The U.S. FDA and HHS have recommended reclassifying cannabis from Schedule I to Schedule III, citing its low abuse potential and low risk of physical and psychological dependence. The report was released following an F.O.I. request and sparked anticipation of DEA action for reclassification. However, it faces opposition from some congressional members citing an “irresponsible pro-cannabis agenda.”
In August last year, the U.S. Department of Health and Human Services (HHS), along with the Food and Drug Administration (FDA), recommended reclassifying cannabis from Schedule I to Schedule III on the controlled substances list. However, the report had not been made public until now.
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Key Criteria for Cannabis Reevaluation in the U.S.
The report’s publication follows a Freedom of Information Act request by lawyer Matt Zorn. The report is 252 pages long and highlights the FDA’s conclusions. According to Mr. Zorn’s analysis, the FDA identified three key criteria for reevaluating the list:
- Low Abuse Potential: The FDA determined that cannabis has a lower potential for abuse compared to drugs or substances in Schedules I and II.
- Recognized Medical Use: After reviewing a vast amount of data, studies, expert opinions, and statements from professional organizations, the FDA affirmed that cannabis has a currently accepted medical use in the United States for specific conditions, including anorexia, nausea and vomiting (induced by chemotherapy), and pain.
- Low Physical and Psychological Dependence: The FDA concluded that while cannabis may lead to moderate or low physical dependence, the likelihood of serious consequences is low, indicating that strong psychological dependence does not occur in the majority of users.
Comparative Risk Assessment
The FDA’s analysis compared the prevalence and harmful effects of cannabis to substances in Schedules I, II, and III. The agency found that the public health risks of cannabis are low compared to other drugs like heroin, cocaine, and benzodiazepines. The report emphasizes that “in terms of overdose deaths, cannabis consistently ranks at the bottom among comparison drugs.”
The FDA report confirms the credible medical use of cannabis in the treatment of anorexia, nausea, and pain. The agency assessed the potential benefits of cannabis for seven indications, including anxiety, epilepsy, inflammatory bowel diseases, and post-traumatic stress disorder. The conclusion highlighted strong evidence of cannabis’s effectiveness, particularly in treating anorexia related to medical conditions, nausea, and pain.
Implications for Controlled Substances Classification
The publication of the FDA’s report has fueled expectations of imminent action by the U.S. Drug Enforcement Administration (DEA) to move cannabis from Schedule I to Schedule III in the U.S. President Joe Biden’s October 2022 directive, advocating for a swift review of cannabis classification, has accelerated the process. Legal experts anticipate a proposed regulation in the near future, with the final regulation expected by mid-summer.
While the FDA’s report has been hailed as a thorough and scientifically founded document, it faces opposition from some quarters. Republican members of Congress, citing an “irresponsible pro-cannabis agenda,” have expressed reservations about the FDA’s recommendation.
The DEA recently reiterated that it alone has the power to reclassify, or not, cannabis.
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