Authorities lobby for regulations on opioid 7-OH derived from kratom plant
The US Food and Drug Administration (FDA) has taken a firm stance against the addition of 7-hydroxymitragynine (7-OH) to dietary supplements or food products, reiterating that it is illegal to do so. This compound, which is drawn from the opioid-like herb kratom, has been a subject of concern for federal health agencies due to a rise in reports of overdoses, poisonings, and emergency room visits associated with products containing 7-OH.
On July 15, the FDA sent warning letters to seven companies marketing 7-OH products. This action is not targeting the kratom leaf or ground-up kratom, but the concentrated synthetic byproduct that is an opioid, as stated by Dr. Marty Makary, FDA Commissioner.
Taken in small doses, kratom and 7-OH can act as a stimulant, and some people use it to manage opioid withdrawal symptoms. However, 7-OH carries risks of addiction but is often sold without dosage controls or warnings.
The FDA is recommending that 7-OH be listed as Schedule I, the most restrictive class of controlled substances. Drugs in Schedule I are defined as having no currently accepted medical use and a high risk of addiction, including heroin, cocaine, cannabis, LSD, and psilocybin.
Current regulations in the United States for natural kratom vary by state, as there is no federal regulation specifically banning or controlling kratom itself. As of early 2025, kratom is illegal in six states - Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin, and the District of Columbia classifies it as a controlled substance. Eighteen states regulate kratom's possession, sale, or manufacture in some way, with others having no controls at all. Age restrictions apply in some states, with minimum purchase ages mostly between 18 and 21 years.
Some states have passed versions of the Kratom Consumer Protection Act (KCPA) that establish safety measures such as product labeling, age limits, banning adulterated products, and requiring testing and good manufacturing practices (GMP). As of mid-2024, thirteen states have enacted KCPA-type laws; Florida's version will become effective in July 2025.
The FDA has not federally scheduled kratom but has expressed concerns about compounds in kratom, especially 7-OH. The agency is cracking down on the marketing and sale of products containing concentrated 7-OH, warning about their risks and lack of approval as drugs or dietary supplements, and has issued import alerts to detain some kratom-containing products.
Future federal regulation may include scheduling of kratom compounds or stricter controls on manufacturing and marketing, but as of mid-2025, this has not been enacted. Former US Centers for Disease Control and Prevention Director Dr. Robert Redfield wrote a June op-ed urging the government to step up regulation of kratom and 7-OH, arguing that health agencies can adopt a standard set forth in recent legislation to regulate kratom.
In conclusion, kratom remains federally unregulated but is subject to increasing federal scrutiny due to safety concerns about some compounds. State-level regulation is the platform where most current legal control occurs, focusing on consumer protection and access restrictions. The FDA will continue to warn the public against the use of kratom for medical treatment until it can evaluate the safety and effectiveness of kratom or its components.
The FDA's recommendation to list 7-OH as Schedule I is a testament to the organization's concerns regarding its health risks and potential for addiction. In the realm of health and wellness, it's crucial to address medical-conditions like the addictive properties of 7-OH, especially when it's often sold without proper dosage controls or warnings. Science plays a significant role in shedding light on the effects of such compounds on our health.
