Federal authorities petition legal classification of gas station items exhibiting opioid-like influences as illicit drugs
The Food and Drug Administration (FDA) has recommended that 7-hydroxymitragynine (7-OH), a potent opioid compound derived from kratom, be classified as an illicit substance under the Controlled Substances Act. This recommendation, if approved by the Drug Enforcement Administration (DEA), would classify 7-OH as a Schedule I drug, indicating it has no accepted medical use and a high potential for abuse.
The FDA's decision comes following a scientific review that highlighted 7-OH’s opioid potency and associated health risks, such as addiction, respiratory depression, liver toxicity, seizures, and death. Currently, 7-OH is not legally permitted in dietary supplements or conventional foods, and the FDA has issued warning letters to companies illegally selling 7-OH products like tablets, gummies, and drink mixes.
The FDA is also actively educating the public and healthcare professionals about the dangers of 7-OH and distinguishing these risks from those posed by natural kratom leaf products. The final authority on scheduling 7-OH rests with the DEA, which will conduct a public review process before making a decision.
Potential implications of classifying 7-OH as a Schedule I substance include severe restrictions on manufacturing, distribution, and sale of 7-OH containing products. This could lead to increased legal risks for companies selling 7-OH products, possibly resulting in more warning letters or enforcement actions by the FDA and DEA.
However, it's important to note that the FDA's focus is on the isolated, concentrated 7-OH—not the whole plant. This means that the availability of natural kratom leaf products may not be immediately affected.
The potential impact on kratom users is also a concern. 7-OH is one of the key active alkaloids converting from mitragynine in the body, and regulation could influence perceptions, accessibility, and legality of kratom-derived products.
Public health messaging emphasizing 7-OH’s opioid-like effects and greater potential danger compared to kratom leaf itself may affect consumer behavior and regulatory approaches at state and local levels.
The FDA currently warns against using kratom products due to the risk of serious side effects, such as seizures and liver toxicity, and because it may lead to substance use disorder. Proponents of kratom argue that it can be useful for pain management and helping people with substance use disorders wean off more dangerous opioids.
In 2016, the DEA planned to regulate the active ingredients in kratom, including 7-OH, as Schedule I substances but dropped the effort due to pushback from kratom advocates. The current FDA push reflects renewed concerns over the rise of concentrated 7-OH products sold in accessible retail locations like vape shops and gas stations.
The Holistic Alternative Recovery Trust disputes the FDA's recommendation, stating that if 7-OH posed an urgent danger, evidence would have been presented. 7-OH products are sometimes misleadingly marketed as kratom.
As of late June, the FDA has issued warning letters to seven companies for illegally marketing products containing 7-OH. Around 1.9 million people ages 12 and up in the U.S. reported using kratom in 2022, according to the National Survey on Drug Use and Health.
The American Kratom Association is not opposed to the FDA regulating kratom products via labels, age restrictions, or limiting the concentration of 7-OH, but maintains that kratom does not have a high potential for abuse or warrant classification as a controlled substance.
In summary, the FDA has escalated efforts to regulate 7-OH due to its opioid potency and associated public health risks, recommending Schedule I classification pending DEA review and public input. This move intensifies scrutiny and restriction of 7-OH products while keeping natural kratom leaf outside the immediate scope of this classification.
- The discussion about 7-OH, a compound derived from kratom, has extended into the realm of health-and-wellness, mental-health, and policy-and-legislation, with the FDA recommending its classification as an illicit substance under the Controlled Substances Act.
- In the political sphere, the DEA holds the final authority on scheduling 7-OH, and a potential classification as a Schedule I drug could impact policy by imposing severe restrictions on manufacturing, distribution, and sale of related products.
- As the debate unfolds, the general-news is featuring opinions from both sides on the matter – from opponents of kratom who argue for stricter regulations to advocates who believe kratom’s benefits in pain management and substance use disorder should be considered.
