Editor's note: This is a follow-up to FDA scientist Dominic Chiapperino's testifying as the DEA's fact witness on the Schedule III recommendation.
Seven anti-cannabis rescheduling groups clawed away like their lives were on the line during the opening days of the Drug Enforcement Administration’s (DEA) administrative law judge (ALJ) hearing on June 29 and 30 in Arlington, Va.
The purpose of the two-week hearing is to allow adversely affected or aggrieved parties to debate the merits of the proposed rule to move cannabis to Schedule III under the Controlled Substances Act (CSA).
In many respects, attorneys for the anti-rescheduling groups claimed their clients represent victims of the state-by-state commercialization of cannabis, arguing that loosening federal restrictions on the plant would only make matters worse for certain demographics, including children who were exposed to it in utero and those aged 18 to 25 who more often experience the onset of serious mental health disorders they say are exacerbated by cannabis use.
Despite the DEA inviting only those who oppose the Biden-era proposed rule to participate in the current administration’s ALJ hearing, some of the seven anti-rescheduling groups have indicated they believe this process not only is political, but that it’s now “rigged” after President Donald Trump issued an executive order in December to “complete the rulemaking process … in the most expeditious manner” possible.
NDASA’s Cross-Examination
While cross-examining the DEA’s first witness, Dominic Chiapperino, Ph.D., of the U.S. Food and Drug Administration (FDA), on Monday, David Evans, one of the attorneys representing the National Drug & Alcohol Screening Association (NDASA), asked, “Is the role of the FDA to disregard political considerations in making decisions like current accepted medical cannabis?”
“Yes,” Chiapperino said.
“Who told you to review the rescheduling and start this whole process?” Evans asked.
Evans established that President Joe Biden ordered the FDA and U.S. Department of Health and Human Services (HHS) to conduct a scientific and medical evaluation to determine cannabis’s appropriate schedule under the CSA, and that Trump ordered his administration to follow through on the FDA and HHS Schedule III recommendation from 2023.
“And do you know who donated $750,000 to President Trump’s inauguration?” Evans asked.
While Evans had intended to indicate Florida-based cannabis company Trulieve, DEA attorney Lisa Man objected to the question, and DEA Chief ALJ Derek C. Julius sustained the objection based on an FDA Touhy letter that legally limited Chiapperino from testifying on anything outside the scope of the 10-month scientific and medical evaluation that concluded in August 2023.
Earlier in the proceedings, Evans even questioned whether Julius should even be presiding over the hearing, pointing to the Department of Justice’s (DOJ) Office of Legal Counsel’s (OLC) 2024 opinion that solidified legal standing for the HHS to make the Schedule III recommendation to the DEA in August 2023.
Evans pointed out that Julius served as the DEA’s foreign section chief within the OLC at the time of the opinion. According to the opinion, the OLC received written views from the State Department regarding the U.S. treaty obligations under the Single Convention on Narcotic Drugs and whether those obligations impede HHS’s two-part test for satisfying current accepted medical use.
“If you in any way had anything to do with any of those opinions, your choice is to recuse yourself as the judge,” Evans told Julius, coming short of making a motion for the judge to do so.
“I can state that I had nothing to do with anything that went over to HHS,” Julius said. “I don't know anything about this memo that came from DEA counsel’s office, if there were one.”
Julius went on to say that he “took no offense” to Evans raising the issue.
Later in the proceedings, while cross-examining Chiapperino, Evans made a motion to dismiss the entire Notice of Proposed Rulemaking (NPRM) – aka the Schedule III proposed rule – at the heart of the hearing, asking Julius to order a new one to be drafted. Evans suggested that the basis of the DOJ’s NPRM resulted from a “shoddy job” performed by Chiapperino and his team during the evaluation process.
Chiapperino is a scientist who serves as the director of controlled substance staff for the FDA’s Center for Drug Evaluation and Research (CDER), a position he’s held since 2018. He’s overseen roughly 40 drug review evaluations for approximately 120 substances, including the FDA’s 10-month evaluation of cannabis that was conducted alongside the HHS.
Evans took issue with how the HHS and FDA evaluation did not have a “breakout evaluation” specific to harms related to cannabis use by pregnant women.
Chiapperino contended that “we based our concerns on the population as a whole,” and “we were not reviewing a drug for potential approval by the FDA. We were doing a drug evaluation for drug scheduling purposes,” adding that the objective was to consider epidemiological databases that represent harms to the American population as a whole.
That wasn’t good enough for Evans.
