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Feds examine loosening restrictions on marijuana for medical use and research

News
Article

HHS supports change from Schedule I drug to Schedule III, but DEA must weigh in.

medical marijuana doctor prescription bottles: © Africa Studio - stock.adobe.com

© Africa Studio - stock.adobe.com

Reclassifying marijuana as a Schedule III drug could be in process at the federal level.

Advocacy organizations and news outlets have pounced on a trove of U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) records showing the government regulators support placing marijuana in Schedule III of the Controlled Substances Act (CSA). For years it has been in Schedule I, largely restricting use and testing for medical purposes. Numerous states have authorized it for medical use, including for chronic pain management for conditions and diseases.

Now, FDA and the National Institute on Drug Abuse agree “marijuana meets the findings for control in Schedule III set forth” in federal law.

“Based on my review of the evidence and FDA’s recommendation, it is my recommendation as the Assistant Secretary for Health that marijuana should be placed in Schedule III of the CSA,” U.S. Public Health Service Adm. Rachel L. Levine, MD, wrote in a letter to Anne Milgram, administrator of the Drug Enforcement Administration in the U.S. Department of Justice.

‘Accepted medical use’

Advocates for legalization celebrated the news, which began spreading Jan. 12.

“It is significant for these health agencies to acknowledge publicly, for the first time, what many patients and advocates have known for decades: That cannabis is a safe and effective therapeutic agent for tens of millions of Americans,” Norml Deputy Director Paul Armentano said in a news release. That organization has been lobbying for decades to end federal and state prohibition on marijuana.

Americans for Safe Access, a national member-based organization promoting legal access to cannabis for therapeutic use and research, said FDA used that group’s suggestions and data in its review, “resulting in their conclusion that cannabis does in fact have accepted medical use,” founder and President Steph Sherer said in a statement.

"We are hopeful that the DEA will agree with HHS’ recommendation to change cannabis’ status and that Congress views HHS’ report as a green light to move forward with a more comprehensive approach to medical cannabis access,” Sherer said.

Past and next

The FDA recommendation does not guarantee a change in the law. The DEA will conduct its own review before making the final determination, according to Norml, and its criteria are different from the Food and Drug Administration.

The advocacy groups noted 2016 was the DEA’s last consideration for legalization. At that time, DEA ruled marijuana “has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.”

DEA acknowledged some states had allowed use of marijuana for medicinal purposes, but cited FDA’s authority to approve drugs for use in the United States. DEA noted some medicines were in use with THC (delta-9-tetrahydrocannabinol), believed to be the main substances that causes marijuana’s psychoactive effect.

Changing times

In the last few years there have been indicators of potential sweeping change for marijuana laws at the national level.

The FDA’s review began when President Joe Biden in October 2022 began steps toward reforming marijuana law. Schedule I of CSA includes the drugs heroin and LSD, and is higher than the classification for fentanyl and methamphetamine, the drugs now driving the nation’s overdose epidemic, according to the White House.

Levine’s letter is dated Aug. 29, 2023. In August last year, news leaked that HHS recommended reclassifying the drug. Levine’s full 252-page review was published in redacted form last year and did not clarify the review process, according to Norml.

In December 2023, lawmakers in the House of Representatives introduced a “modernized” version of the “Strengthening the Tenth Amendment Through Entrusting States Act” that would grant states power to regulate marijuana within their border. Later that month, Biden proclaimed a general pardon for anyone convicted of federal offenses of simple possession of marijuana, attempted simple possession of marijuana, or use of marijuana.

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Georges C. Benjamin, MD