What to Know About 7-OH, the Synthetic Opioid Derived From Kratom Facing an FDA Ban

7-OH is being marketed to kids despite its opioid-like effects. It’s contained in gummies, drink mixes, and shots.

A Thai worker prepares leaves before making kratom tea in Bangkok on Oct. 17, 2021. Lauren DeCicca/Getty Images

A synthetic opioid derived from the kratom plant sold in gummies, tablets, and drink mixes is slated to be restricted because of concerns that it has a serious potential for abuse.

The compound is called 7-hydroxymitragynine, commonly known as 7-OH. It occurs naturally in trace amounts in kratom. Products containing 7-OH have potentially dangerous, enhanced levels and are not approved by the Food and Drug Administration (FDA). 

The Department of Health and Human Services (HHS) announced the recommendation on June 29, stating that the 7-OH should be scheduled under the Controlled Substances Act because of its ability to bind to opioid receptors, which makes it a pain reliever that can be more powerful than morphine.

HHS noted that it is focused on a concentrated byproduct of the kratom plant and not natural kratom products. 

Here’s what to know about the synthetic opioid.

What Is 7-OH?

A variety of products contain 7-OH, including gummies, drink mixes, and shots. While the substance occurs naturally in kratom, it is in trace amounts.

A product also known as 7-hydroxy, 7-OHMG, and “7,”  7-OH is a powerful psychoactive compound added to products in concentrated amounts and, according to the FDA, falsely marketed as kratom. The agency stated that it is “engineered to be addictive” and is a “potent opioid by design.”

According to the FDA, Americans have reported side effects, including dependency, withdrawal, overdose, and death. 

“7-OH is an opioid that can be more potent than morphine,” FDA Commissioner Marty Makary said. “We need regulation and public education to prevent another wave of the opioid epidemic.”

Kratom itself is a plant native to Southeast Asia that has been used by consumers to treat pain, anxiety, and even drug dependence.

Regulators have had kratom in their sights for about 10 years because of concerns about potential negative effects. Both distributors and users have opposed possible regulation, saying kratom is a safer alternative to opioid use to treat pain and drug addiction. 

The FDA stated that 7-OH is not approved for the treatment of pain, depression, anxiety, or other disorders, nor is it approved to treat opioid or selective serotonin reuptake inhibitor withdrawal symptoms.

The availability of 7-OH in products has been a concern of the FDA because it can be purchased online and in local corner stores and vape shops. The department is particularly concerned about the availability to children and teenagers.

According to officials, products with 7-OH may not be labeled clearly or accurately and might be marketed as regular kratom. 

Health Risks 

Due to the ability of 7-OH to bind to the opioid receptors in the brain, it has highly addictive potential, according to a statement by HHS. 

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

Health and Human Services Secretary Robert F. Kennedy Jr. said when announcing the recommendation for 7-OH restrictions that he spoke with Attorney General Pam Bondi and members of the Drug Enforcement Administration (DEA) just days before the announcement and discovered the product was spreading to vape shops around military bases, near schools, and in low-income neighborhoods.

Sen. Markwayne Mullin (R-Okla.) warned that 7-OH can cause a relapse for those recovering from drug addiction, recalling his experience with a family member. 

“They’re clean, they’re doing better,” he said at the July 29 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.”

Government Actions 

The agency’s recommendation on a new classification for 7-OH will be reviewed by the DEA, which sets the federal rules for high-risk ingredients, including both prescription medicines and illicit substances. 

If the agency decides to enact a national ban, it wouldn’t take effect until the agency finalizes new rules that would govern the ingredient.

The FDA hopes to add  7-OH to the list of “scheduled” drugs to be used for medical use only, which are potentially addictive. Scheduled drugs are classified from I to V. Currently, Schedule I drugs are addictive substances such as heroin and LSD, whereas Schedule V drugs include many cough syrups. 

Markey expects  7-OH to be considered a Schedule I drug, but that decision will be made by the DEA. The FDA, however, plans to publish a report about 7-OH, how it differs from other substances, and the potential dangers associated with consumption.