“He was talking about how he had done this great, thorough job, and he didn’t,” Evans said, adding that the FDA “completely waffled” on matters of diversion, that the entire NPRM is “faulty on its face,” and that “I think this should be withdrawn.”
Julius denied the motion, explaining that he doesn’t have the authority to cancel the NPRM, which the DOJ issued after the HHS provided a 252-page analysis of its scientific and medical evaluation, with citations throughout.
“It is what it is,” the judge told Evans. “I’m holding a hearing on what recommendation to make. You can make whatever arguments you would like in terms of whether you think the government has met its burden in getting this rule passed.”
One of Evans’ concerns centered on medical cannabis products not containing the same warning labels as FDA-approved drugs regarding use by pregnant women.
Chiapperino later had to remind Evans that under the rescheduling process, the federal government is “not releasing a drug to the public.” Instead, cannabis products are already in release under state programs, and a Scheduling III listing would not federally “legalize” those products.
“If someone brings a new drug application for marijuana to the FDA, the label, if it is approved, would address all of these issues, or it would not receive approval,” Chiapperino told Evans.
Throughout Evans’ cross-examination of Chiapperino, Julius had to remind him to refrain from editorializing and “venturing into argument” and instead direct his questions to the witness. The judge also had to remind Evans to limit his comments to what’s relevant, as well as to keep his remarks concise and within the scope of the hearing.
With repeated objections from the DEA’s legal team, Evans’ cross-examination lasted longer than two hours, while the other two cross-examinations during Monday’s portion of the hearing stayed within their one-hour allotted time limits.
TBI’s Cross-Examination
Representing the Tennessee Bureau of Investigation (TBI) was Reed Smith, the state’s assistant attorney general.
Smith focused his cross-examination of Chiapperino on diversion, violent crime, delta-8 THC, the fact that cannabis does not have a reproducible profile in plant form, a 2015 Health and Human Services (HHS) recommendation that cannabis remain in Schedule I, and the 2018 Farm Bill’s definition of hemp’s impact on the 2023 recommendation for Schedule III.
Smith began by asking Chiapperino whether the HHS disclosed its entire basis for the 2023 Schedule III recommendation. The FDA official responded that all citations are listed within the 252-page scientific and medical evaluation’s analysis, even if some source documents may not be publicly available.
The TBI attorney established that the federal officials who conducted the evaluation did not discuss the possibility of diversion from state-licensed cannabis programs, nor did they specifically focus on any sort of connection between violent crime and cannabis.
“We focused on scientific and medical considerations, health outcomes from people using marijuana and medical-use marijuana, and tried to form an assessment of marijuana’s safety profile, or lack thereof,” Chiapperino said.
Smith then drew Chiapperino’s attention to a hearing exhibit indicating that cannabis is a “highly polymorphic” species, meaning the plant can take on many forms and compound structures, with various chemovars containing different cannabinoid profiles that offer different effects.
“That means it can have widely varying composition and chemical components?” Smith asked.
“Yes,” Chiapperino said. “It can document the existence of many different chemovars with different profiles.”
While the DEA has traditionally used a five-part test over the past three decades to determine whether a substance has currently accepted medical use (CAMU) – substances that have CAMU can’t be listed in Schedule I – the HHS incorporated a new, narrower two-part test in 2023 to determine that cannabis has CAMU for multiple conditions.
The two-part test removes the burden for cannabis’s chemistry to be “reproducible,” and the OLC determined in 2024 that the HHS’s new two-part test was sufficient and legally permissible – to the dismay of many cannabis prohibitionists.
Smart Approaches to Marijuana (SAM), a prohibitionist organization represented by John McNichols of Torridon Law, who cross-examined Chiapperino on June 30, took a victory lap when Chiapperino indicated on Tuesday that cannabis would not have met the CAMU standard under the old five-part test.
“For decades, this is what the FDA used,” SAM CEO Kevin Sabet said. “They used this rigorous five-part standard. … In 2023, the government created a new, much less demanding two-part test. … It means that the government is asking to move marijuana out of Schedule I, but it did so using a brand-new standard instead of a standard that had applied for years.”
Sabet said that’s why he believes the hearing isn’t just about marijuana but whether the government can “change the rules in the middle of the game to reach a preferred outcome that they think is politically expedient.”
Those who support rescheduling agreed in early 2024 that cannabis – a plant – would not pass the reproducible requirement in the old five-part test unless a compound was extracted from the plant, isolated and turned into a pharma drug.
Chiapperino told Smith that the government’s 2023 evaluation was for cannabis as a category, and that the FDA did not make “individual findings” for different types of cannabis products.
