Marijuana reclassification proposed over lower public health risk, documents show

Federal health officials determined marijuana poses a lower public health risk than other controlled substances and offers possible medical benefits before they proposed ending its designation as among the riskiest drugs, according to documents released Friday.

The extensive scientific review illuminates the rationale underpinning a recommendation last summer that marked a significant shift in how the federal government has treated a drug that is legal for a majority of Americans to purchase. This is the first time the Department of Health and Human Services has publicly acknowledged marijuana’s medical use.

The health agency in August recommended that the Drug Enforcement Administration change marijuana’s classification as a Schedule I drug, a designation reserved for substances that have a high potential for abuse and no accepted medical use. The classification has long been a source of criticism that one of the most commonly used drugs is in the same category as heroin and LSD. The DEA has yet to act on the recommendation.

Marijuana is legal for medicinal purposes in 38 states and D.C. Federal officials proposed classifying marijuana as a Schedule III drug, in the same category as substances that can be obtained with a prescription such as anabolic steroids, ketamine and testosterone.

In the analysis conducted by the Food and Drug Administration, officials determined marijuana is less harmful than other drugs. The nation’s overdose crisis has reached staggering proportions, with opioids and other drugs killing more than 100,000 each year.

“Although abuse of marijuana produces clear evidence of harmful consequences, including substance use disorder, they are relatively less common and less harmful than some other comparator drugs,” the document said.

Federal officials previously declined to answer questions about their justifications for recommending rescheduling and released heavily redacted documents outlining their rationale in response to a Freedom of Information Act request filed by The Washington Post. Matt Zorn, a lawyer in Texas, first released the unredacted documents Friday in his newsletter after successfully suing HHS for their release. HHS confirmed the authenticity of the documents.

In October 2022, President Biden directed his administration to expedite a review of whether marijuana should remain a Schedule I substance.

The move came after the federal government repeatedly rejected entreaties to reclassify the drug. When federal health officials conducted a scientific and medical evaluation for a 2016 review under the Obama administration, they concluded marijuana has a high potential for abuse and no accepted medical use.

The 2023 FDA analysis determined chronic, but not acute, marijuana use can lead to physical dependence that is “moderate to low” and psychological dependence with a low likelihood of severe outcomes. Officials said dependence is “relatively mild” for most individuals but can be more severe with increased exposure.

“While marijuana is associated with a high prevalence of abuse, the profile of and propensity for serious outcomes related to that abuse lead to a conclusion that marijuana is most appropriately controlled in Schedule III,” the evaluation said.

Officials also determined “some credible scientific support” for some of the ways marijuana is being used as medicine. They found it has a “currently accepted medical use” for nausea, vomiting and pain, but noted it did not find support for the drug providing benefit for epilepsy, anxiety and PTSD.

“Additionally, no safety concerns were identified in our review that would indicate that medical use of marijuana poses unacceptably high safety risks for the indications where there is some credible scientific evidence supporting its therapeutic use,” the evaluation said.

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Keith Humphreys, a former White House drug policy adviser, said he does not believe the science is particularly strong for using cannabis as medicine, particularly much-touted claims it relieves pain. He pointed out today’s marijuana products are increasingly potent. But with so many states already operating medical marijuana programs, HHS and FDA’s change of perspective “is a concession to reality,” he said.

“It’s out there already,” Humphreys, a professor of psychiatry at Stanford University, said of medical marijuana. “You can’t put the genie back in the bottle.”

Howard Sklamberg, a former FDA deputy commissioner, said the analysis was “nothing unexpected” but reflected the significant research and information that has emerged since the last time the agency conducted a scientific analysis.

“For years, people said it was important to gather information and publish and eventually it would affect policy - and that’s exactly what happened,” Sklamberg said.

Sklamberg predicted DEA would follow HHS’s recommendation. He noted that DEA, by law, must defer to the FDA’s analysis on the science of marijuana’s potential for medical use.

Zorn, the attorney who sued for the release of the scientific review, said he believes the document has broader implications because the FDA is acknowledging that states, which regulate the practice of medicine, also have a say in defining accepted medical use. That could be important as states explore decriminalizing substances such as psilocybin, the hallucinogen with the potential to treat depression, anxiety and post-traumatic stress disorder. Oregon and Colorado have legalized its supervised use.

“To me, it’s not about the science,” Zorn said. “It’s about the legal shift.”

Experts say marijuana rescheduling could have big implications from lowering tax bills for cannabis companies in states where marijuana is legal and removing barriers to scientific research into the drug.

Some marijuana advocates have cautioned against declaring rescheduling a major victory, noting reclassification alone would not change penalties for major federal marijuana cases and regulatory confusion would persist.

Rep. Earl Blumenauer (D-Ore.), a longtime proponent of relaxing marijuana laws, hailed the changes in how federal health officials view the drugs.

“It is another step toward the inevitable legalization of cannabis and ending this sad chapter of the failed war on drugs,” he said in a statement.