The federal government wants your input on whether marijuana should be reclassified under global drug treaties to which the U.S. is a party.
Specifically, the U.S. Food and Drug Administration (FDA) is asking for public comments about the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of cannabis and several other substances now under international review.
Under current U.S. federal law as well as global drug policy agreements, marijuana is classified in the most restrictive category of Schedule I. At home, that means it is considered illegal and not available for prescription, while research on its potential benefits is heavily restricted. Cannabis’s international status means that nations who are signatories of drug control treaties are not supposed to legalize it, though that hasn’t stopped Canada and Uruguay from doing so.
Public comments on marijuana’s effects and legal status “will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs,” Leslie Kux, FDA’s associate commissioner for policy, wrote in a Federal Register filing published on Wednesday. “WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs.”
WHO’s Expert Committee on Drug Dependence (ECDD) is meeting in Geneva next month to consider the classification of marijuana and other substances, and is now seeking to “gather information on the legitimate use, harmful use, status of national control and potential impact of international control,” the United Nations body said in a notice excerpted in the FDA filing.
Earlier this year, ECDD determined that cannabidiol (CBD), a component of marijuana shown to have medical benefits without intoxicating properties like other cannabinoids such as THC, should not be scheduled under international drug control conventions.
“CBD has been found to be generally well tolerated with a good safety profile,” the UN body found in its critical review. “There is no evidence that CBD as a substance is liable to similar abuse and similar ill-effects as substances…such as cannabis or THC, respectively. The Committee recommended that preparations considered to be pure CBD should not be scheduled.”
The body also agreed to undergo an in-depth critical review of the marijuana plant and its resins and extracts, as well as THC itself. That new review is what triggered the FDA’s request for public comment on Wednesday.
The Trump administration sought public comments from interested parties in advance of an earlier UN pre-review on marijuana as well.
“Any comments received will be considered by [the U.S. Department of Health and Human Services] when it prepares a scientific and medical evaluation for drug substances that is responsive to the WHO Questionnaire for these drug substances,” the new FDA notice says. “HHS will forward such evaluation of these drug substances to WHO, for WHO’s consideration in deciding whether to recommend international control/decontrol of any of these drug substances.”
Legalization advocates are hopeful that a hard look at the data on marijuana’s effects will inevitably lead to a pro-reform conclusion.
“A careful review of the relevant science does not now, nor has it ever, supported a hard-line approach to cannabis scheduling. Cannabis’s abuse potential relative to other substances, including legal substances like alcohol, tobacco and prescription medications, does not warrant its continued criminalization under either U.S. or international law,” Paul Armentano, deputy director of NORML, said in an email. “By any rational assessment, cannabis prohibition is a disproportionate public policy response to behavior that is, at worst, a public health concern. But it should not be a criminal justice matter and international laws should no longer classify it as such.”
Mason Tvert, a spokesman for the Marijuana Policy Project, agreed.
“The time has come for marijuana to be removed from the federal drug schedules. There is no longer any doubt that it has significant medical value, and the science is clear that it is less harmful than many legal medical products,” he said. “While marijuana is not harmless — few, if any, products are — it poses less harm than alcohol to consumers and to society. The U.S. led the world into the quagmire of cannabis prohibition, so it should lead the world out of it by descheduling cannabis and implementing a more evidence-based policy.”
That said, the feds aren’t planning to make any cannabis recommendations to the UN panel ahead of its review meetings next month.
“Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in mid-2018,” the Federal Register notice says. “Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments.”
In addition to marijuana and its components, the WHO committee is also reviewing several synthetic cannabinoids, fentanyls and other substances.
FDA has hinted that international rescheduling of marijuana and its components could influence changes to its legal status here at home.
This month, FDA publicly released a letter it sent to the Drug Enforcement Administration (DEA) earlier this year suggesting that CBD should be completely removed from federal control.
Cannabidiol has a “negligible potential for abuse” and has a “currently accepted medical use in treatment,” the agency found.
But, because of international drug treaty obligations, FDA conceded that the substance needs to be scheduled, concluding that it should be placed under the least-restrictive category of Schedule V.
“If treaty obligations do not require control of CBD, or if the international controls on CBD change in the future, this recommendation will need to be promptly revisited,” FDA wrote in its analysis to DEA.
That document, dated in May, preceded the WHO’s determination that CBD should not be globally scheduled, and was part of the federal government’s approval and rescheduling last month of CBD-based drug Epidiolex, which is used for severe epilepsy disorders. It is not clear why the U.S. government subsequently decided to place FDA-approved CBD medications in the federal Schedule V, with an appeal to global treaties that the UN now says shouldn’t schedule the substance.
For now, FDA is accepting public comments on marijuana and the other substances currently under UN review via the web until October 31. Interested parties can also submit written comments via mail.
Ultimately, WHO will make a scheduling recommendation for marijuana to UN Secretary-General António Guterres, who oversaw the enactment of drug decriminalization as Portugal’s prime minister, a policy he has touted in his current capacity.