Smith turned Chiapperino’s attention to the HHS’s 2015 scientific and medical evaluation of cannabis, from which the department recommended that the DEA keep cannabis listed in Schedule I of the CSA.
Smith pointed to a hearing exhibit stating that one difference between the 2015 Schedule I recommendation and the 2023 Schedule III recommendation rests with Congress amending the definition of marijuana in the Controlled Substances Act under the 2018 Farm Bill.
Chiapperino said the concerns that made the HHS and FDA want to highlight the hemp provisions from the 2018 Farm Bill were grounded in the creation of a “quite large” marketplace for cannabinoid products containing CB1 receptor agonists, like delta-8 and delta-9 THC.
“The contribution of those products that are not actually marijuana by the legal definition may be feeding into some of the same epidemiological databases in terms of health interventions,” he said.
Smith asked whether the HHS and FDA would have landed on the same Schedule III recommendation in 2023 had the definition for marijuana not changed in 2018.
“It’s speculative because we don’t know what the universe of all cannabis users looks like without the 2018 legislation and the hemp-related cannabis market,” Chiapperino said.
Smith also asked about the federal government’s forthcoming implementation of a narrower definition for hemp, and whether that future definition would have changed the scope of the 2023 Schedule III recommendation.
“That I don’t know,” Chiapperino said. “I realize that there are changes to hemp, including total THC. I think that it’s hard to know because I know that the hemp market continues to grow, and I don’t know how that affects cannabis users overall.”
He explained that as the definition changes, so too does the proportion of people using products that are legally considered marijuana versus hemp. Either way, it’s difficult to determine that crossover in epidemiological data that’s influenced by cannabinoids present in the cannabis plant (both marijuana and hemp), he said.
Earlier, Smith had established that the HHS did not specifically analyze the psychoactive effects of delta-8 THC in its evaluation.
While delta-9 THC is the main intoxicating component of cannabis, delta-8 THC is only naturally produced in minuscule amounts in the cannabis plant. Most delta-8 THC products offered in prohibitionist states such as Tennessee are the result of hemp-derived CBD that’s synthesized outside the plant for an intoxicating effect – something many refer to as a loophole in the 2018 Farm Bill.
Chiapperino said the HHS and FDA focused on delta-9 THC in the evaluation “due to its far greater abundance, and it’s most likely being determinative of the effects of the user unless the product was manipulated in some way,” suggesting that delta-8 THC falls more under the hemp domain.
DUID Victim Voices’ Cross-Examination
Patrick Kenneally of Burke Law Group represented Driving Under the Influence of Drugs (DUID) Victim Voices in the party’s cross-examination of Chiapperino.
Kenneally established early on that the FDA did not speak to any parents “whose children had suffered from psychosis,” nor any family members of someone who died in a car accident where another driver was possibly under the influence of cannabis as part of the department’s 2023 scientific and medical evaluation of cannabis.
Also from the get-go, Kenneally attacked the 2023 Schedule III recommendation for what he said was the reliance on outdated survey data that should no longer apply in 2026.
“You’re recommending that marijuana be rescheduled in 2026 as opposed to 2023, is that correct?” Kenneally asked.
“We made our recommendation in 2023,” Chiapperino said.
“Do you still recommend that cannabis be rescheduled?” the attorney asked.
“Yes,” Chiapperino said. “The recommendation is still in effect.”
“Your findings are only as good as the data that you use, correct?” Kenneally asked.
“Correct,” Chiapperino said.
“We’re trying to figure out whether or not we have the data here today to make a finding that in 2026 we should reschedule cannabis from Schedule I to III. Is that correct?” Kenneally asked.
“Yes,” Chiapperino said.
“We want to be relying … on the most reliable data. Would you agree with that?” Kenneally asked.
“Yes,” Chiapperino said. “I think 2023 is actually fairly recent data in the larger scheme of things.”
Kenneally specifically pointed to a National Survey on Drug Use and Health (NSDUH) that the FDA included in the evaluation, with 2019 as the most recent year for data collected from that survey.
The attorney pointed out that only seven states had launched adult-use cannabis sales prior to December 2019, with another 16 states doing so in the years since, arguing that state legalized markets impact usage rates.
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Kenneally then read an excerpt from the HHS 252-page document explaining the 2023 Schedule III recommendation:
“Evidence shows that some individuals are taking marijuana in amounts sufficient to create a hazard to their health and to the safety of other individuals and the community. However, evidence also exists showing that 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.”
The attorney established that this determination was based on the NSDUH survey from 2019 and earlier. He also pointed out that the HHS and FDA’s 2023 evaluation, by default, omits data from 2024, 2025 and 2026.
