Rescheduling Cannabis: An Overview of HHS Documents

This article originally appeared in the American Journal of Endocannabinoid Medicine.

(February 2, 2024) Last year, it was a privilege to work with legal, policy, and medical experts on a report submitted to the US Department of Health and Human Services (HHS) and the FDA for their consideration. This report was submitted while the agencies were working to meet the Biden Administration’s October 2022 mandate for an expedited review for considering the rescheduling of cannabis (aka marijuana). Shane Pennington, JD, Andrew Kline, JD, MPA, Teresa Simon, MPH, and Howard Sklamberg, JD, MALD, (former FDA deputy commissioner) joined me as contributors to the schedule reform report.1 Our perspective on what constitutes accepted medical use and intercomparisons of drugs to make scheduling decisions seems to be shared by the HHS/FDA, which recently released, via lawsuit, more than 250 unredacted pages detailing their justification for moving cannabis out of Schedule I and into Schedule III.2

The Schedule III status will fix banking- and tax-related issues for everyone in the cannabis industry. It will fix many (not all) of the criminal penalties. However, it is incremental reform, not a national health care system revolution. This article aims to clarify what is relevant regarding this incremental reform opportunity.

Credit for our ability to discuss these documents should be given to one person: Matt Zorn, JD.3He spent around 15 hours on the lawsuit and posted a link to the documents he received on X (formerly Twitter). 

A New Standard for Making Science-Based Decisions for Controlled Substances

In evaluating the potential for abuse of cannabis, the HHS conducted a comprehensive comparison between cannabis and other substances, including legal and illegal drugs such as heroin, fentanyl, oxycodone, hydrocodone, cocaine, ketamine, benzodiazepines, zolpidem, tramadol, and alcohol.2 The HHS undertook an extensive review of preclinical, clinical, and epidemiological data, with a particular emphasis on studies published since the last evaluation in 2016, which was conducted in response to a petition for a rescheduling hearing denied by the Drug Enforcement Agency (DEA).4

Furthermore, the HHS introduced a new standard for determining the medical acceptability of cannabis, leveraging state-level data that reflect its widespread medical use under state laws. This approach acknowledges the role of state laws and licensing bodies in regulating medical practices within the federal system. By adopting this new standard, the HHS concluded that cannabis indeed has a recognized medical use. This conclusion was based on a comprehensive analysis that included a wider and more up-to-date data set than those used in previous rescheduling efforts. The focus shifted from the volume of illegal use to a more nuanced consideration of the potential for abuse and the safety profile of cannabis relative to other substances of abuse.2

The following is a quote from the HHS documents highlighting this new standard2:

“The risks to the public health posed by marijuana are low compared to other drugs of abuse (e.g., heroin, cocaine, benzodiazepines), based on an evaluation of various epidemiological databases for ED [emergency department] visits, hospitalizations, unintentional exposures, and most importantly, for overdose deaths. . . For overdose deaths, marijuana is always in the lowest rankings among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time and that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

Additionally, what is amazing about these documents is that they were written by government employees working government jobs. This analysis was part of their day-to-day government employment. They did not put together these documents with billable hours or while working all night—nor should they have.

Cannabis Is Not Becoming an Approved Drug If It Moves to Schedule III

Moving everything cannabis to Schedule III does not mean cannabis is becoming an FDA-approved product or prescription drug or that a prescription will be required. The HHS recognizes that cannabis is not like the products it usually deals with, such as a compound sponsored by pharmaceutical companies with billions of dollars and tons of data.5 Typically, the HHS/FDA looks at data submitted by a pharmaceutical company and decides whether the associated drug or product is safe or effective for interstate commerce. Cannabis was held to different standards and has earned accepted medical use status despite it not being an FDA-approved product or going to become one. 

The Schedule III status would apply to cannabis, and essentially, it would protect the state medical regime. It would protect medical dispensaries as well as those who are recommending cannabis. The HHS report is deferring to them—to the authority of medical practitioners—as the basis for refuting the longstanding view of the federal government that cannabis has no medical utility. Although there is no explicit statement about changing federal law, there is an acknowledgment of the inherent legitimacy of medical practices involving cannabis under state law. 

Adverse Events Data May Be Skewed by Hemp-Derived Cannabinoids

The significance of the 2018 Farm Bill was also highlighted by the HHS, noting that the legislation removed “hemp” from the controlled substances list, thereby excluding it from this cannabis-focused evaluation. The HHS made it clear that the current analysis does not apply to hemp. Nonetheless, the HHS pointed out that some hemp-derived cannabidiol (CBD) products might contain delta-9-tetrahydrocannabinol (THC) or other cannabinoids at levels capable of producing effects commonly associated with cannabis, potentially blurring the legal lines between hemp and cannabis products. Such hemp-derived products, due to their intoxicating properties and widespread use, could inadvertently influence the epidemiological data, thereby impacting the analysis in ways that might exaggerate the perceived risks associated with cannabis.2

This is supported by the observation that there are far more safety concerns, including national health alerts from the Centers for Disease Control and Prevention (CDC), about hemp-derived cannabinoid products.The HHS report details that the number of reports for cannabis as the sole substance involved with an adverse event is low: from 2012 to 2018, <10 cases per year were reported to FDA’s FAERS/CAERS databases. Meanwhile, hemp-derived cannabinoid products containing THC have received hundreds of adverse-event reports in a single year, according to national sentinel systems.6  Hemp-derived products labeled as delta-8 THC, for example, are associated with a high number of AEs.7 

A Chance to Make History

We are still waiting for the DEA to respond to the HHS recommendation and analysis. The DEA can accept or disagree with this recommendation. Either way, once the DEA releases its response later this year, the public will have 60 days to comment on the rulemaking process. During that 60-day window, there will be an opportunity for health care practitioners to submit their comments. I encourage you to be involved in this historic process by showing your support for the HHS analysis or by joining the opposition to keep “marijuana” in Schedule I. 

References:

1. Pennington S, Kline A, Mullin HB, Marcu J, Simon T. Coalition for Cannabis Scheduling Reform Report June 2023. Accessed February 2, 2024.

2. Garland M, Milgram M. Basis for the recommendation to reschedule marijuana into Schedule III of the Controlled Substances Act August 29, 2023. Accessed February 2, 2024. https://www.warren.senate.gov/download/20240129-letter-to-dea-on-descheduling-marijuana

3.   HHS releases cannabis recommendation.  Zorn M, Pennington S. On Drugs. January 12, 2024. Accessed February 2, 2024.  

4. Americans for Safe Access. The DEA’s denial of existing medical cannabis research 2016. Accessed February 2, 2024. https://www.safeaccessnow.org/deareport_report

5. Marcu J. The legalization of cannabinoid products and standardizing cannabis-drug development in the United States: a brief report. Dialogues Clin Neurosci. 2020;22:289-293. doi:10.31887/DCNS.2020.22.3/jmarcu

6. Centers for Disease Control and Prevention. CBD: What you need to know. August 8, 2022. Accessed February 2, 2024. https://www.cdc.gov/marijuana/featured-topics/CBD.html

7. Simon TA, Simon JH, Heaning EG, Gomez-Caminero A, Marcu JP. Delta-8, a cannabis-derived tetrahydrocannabinol isomer: evaluating case report data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database. Drug Healthc Patient Saf. 2023;15:25-38. doi:10.2147/DHPS.S391857