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FDA on rescheduling: “not in a position to speculate the implications of that wide-ranging issue.”
On Thursday, just as cannabis rescheduling news was breaking, the Food and Drug Law Institute hosted a panel called “Forecasting the Future of Federal Cannabis Regulation.”
Alva Mather, a partner at McDermott Will & Emery, moderated the panel, which included Amy Cadwallader, director of Regulatory and Public Policy Development at the U.S. Pharmacopeia, Patrick Cournoyer, senior science advisor and lead of the Cannabis Product Committee at the U.S. Food and Drug Administration, and Andrew Kline, senior counsel at Perkins Coie.
The FDA, within the Department of Health and Human Services, has been an integral part of the rescheduling process, and is also part of the ongoing discussion around how to regulate hemp-derived cannabinoids, including CBD.
So, here’s what Cournoyer had to say on these topics:
“We understand there’s widespread interest in these products being on the market, people having access to them, but there’s a desire for some type of oversight. And to provide that type of oversight, what we’ve proposed is legislation that would create a new regulatory pathway that would allow for the risk profile that CBD has, but also provide authorities that could enable the FDA to provide oversight and to provide for harm reduction, risk mitigation, approaches that would help people manage their risk from these products,” Cournoyer said.
Cournoyer also brought up several “misconceptions” about what the FDA had said it would or could do with regard to CBD.
“We didn’t say that we were going to issue those regulations. It was contingent on CBD being safe enough to go into foods and supplements,” he said. “So right there, this misconception has led to a lot of grief. Because I think there was an expectation that things would go differently than they have, and that’s unfortunate.”
When the news came down, Mather asked each panelist what the news meant to their work.
“Unfortunately, I’m not in a position to speculate the implications of that wide-ranging issue,” Cournoyer said.
Cournoyer concluded by saying that the FDA has watched and been unsettled by how the cannabinoid marketplace has evolved.
“We monitor the marketplace. We see what’s going on out there to the best of our ability. And we have to keep moving the goalposts in terms of what we consider to be really scary. The milligrams per gummy, the combinations of different cannabinoids, designer cannabinoids that are being derivatized from CBD, presumably,” he said. “It is really astonishing. And so it keeps us up at night.”
How will NYC handle its enforcement load?
In New York City, at least, 75 shops have been shuttered as of Tuesday, Mayor Eric Adams announced.
In the first week, a group comprised of people from the Sheriff’s Office, the NYPD, and the New York City Department of Consumer and Worker Protection (DCWP) “sealed” a total of 75 unlicensed cannabis shops and issued almost $6 million in fines.
Here’s a borough breakdown:
Bronx: 13
Brooklyn: 14
Manhattan: 18
Queens: 20
Staten Island: 10
Now what?
Councilmember Gale Brewer would like to know if the Office of Administrative Trials and Hearings will be able to handle the coming tsunami of hearings spurred by Operation Padlock to Protect. She has “concerns.”
Cannabis Wire obtained a letter Brewer sent last week to Asim Rehman, OATH Commissioner & Chief Administrative Law Judge, Brewer noted that while she thinks Adams’ timeline to close all unlicensed shops is “hyperbole,” the uptick in trying to close thousands of unlicensed shops means that there will be a spike in the number of hearings.
“How will OATH manage the influx of Operation Padlock to Protect cases?” Brewer asked. “How will this impact the calendaring and decision times for all other hearings? What additional resources does OATH need to be successful?”
Rehman responded on May 14, essentially telling Brewer that OATH was ready for the influx related to unlicensed sales, and that the office started “hearing these new matters” on Friday.
“…at a very early stage, OATH began planning internally and engaging externally to prepare for this new workflow,” Rehman wrote. “That external engagement included regular discussions with the administration regarding the types of resources OATH required to meet this need. Internally, we have developed the appropriate processes, conducted the requisite trainings for staff, and taken other steps to support these efforts, and we are actively working to hire additional staff.”
“At this stage, it is too early to assess the impact that cannabis-related cases will have on other work at OATH. As this work proceeds, we will continue to review internally and engage externally if there are resource or logistical issues,” Rehman wrote.
Germany’s cannabis legalization opponents aren’t letting up. (But they also haven’t stopped much.)
In March, just as Germany’s adult use law was clearing the finish line, European Parliament member Christine Anderson, a member of Germany’s right-wing Alternative for Germany party, posed several questions to the European Commission regarding legalization, which she opposes.
She asked:
“1. Is Germany’s new law compatible with EU law?
2. What is the Commission’s assessment of the health risks posed by the use of cannabis? What predictions does the Commission make with regard to these risks following legalisation in Germany?
3. Does the Commission intend to recommend that the other Member States do the same, or will it advise them against following Germany’s example?”
Last week, Ylva Johansson, the European Commissioner for Home Affairs at the European Commission, responded. Her answers weren’t exactly revealing, but they are worth noting as Germany, and other countries in Europe, move toward further reform. Especially her point about being “evidence-based,” considering that there are adult use pilots collecting data from the Netherlands to Switzerland.
“The Commission is aware of the entry into force of the first part of the new law in Germany on 1 April 2024. As it is common practice, the Commission will assess the Cannabis Act’s conformity with EU law accordingly,” Johansson wrote.
“In line with the EU Drugs Strategy, EU drugs policy is evidence-based. The Commission therefore follows the developments in the EU Member States as well as beyond to examine the impact of changes in cannabis policies.”
+ More: developments out of Germany:
As we reported in this newsletter earlier this week, the German Parliament is preparing to make some tweaks to the adult use law. The bills would define cannabis-impaired driving and would also empower German states when it comes to regulating cannabis clubs’ cultivation.
