In October 2022, President Biden asked the Department of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. In August 2023, the HHS marijuana recommendation went to the Drug Enforcement Administration (DEA). In October 2023, HHS released a heavily redacted copy of its recommendation to DEA. And until last Friday, no one outside of Bloomberg News and choice government insiders had seen the totality of the HHS marijuana recommendation. However, thanks to a Freedom of Information Act legal battle by lawyer Matt Zorn, the public can now see all 252 pages of (and related to) HHS’s marijuana recommendation to DEA.

The “8FA”

We recently wrote about marijuana and the drug rescheduling process under the Controlled Substances Act (CSA), which included a rundown of the eight-factor analysis (8FA) HHS must undertake off the back of an eligible rescheduling petition. Here are the “TL;DR” highlights of the 8FA from the HHS marijuana recommendation:

  1. Actual or Relative Potential For Abuse. There are multiple factors that go into HHS’s analysis of marijuana’s actual or relative potential for abuse. Sparing our readers on the scientific and medical research, HHS’s ultimate conclusion is that data shows that “marijuana has the potential for creating hazards to the health of the user and to the safety of the community. However, as a relative finding on abuse liability, when comparing marijuana to heroin, oxycodone, hydrocodone, fentanyl, cocaine, ketamine, benzodiazepines, zolpidem, tramadol, and alcohol in various epidemiological databases that allow for some or all of these comparisons, marijuana is not typically among the substances producing the most frequent incidence of adverse outcomes or severity of substance use disorder”. Translation: marijuana has considerably less actual or potential abuse when compared to other drugs, including alcohol.
  2. Scientific Evidence of Marijuana’s Pharmacological Effect, If Known. The science analyzed by HHS involved animals and humans and their reactions to delta-9 THC, the psychoactive compound in marijuana. With animals, HHS concluded that marijuana “produces rewarding responses,” and, with humans, HHS found that “marijuana produces euphoria and other pleasurable responses, as well as sedation and anxiety responses.” HHS further determined that psychiatric, social, and cognitive responses were also reported by human subjects as well as certain physiological responses like dry mouth, ataxia, and increased hunger. HHS also noted that the “abuse of marijuana by individuals can lead to other negative consequences, including addiction and the need to seek medical attention through calls to poison centers or visits to an Emergency Department (ED)”.
  3. The State of Current Scientific Knowledge Regarding Marijuana. Under this criterion, HHS has to examine “the chemistry and human pharmacokinetics of marijuana,” and maybe most importantly “whether marijuana has a currently accepted medical use (CAMU) in the United States.” The chemistry analyzed by HHS really doesn’t tell us anything new–marijuana is a dynamic plant substance with hundreds of chemovars representing its complex composition; it comes in a huge variety of forms with varying and differing degrees of potency and purity. Pharmacokinetics is the study of how the body interacts with administered substances for the entire duration of exposure. HHS examined the human body’s interaction, distribution, metabolizing, and excretion of and with delta-9 THC through various forms of administration, including inhalation and oral consumption. HHS ultimately concluded that “the pharmacokinetic profile of marijuana varies greatly depending on route of administration”. The CAMU analysis is below.
  4. Marijuana’s History and Current Pattern of Abuse. HHS looked at a variety of data points to evaluate marijuana’s history and current pattern of abuse, including looking at its history under the CSA, state level policies around legalization and medicalization, the National Survey on Drug Use and Health, and the Behavioral Risk Factor Surveillance System (among other things). The data generally yields that “use of marijuana for medical and nonmedical purposes is extensive in the United States, but . . . its prevalence of use is less than that of alcohol and significantly more than that of other drugs of abuse that are scheduled under the CSA.”
  5. Marijuana’s Scope, Duration, and Significance of Abuse. Using essentially the same data points from Factor 4, HHS concluded that, for the years studied (2015-2020), alcohol, heroin, and cocaine had the greatest “adverse consequences” for users as compared to marijuana. The same was true for “serious medical outcomes”, including death (marijuana was in the lowest ranking group of drugs). HHS also remarked that “although abuse of marijuana produces clear evidence of harmful consequences, including substance use disorder, they are relatively less common and less harmful than some other comparator drugs.”
  6. Marijuana’s Risk to the Public Health, if Any. Using another set of epidemiological databases and data points (namely ED visits, hospitalizations, unintentional exposures, and overdose deaths), under Factor 6, HHS determined that marijuana is behind heroin, cocaine, and benzodiazepines when it comes to public health risks. Specifically, for overdose deaths, “marijuana is always in the lowest rankings among comparator drugs.” And HHS reiterated 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.”
  7. Marijuana’s Psychic or Physiological Dependence Liability. Under this factor, HHS examined marijuana’s potential for causing addiction and substance use disorder. After again examining a slew of reported addiction data, HHS concluded that “experimental data and clinical reports demonstrate that chronic, but not acute, use of marijuana can produce both psychic and physical dependence in humans,” and that evidence under Factors 4 and 5 also demonstrate “additional evidence of psychic dependence.” Still, per HHS, “the symptoms associated with both kinds of dependence (i.e., physical and psychic) are relatively mild for most individuals, although the severity may be greater with increased exposure to marijuana.”
  8. Whether Marijuana is an Immediate Precursor of a Substance Already Controlled. HHS determined that marijuana is not an immediate precursor (i.e., a substance that is the principal compound commonly used or produced primarily for use in manufacturing a controlled substance) of another controlled substance.

