A federal appeals court gave medical cannabis patients and reform advocates a small but significant procedural victory on Thursday, ruling that it would hold open a case challenging the scheduling status of marijuana under federal law.
In essence, the court is putting the federal government on notice that it must “promptly” make a decision on marijuana rescheduling so that those who rely on its medical benefits don’t unduly suffer.
A group of patients and advocates filed a lawsuit against the Justice Department in a U.S. District Court in 2017, alleging that the Schedule I status of cannabis under the Controlled Substances Act (CSA) poses serious health risks and unfair economic disadvantages.
The court dismissed the case last year, siding with the government in its scheduling determination and shooting down each of the plaintiffs’ claims. It also argued that the plaintiffs should have first pursued reform through an administrative process, seeking relief from the federal agencies responsible for drug scheduling, before pursuing judicial action.
Now, in a new opinion on an appeal filed by patients and their supporters, the U.S. Court of Appeals for the Second Circuit has agreed that they took the issue to the judicial branch prematurely when they should have exhausted their administrative options—but the court also determined that unique circumstances apply, particularly as it concerns the two children plaintiffs who argued that federal law jeopardizes their health and creates legal uncertainty.
“[W]e are troubled by the Drug Enforcement Administration (DEA)’s history of dilatory proceedings,” U.S. Circuit Judge Guido Calabresi wrote for the majority. “Accordingly, while we concur with the District Court’s ruling, we do not dismiss the case, but rather hold it in abeyance and retain jurisdiction in this panel to take whatever action might become appropriate if the DEA does not act with adequate dispatch.”
In other words, the appeals panel could have simply upheld the lower court ruling and dismissed the case, but instead it will keep the matter open so that it can take action if DEA fails to appropriately consider a change to marijuana’s legal status within a reasonable amount of time.
The case is “unusual,” the court wrote, because “among the Plaintiffs are individuals who plausibly allege that the current scheduling of marijuana poses a serious, life‐or‐death threat to their health.”
“Taking the facts as alleged, and, accordingly, taking the supposed benefits some Plaintiffs have experienced from marijuana as true as well, we—like the District Court below—are struck by the transformative effects this drug has assertedly had on some Plaintiffs’ lives. As a result, we are troubled by the uncertainty under which Plaintiffs must currently live.”
It’s a ruling that sets this case apart from several other attempts to change the federal drug scheduling system through the courts, all of which have so far failed.
“I think what we have here is perhaps the most significant judicial milestone in the war against prohibition,” Joseph A. Bondy, an attorney who has worked pro bono on the case, told Marijuana Moment in a phone interview.
The plaintiffs in the case, which include young cannabis patients and advocates Alexis Bortell and Jagger Cotte, who suffer from rare conditions that they’ve effectively treated with cannabis products, told the court that they were concerned that DEA would “not move quickly enough to afford them adequate relief.”
With that in mind, the court said it would “retain jurisdiction of the case in this panel, for the sole purpose of taking whatever action might become appropriate should the DEA not act with adequate dispatch.” It emphasized, however, that it holds “no view whatever on the merits of Plaintiffs’ case—that is, on whether marijuana should be listed or not.”
“It is conceivable that, in response to a petition from Plaintiffs along the lines advanced before us now, the DEA would reschedule marijuana, rendering the current case moot,” the opinion says. “And if the DEA did not, the administrative process would generate a comprehensive record that would aid in eventual judicial review.”
The court also seemed to acknowledge the plaintiffs’ argument that the scheduling of cannabis may not fulfill its stated objectives—that as our understanding of the benefits and harms of marijuana continue to evolve, they raise questions about “whether the extant regulatory regime continues to advance the CSA’s goals in light of the current state of our knowledge about the drug.”
“It is possible that the current law, though rational once, is now heading towards irrationality; it may even conceivably be that it has gotten there already,” Calabresi wrote. “Courts are not especially good at dealing with situations of this sort by themselves. In such circumstances, dialogue between courts and other law‐defining institutions, like agencies, often works best.”
