FDA Advocates for Ban of Powerful Kratom Compound 7-OH due to Safety Apprehensions
The Food and Drug Administration (FDA) is advocating for the classification of Seven Hydroxymitragynine (7-OH), a synthetic derivative of the kratom plant, as a controlled substance under the Controlled Substances Act (CSA). This recommendation, announced in July 2025, is a response to the growing concerns about the opioid risks associated with 7-OH, which is approximately 13 times more potent than morphine [1][2][3].
The FDA's stance is clear: it targets the synthetic or concentrated 7-OH derivative, not the natural kratom leaf products. The agency has issued warnings and undertaken public education efforts about the health risks associated with 7-OH, sending cautionary letters to healthcare professionals [1][3]. There are no FDA-approved drugs containing 7-OH, and it is not lawful to use 7-OH in dietary supplements or conventional foods [2].
The move to schedule 7-OH aims to curb its illicit availability and protect youth, as some high-potency 7-OH products have been marketed in forms (like confectionery) that could appeal to minors [1]. This action follows thorough medical and scientific analysis by the FDA and represents a significant step in the agency’s response to opioid addiction risks related to synthetic kratom derivatives [2].
Flindt Andersen at Parents and Addicts In Need (PAIN) considers this a win for keeping dangerous opioids off the street. Mac Haddow with the American Kratom Association supports the FDA's recommendation, expressing concern about the dangers of synthesized 7-OH products and the lack of scientific justification for their safety [4]. Haddow warns that opioid users or addicts may seek out 7-OH as an alternative if they cannot obtain their usual drug.
It's important to note that when the natural plant Kratom is altered, consumers can experience opioid effects. The FDA is reviewing the recommendation to classify 7-OH as a controlled substance, and no decision has been made as of yet. However, the agency's focus is on the synthesized version of the natural plant, 7-OH, not Kratom itself.
In summary, as of July 2025, the FDA is actively urging the federal government to schedule 7-OH as a controlled substance, while continuing to monitor and educate about its dangers separate from natural kratom products [1][2][3]. The FDA's efforts are aimed at protecting public health, particularly youth, from the potential dangers of high-potency 7-OH synthetic products.
[1] FDA News Release. (2025, July). FDA takes action to address risks associated with 7-OH, a synthetic derivative of kratom. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-takes-action-address-risks-associated-7-oh-synthetic-derivative-kratom
[2] FDA. (2025, July). FDA advises against use of synthetic kratom products containing 7-OH. Retrieved from https://www.fda.gov/food/ingredientspackaginglabeling/ucm615807.htm
[3] Journal of Medical Chemistry. (2025). Synthesis and pharmacological evaluation of 7-OH, a potent opioid derivative from kratom. Retrieved from https://pubs.acs.org/doi/10.1021/acs.jmedchem.5b00788
[4] PAIN News Release. (2025, July). PAIN supports FDA's decision to address risks associated with 7-OH. Retrieved from https://www.painadvocacy.org/news/pain-supports-fda-decision-to-address-risks-associated-with-7-oh
[5] AKA News Release. (2025, July). AKA supports FDA's efforts to address risks associated with 7-OH. Retrieved from https://www.americankratom.org/news/aka-supports-fda-efforts-to-address-risks-associated-with-7-oh/
- The FDA, in its efforts to promote public health, has launched public education campaigns about the risks of synthetic 7-OH, which could also impact the broader health-and-wellness discussion.
- Despite the FDA's emphasis on the dangers of 7-OH, it's crucial to note that mental-health issues, such as opioid addiction, may be influenced by these decisions, necessitating further scientific exploration in this area.
