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.
White House Completes Review Of CBD Guidance From FDA
The White House recently completed its review of pending Food and Drug Administration (FDA) guidance on marijuana and CBD research—though it remains to be seen whether the draft document will ultimately be released to the public.
FDA submitted its proposed plan—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—to the Office of Management and Budget (OMB) in May. Few details are known about its contents, but an FDA spokesperson previously told Marijuana Moment that it could inform the agency’s approach to developing regulations for the marketing of CBD.
OMB finished its review last week, as first reported by InsideHealthPolicy. This comes days after a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
Despite the review being finalized, however, an FDA representative told Marijuana Moment on Friday that the agency “cannot provide an update of when (or even if) this guidance will issue.”
“It will be announced via the Federal Register should it move to publication,” they said.
It’s not entirely clear why the guidance wouldn’t be published in the end, but it may take some time for FDA to implement any edits suggested by the White House over the past month, and it’s possible there are additional layers of review beyond OMB that could determine when and whether it will be finalized.
It also remains to be seen whether FDA plans to wait for this specific guidance to be finalized and for the resulting research to be completed before it gets around to issuing final rules for CBD products in general. Stakeholders have been eagerly awaiting those regulations so they can fully take advantage of the legalization of hemp and its derivatives.
Former FDA Commissioner Scott Gottlieb said in May that White House policies requiring OMB to review scientific documents in the first place represent an onerous step that’s delayed the issuance of guidance.
Beyond sending the draft research plan to the White House for review, FDA is also soliciting public input about the safety and efficacy of CBD in comment period it has decided to keep open indefinitely. The agency said in an update to Congress in March that it has several specific questions it wants answered before deciding whether the cannabidiol can be lawfully marketed. That includes questions about the impact of different methods of consumption and drug interactions.
This week, FDA 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.
In the meantime, FDA is maintaining enforcement discretion when it comes to action against companies that sell CBD products regardless of the lack of regulations and has said it is currently targeting sellers that make especially outlandish or unsanctioned claims about the therapeutic value of their products.
It sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection, for example.
FDA sent a letter warning to a company about its marketing of injectable CBD products that led to a voluntary recall in May.
The agency also publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Photo by Kimzy Nanney.
Veterans Working In Marijuana Industry Aren’t Automatically Blocked From Home Loans, VA Says
The U.S. Department of Veterans Affairs (VA) recently clarified to Congress that it does not have a policy automatically barring veterans from receiving home loans solely because they work in the marijuana industry—and now a key House committee is asking the department to better communicate that to lenders and would-be borrowers.
For the past year, Rep. Katherine Clark (D-MA) and other lawmakers have been pressing VA on difficulties some veterans have faced in securing the benefit, with at least one constituent telling Clark that they were denied a home loan because of their work in the state-legal cannabis market. That prompted the congresswoman to circulate a sign-on letter and introduce an amendment to resolve the problem.
However, in a report submitted to Congress last month that was obtained by Marijuana Moment, VA said there is no policy on the books that calls for home loan denials due to employment at a cannabis business. Instead, the department clarified that conflicting state and federal laws makes it “difficult to prove the stability and reliability of cannabis-derived income,” which are key factors in determining loan eligibility.
“VA is committed to working diligently to serve our Nation’s Veterans by providing eligible Veterans with home loan guaranty benefits,” VA said. “There is nothing in VA statutes or regulations that specifically prohibits a Veteran whose income is derived from state-legalized cannabis activities from obtaining a certificate of eligibility for VA home loan benefits. However, given the disparity between Federal and State laws on cannabis, determining whether such a Veteran is able to obtain a loan has become a complex issue.”
A person’s “reliance on [marijuana-derived] income may hinder a Veteran’s ability to obtain a VA-guaranteed home loan, a result that is consistent with other federal housing programs,” the report states. “VA also notes that many lenders have established their own income thresholds and policies on overlays, which are often more stringent than VA’s requirements, to ensure that the VA-guaranteed loan will be purchased by an investor in the secondary mortgage market.”
In other words, individual lending companies may be denying home loans to veterans because the cannabis industry-derived income they would use to pay back loans isn’t necessarily stable and reliable due to the fact that federal officials could shut down their employers at any time.
If that’s the case, then it doesn’t appear it would be necessary to pass legislation targeting the narrow issue in the way lawmakers did last year. Clark’s amendment to address the problem was approved by the House as part of a defense spending bill—though leaders in the chamber agreed to scrap it after the Senate didn’t include it in its version of the legislation.
The House Appropriations Committee also approved report language last year attached to the bill that funds VA expressing concern that the department “has never publicly stated its position on this matter, hindering Veterans’ ability to fully understand and consider how employment decisions could affect future eligibility for earned benefits.”
The newly released explanation from VA is a result of that provision.
Now, for the next fiscal year, a new report attached to the latest Military Construction, Veterans Affairs, and Related Agencies spending bill acknowledges VA’s recent policy clarification—but lawmakers are asking the department to do more.
