FDA Moves to Restrict Opioid Extract Derived From Kratom Plant

The agency said the substance is a concentrated, synthetic form of the plant’s extract and had the potential to be highly addictive.

Food and Drug Administration (FDA) Commissioner Dr. Marty Makary speaks alongside US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., at HHS headquarters in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images

The Department of Health and Human Services announced on July 29 that it is looking to restrict sales of a widely available substance commonly used as a pain reliever.

The substance 7-Hydroxymitragynine, commonly known as 7-OH, is a synthetic, concentrated form of kratom, a plant extract that is a stimulant at low doses, but has sedative effects when taken in high doses.

FDA Commissioner Dr. Marty Makary warned that “7-OH is an opioid that can be more potent than morphine.”

The FDA will take steps to add 7-OH to its list of “scheduled” drugs, categorizing it according to medicinal use and potential for addiction, Dr. Makary said at a press conference on Tuesday.

Drugs are scheduled in a range from I to V: Schedule I drugs include heroin and LSD, Schedule V includes cough syrup.

Makary said he expects 7-OH to be a Schedule I drug, but that decision is ultimately up to the Drug Enforcement Administration (DEA).

Because 7-OH binds to opioid receptors in the brain, it has the potential to be highly addictive, the Department of Health and Human Services said in a statement.

“The FDA is particularly concerned with the growing market of 7-OH products that may be especially appealing to children and teenagers, such as fruit-flavored gummies and ice cream cones,” the statement said.

It is also sold in drink form or as a dietary supplement.

“These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom.”

The FDA also plans to publish a report to inform the public about the difference between the two substances and the potential dangers of 7-OH, Makary said.

Although the FDA has issued warnings about kratom since it has not received approval for medical use, he said the agency has no plans to regulate it, and is focused on 7-OH.

Health Secretary Robert F. Kennedy Jr. said he consulted with Attorney General Pam Bondi and members of the DEA on July 27, and found that vape shops selling 7-OH were popping up around military bases, as well as schools and impoverished neighborhoods.

Sen. Markwayne Mullin (R-Okla.) warned that 7-OH carries an additional danger: relapse for recovering drug addicts.

Mullin said he spoke from experience, as the family member of a struggling addict.

“They’re clean, they’re doing better,” he said at Tuesday’s press conference.

“They find out they can go to a gas station, or a vape shop, or skate shop, or bike shop, and they can find something that’s legal … that gives them the same high, and they can still pass drug tests, even though they’re on probation.”