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News Brief: FDA Recommends Scheduling 7-OH Products as Controlled Substances

Worst Pills, Best Pills Newsletter article December, 2025

7-hydroxymitragynine, known as 7-OH, is a naturally occurring substance that is a minor constituent of the kratom plant, a tropical evergreen tree native to Southeast Asia.

After 7-OH is concentrated, it becomes a potent opioid. 7-OH products are readily available in gas stations, vape shops and online, and they are often sold as fruit-flavored gummies, drink mixes and even ice cream cones — items that are particularly appealing to children and teenagers.

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7-hydroxymitragynine, known as 7-OH, is a naturally occurring substance that is a minor constituent of the kratom plant, a tropical evergreen tree native to Southeast Asia.

After 7-OH is concentrated, it becomes a potent opioid. 7-OH products are readily available in gas stations, vape shops and online, and they are often sold as fruit-flavored gummies, drink mixes and even ice cream cones — items that are particularly appealing to children and teenagers.

Products containing concentrated 7-OH have no approved medical uses, are not lawful in dietary supplements, and cannot be legally added to foods. In July 2025 the Food and Drug Administration (FDA) recommended that the Drug Enforcement Administration (DEA) schedule certain 7-OH products as controlled substances under the Controlled Substances Act.[1] The growing availability, marketing and illegal use of 7-OH products have placed them on the agency’s watch list as an emerging opioid threat to public health.

The FDA’s recommendation is based on medical reports and surveillance data examining the chemical, pharmacological and epidemiological profiles of 7-OH concentrates.[2] Findings show that 7-OH produces clinical effects, side effects, addiction potential and withdrawal symptoms like those of other opioids such as morphine and oxycodone.[3] When people become ill after ingesting 7-OH products, they may experience euphoria, sedation and respiratory depression, as well as withdrawal symptoms.

Under the Controlled Substances Act, substances are placed into one of five schedules based on their potential for abuse, accepted medical use, and safety profile, with Schedule I drugs carrying the highest risk.

Alongside this recommendation, the FDA has issued warning letters to companies illegally distributing 7-OH products, released educational materials for the public, and sent “Dear Colleague” letters to health care professionals about the dangers of synthetic 7-OH concentrates. In August 2025, Florida issued an emergency rule classifying certain 7-OH products as Schedule I controlled substances.[4] As of early November 2025, the DEA had yet to act on the FDA’s recommendation.
 



References

[1] Food and Drug Administration. FDA takes steps to restrict 7-OH opioid products threatening American consumers. July 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers. Accessed August 22, 2025.

[2] Food and Drug Administration. 7-hydroxymitragynine (7-OH): An assessment of the scientific data and toxicological concerns around an emerging opioid threat. July 2025. https://www.fda.gov/media/187899/download?attachment. Accessed August 22, 2025.

[3] Ibid.

[4] Florida Office of the Attorney General. Attorney General James Uthmeier files emergency rule immediately removing dangerous 7-OH products. July 2025. URL. Accessed August 22, 2025.