The Food and Drug Administration (FDA) published draft guidance on developing cannabis-based drugs on Tuesday.
This comes weeks after the White House completed its review of the document, clearing its path for public release.
FDA is still in the process of developing regulations that could allow for CBD to be marketed as a food item or dietary supplement, but in the meantime it has worked to create these new research guidelines for drug manufacturing.
Much of the guidance—which is “limited to the development of human drugs and does not cover other FDA-regulated products”—covers the basics of conducting federally authorized research for drug development purposes such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.”
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” FDA Principal Deputy Commissioner Amy Abernethy said in a press release. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”
The chief legislative change she referenced is the 2018 Farm Bill, which federally legalized hemp and its derivatives such as CBD.
For researchers, that reform means they are no longer bound to certain restrictions that exist for marijuana. For example, FDA noted in the new document that as long as a manufacturer produces hemp products that meet the federal definition of containing no more than 0.3 percent THC, scientists can use that for studies rather that rely on the nation’s only federally authorized marijuana manufacturer at the University of Mississippi.
“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” FDA wrote.
FDA has issued draft guidance describing the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. https://t.co/nncAluuUSZ pic.twitter.com/hv4EEcAZkF
— Media Affairs (@FDAMedia) July 21, 2020
Because excess THC concentrations could render hemp illicit under federal law, FDA dedicated a section to testing standards for hemp-derived products.
“Sponsors and investigators proposing drug development activities involving controlled substances should consult with [Drug Enforcement Administration] about the applicable requirements,” it said. “Sponsors and investigators may find it useful to calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain insight into the potential control status of their product.”
“Regardless of whether cannabis or a cannabis-derived compound meets the definition of hemp, sponsors and applicants should work with reliable laboratories for analytical testing,” it continued.
Applicants for an investigational new drug should submit information to FDA that includes “quantitative data, such as a certificate of analysis from a laboratory” on THC content and “detailed descriptions of testing methods used to evaluate the level of delta-9 THC.” They should also provide “quantitative data regarding phytochemicals that are present in their proposed product, including but not limited to, cannabinoids, terpenes, and flavonoids.”
“Many sponsors initiating clinical research for drugs containing cannabis and cannabis-derived compounds may be unclear regarding, or unfamiliar with, applicable drug quality expectations,” FDA said.
The agency discussed how calculating dry weight for hemp is unique in that it should be based on “the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.” It’s not clear if that standard would prove burdensome for hemp producers, but it is the case that many farmers have already complained about existing stringent THC testing policies under U.S. Department of Agriculture guidance.
The new FDA guidance gives a step-by-step overview of how to test for THC on a dry weight basis in a way that meets their standards.
“We recommend that you consult DEA regarding the control status of cannabis or cannabis-derived materials or products that are under development,” the document states. “We note that intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight, even if the starting materials meet the definition of hemp, may no longer meet the definition of hemp and may be considered a Schedule I controlled substance.”
“We invite comment from the public on this recommended approach,” the agency said in a Federal Register notice accompanying the new draft guidance. “In addition, FDA invites public comment on the appropriate manufacturing controls over materials that cross under the 0.3 percent delta-9 THC by dry weight threshold during the production of a drug that contains cannabis or cannabis derived compounds.”
A 60 day public comment period will be opened for stakeholders to weigh in on the proposed research guidelines. At the same time, the agency has a separate comment period indefinitely open for information on the safety and efficacy of CBD.
FDA stressed that guidance documents such as this one “do not establish legally enforceable responsibilities.”
“Instead,” it said, “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”
The agency said researchers should take other non-cannabis-specific past guidance on the development of botanical drugs into account as well and laid out several other considerations.
“Cannabis is held to the same regulatory standards as any other botanical raw material, botanical drug substance, or botanical drug product,” the guidance states. To that end, researchers should be doing things like chemical fingerprinting to ensure consistency and testing for residual pesticides. FDA also noted that any drug products that require a device like an inhaler fall under their own category with its own set of requirements.
Further, researchers should “consider selection of a container closure system carefully.”
The agency also emphasized that “a naturally occurring compound isolated from a botanical source would be expected to have a different impurity profile from the corresponding synthetically produced cannabis related compound, and impurities for the naturally occurring compound should be controlled accordingly” as opposed to “synthetic single-chemical active pharmaceutical ingredients.”
Advocates, industry representatives, regulators, health professionals and marijuana legalization opponents stood up before FDA last year at a historic public hearing to share their perspectives on how to best approach regulating CBD.
“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” the agency’s Abernethy said. “The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.”
“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes—and one key element of this support involves development of guidance, like this one,” she said.
