FDA declares cannabis has medical merit, pushing US rescheduling effort forward

The Cannabis Observer ·
FDA declares cannabis has medical merit, pushing US rescheduling effort forward

The United States has moved closer to downgrading the federal classification of cannabis after the Food and Drug Administration (FDA) concluded there is "credible evidence" that the drug carries genuine medicinal value.

The FDA also determined that the risk of physical dependence among young cannabis users was low enough to justify recommending a move from its current schedule one classification down to schedule three.

Those findings, set out in a 252-page report, will now go before the Drug Enforcement Administration (DEA), which must sign off on the recommendation before any rescheduling can take effect.

The review was triggered by an order from President Joe Biden in late 2022 to examine the federal standing of cannabis, a substance that has long been treated as highly dangerous under US law.

Schedule one is reserved for substances deemed to have no accepted medical use and a high potential for abuse. Heroin and LSD currently sit alongside cannabis in that category.

The FDA report could — as widely anticipated — pave the way for cannabis to be elevated to schedule three status.

The National Institute on Drug Abuse is among those backing the change. In August, Rachel Levine, assistant secretary at the US Department of Health Services, called on the DEA to strip cannabis from the list of high-risk controlled substances.

The FDA stated in the report that there is "some credible level of support for some of the therapeutic uses for which marijuana is being used in clinical practice in the United States," citing conditions including nausea, chronic pain and anorexia.

Even so, the agency stopped short of saying that the available safety and effectiveness data was sufficient to support formal approval of cannabis as a recognised medical treatment.

Demonstrating that a substance has medical benefits is one of three criteria required for reclassification to schedule three.

The review concluded that cannabis satisfies all three. Beyond its therapeutic properties, researchers found that cannabis carries a lower potential for abuse than other schedule one drugs, and that the risk of physical dependence among young users was low to moderate.

The report's authors observed that despite the "high prevalence of non-medical [cannabis] use" and the widespread availability of high-THC products, the drug does not produce serious outcomes comparable to those associated with heroin, oxycodone or cocaine.

Recreational cannabis is currently legal in 24 US states, two territories and Washington DC, while 38 states allow the medicinal use of cannabis products.

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