“A sensible response to our evolving understanding about the effects of marijuana might require creating new policies just as much as changing old ones. This kind of constructive governmental work, mixing adjudication and program‐design, creating policy through the balancing of competing legitimate interests, is not generally best accomplished by federal courts on their own; it is, however, the stock‐in‐trade of administration.”
(2/3) This case represents the first time in history that a lawsuit challenging the constitutionality of the CSA has survived dismissal. #TheFightGoesOn, as we continue to advocate for de-scheduling of Cannabis, patient liberation, & freedom for those wrongfully imprisoned.
— Michael Hiller (@MikeHillerEsq) May 30, 2019
Sebastien Cotte, a reform advocate and father of Jagger, told Marijuana Moment that the court’s judgement was groundbreaking.
“[K]ids like Jagger and Alexis don’t have time to wait for the government and their endless process,” he said. “We are talking about human lives that are running out of time quickly. So I’m hopeful this could be the game-changing case that every suffering and dying kid and patient in the country needs.”
Throughout the opinion, the court emphasized that the wellness of the plaintiffs, and the success they claimed to have had using cannabis as a treatment option, inspired their novel decision in the case. Calabresi said the court empathized with their situation and said their claims about medical cannabis “are no small things.”
Indeed, the plaintiffs “should not be required to live indefinitely with uncertainty about their access to allegedly life‐saving medication or live in fear that pursuing such medical treatment may subject them or their loved ones to devastating consequences.”
Bondy said he and his team will be working with experts to draft a petition for DEA action on marijuana scheduling over the next few months. While the court didn’t provide a timeline outlining how long the agency has to act on the petition, Bondy said that 180 days seemed reasonable, though that may change.
If the DEA declines to take action or delays its decision—rescheduling petitions typically take about nine years to go through the process, the appeals panel’s opinion noted—then the court has several judicial options at its disposal.
“Those actions could include things like compelling them to act—issuing what’s called a writ of mandamus—sanctioning them, having a hearing or finding at that point that we were correct” in arguing that their situation exempted them from first seeking administrative relief “and hearing us on the merits,” Bondy said.
Here’s more from the court’s conclusion:
“But we exercise our discretion to keep jurisdiction of the case in this panel, to take whatever action may become appropriate if Plaintiffs seek administrative review and the DEA fails to act promptly. And we note that, under the unusual health‐related circumstances of this case, what has counted as appropriate speed in the past may not count as appropriate speed here.
“In doing this, we specify that we are not retaining jurisdiction to review the actions the agency may take. Jurisdiction over those may well lie solely in another circuit. Nor do we intend to retain jurisdiction indefinitely. Unless the Plaintiffs seek agency review and so inform us within six months, we will affirm the District Court’s judgment dismissing this case. (And if only some Plaintiffs seek agency review, we will dismiss the complaint as to those who do not.) But if Plaintiffs do seek agency review, and the agency fails to act with alacrity, Plaintiffs may return directly to us, under our retained jurisdiction.
“To be clear, we repeat that this case remains in our purview only to the extent that the agency does not respond to Plaintiffs with adequate, if deliberate, speed. In other words, we retain jurisdiction exclusively for the purpose of inducing the agency to act promptly.”
Bondy said he felt emboldened by the court’s judgement and that it speaks to success and energy of the broader reform movement.
“We are on the right side of this issue—the advocates, the activists—pursuing things like social equity, the right to medicate yourself with cannabis, the right to travel with cannabis, the right to decide what you’re going do with your body,” he said.
Read the court’s full opinion below:
18-859 Documents 2 by on Scribd
House Democrats Block Amendment To Restrict Marijuana Products In Anti-Vaping Bill
House Democrats pushed back against a Republican attempt to include a flavored marijuana vaping ban in a broader anti-vaping bill that passed the chamber on Friday, arguing that it doesn’t make sense to prohibit products that are already illegal under federal law.
Instead, several lawmakers argued that Congress should enact separate cannabis reform legislation that could include provisions designed to protect public health and reduce the appeal of marijuana to youth.
The issue first came up during a House Rules Committee hearing on Wednesday, with Rep. Morgan Griffith (R-VA) introducing an amendment to “include a prohibition against flavored marijuana products” such that they would be “treated in the same manner as flavored tobacco products” under the bill.