Federal Court Dismisses Suit Against DEA Over Marijuana Growing Applications
A federal court dismissed a lawsuit against the Drug Enforcement Administration (DEA) on Friday after determining that the agency had fulfilled a requirement to process applications for research-grade marijuana manufacturers.
DEA was sued in June after declining to act on the more than two dozen applications that it received for approval to cultivate cannabis for research purposes. It’s been more than three years since the agency first announced it was opening the process to consider additional producers.
The suit, brought by the Scottsdale Research Institute (SRI), argued that the marijuana grown at the University of Mississippi—currently the only facility that’s federally authorized to cultivate the plant—is of poor quality, does not reflect the diversity of products available on the commercial market and is therefore inadequate for clinical studies.
Indeed, that’s a point that several policymakers have made, and it’s bolstered by research demonstrating that the federal government’s cannabis is genetically closer to hemp than marijuana that consumers can obtain in state-legal markets.
In July, the U.S. Court of Appeals for the District of Columbia Circuit ordered DEA to respond to the legal challenge within 30 days—and as that deadline approached in August, the agency published a notice in the Federal Register stating that it was taking steps to approve the pending applications.
Due to the volume of the applications, DEA said it would have to develop alternative rules to process them. And on Friday the court said that DEA had fulfilled its obligations and that the suit “is now moot.” While no applications have been approved to date, there’s a public comment period that will last until October 28 and then the agency will have an additional 90 days to take action on the inquiries.
“The Court dismissed our case because, according to the Court, DEA gave us the relief we had requested,” attorney Matt Zorn, who was involved in the suit, told Marijuana Moment. “Last week, on October 11, DEA published a correction to the notice it had previously published on August 26, two days before it had to respond to the Court’s order. The Court said this second notice meant there was nothing more the Court could give us.”
“The Court also declined to maintain jurisdiction over the case, because it did not find a history of chronic delay or bad faith in the record,” Zorn said. “But it also indicated that we could return to court if DEA significantly delays going forward.”
Sue Sisley, a researcher with SRI, said that despite the case being dismissed, it “moved the ball forward for everyone.”
“We would have liked to take the case one step further to ensure that all 33 applications are processed promptly—protecting the health and welfare of our nation’s medically ill patients ought to be a national priority for this administration,” she said. “By delaying these 33 applications, the administration has prevented our US scientists from investigating the clinical efficacy of real-world cannabis to treat combat veterans with PTSD. Fortunately, the Court’s order today allows us to return to court for additional relief if Trump’s DOJ/DEA continues to violate the law and put public health at risk through delay or otherwise.”
In a separate case in May, another federal court ordered DEA to “promptly” consider applications to reschedule cannabis under the Controlled Substances Act.
Read the appeals court’s ruling on the DEA marijuana application case below:
Former VA Secretary Who Oversaw Marijuana Research Blockade Now Backs Cannabis Studies For Veterans
Former U.S. Department of Veterans Affairs (VA) Secretary David Shulkin is officially on board with having the department research medical marijuana—a development that comes a year after he was in a position to actually make that happen.
In an interview with Task & Purpose that was published on Thursday, Shulkin said that “the time is now” for VA to facilitate studies into the therapeutic potential of cannabis for veterans.
“I believe that the VA should be involved in research on anything that could potentially help veterans and improve their health and well-being,” he said.
That appears to represent a notable departure from the position he held while he headed the department.
For example, VA under his leadership refused to provide assistance to an Arizona-based research facility that was soliciting veterans to participate in a federally approved clinical trial looking at the potential benefits of cannabis in the treatment of post-traumatic stress disorder (PTSD).
“Federal law restricts VA’s ability to conduct research involving medical marijuana, or to refer veterans to such research projects,” a VA official told Air Force Times in 2017. “The researcher is free to work with veterans service organizations and state veterans officials who may not face such restrictions to identify candidates for her study.”
But according to the Brookings Institute, that’s not an accurate assessment because “doctors and researchers at the VA or in VA hospitals could conduct research into the medical efficacy of marijuana while remaining completely compliant with federal laws, regulations, and the United States’ obligations under international agreements.”
While the former secretary still said during this latest interview that congressional action is necessary to prompt VA research efforts, he seems to have become decidedly more vocal about the importance of such studies as compared to his time in office.
“In particular, with the VA’s focus on suicide as the top priority, people just don’t take their lives because of no reason,” he said. “They take their lives, often because of issues related to chronic pain, depression, substance abuse, and there is growing evidence that medical marijuana—I’m not talking about recreational marijuana—but properly prescribed, may have some real benefits in anxiety improvement, in pain management, and potentially, in the issue of substance abuse.”
“And therefore, I believe it’s extremely appropriate for VA to be researching and developing therapies that can help veterans, particularly in areas where we don’t have enough good therapies or answers,” he said.
Task & Purpose followed up to ask about potential obstacles such to having VA conduct research into the issue, and Shulkin said that because marijuana is a federally controlled substance, “the challenge of doing research with the regulations, and the hoops that you have to go through, are making it too difficult to do for many of the researchers.”