FDA also recently submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
Also this month, a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
Read FDA’s draft guidance on cannabis research below:
Photo courtesy of Philip Steffan.
Most Kansas City Government Workers Will No Longer Face Pre-Employment Marijuana Tests Following City Council Vote
Most government workers in Kansas City, Missouri will no longer face pre-employment drug tests for marijuana under an ordinance that the City Council approved on Thursday.
The measure, which was introduced by Mayor Quinton Lucas (D) in July, was passed by local lawmakers in an 11-2 vote.
“It shall be unlawful for the City of Kansas City to require a prospective employee to submit to testing for the presence of marijuana in the prospective employee’s system as a condition of employment,” the text of the ordinance states.
Lucas, who last year filed a since-enacted measure to remove all local criminal penalties for cannabis possession, celebrated the latest development.
Opportunities should not be foreclosed unnecessarily.
Glad to see passage of our law eliminating pre-employment screening for marijuana at Kansas City government for most positions.
One step of many in becoming a fairer city.
— Mayor Q (@QuintonLucasKC) September 23, 2021
“Opportunities should not be foreclosed unnecessarily. Glad to see passage of our law eliminating pre-employment screening for marijuana at Kansas City government for most positions,” he said. “One step of many in becoming a fairer city.”
There are some exceptions to the policy change. Law enforcement, workers who require a commercial driver’s license and those who are involved in the supervision of “children, medical patients, disabled or other vulnerable individuals” can still be screened for cannabis.
Last year, the mayor announced a pardon program for those with previous convictions for possession of marijuana or paraphernalia.
Drug testing for cannabis has become a hot topic of late since the Olympics suspension of U.S. runner Sha’Carri Richardson, with more people arguing that use of the plant shouldn’t lead to punishments, especially given the ongoing rise of the legalization movement. The World Anti-Doping Agency recent announced that it would review its marijuana policy for athletes next year.
The Biden administration has come under fire this year for terminating or otherwise punishing staffers who were honest about their past cannabis use as part of the background check process.
White House Press Secretary Jen Psaki has said that nobody in the White House was fired for “marijuana usage from years ago,” nor has anyone been terminated “due to casual or infrequent use during the prior 12 months.” However, she’s consistently declined to speak to the extent to which staff have been suspended or placed in a remote work program because they were honest about their history with marijuana on a federal form that’s part of the background check process.
In June, a powerful congressional committee released a report that urges federal agencies to reconsider policies that result in the firing of employees who use marijuana legally in accordance with state law.
Separate standalone legislation has been previously introduced by Rep. Charlie Crist (D-FL) to provide protections for federal workers who consume cannabis in compliance with state law, but it never received a hearing or a vote and has not been refiled so far this Congress.
As of last year, New York City employers are no longer able to require pre-employment drug testing for marijuana as a part of the hiring process—though there are a series of exemptions to the policy. The City Council approved the ban in 2019, and it was enacted without Mayor Bill de Blasio’s (D) signature.
Statewide in Missouri, voters may see multiple marijuana initiatives on the state’s 2022 ballot, with a group filing an adult-use legalization proposal last month that could compete with separate reform measures that are already in the works.
Photo courtesy of Brian Shamblen.
Full-Page Washington Post Ad Calls For Marijuana Prisoner’s Freedom While Celebs Make Money In Industry
Supporters of a 26-year-old man who is currently incarcerated while awaiting sentencing for a federal marijuana charge took out a full-page ad in The Washington Post on Thursday, blasting the hypocrisy of his imprisonment while celebrities like Beyonce, Jay Z, Seth Rogen and Willie Nelson stand to profit off the legal cannabis industry.
Jonathan Wall faces up to 15 years in prison on charges that he and other conspired to traffic marijuana from California to Maryland over two years. His family says this is a flagrant miscarriage of justice that highlights the need for relief for Wall and for broader federal marijuana reform.
The ad has the headline, “Who will be the last person incarcerated for marijuana in the United States?”
“Cannabis corporations are in Maryland and 26 other states making billions in revenue growing, manufacturing and distributing pot,” it says. “Cannabis conglomerates wonderfully engaged in branding, licensing , product innovation, research and development.”
It notes that, just miles away from where Wall is being held, consumers can buy marijuana from major marijuana businesses like Curaleaf or Acreage Holdings, which counts former GOP House Speaker John Boehner (R-OH) among its board members.
“But then you—along with the likes of Jay Z, Seth Rogen, and Willie Nelson—would be in violation of U.S. federal law and subject to incarceration,” the ad says. “26-year-old Jonathan Wall faces life in prison while Beyonce says that she’s starting a cannabis farm. This is not the way the law is supposed to work.”