HHS Recommendation to Move Marijuana to Schedule III

After completion of (and based on) the 8FA, in order to make the case that marijuana should be moved to schedule III (or be scheduled at all), HHS must then make three findings: 1) marijuana’s abuse potential compared to other drugs; 2) whether marijuana has a CAMU (and the CAMU analysis has its own two-part test); and 3) marijuana’s relative safety or ability to produce physical dependence compared to other drugs. Here are HHS’s three conclusions:

  • Abuse. In its recommendation, HHS states that marijuana “has a potential for abuse less than the drugs or other substances in Schedules I and II”. While marijuana is the most frequently abused federally illicit drug in the U.S., it doesn’t produce “serious outcomes” like the controlled drugs listed on Schedule I and II (even with consumers using marijuana products with high amounts of delta-9 THC, including non-medically).
  • CAMU. The two-part CAMU test consists of 1) whether there is widespread current experience with medical use of marijuana in the United States by licensed healthcare providers (HCPs) operating in accordance with implemented state-authorized programs, where such medical use is recognized by entities that regulate the practice of medicine under these state jurisdictions; and 2) whether there exists some credible scientific support for at least one of the medical conditions for which the Part 1 test is satisfied.
    • Part 1. The analysis by the Office of the Assistant Secretary for Health (OASH) is attached to the HHS marijuana recommendation starting at page 79. OASH found widespread current experience with medical marijuana by HCPs in line with applicable state laws (the exact numbers are 30,000 HCPs authorized to recommend the use of marijuana for more than six million registered patients). Additionally, OASH identified at least 15 medical conditions where there is widespread current experience with medical marijuana, which triggered Part 2 of the CAMU test, which the Food and Drug Administration (FDA) conducts. FDA analyzed 7 of the 15 medical conditions–anorexia, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting, pain, and post-traumatic stress disorder.
    • Part 2. The analysis by the FDA is attached to the HHS marijuana recommendation starting at page 99. FDA evaluated systematic reviews of studies investigating the safety and effectiveness of marijuana, relevant professional societies’ position statements, data from state medical marijuana programs and United States national surveys, and the labeling of FDA-approved products relevant to the subject indications. In this instance, the FDA didn’t find a CAMU for every single medical indication. However, data revealed that marijuana indeed has a CAMU in the United States for anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy-induced), and pain. This does not mean that FDA evaluated marijuana for FDA-approved safety and efficacy standards as applied to these indications. It only means that some credible scientific evidence exists for marijuana for these therapeutic uses.
  • Dependence. Based on the 8FA, abuse of marijuana may lead to “moderate or low physical dependence, depending on frequency and degree of marijuana exposure.” Marijuana can also produce “psychic dependence in some individuals, but the likelihood of serious outcomes is low, suggesting that high psychological dependence does not occur in most individuals who use marijuana.”

What’s Next?

Nothing has changed since our blog post on the rescheduling process. DEA publicly confirmed at the end of 2023 that it’s undertaking its own review of the rescheduling request while reviewing the HHS marijuana recommendation–this review will take weeks or even months.

To me, the most interesting development here is that, per the CSA, the medical and scientific findings of HHS (i.e., the 8FA and the three scheduling findings) are actually binding on the DEA even though the DEA has final authority to make the rescheduling call. In 2016, with the last unsuccessful petition to reschedule marijuana, HHS found that (based on the 8FA) marijuana should remain in Schedule I. DEA tacked on to that its own five factor analysis for CAMU (which it adopted in 1992) to determine that marijuana had no CAMU for any medical indication, justifying its remaining on Schedule I. Further, the DEA has also touted international drug treaties as yet another reason for refusing to reschedule.

While the DEA is bound by HHS’s medical and scientific findings, the agency is not entirely bound by the recommendation, itself. However, the DEA has never overridden a HHS scheduling recommendation either. While many inside and outside of the cannabis industry firmly believe that the DEA will accept HHS’s marijuana recommendation and engage in rulemaking to accommodate rescheduling, it’s still not a sure thing (though, to me, it’s increasingly looking like the DEA will have a tough time lawfully escaping that outcome).

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Photo of Hilary Bricken Hilary Bricken

With a passion for organizational growth, Hilary advises clients in the cannabis, healthcare, and life sciences spaces on transactions, regulatory compliance, governance matters, and other corporate needs.

Hilary likes being a dealmaker: she values building collegial relationships with clients and other attorneys, and

With a passion for organizational growth, Hilary advises clients in the cannabis, healthcare, and life sciences spaces on transactions, regulatory compliance, governance matters, and other corporate needs.

Hilary likes being a dealmaker: she values building collegial relationships with clients and other attorneys, and she loves helping clients create value and business opportunities. She also appreciates the in-depth strategies that transactions rely on.

Much of Hilary’s practice is devoted to mergers, acquisitions, and other transactions, as well as to serving as first point of outside counsel for certain clients. She also assists with entity formation and the drafting of various governance documents and asset portfolio management. In addition, Hilary advises clients on industry-specific regulatory compliance.

Hilary’s experience with the cannabis industry dates to 2010, when she began assisting medical cannabis providers with business questions. It was immediately clear to her that this emerging, growing industry had a massive need for corporate counsel, and she has advised cannabis clients—including many major national and international companies—ever since. Her experience includes cannabis licensing; marijuana and industrial hemp regulatory compliance; mergers and acquisitions; corporate and transactional matters, including negotiating management services agreements, fee slotting agreements, cultivation supply agreements, and intellectual property licensing agreements; receiverships; dissolution and wind downs; and financing and debt restructuring. In 2023, Hilary joined Husch Blackwell out of enthusiasm for the firm’s deep bench of innovators in the cannabis and healthcare space.

Hilary also devotes a significant portion of her practice to healthcare clients, including physicians, physician groups, and medical services organizations, and she represents clients regarding the off-label application of controlled substances.

Known for offering a commonsense business approach to legal questions, Hilary never gives legal advice in a vacuum. She provides clients with definitive guidance that has practical applications, adding value and supporting business goals.