While the congressman argued that language of the legislation implicitly already provides for such a ban, he said it was important to clarify to send a message to young people that they can’t vape products containing nicotine or THC.
“Let it not be said in 2029 that we had a chance and we felt maybe we were getting to it in 2020,” he said. “Let’s just go ahead and do it. Let’s say you can’t sell flavored marijuana THC vaping products. My amendment makes that clear.”
Watch the conversation below:
Democratic members said they shared Griffith’s concern about underage use of flavored cannabis vaping products. However, Rep. Ed Perlmutter (D-CO) pushed back and said the proposal is not germane because marijuana remains illegal under federal law and so regulating these products requires separate congressional action.
Earlier in the hearing, he suggested that his House-passed cannabis banking bill—the Secure and Fair Enforcement (SAFE) Banking Act—could serve as a vehicle to address the body’s concerns.
“We have to start addressing it because we have 47 states that now are allowing some level of marijuana use when the statute under the Controlled Substance Act clearly makes it illegal,” the congressman said. “There’s a bill sitting in the Senate called the SAFE Banking Act that may get back here at some point, and we could put some testing and regulatory components on it.”
Watch this exchange below:
Is a flavored marijuana vaping ban even necessary?
Also during the hearing, Rep. Rob Woodall (R-GA) pressed Rep. Frank Pallone (D-NJ) about the lack of specificity in the bill as it concerns marijuana vaping products. Woodall said he wanted that aspect addressed before he leaves office in nine months.
“It strikes me…more than strange that banana crush [nicotine vaping products] will no longer be available to adults in my district. But banana strawberry cream, which is an illegal [marijuana] product today, will continue to be available at 180 retailers near you,” Woodall said. “I don’t know how I take that message into my high schools and say that we’re going to reduce drug dependency in the months and years ahead.”
Watch the conversation below:
Pallone said he appreciates Woodall’s concern that flavored vaping products can mislead consumers about what they’re actually putting into their bodies and that he “would tend to think that the same problem would exist” for flavored marijuana products. However, he said there’s a distinction to be made.
“Most people tell me that nicotine is much more toxic and much more dangerous to your health than marijuana so maybe we shouldn’t have restrictions on marijuana at all and maybe we shouldn’t have any restrictions on flavored marijuana because the marijuana doesn’t have the same health problems that nicotine has,” he said. “Maybe I should say, assuming that marijuana is dangerous then maybe the flavored should be. But it’s not as dangerous.”
“The reality is that we know that nicotine is much more dangerous than marijuana so maybe the flavors masking it is not as serious a problem as it would be for nicotine,” he said.
Griffith’s amendment was blocked from floor consideration in a party-line vote of 3-6 by the panel, but the conversation around flavored marijuana products continued on Friday on the House floor.
Rep. Greg Walden (R-OR) brought a poster board showing pictures of flavored cannabis vaping products and lamented that they are not explicitly included in the anti-vaping bill.
“If you want to do something about kids—if you want to do something about lung disease—then we need to do something about marijuana and the oils it gets mixed with that this bill does not address,” he said.
But Rep. Earl Blumenauer (D-OR) pointed out that if Republicans are interested in ensuring that such marijuana products are properly regulated, the substance needs to be removed from the Controlled Substances Act to provide Congress with the means to enact regulations.
Rep. Earl Blumenauer counters by pointing to marijuana's schedule I status, saying federal regulation of flavored cannabis would be like trying to regulate "flavored heroin." Plugs the MORE Act to deschedule marijuana. https://t.co/w4Jpudt137
— Emily Kopp (@emilyakopp) February 28, 2020
Imposing regulations on marijuana while it’s still federally prohibited is “like regulating flavored heroin,” he said. The congressman added that a bill to deschedule marijuana called the Marijuana Opportunity Reinvestment and Expungement (MORE) Act would give lawmakers the tools to protect public health.
“The challenge that we have now is to be able to move forward—to be able to protect young people and the public,” Blumenauer said. “Cannabis is a red herring. If we tax and regulate it, then we can deal with the products they’re talking about. But unless and until we bring it—as two-thirds of the states have done—to actually tax and regulate it, we can’t deal with that. It doesn’t matter.”
