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State-regulated medical cannabis programs and illicit users are at least in part to thank for the Biden administration’s recommendation that marijuana be moved from Schedule 1 to Schedule 3 of the Controlled Substances Act.
Federal health authorities who recommended rescheduling cannabis also concurred with one of marijuana advocates’ core arguments: Compared to other widely available and abused substances – namely, alcohol – cannabis is safer, if not harmless.
The significance of the U.S. Department of Health and Human Services’ 252-page memo to the Drug Enforcement Administration – released Friday – and how the HHS reached its conclusion is profound, legal observers told MJBizDaily.
Nothing yet has changed for U.S. cannabis laws or the $34 billion state-legal industry after the first public disclosure of health officials’ rationale for recommending that marijuana be rescheduled.
That Aug. 29 recommendation from the HHS to move marijuana from Schedule 1 to Schedule 3 of the Controlled Substances Act – the latter level is reserved for drugs with low to moderate risk of addiction – remains under consideration by the DEA.
Most analyses of the DEA’s powers indicate the agency is unlikely to defy the HHS on the science and will almost certainly move to reschedule marijuana.
But exactly when the DEA will issue a suggested change to federal law is not known.
And so, it’s unclear when cannabis businesses could see the federal tax relief expected to follow rescheduling.
Nevertheless, cannabis legal experts touted the importance of the memo released by the HHS.
“FDA’s acknowledgment of the medical efficacy of cannabis and its relatively low potential for abuse is one of the most significant shifts in drug policy in this century,” said Shawn Hauser, a Denver-based partner at Vicente and co-chair of the law firm’s Hemp and Cannabinoids practice.
Among other things, federal health regulators considered data on use patterns and outcomes submitted by state medical marijuana programs.
The health officials also chose to emphasize scientific and medical studies produced after 2016, when the DEA last considered (and rejected) a rescheduling petition – albeit not one ordered by the president.
The fact that the HHS did include more recent studies completed in a more relaxed and accommodating era for cannabis in the most recent review suggests this time might be different – and could have a different outcome.
Added Hauser, “This is a very positive step toward the end of prohibition and for public health, and (it) signals that the Biden administration is poised to complete its expeditious review to reclassify cannabis.”
Here’s a rundown of major takeaways and questions that remain after an analysis of the rescheduling recommendation documents:
What is the Biden administration doing, and what did it find?
In October 2022, President Joe Biden directed federal officials to “expeditiously” review marijuana’s status under the federal Controlled Substances Act and to suggest any appropriate revisions.
Schedule 1 drugs, which include peyote, LSD and heroin as well as marijuana, are deemed to have no medical value and a high potential for abuse.
Summarized briefly, the HHS found that classification is inappropriate.
Instead, marijuana should be in Schedule 3 of the CSA, according to the rescheduling recommendation.
Schedule 3 includes drugs with medical value and a “moderate to low” potential for abuse such as ketamine, Tylenol with codeine and anabolic steroids.
How did the HHS determine that marijuana is safer than heroin and alcohol but still potentially harmful?
Health officials reviewed the science and data.
Research is necessary to demonstrate cannabis’ medical value – or its relative safety compared to other drugs – but because marijuana is Schedule 1, it’s hard to research.
The HHS shifted the goalposts slightly to review that research, observed attorneys Shane Pennington and Matt Zorn. (Zorn compelled the document release with a Freedom of Information Act lawsuit.)
Marijuana has a currently accepted medical use in the United States.
Marijuana having medicinal use pulls the drug straight out of Schedule 1.
To get there, the Office of the Assistant Secretary of Health crafted a “new two-part test” to determine “currently accepted medical use.”
They “took into account the current widespread medical use of marijuana under the supervision of licensed (health care professionals) under state-authorized programs,” according to the HSS’ 252-page document.
Based on that, the HHS “concluded there is widespread current experience with medical use of marijuana,” the agency stated on page 63 of its document.
What medical conditions does marijuana treat, according to the federal government?
Once the federal health officials determined marijuana is being used medicinally, they looked at whether there was scientific support for such an application.
They found “there exists some credible scientific support for the medical use of marijuana in at least one of the indications for which there is widespread current experience” by health professionals, “specifically for the treatment of anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy-induced), and pain.”
High-THC products and frequent cannabis users helped prove marijuana is medicine and less harmful than cocaine, heroin and other drugs.
While prohibitionists, child-health advocates and law enforcement bemoan the easy access to cheap products high in THC, that same access – and the lack of appreciable subsequent harms – informed the HHS decision.
As the agency wrote, “the epidemiological data described in this evaluation inherently include the outcomes from individuals who use marijuana and marijuana-derived products that have doses of (delta)-9-THC that range from low to very high.”
The HSS added that an “evaluation of various epidemiological databases for (emergency room) visits, hospitalizations, unintentional exposures, and most importantly, for overdose deaths” creates a data set that “demonstrate(s) that these products overall are producing fewer negative outcomes than drugs in Schedules (1 or 2).”
The agency continued: “Marijuana is not typically among the substances producing the most frequent incidence of adverse outcomes or severity of substance use disorder.
“For overdose deaths, marijuana is always in the lowest rankings among comparator drugs.”
Marijuana is still potentially harmful and can be abused.
While “the vast majority of individuals who use marijuana are doing so in a manner that does not lead to dangerous outcomes to themselves or others,” that doesn’t mean the drug is harmless.
Abuse, as broadly defined by the FDA, is the “intentional, non-therapeutic use of a drug to obtain a desired psychological or physiological effect.”
Medical researchers and scientists posit that “cannabis use disorder” – which, broadly speaking, is any pattern of use that interferes with “normal” daily activities such as work, school or social obligations – affects about 10% of the global user base for marijuana.
The FDA did not dispute that premise and is unlikely to do so.
Chris Roberts can be reached at chris.roberts@mjbizdaily.com.
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