Analysis of HHS Cannabis Rescheduling Rationale

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On August 30th, 2023, the Department of Health and Human Services (HHS) announced it recommended the reclassification of marijuana to Schedule III to the Drug Enforcement Administration (DEA). Four months later, HHS released an unredacted version of its recommendation to reclassify the drug. The 252-page review had been hidden from the public and was only released after legal action was threatened against HHS.  

This HHS recommendation is based on cherry-picked data and represents a weak and intellectually dishonest argument to reschedule marijuana. This summary describes just a few of the many flaws in the HHS methodology and conclusions. SAM’s full report provides an in-depth analysis of what the HHS got wrong and how the process could have been strengthened.  

1. In years past, the FDA, an agency of the HHS in charge of approving medicinal drugs, used an established five-factor analysis in determining whether Schedule I drugs have “currently accepted medical use.” In the current report supporting the recommendation to reschedule marijuana, the FDA changed these criteria to get its desired answer.  

 If marijuana had been held to the same standards as other drugs, it would not be deemed to have “currently accepted medical use,” due to the infeasibility of measuring all strains and the insufficient amount of existing research into its safety and efficacy. In fact, the FDA’s new two-factor test explicitly states that studies used to support marijuana’s accepted medical use do not need to be controlled, a standard that was required in the five-factor test (save an evaluation done by a consensus of experts). 

2. It is not clear why the FDA moved away from the five-factor test, unless the agency approached the rescheduling review with a pre-determined conclusion.  

The five-factor test has been used for decades by Republican and Democratic Administrations. Additionally, the United States Court of Appeals for the District of Columbia Circuit examined and validated the test in Alliance for Cannabis Therapeutics v. Drug Enforcement Administration. The marijuana industry petitioners in that case even conceded that the five-factor test had no flaws, as explained in the opinion for the court. 

3. The FDA now considers the existence of state medical marijuana programs as evidence that marijuana has currently accepted medical use.  

A drug’s popularity among the public has never been used as a standard to determine medicine. Supreme Court Justice Steven Breyer in Gonzalez v Raich (545 U.S. 1 (2005), a case involving a medical necessity for the use of marijuana, opined during oral arguments that “medicine by regulation is better than medicine by referendum.” The Court’s 6-3 decision, which Justice Breyer joined, upheld the prohibition of marijuana for medical use under the Controlled Substances Act (CSA). The FDA’s novel standard in recommending marijuana’s rescheduling is rooted in a logical fallacy: some people say that marijuana is medicine, so marijuana must be medicine. The FDA is delegating its authority to determine that medications are safe and effective to popular opinion, a practice that not only exceeds the statutory authority of the agency but makes a mockery of the congressional intent of the Food, Drug, and Cosmetic Act to protect the public health. Following the FDA’s logic, psychedelic drugs, which are seeing a popular push for medical legalization, could also be considered medicine and be rescheduled due to shifting public opinion. 

4. The FDA compares marijuana to a limited, hand-picked list of other controlled and noncontrolled substances (e.g., heroin, alcohol, cocaine), not all Schedule I drugs. 

In the recommendation, the FDA measured marijuana’s potential for abuse by comparing it to a hand-picked selection of Schedule I, II, and III drugs. For example, the FDA compared marijuana to heroin, another Schedule I drug. The recommendation claims that because marijuana has a lower abuse potential than heroin, it shouldn’t be in the same category. Yet the FDA failed to compare marijuana to other Schedule I drugs, such as LSD. Comparing marijuana’s abuse potential against all Schedule I drugs would have allowed for a more rigorous analysis, but it would not have allowed the FDA to conclude that marijuana belongs in Schedule III. To qualify for Schedule III, a drug or other substance must have “potential for abuse less than the drugs or other substances in Schedules I and II” (21 USC 812(b)). Fifty years of data published by HHS show that marijuana does not meet this standard. 

5. None of the studies used by the FDA to justify its claim that marijuana is medicine support that conclusion. 

The FDA determined that marijuana is acceptable for medical use for pain, nausea and vomiting, and anorexia. Only three studies were used to justify this claim. The first (University of Florida), concluded that results were “inconclusive or mixed.” The second (National Academies of Sciences & Medicine) relied primarily on a study for which the results were not statistically significant. For the third (Agency for Healthcare Research and Quality), the FDA concluded that the positive effects of marijuana in the study were small and that “the increased risk of dizziness, nausea, and sedation [from marijuana use] may limit the benefit” (page 27 of 252). Furthermore, some of these studies were with inhalable marijuana; prior FDA evaluations have excluded inhalable marijuana studies because of their unreliability and questionable practices. 

