Federal Administration Pushes for Prohibition of 7-OH Substances
In recent developments, the U.S. Food and Drug Administration (FDA) is targeting products containing the drug compound 7-hydroxymitragynine (7-OH), a potent opioid derived from the kratom plant. The focus is not on banning natural kratom, but on controlling the highly concentrated version of 7-OH [1][2][3].
7-OH acts on opioid receptors similarly to morphine and has significant abuse potential. The FDA recommends scheduling 7-OH products as controlled substances, particularly targeting concentrated or synthetic 7-OH substances, not the raw kratom leaf or traditionally used forms [1][3].
There are no FDA-approved medical uses for 7-OH, and it cannot lawfully be added to dietary supplements or foods. Concentrated kratom extracts with elevated 7-OH levels have been implicated in risks including addiction and contamination from unregulated manufacturing [2][3].
The lack of regulation has turned 7-OH-containing products into a growing health threat. Many of these products do not come with proper warnings, dose information, or medical oversight. Some people are unknowingly taking a strong opioid-like substance due to the lack of proper labeling [2][3].
Public health concerns revolve around 7-OH’s high potency and the risk of injury or death when used non-medically, especially when sold in unregulated markets or as concentrated extracts that have been marketed aggressively despite a lack of safety data [2][3].
Several states have banned kratom and its alkaloids including 7-OH entirely (e.g., Alabama, Arkansas, Indiana, Rhode Island, Vermont, Wisconsin), while other states regulate kratom or have local bans. Regulations are evolving and vary widely by jurisdiction [4].
The FDA wants 7-OH listed as a Schedule I drug, which is a category for drugs seen as having no accepted medical use and a high risk for abuse. Doctors are expressing concern about the ease of access to products containing 7-OH without proper instructions or safety labels [1][2][3][4].
In response, health departments are working on new education programs and more research to better understand the dangers of 7-OH. The move to restrict 7-OH could have a significant impact on the sale of related products in the future [1].
Health leaders are concerned about the unregulated and risky way this drug is showing up in supplements and store items. Officials are seeing an increase in ER visits due to the use of products containing 7-OH [1].
The government is sending a message that stronger rules are needed when it comes to the sale of 7-OH-containing products to the public. The classification of 7-OH as a top-level controlled substance is a step towards enforcing these rules [1].
The new recommendation is to classify 7-OH as a top-level controlled substance. With this move, the sale of products containing the potent opioid 7-OH may face federal scheduling to curb abuse and health risks. Consumers and retailers should be aware that 7-OH concentrates are likely to be banned or heavily restricted, and many states have their own laws banning whole kratom or its potent alkaloids [1][2][3][4].
[1] FDA. (2021, March 15). FDA takes action against companies selling unapproved kratom-containing products with hidden dangers. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-takes-action-against-companies-selling-unapproved-kratom-containing-products-hidden-dangers
[2] FDA. (n.d.). Kratom. Retrieved from https://www.fda.gov/consumers/consumer-updates/kratom
[3] DEA. (n.d.). Kratom. Retrieved from https://www.dea.gov/druginfo/ds.shtml?src=rnd&q=kratom
[4] American Kratom Association. (n.d.). State kratom laws. Retrieved from https://www.americankratom.org/state-laws/
Science has raised concerns about medical-conditions and chronic-diseases associated with the use of the potent opioid 7-OH, derived from the kratom plant. The FDA is advocating for scheduling 7-OH products as controlled substances, particularly those containing high concentrations of 7-OH, due to risks such as addiction and contamination.
Health-and-wellness products and supplements containing 7-OH lack proper warnings, dose information, and medical oversight, posing serious health threats to consumers. Mental-health professionals are expressing concern about the ease of access to these products.
In response to these risks, therapies-and-treatments for 7-OH addiction and proper regulation of its sale are being explored, aiming to protect public health and ensure the safety of consumers.
