Ban Synthetic 7-OH: Natural Leaf Kratom Presents No Major Health Risk

Public awareness of ‘kratom’ is rising, fueled by growing media coverage and the spread of products labeled “kratom” in stores, that in many cases are entirely chemically distinct from natural kratom.Despite the chemical differences, leaf kratom is increasingly being grouped in the public narrative with synthetic concentrated 7-hydroxymitragynine (7-OH) products being called “kratom,” creating confusion and unnecessary alarm among users and health care providers.

FDA Action on 7-OH Products

In late July, the FDA announced that synthetic concentrated 7-OH products, sometimes sold as “enhanced kratom,” should be considered for scheduling under the Controlled Substances Act. The FDA emphasized thattheir focus was on synthetic concentrated 7-OH opioid products and not leaf kratom, which they noted has limited health concerns.¹

The FDA is right to focus their concern on synthetic concentrated 7-OH opioid products. In contrast, whole fresh kratom leaves and dried natural kratom leaf powder have centuries of extensive use in indigenous populations in Southeast Asia and decades of use in the United States. These natural products contain numerous alkaloids that act on serotonin, alpha-1 and alpha-2 adrenergic, and partially on the mu-opioid receptors, producing an “entourage effect.” Mitragynine, the most abundant alkaloid, has only mild and partial mu-opioid activity while also stimulating serotonin and adrenoceptors. The combination of alkaloids in natural kratom leaf produces milder effects than isolated or chemically altered alkaloids. The FDA recently conducted a clinical trial assessing the tolerability of leaf kratom with no concerns, even at servings of 12 grams, which is 4 times what is typical for a US consumer.

7-OH Versus Natural Kratom

To create synthetic concentrated 7-OH products, manufacturers chemically oxidize mitragynine extract, using harsh chemicals such as pool shock to create a potent semi-synthetic opioid. Concentrated synthetic 7-OH opioid products contain synthetic 7-OH at levels that are more than 100 times higher than the natural 7-H found in dried leaf, creating a product that is 13 times more potent than morphine. Animal studies have shown that high doses of 7-OH, like those found in concentrated synthetic 7-OH products, are as addictive as prescription opioids with a similar risk of causing respiratory depression. There are no known serotonin or alpha-2 adrenoceptor effects with concentrated isolated 7-OH and no entourage effect from natural alkaloids.²

Synthetic concentrated 7-OH opioid products have recently been associated with severe addiction, rapid dosage escalation, and problems with breathing, agitation, seizures, hypertension, tachycardia, and death in consumers. These findings show the substantial risks of synthetic concentrated 7-OH opioid products and demonstrate the enhanced need for controlled substance scheduling.³

Considerations for Patients and Pharmacists

Pharmacists, and other frontline health professionals, should be aware that synthetic concentrated 7-OH opioid products are not “natural,” “organic,” or “pure,” and are not even kratom. Patients with opioid use disorder should be counseled to use FDA approved therapies, such as buprenorphine (Suboxone; Indivior), methadone, and naltrexone (Vivitrol; Alkermes, Inc). For patients successfully self-treating with kratom, they should be counseled never to try a synthetic concentrated 7-OH opioid product. There are numerous cases of people feeling euphoria on the synthetic concentrated 7-OH opioid product and losing control of their consumption, highlighting the risks associated with these synthetic concentrated products.

If someone experiences adverse events using a “kratom” product, it is important to try and get the name of the product or the original bottle before filling out the FDA’s MedWatch form. Misattribution of adverse events to kratom makes it difficult to tease out the risks from synthetic concentrated 7-OH versus leaf kratom products. Importantly, synthetic concentrated 7-OH is not on a standard drug screen and you will not detect it unless you specifically ask for the test to be run.

Synthetic concentrated 7-OH is also very unstable in biological fluids (even under refrigeration), so samples should be analyzed within the first 7 days, or they will increasingly underreport the actual concentration of 7-OH in the body over time. Accurate reporting will help ensure health care professionals and the general public fully understand the dangers associated with synthetic concentrated 7-OH products without misattributing them to natural leaf kratom.⁴

Educating both clinicians and consumers about the distinct risks of synthetic concentrated 7-OH products versus leaf kratom is key to protecting public health and preventing confusion or misattribution of harm. Synthetic concentrated 7-OH products pose significant risks and should be designated as controlled substances. Natural leaf kratom products, in contrast, carry a much lower risk when used responsibly.

REFERENCES

1. FDA takes steps to restrict 7-OH opioid products threatening American consumers. News release. FDA. Published July 29, 2025. Accessed October 30, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers

2. Matsumoto K, Horie S, Ishikawa H, et al. Antinociceptive effect of 7-hydroxymitragynine in mice: Discovery of an orally active opioid analgesic from the Thai medicinal herb Mitragyna speciosa. Life Sciences. 2004;74:2143-2155. doi:10.1016/j.lfs.2003.09.054

3. Have “7” products with 7-hydroxymitragynine (7-OH) been proven to be safe? Kratom Consumer Advisory Council. Accessed October 30, 2025. https://static1.squarespace.com/static/6508b3f79033221c2aa1ea17/t/68792ce4e1c0dc30c29f3a1f/1752771814764/KCAC+-+Position+Statement_July+%2725_V3.pdf

4. Why poison control center mortality data cannot accurately reflect concentrated synthetic 7-OH risk. Kratom Consumer Advisory Council. https://static1.squarespace.com/static/6508b3f79033221c2aa1ea17/t/68d2bcaff487b72b1adab9a5/1758641327216/KCAC+-+Fact+Sheet_Undercounting+Death_V3.pdf