Another sad story of loss brought to us by the marijuana industry.

By Aubree Adams

I absolutely loved living in Colorado.

Family-oriented Pueblo is the state’s best-kept secret. Lake Pueblo, Pueblo Mountain Park, and Devil’s Canyon are perfect places to hike. We lived in an old Craftsman home in the historic district, with a beautiful garden and wonderful neighbors. I felt like I was living in a dream.

And then legalized marijuana came, and everything changed. It’s taken nearly a decade for Colorado’s elected leaders to understand the damage pot is doing to our children. I saw it years ago.

My eldest son entered eighth grade in 2014, the year recreational marijuana stores opened in Colorado. Soon, his behavior changed. He became irrational and repeated things that didn’t make sense. I dismissed it as adolescent mood swings. He’d just broken up with a girlfriend. That’s all it was, I told myself.

By his freshman year, I realized he was using marijuana. I was still in denial, though, until he attacked his younger brother and then tried to kill himself. The hospital treated him and sent him home. A few days later, when it was clear he was still suicidal, I took him back to the emergency room. Don’t worry, they told me. It’s just marijuana. 

Marijuana is a serious drug

Eventually, my son told me he was dabbing, which I had never heard of. A dab (or wax or shatter) is a highly concentrated form of THC, marijuana’s active ingredient. It’s heated and smoked, delivering an instant, overwhelming high. Crack weed, my son called it. He knew it was making him crazy. He wanted to quit, but addiction had him firmly in its grip.

And yes, he was addicted. Addiction is a pediatric disease. In 9 out of 10 cases, it originates with drug or alcohol use before age 21. Marijuana, which has been linked to mental illness and psychosis in teens and young adults, slowly takes away your humanity. That’s what it did to my son, who turned to running the streets with homeless people. He had no trouble finding people to feed his addiction in return for selling their legally home-grown marijuana. 

I quit working, making it my full-time job to save my son. I soon found out that getting treatment wasn’t easy. Beds were full. Officials minimized marijuana's addictiveness.

I found a highly regarded treatment center in Utah; they required $36,000 up front that I didn't have. Finally, I found a place in San Diego that helped restore his health. He regained confidence and looked good. In the meantime, I had learned about a recovery community in Houston, where host families provide positive peer support. My son got better when he left Colorado, so I moved him there in 2016. My other son, who had developed post-traumatic stress disorder, and I followed in 2018.

Rein in this monster

Sadly, my story isn’t unique. Families across Colorado have experienced the same heartbreak and worse. More and more, marijuana is implicated in teen suicides. From 2014 to 2018, marijuana was present in nearly one-third of teen suicides. Pot is taking our children from us.

That’s why a bipartisan legislature this year passed a bill that begins to rein in this monster. The bill:

► Authorizes a study on the effects of high-potency THC products on the developing brain and how to keep those products away from teens. These unbiased experts will make a recommendation for next steps to the legislature.

► Requires doctors issuing medical marijuana recommendations to consider the person's mental health history; 

► Orders a report on hospital discharge data when marijuana use is likely;

► Directs coroners to screen for THC in non-natural deaths;

► Reduces the amount an 18-year-old medical card user can purchase in a single day. This closes a loophole that could be exploited to stock up on marijuana concentrates, which they sell to their younger friends. 

It’s a baby step, but it’s significant that the state that pioneered marijuana legalization is finally recognizing there are harmful consequences.

We can’t keep going down this road. We can’t keep sacrificing our children on the altar of pot. Big Marijuana promotes high-potency, addictive concentrates with no proof they are safe for anyone. Colorado’s commission, when it reviews all the research already done, will confirm that this product is dangerous to children and much too easy for them to get.

Maybe lives will be saved. Maybe other states will be warned against following Colorado’s lead Maybe no more families will have to endure the hell that mine has.

But it comes too late for me and my oldest son. He started using again. I haven’t seen him in a year.

Aubree Adams is director of Every Brain Matters. She is the parent coordinator for a Houston recovery community, where she lives with her youngest son and two dogs.