“President Biden recently gave a speech about how 20 years in Afghanistan was too long and that our continued involvement there was a mistake. Well, what about more than 50 years of proven failure, 50 years of gross economic waste, 50 years of caging our own citizens, 50 years of asset forfeiture abuse, 50 years of enforcement disparity and evisceration of the constitutional rights of people of color. In a country where you can guy an assault rifle and fifth of whiskey, federal prohibition of cannabis has never been about more than fear, bias, race, stigmatization and control.”
This isn’t the first time that the Biden administration has faced demands to provide relief for people criminalized over marijuana.
Congressional lawmakers have also recently pushed President Joe Biden to grant clemency to nearly 20,000 people in the federal prison system—including those with drug convictions.
A group of more than 150 celebrities, athletes, politicians, law enforcement professionals and academics separately signed a letter that was delivered to Biden, asking him to issue a “full, complete and unconditional pardon” to all people with non-violent federal marijuana convictions.
While advocates are looking for more, the Biden administration is asking a fraction of people with drug convictions who were placed on home confinement amid the coronavirus pandemic to apply for the relief.
“It is time for our government to admit that it has made a mistake,” the new ad says.
House Officially Passes Defense Bill With Marijuana Banking Protections, But Key Senators May Block Path Ahead
The U.S. House of Representatives on Thursday approved a large-scale defense spending bill that includes an amendment to shield banks that works with state-legal marijuana businesses from being penalized by federal regulators. Now advocates and industry stakeholders are left wondering: what’s the fate of the reform in the Senate? And can it make it to the president’s desk?
New comments from Sen. Cory Booker (D-NJ)—who’s helping lead the charge to advance comprehensive marijuana legalization and who has been severely critical of efforts to enact banking reform first—signal that the path to pass the incremental policy change through the National Defense Authorization Act (NDAA) could be in jeopardy in the Senate. Other key senators have also expressed skepticism about the reform’s prospects through this process.
For supporters, things may have been more simple if the Senate had moved to include cannabis banking reform in its own version, but the text of NDAA released by Senate Armed Services Committee on Wednesday does not contain that language. That means the matter will need to be settled in a bicameral conference committee after the full Senate formally passes its bill. At that point, negotiators from both chambers will work to resolve differences between their separate proposals.
Already, there’s pushback from key senators to including the Secure and Fair Enforcement (SAFE) Banking Act in the NDAA that’s ultimately sent to President Joe Biden. That’s not especially surprising considering that leadership, including Senate Majority Leader Chuck Schumer (D-NY), has insisted on passing comprehensive justice-focused marijuana legalization first rather than advance an incremental reform on banking. But recent statements do raise questions about the prospects of enacting the reform through the defense bill.
It’s not that the SAFE Banking Act is partisan or especially controversial on its face; it’s a matter of legislative priorities for certain senators and a question of germaneness in NDAA. As of Tuesday, when the reform amendment was officially attached to the House version of the bill, it has now passed five times in the chamber, usually along largely bipartisan lines.
Rep. Ed Perlmutter (D-CO), chief sponsor of the SAFE Banking Act, spoke with Marijuana Moment about the process moving forward in a phone interview on Wednesday. He was optimistic about the measure’s prospects with NDAA as the vehicle, though he conceded that he hadn’t spoken with Schumer or other key senators who are actively finalizing legalization legislation that they hope to see move first.
“I think the fifth time is the charm,” he said. “I mean, obviously, we still have to do some work to make sure that it remains part of the NDAA as the House and the Senate go to conference. So we still have work to do with the Senate to make sure that it remains part of it. But I think that it will.”
“I mean, the fact that it deals with cartels and national security, on top of the need for the public safety piece of this thing, I think that we’ll be able to convince the conference committee and the conferees generally to keep it in,” he said. “But we still have work to do.”
Marijuana Moment is already tracking more than 1,200 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.
Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.
Some advocates have expressed support for enacting the achievable banking policy change while working to build support for more comprehensive reform.
“Enactment of the SAFE Banking Act would improve public safety and business efficiency in the 36 states that currently permit some form of retail marijuana sales,” NORML Political Director Justin Strekal said. “The Senate should ensure this provision remains in the final version of this funding package and enact it swiftly.”
“The SAFE Banking Act is only the first step toward making sure that state-legal marijuana markets operate safely and efficiently,” he said. “The sad reality is that those who own or patronize these currently unbanked businesses would still be recognized as criminals in the eyes of the federal government and by federal law. This situation can only be rectified by removing marijuana from the list of controlled substances.”
Schumer and certain other senators, meanwhile, have insisted the banking issue should be tackled by holistically ending marijuana prohibition. They argue that it is inappropriate to pass what is seen as an industry-focused reform that helps businesses and investors while leaving unaddressed the harms of decades of racially disparate prohibition enforcement that should be addressed with equity-focused legalization.