We have a crisis of youth vaping. And we’ve seen a disturbing number of lung injuries & deaths tied to the oil used in marijuana vaping. Unfortunately #HR2339 before us today does nothing to impact either. Instead, it's a partisan publicity stunt by big government liberal elites. pic.twitter.com/AUx8ZMar0L
— Richard Hudson (@RepRichHudson) February 28, 2020
Not all Democrats were on board with the anti-vaping bill.
It was a tight 213-195 vote in the House on Friday. Top Democratic leaders are faced challenges as they worked to get the broader legislation approved. Some members of the party have expressed opposition over policies to ban flavored tobacco, including menthol, which they argue would lead to overpolicing of minority communities.
Image by Lindsay Fox from Pixabay.
Banning CBD Products Would Be ‘A Fool’s Game,’ FDA Chief Admits
Products containing cannabidiol (CBD) are here to stay, Food and Drug Administration (FDA) Commissioner Stephen Hahn acknowledged on Wednesday, calling it “a fool’s game” to attempt to pull the products off the market.
“People are using these products,” Hahn, a cancer doctor, said in his first public speech on CBD since taking office as commissioner in December. “We’re not going to be able to say you can’t use these products. It’s a fool’s game to try to even approach that.”
Hemp and its derivatives have been federally legal in the U.S. since passage of the 2018 Farm Bill, but policies governing the marketing of CBD have been murkier. FDA is still in the process of developing rules to allow businesses to sell the cannabis compound in foods or nutritional supplements—a process that Hahn’s predecessor, former FDA Commissioner Scott Gottlieb, has said could take years without congressional action.
Hahn’s latest comments suggest that while FDA may not be happy with CBD’s explosion onto the consumer market, the agency at least isn’t planning an immediate, industry-wide crackdown.
“We have to be open to the fact that there might be some value in these products, and certainly Americans think that’s the case,” the FDA chief said. “But we want to get them information to help them make the right decisions.”
The commissioner was addressing the National Association of State Departments of Agriculture at its winter policy conference in Arlington, Virginia.
Since Congress began lifting restrictions on hemp cultivation in 2014, all but three states have submitted plans to the U.S. Department of Agriculture (USDA) to regulate hemp production, and states such as Kentucky have embraced hemp as a promising commercial crop.
After Hahn was nominated to lead the FDA last year, Senate Majority Leader Mitch McConnell (R-KY) pressed him on the need to establish a regulatory framework for CBD products.
“Like many Kentuckians who are taking advantage of hemp’s legalization,” McConnnell said at the time, “I am eager for FDA’s plans to create certainty for CBD products.”
Last week, however, the agency missed a deadline outlined in a report attached to an annual spending bill to provide an update on the development of enforcement guidelines around CBD products. “We haven’t received the report yet,” House Appropriations Committee Communications Director Evan Hollander told Marijuana Moment in an email. “That’s not surprising; agencies typically submit these very late.”
Meanwhile, Congress is taking separate steps to allow and regulate hemp-derived CBD. Bipartisan legislation filed last month would allow the cannabinoid to be marketed and sold as a dietary supplement.
While regulations for CBD have yet to be finalized, the government’s enforcement actions have been infrequent and sometimes unpredictable. The FDA has said it’s using its enforcement discretion to target businesses making outlandish, unsupported claims about CBD’s health benefits.
Also at Wednesday’s agriculture event, a USDA undersecretary announced that the agency would be delaying a requirement for hemp testing laboratories to register with the DEA. On Thursday, USDA issued a notice clarifying it would temporarily suspend enforcement of that rule as well as one on the disposal of crops with too much THC.
Photo by Kimzy Nanney.
USDA Announces Two Temporary Changes To Restrictive Hemp Rules
The U.S. Department of Agriculture (USDA) announced on Thursday that it will be temporarily delaying enforcement of two provisions of its hemp regulations.
Hemp producers will not be required to use a laboratory registered with the Drug Enforcement Administration (DEA) to conduct potency tests on their crops, at least for now. And for the time being, they won’t have to dispose of so-called “hot hemp” containing excess THC through DEA or a law enforcement body.
