AMA urges FDA to keep strict scientific standards for botanical cannabis drugs

The American Medical Association announced on 30 October that it had sent a 28 October letter to FDA Deputy Commissioner Grace R. Graham urging rigorous scientific standards for botanical drug products, including cannabis. MMJ International Holdings, a pharmaceutical cannabinoid developer, publicized the letter in a 2 November announcement.

The letter

The AMA urged the FDA to preserve rigorous, evidence-based requirements for botanical products, including cannabis, in the agency's Advancing Development of Botanical Drug Products initiative. It warned against allowing popularity, anecdotal medical claims or commercial pressures to substitute for controlled clinical trials and appropriate regulatory oversight. The association said safety and efficacy should be established before botanical products are marketed or prescribed to treat medical conditions.

AMA President Willie Underwood III drew the distinction sharply. "Calling something 'natural' doesn't make it safe," he said.

The distinction matters because state authorization to sell marijuana for medical purposes does not by itself establish FDA approval of a drug's safety or effectiveness, according to MMJ. That gap can affect patients who assume a dispensary product has cleared the same bar as a prescription medicine.

Why it matters

The letter lands during a federal marijuana rescheduling proceeding. On 22 October, DEA Chief Administrative Law Judge Derek Julius admitted a 23 September GAO report into the administrative record. He denied requests to reopen the hearing for additional discovery and testimony, but invited narrowly tailored briefs on how much weight the report should carry. Initial supplemental briefs were due 29 October. Optional reply briefs are due 5 November.

The GAO report, GAO-26-108623, is titled Drug Scheduling: While DEA Decisions Have Aligned with Recent HHS Recommendations, Both Need Comprehensive Policies. It found that the DEA lacks comprehensive policies identifying roles, responsibilities and procedures for scheduling evaluations. It found that the FDA lacks written policies on how staff should conduct certain evaluations and develop recommendations. It also said FDA procedures do not adequately specify criteria for judging a substance's abuse potential against other controlled substances. The FDA-NIH memorandum governing coordination of scheduling recommendations is more than four decades old and does not reflect current procedures, the report found.

The DEA, FDA and NIH concurred with the GAO's recommendations for corrective action. The report did not conclude that marijuana rescheduling was unlawful.

If Julius recommends keeping marijuana in Schedule I, recreational cannabis remains federally illegal under Schedule I. If he backs Schedule III, DEA Administrator Terrance Cole would review the record and decide whether to issue a final rule. No deadline has been set for Julius's recommendation.

The April 2026 Justice Department order already moved FDA-approved marijuana products and marijuana covered by qualifying state medical marijuana licenses to Schedule III. Everything outside those categories, recreational cannabis included, remains Schedule I.

Trump signed an executive order in December 2025 directing the attorney general to complete marijuana rescheduling as quickly as permitted under federal law. The proposal originated under President Joe Biden, whose administration formally proposed moving marijuana to Schedule III in May 2024.