HHS Releases Unredacted Letter Confirming Agency’s Recommendation to DEA to Reclassify Marijuana to Schedule III

Officials with the US Department of Health and Human Services released unredacted documents late Friday publicly affirming the agency’s decision that marijuana be reclassified from Schedule I to Schedule III of the US Controlled Substances Act.

The Biden Administration in 2022 requested “the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” Under this process, representatives from HHS and DEA weigh in on the matter, although DEA makes the final determination.

News of HHS’ recommendation letter to DEA was initially leaked to a Bloomberg News reporter last August, but neither the content of the letter nor any supporting documents were made public at that time. In response to litigation, HHS released redacted documents last month, but those documents failed to provide any clarity as to the agency’s decision or its decision-making process.

By contrast, the unredcated documents released today explicitly clarifies the agency’s position, stating, “Pursuant to the Controlled Substances Act (CSA), I, the Assistant Secretary for Health, am recommending that marijuana, referring to botanical cannabis, … be controlled in Schedule III of the CSA.”

The letter adds that both the US Food and Drug Administration and the US National Institute on Drug Abuse are in agreement with HHS’ recommendation. Supporting documentation provided by the agency states that thousands of doctors are currently recommending medical cannabis in accordance with state laws, that there exists “considerable evidence in favor of [its] effectiveness” in the treatment of various conditions, like pain, and that its abuse potential is less than those of substances classified in either Schedule I or Schedule II.

Commenting on the documents’ release, NORML Deputy Director Paul Armentano said, “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.”

HHS’ recommendation is currently before the DEA, which is conducting its own review. Historically, the DEA has employed its own five-factor test (which differs from HHS’ criteria) to determine whether or not cannabis ought to be rescheduled. On four prior occasions, the agency has determined that cannabis failed to meet any of its five criteria. In 2016, for instance, the agency concluded, “Based on the established five-part test for making such determinations, marijuana has no ‘currently accepted medical use’ because … the drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.”

NORML has long called for removing cannabis from the CSA altogether in a manner similar to tobacco and alcohol so that state governments, rather than federal officials, can be the primary arbiters of marijuana policy.

Additional information is available from the NORML Fact Sheet, “A Brief History of Cannabis Rescheduling Petitions in the United States” and in NORML’s op-ed, “Cannabis Must Be Removed from the Controlled Substances Act to Resolve State/Federal Conflicts.”