Booker, who is helping Schumer alongside Senate Finance Committee Chairman Ron Wyden (D-OR) to produce a final legalization bill has said he would proactively work to block any senators who attempt to get marijuana banking reform passed before enacting social justice-focused legalization legislation.
And Booker told Politico on Wednesday that cannabis banking is “something that should not be included” in NDAA.
Senate likes to send NDAA amendments to a vote by unanimous consent. If one senator raises an objection to an NDAA Amendment, it can kill or stall it. Booker wouldn’t discuss his plans but said has “a lot of options as an individual senator” should the amendment be proposed.
— Natalie Fertig (@natsfert) September 22, 2021
“It undermines the ability to get comprehensive marijuana reform and the kind of things that are harder to get done like expungement of people’s records,” he said, echoing a point that Schumer made in an interview with Marijuana Moment in April. And a spokesperson for the majority leader affirmed that his position has not changed in light of the House development.
Should a senator propose a floor amendment to the chamber’s version of the defense bill to incorporate SAFE Banking, Booker left open the possibility of standing in its way.
Sen. Jeff Merkley (D-OR), sponsor of the standalone Senate version of the SAFE Banking Act, also declined to say whether he would push to attach the reform to NDAA and told Politico he’d “love to see if we can even do the more comprehensive [reform]—that’d be even better.”
Senate Armed Services Committee Chairman Jack Reed (D-RI), meanwhile, told Roll Call that the issue hasn’t been discussed by members of his panel. And bipartisan supporters of the reform—including Sens. Brian Schatz (D-HI) and Rand Paul (R-KY)—told the outlet they weren’t certain that the Senate would pursue marijuana banking through NDAA.
Schatz also said that Senate Minority Leader Mitch McConnell (R-KY) “doesn’t like” the marijuana banking proposal, and so “he’s going to have to consult with the Republicans in his conference who are in favor of this reform, but so far he’s been blocking it.”
Based on these comments, it seems increasingly clear that the effort to enact SAFE Banking through the must-pass defense bill faces a tough road ahead. And despite bipartisan support for the proposal on its own, it’s an open question as to whether the negotiators in committees of jurisdiction will be able to reach a consensus.
At an initial meeting of the House Rules Committee about NDAA on Monday, House Armed Services Committee Chairman Adam Smith (D-WA), who is managing the bill for the chamber, acknowledged that while some members might consider certain amendments “superfluous” to defense spending matters, the annual legislation has been used as a vehicle to advance non-germane legislation in the past. He added, though, that doing so has historically required the issues at hand to have broad bipartisan support in order to survive the House-Senate conference committee process.
He didn’t specifically cite the cannabis banking proposal, but Perlmutter himself said earlier in the hearing that “whether something is superfluous is always in the eyes of the beholder,” signaling that he feels his measure’s germaneness in this context is up for interpretation.
Smith said that “whatever superfluous items the Rules Committee decides to put in order and get attached to this bill, we go to conference, and in conference, we work in a bipartisan fashion.”
But beyond Smith and Reed, it will also be up to leading members of key committees that handle banking issues to decide whether the measure gets a ride to the president’s desk in NDAA.
“We’re not going to pull one over on anybody here. We’re going to have to work with committees of jurisdiction—not just the chairs, but the ranking members as well—to come to some agreement on those before we go forward,” he said. “So if you see an item that you consider to be superfluous being added to the bill, don’t freak out.”
The chair’s comments about needing support from leaders of committees of jurisdiction raise questions about whether the amendment stands a chance in conference with the Senate following House approval. Not only did House Financial Services Committee Ranking Member Patrick McHenry (R-NC) vote against the standalone SAFE Banking Act this year and in 2019, but on the Senate side, even Banking Committee Chairman Sherrod Brown (D-OH) has been generally unenthusiastic about advancing the reform.
On the flip side, House Finance Services Committee Chairwoman Maxine Waters (D-CA) is a supporter of the banking reform and brought it through her panel last Congress. Senate Banking Committee Ranking Member Pat Toomey (R-PA), for his part, has previously voiced support for advancing the SAFE Banking Act.
Perlmutter has said that he appreciates that Senate leadership is pushing for a more comprehensive end to federal marijuana prohibition—and he agrees with Booker that promoting social equity is an important objective—but he feels the SAFE Banking Act is urgently needed to address public safety issues resulting from the industry’s lack of access to traditional financial institutions.
Some of the strongest proponents for broad reform like Rep. Earl Blumenauer (D-OR) voted in favor of the SAFE Banking Act in April despite the body yet having taken up a legalization measure this session.