On Monday (June 29), the most consequential hearing in the history of US cannabis policy began proceedings, as the DEA and the seven invited representatives made their opening statements.
Perhaps the most consequential part of the now-multi-year and multi-administration effort to reschedule cannabis, the Administrative Law Judge (ALJ) hearing on whether adult-use cannabis should be reclassified, has captured the attention of the global cannabis industry this week.
Days before the hearing began, MEDCAN24 reported that the DEA had chosen only cannabis critics to participate in the hearing, raising alarm bells that the administration could seek to undermine the process. The long delay in the process, after all, was due to allegations the DEA had colluded with anti-cannabis groups.
These fears, to the surprise of many advocates who have been burned before, so far appear to be unfounded.
Day 1
James J. Schwartz, an attorney in the DEA’s Diversion Section, told the court room that the DEA is not merely the proponent of the proposed reclassification, but supports it.
Crucially, he made it clear that the ALJ hearing was called to establish whether cannabis is considered to have ‘currently accepted medical use’ (CAMU) under the controlled substances act, and any debate straying from this narrow legal question was not on the table.
Participants present at the hearing, chosen specifically because they were ‘adversely affected or aggrieved’ by the proposed reclassification, appeared to be just as surprised by the DEA’s stance as the scores of advocates watching the developments closely.
Kevin Sabet, president of Smart Approaches to Marijuana, described the proceedings as ‘surreal’ in a social media video, in which stated that the DEA was ‘arguing the opposite of what it’s been arguing for the last 50 years’.
Under the Controlled Substances Act, a substance cannot remain in Schedule I if it has at least one currently accepted medical use. For decades, the DEA applied a five-part test requiring, among other criteria, that a drug’s chemistry be known and reproducible.
That standard effectively barred any botanical substance from rescheduling, since a plant with dozens of active compounds cannot satisfy a test designed around a single synthesisable molecule. The FDA instead applied a two-part framework, established in a July 2023 letter from the assistant secretary of health and since validated by a binding DOJ Office of Legal Counsel ruling in 2024. Under that framework, the government concluded that cannabis has CAMU for three conditions: anorexia related to a medical condition, chemotherapy-induced nausea and vomiting, and pain.
The government’s first witness, Dominic Chiapperino, Director of Controlled Substance Staff at the FDA’s Center for Drug Evaluation and Research spent most of his time during the first day laying out the evidence.
Drawing on five data sources, including national surveys, peer-reviewed literature reviews, state programme data and the approved dronabinol medicines, Chiapperino’s team found CAMU for three conditions including anorexia related to a medical condition, chemotherapy-induced nausea and vomiting, and pain.
On pain alone, the FDA reviewed 39 clinical trials, with the strongest findings around neuropathic pain. The FDA went on to compare cannabis against eight reference substances: heroin, fentanyl, oxycodone, hydrocodone, cocaine, ketamine, benzodiazepines and alcohol.
Cannabis showed fewer overdose deaths than all of them. Where cannabis does appear in fatality reports, Chiapperino testified, deaths are typically attributable to secondary causes such as accidents or acts of self-harm rather than direct toxicity. On withdrawal, cannabis was found to be comparable to tobacco, causing irritability and restlessness. Alcohol withdrawal, by contrast, can include seizures and death.
Cross-examination began in the afternoon and was focused squarely on the FDA’s CAMU test. David Evans, an attorney representing the National Drug and Alcohol Screening Association, ran over the allotted cross examination time by an hour in efforts to pick apart the FDA’s reasoning. Julius made it clear that the two-part test was not a matter for this hearing.
Day Two
This cross examination continued into the second day. Under questioning by attorneys representing the states of Idaho, Indiana and Nebraska, Chiapperino acknowledged that cannabis would not have passed the traditional five-part test.
He also confirmed that the two-part framework his team applied had only been introduced to them two months before they completed their analysis, in a July 2023 letter from the assistant secretary of health. Julius overruled the DEA’s objection to that line of questioning, allowing the admission to stand on the record.