“I do think that the way forward is a legislative solution, much of what VA responds to are changes in the law, where medical research for veterans in this area could be streamlined and clarity around what regulations and rules need to be followed to be able to do this research, as well as guidance about the type of research that can and should be done, which reports back to Congress.”
He added that he doesn’t anticipate that President Trump would resist legislation empowering VA to study marijuana for veterans.
Brad Burge, director of strategic communication at the Multidisciplinary Association for Psychedelic Studies (MAPS), the group behind the study into cannabis for PTSD, told Marijuana Moment that they are “pleased that Shulkin has now expressed his support for medical marijuana research, even though that support would have been much more valuable when he was still in office.”
“Nevertheless we are looking forward to the VA’s support of marijuana research and see Shulkin’s change of stance as a promising sign for veterans suffering from PTSD,” Burge said.
It wasn’t just that Shulkin’s VA put up roadblocks to cannabis research, he also resisted providing veterans with access to marijuana by declining to change internal VA policy that could empower its doctors to issue recommendations in states where it’s legal.
The reasoning, he said in 2017, is that it’s “not within our legal scope to study that in formal research programs or to prescribe medical marijuana, even in states where it’s legal” because of federal law. But advocates argued that the only thing standing in the way of VA cannabis research is VA policy itself, which Shulkin could have amended.
Getting a VA cannabis reform bill passed as the former official is now recommending has already proved difficult this year, with current VA officials voicing opposition during a congressional committee hearing in June to modest proposals such as allowing their doctors to recommend cannabis or even surveying veterans about their marijuana use.
Rep. Earl Blumenauer (D-OR) said that same month that he pulled an appropriations amendment to allow for VA marijuana recommendations from floor consideration partly because of opposition from the department.
Mexican Committees Unveil Marijuana Legalization Bill Ahead Of Supreme Court Deadline
Several Mexican Senate committees unveiled draft legislation late on Thursday to legalize marijuana.
Leaders of the Health, Justice, Public Security and Legislative Studies Committees announced last week that they would remain in permanent session to finalize the legalization bill ahead of a coming Supreme Court deadline.
The court determined last year that the country’s ban on personal cannabis consumption and cultivation is unconstitutional, though lawmakers now want to go even further by legalizing commercial production and sales.
The committees are expected to formally vote on the legislation in the coming days, after which point it will head to the full Senate and then the Chamber of Deputies. Leaders said a vote in the legislature could occur before the end of the month, though it’s possible they could ask the Supreme Court for a deadline extension.
Ayer, antes de medianoche, fue entregado a los senadores de las comisiones de Justicia, Salud, Estudios Legislativos, Segunda y Seguridad Pública el predictamen📃🌿 de la ‘Ley para la regulación de la cannabis’. Está conformado por 74 artículos y once transitorios. pic.twitter.com/8IKOF7pA1i
— Cáñamo México (@canamo_mexico) October 18, 2019
Here are some of the key provisions, according to a translation:
—Adults 18 and older can possess cannabis for personal use, cultivate up to four plants and purchase marijuana from licensed retailers.
—An independent body called the “Cannabis Institute” would be charged with issuing licenses, setting potency limits and monitoring the implementation of the law, among other responsibilities.
—Low-income individuals, small farmers and indigenous people would have licensing priority.
—Strict restrictions would be imposed on cannabis packaging. That includes requiring nondescript, standardized containers that do not feature depictions of real or fictional people or testimonials.
—Marijuana can only be consumed in private spaces.
—Only medical cannabis patients would be allowed to purchase infused edibles and beverages.
—Unregistered seeds or plants would be subject to forfeiture.
—No pesticides could be used on cannabis plants.
The bill seeks to “improve the living conditions of people living in the United Mexican States, combat the consequences of the problematic use of cannabis and reduce the crime incidence linked to drug trafficking [while] promoting peace, the security and well-being of individuals and communities,” according to the text.
Sen. Julio Menchaca Salazar, head of the Justice Committee, said in a tweet that “we are legislating to regulate the illicit market of the #marihuana and decrease the crime incidence linked to the #narcotráfico, promoting peace and security for all Mexicans.”
— Julio Menchaca S. (@Julio_Menchaca) October 18, 2019
Lawmakers have said that the legislation is largely based on a proposal that Interior Secretary Olga Sánchez Cordero filed last year while still serving as a senator, but the committees are also merging in provisions from among more than a dozen other marijuana reform bills that since have been introduced.
“They all have something good that we can be translating into law,” Menchaca Salazar, who is a member of the ruling MORENA party, said.
Debate on the measure will also be informed by findings from a series of events the Senate organized to gather public input on marijuana legalization. That includes a panel led by a former White House drug czar, who stressed the need for “robust regulations” of a legal cannabis market.
The leader of the MORENA party in the Senate, Sen. Ricardo Monreal, said earlier this month that the chamber was set to vote on a legalization bill ahead of the October 24 deadline.
“It will undoubtedly be a great discussion with the elements we have and also with all the willingness to incorporate the opinions of legislators, but it would come out this month, there are the conditions for that to be,” Menchaca Salazar said.
Read the full text of the Mexican committees’ marijuana legalization proposal below:
This story is developing and will be updated.