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:
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Former FDA Chief Wants Federal Government To Regulate State Marijuana Markets
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said on Monday that the federal government should regulate state marijuana programs.
In his clearest comments on the issue to date, Gottlieb said in a CNBC appearance that the rise in vaping-related lung injuries underscores the need for a federal regulatory scheme that would empower agencies to impose industry standards on aspects of legal cannabis markets such as THC potency and allowable forms of consumption.
Previously, the official had been ambiguous about the extent to which the federal government should get involved, broadly arguing that vaping issues reflect a consequence of conflicting state and federal laws without specifically saying what his preferred policy fix would be. However, in an editorial for The Wall Street Journal published last week, he provided some clarification—hinting that federal drug scheduling laws should be reformed for cannabis—but still left room for interpretation.
But now, he is beginning to lay out specific details of a regulatory agenda.
Gottlieb said during the TV interview that enforcing prohibition is no longer “politically practicable” and that Congress should pass “a federal law that actually can be enforced and allow federal regulatory authorities to impose appropriate supervision.”
While he said he’s not in favor of adult-use legalization and would “like to see the recreational uses shut down entirely,” the reality is that many states have made that decision and so any federal regulatory scheme would have to include “some accommodation of that.”
“I think the time has come that we need to grapple with this at a federal level. We can’t ignore it any more.”
Asked whether states are capable of providing the types of regulations he’s calling for, Gottlieb said no because there’s a patchwork of policies across the country and states “don’t have the capacity to both police what’s being sold in their so-called legal dispensaries as well as shut down the black market.”
“I think you’re going to need federal authorities in there to do that,” he said.
Under the regulatory model Gottlieb is envisioning, FDA and other agencies such as the Drug Enforcement Administration (DEA) “could regulate what’s being sold for the potency, for the manufacturing, for the ingredients, for the claims that are being made.”
“Even if we were to federalize it and allow some form of recreational use, we could limit what can be sold, the potency of what could be sold, the forms in which it can be sold,” he said, adding that he doesn’t think vaping THC products should be allowed.
Federal agencies could impose “tighter controls on the medical claims, holding them to a higher standard and allowing some form of recreational use, probably for products that are lower concentration, that are only delivered in forms that pose less harm than vaping e-liquids,” he said.
“There’s a way to have a compromise where you allow some form of recreational access in the states that want to allow it but something that looks far different than what you have today, something that’s far less permissive than the state laws,” he said. “That’s not a great outcome in my view from a public health standpoint, but what we have now is far worse where you have a federal government not enforcing the law at all—barely enforcing the law—because they know the existing law isn’t practical, and the states not imposing any supervision because they’re incapable of doing it or they don’t want to step in in a vigorous way.”
Photo courtesy of YouTube/CNBC.
Scotland’s Ruling Party Unanimously Backs Drug Decriminalization Measure
Delegates of the Scottish National Party (SNP) unanimously approved a resolution calling for the decriminalization of drug possession and consumption on Sunday.
At a conference in Aberdeen, lawmakers representing Scotland’s largest party and the third largest in the UK Parliament argued that removing criminal penalties for drug offenses and treating addiction as a public health issue would combat an ongoing overdose crisis.
The proposed amendment to the 1971 Misuse of Drugs Act stipulates that the current law is “not fit for purpose in 21st Century Scotland” and would add a provision “to allow for decriminalization of possession and consumption of controlled drugs so that health services are not prevented from giving treatment to those that need it.”
— Alison Thewliss (@alisonthewliss) October 13, 2019
Members of Parliament Tommy Sheppard, Ronnie Cowan and Alison Thewliss of the SNP introduced the measure.
“Our law enforcement agencies are focused on the weak and vulnerable at the bottom of the pyramid, when they should be focused on the organized criminals at the top,” Sheppard said.
He added that if the UK government declines to pursue the reform move, it should “give Scotland the ability to do it instead, because we will take the steps necessary.”
As SNP back decriminalisation to address the drug-death crisis, we spoke to @TommySheppard MP on the need for urgent action to save lives. If Westminster won't act, Scotland must. #SNP19 #skotia pic.twitter.com/zoUWeVYkIZ
— Skotia (@TheSkotia) October 13, 2019
Cowan noted that many people suffering from addiction have experienced some form of trauma and are self-medicating.