Despite opponents widely heralding this as a win, the DOJ’s Office of Legal Counsel had already ruled in 2024 that the five-part test was ‘impermissibly narrow’, explicitly validating the two-part framework the FDA used.
An attorney present in the room told the newsletter Cultivated that the opponents’ focus on the test was ‘like ships passing in the night’, an argument about a question the hearing cannot resolve.
The government’s second witness Dr Corey Burchman, a pain management physician from New Hampshire, followed Chiaperrino with his testimony on the real-world case for cannabis as a substitute for opioids.
According to sources in the room who spoke with Marijuana Moment (official transcripts have not yet been published), Burchman described cannabis as ‘extremely helpful in chronic pain patients as a means of analgesia’ and said he and his colleagues would ‘avidly use’ its availability to reduce patients’ opioid prescriptions.
“Withdrawal from opioids is like a dumpster fire. Withdrawal from marijuana is more like a dying glowing ember of a campfire,” he said.
Key takeaways from the hearing so far
Industry reaction to the hearings so far has been ‘cautiously optimistic’, thanks both to the strength of the government’s defence and the weakness of the opposition’s attacks.
The government’s case is based squarely in science, medical use and comparative safety, drawing on analysis that predates this administration and has been formally validated at federal level.
Meanwhile, the opposition’s main points of attack are focused on process and methodology rather than data. While they raised legitimate concerns around impaired driving, adolescent brain development and addiction potential, the FDA’s scientific review has already dealt with this counter-evidence.
Proceedings are set to conclude no later than 15 July. Julius’s recommendation to the DEA administrator is non-binding, and the administrator faces no deadline to act on it. Anti-rescheduling witnesses are scheduled to take the stand in the coming days, and Burchman returns for cross-examination.
This article draws on in-court and in-room reporting by Cannabis Business Times, the only media outlet present during Day One morning proceedings, and Marijuana Moment (Tom Angell), whose Day Two coverage was based on accounts from attendees present in the room.
The ALJ hearing is not being livestreamed and is open to a public gallery of around 25 people. Official transcripts have not been published.
On Monday (June 29), the most consequential hearing in the history of US cannabis policy began proceedings, as the DEA and the seven invited representatives made their opening statements.
Perhaps the most consequential part of the now-multi-year and multi-administration effort to reschedule cannabis, the Administrative Law Judge (ALJ) hearing on whether adult-use cannabis should be reclassified, has captured the attention of the global cannabis industry this week.
Days before the hearing began, MEDCAN24 reported that the DEA had chosen only cannabis critics to participate in the hearing, raising alarm bells that the administration could seek to undermine the process. The long delay in the process, after all, was due to allegations the DEA had colluded with anti-cannabis groups.
These fears, to the surprise of many advocates who have been burned before, so far appear to be unfounded.
Day 1
James J. Schwartz, an attorney in the DEA’s Diversion Section, told the court room that the DEA is not merely the proponent of the proposed reclassification, but supports it.
Crucially, he made it clear that the ALJ hearing was called to establish whether cannabis is considered to have ‘currently accepted medical use’ (CAMU) under the controlled substances act, and any debate straying from this narrow legal question was not on the table.
Participants present at the hearing, chosen specifically because they were ‘adversely affected or aggrieved’ by the proposed reclassification, appeared to be just as surprised by the DEA’s stance as the scores of advocates watching the developments closely.
Kevin Sabet, president of Smart Approaches to Marijuana, described the proceedings as ‘surreal’ in a social media video, in which stated that the DEA was ‘arguing the opposite of what it’s been arguing for the last 50 years’.
Under the Controlled Substances Act, a substance cannot remain in Schedule I if it has at least one currently accepted medical use. For decades, the DEA applied a five-part test requiring, among other criteria, that a drug’s chemistry be known and reproducible.
That standard effectively barred any botanical substance from rescheduling, since a plant with dozens of active compounds cannot satisfy a test designed around a single synthesisable molecule. The FDA instead applied a two-part framework, established in a July 2023 letter from the assistant secretary of health and since validated by a binding DOJ Office of Legal Counsel ruling in 2024. Under that framework, the government concluded that cannabis has CAMU for three conditions: anorexia related to a medical condition, chemotherapy-induced nausea and vomiting, and pain.