“That’s the life of the rulemaking process sometimes,” Chiapperino said.
Kenneally’s line of questioning later shifted to the HHS and FDA’s findings on cannabis’ relative abuse potential, physical dependence, and public health and safety concerns when compared to other controlled substances.
The government specifically used the following comparators: heroin (Schedule I); fentanyl, oxycodone, hydrocodone and cocaine (Schedule II); ketamine (Schedule III); benzodiazepines, zolpidem and tramadol (Schedule IV); and alcohol and tobacco (not scheduled).
Kenneally drew attention to the HHS and FDA’s inclusion of just one Schedule I substance as a comparator. Kenneally questioned why cannabis, a Schedule I drug, wasn’t compared to more Schedule I drugs outside of heroin, suggesting that there should be data available for other substances in that class.
Chiapperino said, “Our decisions to include comparators are based on many things, not just whether there is data available,” explaining later that both Schedule I and Schedule II substances are considered to have high potential for abuse under the CSA, and the evaluation included four Schedule II drugs as comparators.
“The only difference between the [Schedule I and II] comparators chosen is that some have medical use and heroin does not,” he said.
Kenneally also directed his line of questioning to establish that doctors don’t prescribe state-licensed medical cannabis – they merely can recommend it under its current Schedule I status – and federally regulated pharmacists don’t provide it; rather, dispensary workers do. The lawyer drew attention to how FDA-approved medications are prescribed, dosed and administered.
Kenneally also tried to poke holes in another survey that the HHS and FDA utilized in the evaluation from the Behavioral Risk Factor Surveillance System, a national telephone survey by the Centers for Disease Control and Prevention (CDC). The survey helped the government establish how often people are using cannabis and its potential for abuse.
“Somebody who is in an inpatient hospital suffering from cannabis-induced psychosis, do you think they’re going to pick up the phone and answer the survey here?” he asked.
Julius sustained an objection from the DEA’s legal team that the question called for speculation.
“Monthly data is important because it could be a reflection of how many people are abusing cannabis. Is that fair to say?” Kenneally asked.
“People using it for a medical purpose often have a reason to use it daily,” Chiapperino said.
Kenneally also focused his questions on the proportion of poison center cases that involved abuse, suggesting that the numbers from HHS’s 252-page document were not accurate.
The HHS used data from America’s Poison Centers’ National Poison Data System to provide information on the scope of contacts with a poison center (PC) following marijuana abuse (versus accidental consumption), relative to the abuse of other drug comparators.
The HHS determined that the highest number of PC abuse cases from 2015 to 2021 were observed for alcohol (56,143), heroin (34,083) and benzodiazepines (33,688), followed by cannabis (22,731) and cocaine (15,196).
This HHS calculation also showed that abuse cases made up the largest proportion of overall PC cases that involved fentanyl (72%), heroin (65%), cocaine (41%) and ketamine (40%), following my cannabis (36%) and alcohol (15%).
“It says 41% of cocaine cases were PC abuse cases,” Kenneally said. “That would mean 59% of the poison control cases were not abuse cases. Do you think 59% of the people are accidentally snorting cocaine up their nose?”
The HHS also utilized survey data to calculate the likelihood that use of a substance will result in PC abuse cases when considering how many people use the substance for any reason or for nonmedical reasons.
“When utilization-adjusted abuse rates (PC abuse cases per 1 million people with any past year use for a substance alone or with another substance) were calculated using data from 2015 to 2019, the highest rate was seen for heroin (increasing from 4,038 to 7,201 cases per 1 million people),” according to the HHS document.
Kenneally’s line of questioning focused on how heroin and cocaine are primarily obtained from unregulated sources, whereas cannabis users often obtain their products from state-regulated dispensaries that have testing parameters in place to ensure there are no adulterants, such as deadly doses of fentanyl.
“Did you consider the fact that heroin and cocaine seemed to be so much more dangerous than marijuana … that probably the explanation has to do with the fact that most people are getting it from illicit sources and don’t know what’s in it?” he asked.
Chiapperino said the evaluation was a “totality of the data,” and “if you look at all of the databases, the trends we’ve noted is that marijuana is not usually in the same category as Schedule I and II in terms of the harms.”
“That’s fine,” Kenneally said, but “you’ve acknowledged some flaws.”
The attorney argued that the 252-page analysis fails to mention any shortcomings in the databases that government officials pulled their conclusions from.
Chiapperino conceded. “We did not comment, you’re right, on those particular flaws with this data,” he said.
Kenneally said, “And if you didn’t comment on it, chances are you didn’t consider it.”
