that the manufacturers of certain 7-OH products capitalized on kratom’s potentially addictive properties by refining, marketing and selling the substance to unknowing consumers, eventually leading to addiction, withdrawal, and in some cases, overdose and death.

Regulators say they are currently focusing their efforts on 7-OH rather than natural kratom, since research shows that products containing the synthetic substance pose a growing risk for abuse.

The FDA’s federal scheduling recommendation comes after it conducted a comprehensive medical and scientific review, as part of broader efforts to address concerns over the increasing availability and use of 7-OH products.

Regulators have found that 7-OH products are commonly sold online, as well as in gas stations, convenience stores and vape shops. Officials are especially concerned about the growing popularity of fruit-flavored versions, such as gummies and ice cream cones, which may appeal to children and teens.

Furthermore, regulators stated that many of these products are misleadingly labeled or disguised as pure kratom, without clearly disclosing that they contain the more potent 7-OH compound.

In June, the FDA sent warning letters to seven companies for unlawfully marketing products containing 7-OH in forms such as tablets, gummies, drink mixes and shots. It is now issuing a letter to health care providers and warning consumers about the potential dangers of 7-OH products, noting that no 7-OH products have been approved by the government, and are not permitted in dietary supplements or conventional foods.

“After the last wave of the opioid epidemic, we cannot get caught flat-footed again. 7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

-Marty Makary, M.D., M.P.H., FDA Commissioner

In accordance with the federal rulemaking process, the U.S. Drug Enforcement Administration (DEA), which has final authority on scheduling, is reviewing the FDA’s recommendation, and providing a period for public comments prior to any action being finalized.

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