“Decriminalization demystifies drugs and places them firmly in the health arena,” he said. “Drug policy is about a mindset. Decriminalization changes the mindset and by changing that you can treat people as human beings and we can start a recovery process.”
As Common Space reported, previous SNP conferences have also seen the passage of progressive drug reform amendments, including one that would establish safe consumption sites to prevent overdoses and help people transition into treatment. Advocates have expressed frustration that the UK Parliament has generally resisted such harm reduction policies.
The Labour Party announced last month that it would launch a Royal Commission dedicated to reviewing the country’s drug laws if elected to the majority.
“The UK government’s cavalier attitude towards Scotland’s drugs emergency is simply appalling,” Thewliss said. “People are dying on our streets and the risk to the general public from discarded needles and transmission of blood borne diseases is very real—yet the Tories at Westminster sit on their hands.”
Glasgow Councillor Mhairi Hunter said at the conference that “challenging the stigma around addiction means challenging the laws that criminalize addiction.”
Over in the U.S., lawmakers remain primarily focused on reforming federal marijuana laws, but talk of broader decriminalization is growing. A survey released earlier this month found that a majority of Americans (55 percent) support the policy change.
Dietary Supplement Industry Pushes Congress To Allow CBD Product Sales
Four trade associations representing the dietary supplement industry signed a letter urging federal lawmakers to take action to provide for the lawful marketing of CBD products while the Food and Drug Administration (FDA) develops its regulations.
The American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition and United Natural Products Alliance said Congress should “pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria.”
To do that, the groups recommended granting a limited waiver that would exempt CBD products from a provision of the Food, Drug and Cosmetic Act that would allow companies to sell CBD as dietary supplements as long as the products are derived from hemp and meet health and safety standards.
“Given the rapidly growing marketplace of products, it is crucial that Congress take quick action to clarify the legal status of hemp-derived CBD dietary supplements,” the letter states. “At the same time, it is equally essential for FDA to have the resources it needs to protect the public from unsafe CBD products.”
A united supplement industry is urging Congress to take swift action on CBD to assure consumer protection and a clear regulatory framework. See what CHPA, @AHPAssociation, @CRN_Supplements, and @unpafrank have to say, here: https://t.co/pUBGSpXFQf
— CHPA (@CHPA) October 10, 2019
“These actions are urgent given the strong consumer interest in CBD, the growth in products and sales, and the need for clarity among consumers, retailers, and manufacturers about the legal status of these products,” the groups said.
Congressional action is needed, they argued, because FDA officials have indicated that the rulemaking process for CBD could take up to five years. They also expressed appreciation for agriculture spending legislation approved by a the Senate committee that would allocate $2 million to FDA to support their efforts to develop cannabidiol regulations.
“We urge Congress to go even further to include substantial new resources to enable effective FDA oversight of this fast-growing category, including funding for efficient and timely review of new dietary ingredient notifications and enforcement of existing laws governing the safety, manufacturing, and labeling of dietary supplements containing CBD,” the letter continues. “We urge that you work with FDA to determine a level of funding adequate to assure effective regulation of the CBD marketplace that does not detract from other agency enforcement priorities.”
“This is the best, most efficient, and most timely way to both set a clear regulatory framework for the marketplace and better assure consumer protection. While we can appreciate the FDA’s deliberative interest in making sure that consumers have access to safe CBD products, we are concerned that continuing to leave the marketplace without clarity and adequate oversight for an extended period of years will both endanger consumers and the bright future of the hemp-derived products they seek. Since it appears FDA is unlikely to provide a timely and effective resolution to this challenge, Congress must act.”
The dietary supplement industry is far from alone in its call for an expedited process to allow CBD products to be marketed.
A bipartisan coalition of senators—and notably, Senate Majority Leader Mitch McConnell (R-KY)—have also urged FDA to clear a path to allow for the lawful marketing of CBD products while the agency continues to develop regulations.
Read the full CBD letter from the dietary supplement industry groups below:
Photo by Kimzy Nanney.