“Because currently there isn’t sufficient capacity in the United States for the testing and disposal of non-compliant hemp plants, USDA has worked hard to enable flexibility in the requirements in the Interim Final Rule for those issues,” USDA Under Secretary for Marketing and Regulatory Programs Greg Ibach said in a press release announcing the enforcement decision.
These changes come in response to feedback from industry stakeholders, who argued that the policies included in USDA’s interim final rule on hemp would prove cost prohibitive for farmers and inhibit the growth of the market since the crop was federally legalized under the 2018 Farm Bill.
USDA received significant feedback from lawmakers and hemp interests during a public comment period that ended last month. The department said earlier this month that it was open to making certain changes based on those responses, but it also said certain proposed changes—such as increasing the threshold of allowable THC in hemp—are statutory matters that it cannot revise on its own.
A follow-up comment period will launch after this current planting season, USDA said.
In the meantime, the laboratory testing and disposal requirements are being delayed until October 31, 2021, or until a final rule is released. USDA said the delay will “serve as a temporary measure to allow a smooth transition into regular enforcement” and give DEA enough time to increase “registered analytical lab capacity.”
I applaud @USDA_AMS Under Secretary Greg Ibach and his team for releasing two new updates to federal rules for hemp production. Updates at the link, and my statement below. #KyAg365 @USDA @NASDANews https://t.co/qllLNaigyG pic.twitter.com/d7WujpdtHG
— Commissioner Quarles (@KYAgCommish) February 27, 2020
“Through these conversations, we have learned that these provisions will serve as a significant hindrance to the growth of a domestic hemp market at this nascent stage,” USDA said. “For instance, we now better understand how the limited number of DEA-registered labs will hinder testing and better understand the associated costs with disposing of product that contains over 0.3 percent THC could make entering the hemp market too risky.”
“Because USDA is exercising its enforcement discretion to adopt a temporary policy of non-enforcement for producers who—due to the dearth of registered laboratories and limited access to reverse distributors or law enforcement disposal—are unable to comply with the testing and disposal procedures promulgated through the [interim final rule], we believe that this guidance is a statement of agency policy not subject to the notice and comment requirements,” the notice states.
Hemp will still have to be tested, and it must be disposed if it contains too much THC, but processors will be able to use other facilities and methods and still be in compliance.
The department stressed that laboratories that aren’t registered with DEA will have to “adhere to the standards of performance as outlined within the [interim final rule].” For example, they must test “total THC employing post-decarboxylation or other similarly reliable methods” and “make arrangements to be compliant with registration requirements before this period of delayed enforcement expires.” DEA will review applications from laboratories who wish to participate.
USDA also included a guideline for compliant, alternative disposal methods. The department’s intent is “that these methods allow producers to apply common on-farm practices as a means of disposal while rendering the controlled substance non-retrievable or non-ingestible,” it said. A list of alternative disposal options include burning, composting and burying hemp.
It added that the department will “conduct random audits of licensees to verify hemp is being produced in accordance with” regulations.
“One of the top considerations in making these changes was the desire to provide additional options that minimize, to the extent possible, the resource impact to state and local law enforcement in handling hemp that is out of compliance,” Ibach said. “We look forward to partnering with producers, states, tribes and other stakeholders to deliver regulations that work for everyone.”
The new announcement could help clear up some confusion about comments that Ibach made at an agriculture policy conference on Wednesday. According to the advocacy group Vote Hemp, there has been misreporting that suggested the official said the provision requiring DEA-registered labs to test hemp was being eliminated.
A recording of the discussion that Vote Hemp released shows that the undersecretary said enforcement of the provision would simply be delayed for the current planting season.
While USDA is still in the process of developing rules for the crop, it has started accepting state regulatory plans for hemp. Wyoming and Washington State became the latest to have their proposals approved. Previously, USDA accepted regulations from Texas, Nebraska, Delaware, Louisiana, New Jersey and Ohio, as well as several tribal plans.
Meanwhile, at the same agriculture conference that Ibach spoke at, the commissioner of the Food and Drug Administration admitted that it would be “a fool’s game” to try to keep hemp-derived CBD products off the market.
Photo courtesy of Pixabay.