The government’s first witness, Dominic Chiapperino, Director of Controlled Substance Staff at the FDA’s Center for Drug Evaluation and Research spent most of his time during the first day laying out the evidence.
Drawing on five data sources, including national surveys, peer-reviewed literature reviews, state programme data and the approved dronabinol medicines, Chiapperino’s team found CAMU for three conditions including anorexia related to a medical condition, chemotherapy-induced nausea and vomiting, and pain.
On pain alone, the FDA reviewed 39 clinical trials, with the strongest findings around neuropathic pain. The FDA went on to compare cannabis against eight reference substances: heroin, fentanyl, oxycodone, hydrocodone, cocaine, ketamine, benzodiazepines and alcohol.
Cannabis showed fewer overdose deaths than all of them. Where cannabis does appear in fatality reports, Chiapperino testified, deaths are typically attributable to secondary causes such as accidents or acts of self-harm rather than direct toxicity. On withdrawal, cannabis was found to be comparable to tobacco, causing irritability and restlessness. Alcohol withdrawal, by contrast, can include seizures and death.
Cross-examination began in the afternoon and was focused squarely on the FDA’s CAMU test. David Evans, an attorney representing the National Drug and Alcohol Screening Association, ran over the allotted cross examination time by an hour in efforts to pick apart the FDA’s reasoning. Julius made it clear that the two-part test was not a matter for this hearing.
Day Two
This cross examination continued into the second day. Under questioning by attorneys representing the states of Idaho, Indiana and Nebraska, Chiapperino acknowledged that cannabis would not have passed the traditional five-part test.
He also confirmed that the two-part framework his team applied had only been introduced to them two months before they completed their analysis, in a July 2023 letter from the assistant secretary of health. Julius overruled the DEA’s objection to that line of questioning, allowing the admission to stand on the record.
Despite opponents widely heralding this as a win, the DOJ’s Office of Legal Counsel had already ruled in 2024 that the five-part test was ‘impermissibly narrow’, explicitly validating the two-part framework the FDA used.
An attorney present in the room told the newsletter Cultivated that the opponents’ focus on the test was ‘like ships passing in the night’, an argument about a question the hearing cannot resolve.
The government’s second witness Dr Corey Burchman, a pain management physician from New Hampshire, followed Chiaperrino with his testimony on the real-world case for cannabis as a substitute for opioids.
According to sources in the room who spoke with Marijuana Moment (official transcripts have not yet been published), Burchman described cannabis as ‘extremely helpful in chronic pain patients as a means of analgesia’ and said he and his colleagues would ‘avidly use’ its availability to reduce patients’ opioid prescriptions.
“Withdrawal from opioids is like a dumpster fire. Withdrawal from marijuana is more like a dying glowing ember of a campfire,” he said.
Key takeaways from the hearing so far
Industry reaction to the hearings so far has been ‘cautiously optimistic’, thanks both to the strength of the government’s defence and the weakness of the opposition’s attacks.
The government’s case is based squarely in science, medical use and comparative safety, drawing on analysis that predates this administration and has been formally validated at federal level.
Meanwhile, the opposition’s main points of attack are focused on process and methodology rather than data. While they raised legitimate concerns around impaired driving, adolescent brain development and addiction potential, the FDA’s scientific review has already dealt with this counter-evidence.
Proceedings are set to conclude no later than 15 July. Julius’s recommendation to the DEA administrator is non-binding, and the administrator faces no deadline to act on it. Anti-rescheduling witnesses are scheduled to take the stand in the coming days, and Burchman returns for cross-examination.
This article draws on in-court and in-room reporting by Cannabis Business Times, the only media outlet present during Day One morning proceedings, and Marijuana Moment (Tom Angell), whose Day Two coverage was based on accounts from attendees present in the room.
The ALJ hearing is not being livestreamed and is open to a public gallery of around 25 people. Official transcripts have not been published.
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Registration of Medical Products in Poland