The US Food and Drug Administration has recommended that 7-hydroxymitragynine (7-OH), commonly known as “legal morphine,” join the Schedule I controlled substance list, marking a significant step towards a potential legal morphine ban across America. Furthermore, retailers have increasingly sold this synthetic, concentrated substance derived from kratom leaves at petrol stations, smoke shops, and online without proper regulatory oversight.

Moreover, the FDA’s recommendation comes alongside urgent warnings to physicians about the dangers of this opioid-like substance that binds to the same brain receptors as morphine and heroin. Meanwhile, studies suggest that concentrated 7-OH formulations possess 13 times more potency than morphine itself.

Commissioner Warns of Hidden Opioid Threat

However, FDA Commissioner Dr Marty Makary emphasised the deceptive nature of this dangerous synthetic opioid ban target during a press conference. Indeed, he explained that “7-OH is not just like an opioid” but “scientifically, by definition, it is an opioid” that operates by binding to mu opioid receptors in the brain.

“And yet retailers sell it in vape stores, smoke shops, convenience stores and petrol stations that appear all over the United States, and nobody knows what it is,” Dr Makary stated. Consequently, this widespread availability of an unregulated opioid-strength substance poses serious public health risks.

Additionally, manufacturers market the substance under various names including “7-hydroxy,” “7-OHMG,” “7,” and most concerningly, “legal morphine,” despite its potent effects and high addiction potential.

DEA Review Process Begins

Nevertheless, the Drug Enforcement Administration must now review the FDA’s recommendation and launch a comprehensive public rule-making process. Furthermore, this process includes public consultation periods and could take several months to conclude before any legal morphine ban takes effect.

Subsequently, if the DEA follows the FDA’s guidance, 7-OH would join the same classification as heroin, morphine, and other highly controlled psychoactive substances. Therefore, this reclassification would significantly restrict access to products containing concentrated 7-OH.

Importantly, the FDA clarified that the synthetic opioid ban recommendation would not affect natural kratom products, as the scheduling would apply only to concentrated 7-OH formulations.

Limited Data Drives Preventive Action

Despite limited epidemiological data on 7-OH misuse, health officials argue that preventive action is necessary to avoid “another wave of the opioid epidemic.” Moreover, Deputy Secretary Jim O’Neill of the Department of Health and Human Services warned that “7-OH carries a high risk for addiction—on purpose.”

“Manufacturers mislead young people, veterans, and people who suffer from chronic pain or addiction into thinking that these are safe alternatives. They are not,” O’Neill emphasised during the announcement.

Additionally, whilst biological testing can identify mitragynine presence in toxicology reports, investigators cannot distinguish whether the substance originated from natural kratom or concentrated 7-OH products, complicating efforts to track the legal morphine ban necessity.

Industry Response and Medical Concerns

Meanwhile, the American Kratom Association has praised the FDA’s move towards a synthetic opioid ban for 7-OH products. Indeed, Mac Haddow, senior fellow on public policy for the association, stated that “these 7-OH products are not kratom” but rather “chemically altered substances that carry potent opioid-like effects.”

Furthermore, medical experts support the intervention despite limited documented cases. Dr Lief Fenno, chair of the American Psychiatric Association’s Council on Addiction Psychiatry, views the legal morphine ban as “a good first step” in addressing kratom-related dependencies.

“Patients experience kratom very similarly to addiction to any other opioid,” Dr Fenno explained, drawing from his clinical experience treating patients in an opioid addiction clinic.

Proactive Approach to Substance Control

Ultimately, Commissioner Makary defended the decision to act without extensive epidemiological evidence, arguing that “public health is supposed to prevent disasters, not just clean them up after they’ve killed thousands and thousands of people.”

Consequently, this proactive stance represents a shift from previous approaches where regulatory action occurred only after extensive documented harm. Therefore, the potential synthetic opioid ban aims to prevent the establishment of another addictive substance in the marketplace before widespread dependency develops.

Finally, the FDA’s comprehensive approach includes warning letters to companies illegally marketing 7-OH products and educational materials for both healthcare providers and consumers about the risks these unregulated opioid-strength substances pose.

Source: Medscape