Close-up of two dried cannabis flower buds resting on a person's fingertips, showing dense green leaves, orange pistils, and a frosty coating of trichomes.

GuideJuly 6, 2026

The FDA Is Considering Placing Marijuana in A Category That Indicates It Might Be Safer

The FDA has recommended moving marijuana from Schedule I to Schedule III, citing growing evidence of medical use and a lower risk of misuse than previously classified substances. Here's what the proposed change could mean for patients, healthcare, and federal policy.

The U.S. Food and Drug Administration (FDA) headquarters, the federal agency responsible for regulating food, drugs, medical devices, and evaluating scientific evidence that informs public health policy.

According to documents from the US Food and Drug Administration, marijuana is less likely to be misused compared to other drugs facing similar restrictions. Researchers believe there's scientific evidence backing its use as a medical treatment. They suggest reclassifying it as a Schedule III substance.

The FDA gave its advice in a long report with 252 pages. They sent this report to the US Drug Enforcement Administration (DEA) in August 2023.

In August, Bloomberg News shared a report, possibly leaked, about the FDA's recommendation on marijuana scheduling. Attorney Matthew Zorn, who wasn't representing anyone, wanted the FDA to disclose this info. The FDA responded just before the court deadline. Zorn said it was absurd to debate public policy without seeing the recommendation.

Despite the report sparking discussion, no one else had the full, unedited FDA recommendation. Now that it's public, the DEA might feel more pressure to act. However, they're not obligated to do anything, and there's no specific timeline. Lawyers anticipate a proposal to move cannabis from Schedule I to III soon due to the President's directive in October 2022.

President Biden asked Health and Human Services and the US Attorney General to quickly review marijuana's federal scheduling. Lawyers believe a rule proposal could come soon, given Biden's push and supportive evidence. Howard Sklamberg from Arnold & Porter expects a proposed rule shortly, with a final rule around mid-summer. He thinks agencies prefer finishing significant rules before the political season heats up.

Legitimate Medical Use

According to the FDA, marijuana is considered to be a low-risk threat to public health, and it is less likely to be misused compared to drugs like heroin or cocaine, which fall under Schedule I or II.

While some people use marijuana in ways that could be harmful to their health and safety, the majority of users do so without causing danger to themselves or others, as per the FDA's findings.

The FDA evaluated various factors, including emergency room visits, hospitalizations, unintentional exposures, and overdose deaths, and concluded that the risks associated with marijuana are lower compared to other abused substances like heroin, cocaine, and benzodiazepines.

The FDA also looked into the accepted medical uses of cannabis, such as for anorexia, anxiety, epilepsy, inflammatory bowel disease, nausea, vomiting, pain, and posttraumatic stress disorder. The strongest evidence was found for medical conditions related to anorexia, nausea and vomiting, and pain.

Interestingly, the FDA used alcohol as a point of comparison, even though it is not a controlled substance. This was done because alcohol, like marijuana, is widely available and used for nonmedical purposes.

Sklamberg, a representative, found it intriguing that a majority of adults have either used cannabis or know someone who has, drawing parallels with alcohol. He noted that many Americans have formed their own opinions about marijuana, believing that placing it in Schedule I exaggerates the health risks, similar to their views on alcohol.

Disagreement among members of Congress

Close-up of a U.S. congressional bill titled "Regulate Marijuana Like Alcohol Act," highlighting proposed federal legislation to regulate and decriminalize marijuana. — Proposed federal legislation could reshape cannabis policy by changing how marijuana is regulated and classified under U.S. law.

There's uncertainty about whether cannabis will be reclassified. After a report by Bloomberg in August, Republican members of Congress sent a letter to DEA Administrator Anne Milgram, stating that the drug should not be reclassified.

Senator James Lankford from Oklahoma argued in September that the suggestion to remove cannabis from the DEA's list is not based on science but on a pro-marijuana agenda. The letter claimed that there's no proven medical use for cannabis and that the information about marijuana hasn't changed since 2016.

However, the FDA used data from over 30,000 healthcare providers and six million patients who used medical marijuana in state programs, mainly established since 2016, for its recommendations. Congress has directed the FDA to consider more real-world evidence when evaluating products. Sklamberg from the FDA noted that the FDA report is thorough, impressive, and grounded in science and medicine.

This article is adapted from Medscape:

Ault, A (2024, January 16). FDA Recommends DEA Move Cannabis from Schedule I to III. Medscape. https://www.medscape.com/viewarticle/fda-recommends-dea-move-cannabis-schedule-iii-2024a100010v

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