“The Committee understands that as directed by House Report 116–63, VA has clarified that nothing in VA statutes or regulations specifically prohibits a Veteran whose income is derived from state-legalized cannabis activities from obtaining a certificate of eligibility for VA home loan benefits,” the report states. “The Committee directs the VA to improve communication with eligible lending institutions to reduce confusion among lenders and borrowers on this matter.”
Clark told Marijuana Moment that “no veteran should be denied benefits simply because they work within the legal cannabis industry.”
“This must be crystal clear in our laws and communicated directly to both borrowers and lenders,” the congresswoman said. “By including this language, we’re eliminating any doubt about the rights of our service members and protecting their ability to access what they’ve rightfully earned.”
In other veterans and cannabis news this year, the Congressional Budget Office released an analysis on a marijuana research bill for veterans and determined that it would have no fiscal impact. And a federal commission issued recommendations to promote research into the therapeutic potential of both cannabis and psychedelics such as psilocybin mushrooms and MDMA.
Read VA’s report on its home loan policy for veterans working in the marijuana industry below:
Photo courtesy of Mike Latimer.
Idaho Medical Marijuana Activists Ask State For Electronic Signature Gathering Option Following Court Ruling
Idaho activists have formally requested that the state allow them to collect signatures electronically for a medical cannabis legalization initiative following a series of federal court rulings on the issue in a case filed by a separate campaign.
While the signature submission deadline passed in May, advocates for an education funding campaign filed a suit against the secretary of state, arguing that social distancing restrictions that were put in place due to the coronavirus pandemic meant the state should give them more time to digitally petition. The judge agreed and ordered the state to allow them to do so for 48 days starting Thursday.
The marijuana reform campaign feels that the same relief should be extended to them as well, and an attorney representing the group sent a letter to the secretary of state this week, asking that the Elections Division also provide cannabis activists with the digital petitioning and deadline extension concessions that the federal judge granted to the education funding group.
In one of the latest developments, the state’s request to the U.S. Court of Appeals for the Ninth Circuit to temporarily force the suspension of electronic signature gathering was denied on Thursday, though the appeal on the broader case is ongoing. That’s given the cannabis activists more hope as they pursue legal routes to have the lower court’s ruling apply to them.
BREAKING: State of Idaho's request to block our e-signature drive for K-12 funding DENIED by the Ninth Circuit Court of Appeals. It's time to give Idaho voters a chance to do what those in power refuse to do: Save our schools from deep budget cuts & invest in our children. #idpol
— Luke Mayville (@lukemayville) July 9, 2020
Russ Belville, campaign spokesperson for the Idaho Cannabis Coalition, told Marijuana Moment that the group was “thrilled” to see the appeals court refuse to stay the electronic signature gathering decision.
“Our attorneys are working to convince the state to provide our Idaho Medical Marijuana Act petition the same electronic signature gathering relief, as we have suffered the same infringement of our petitioning rights,” he said. “It’s a shame it takes a pandemic to even consider allowing electronic signatures on petitions. Idaho should make every effort to make exercising our rights as easy as possible, especially for sick, disabled, elderly, infirm and rural folks without easy access to an in-person petitioner.”
In the new letter to Idaho Secretary of State Lawerence Denney, attorney Bradley Dixon said his client “has standing to pursue a remedy given the impact that the COVID-19 restrictions have had upon it.” The campaign “can show (1) they have suffered an injury in fact, which is both concrete and particularized, and actual or imminent; (2) their injury is fairly traceable; and (3) their injury will likely be redressed by a favorable outcome.”
“Moreover, just like Reclaim Idaho, as illustrated above, our client can show that it was diligent in collecting signatures and had adopted a thorough plan to achieve ballot success in advance of the unforeseeable coronavirus outbreak. Considering the merits of a possible case, our client’s First and Fourteenth Amendments rights have been harmed because the State of Idaho and its agents did not provide an alternative means to signature collection during the stay at home order, or during any of the phased reopening stages.”
The state’s stay-at-home order “made it impossible to retrieve all statutorily-required signatures because of both the reduction in time to collect such signatures, and the deadline date to obtain signatures falling on the same day as the end of the stay at home order,” the attorney said.
If the campaign is ultimately allowed to proceed with signature gathering, they will need 55,057 valid signatures to qualify for the November ballot. Activists said they have about 45,000 unverified signatures on hand at this point, and they’re confident that can fill the gap if they get the deadline extension and electronic petitioning option.
The group has indicated it is prepared to seek relief directly from the courts if the secretary of state does not comply with their request to his office.
Under the proposed ballot measure, patients with qualifying conditions could receive medical cannabis recommendations from physicians and then possess up to four ounces of marijuana and grow up to six plants.
Advocates say that passing medical cannabis in one of the remaining states without such policies on the books would be a significant victory for patients in its own right—but it could also have outsized federal implications. A House-passed bill to protect banks that service state-legal cannabis businesses from being penalized by federal regulators is currently pending action in a Senate committee chaired by a senator who represents the state.
Creating a medical marijuana program in Idaho, which is one of small handful of states that don’t yet even have limited CBD laws, could put additional pressure on Senate Banking Committee Chairman Mike Crapo (R-ID) to move the financial services legislation in Congress.
Read the letter to the secretary state on allowing electronic signature gathering for medical marijuana below: