The Food and Drug Administration (FDA) once again rejected an attempt by a prohibitionist group to add marijuana and THC to a list of restricted over-the-counter drugs.
Drug Watch International (DWI), an anti-drug group led by a former Drug Enforcement Administration special agent, initially submitted a petition asking FDA to classify cannabis and THC as “negative monographs” in November 2017, arguing that doing so would send a message to the marijuana industry and mitigate public health risks.
A negative monograph is a classification for substances that FDA does not consider “generally recognized as safe and effective,” meaning they are illegal to market.
FDA denied that petition in July 2018 and laid out various reasons the request was unfounded. While stating that FDA appreciated the petitioners concerns about the unlawful marketing of products containing cannabis, the agency said defining marijuana and THC as negative monographs “is not necessary for the protection of public health” and that existing laws are in place to prevent such illegal marketing.
Two months later, DWI submitted a “petition for reconsideration,” stating that FDA is “not enforcing laws to halt unlawful marketing of unapproved cannabinoid medicines.” The group argued that adding the substances as negative monographs would “clarify the [legal] status of cannabinoid drugs” and emphasized that FDA has added other drugs to the restricted list “that are less dangerous than marijuana.”
In a letter dated July 18, 2019, FDA shot down the appeal and systematically rejected each of DWI’s arguments.
“We have carefully considered the Reconsideration Petition and comments submitted to the public docket for the Reconsideration Petition,” FDA wrote. “For the reasons set forth below, FDA denies your Reconsideration Petition.”
To start with, FDA explained that it is not required to consider petition appeal requests that include “new information and views,” which is exactly what DWI included in its request. The agency decided to review the appeal anyway, and it still found that the request was baseless.
“We conclude that the Reconsideration Petition does not warrant modifying or overruling the Original Petition Response,” Lowell Schiller, FDA’s principal associate commissioner for policy, wrote. “We have not found that granting the Reconsideration Petition would be in the public interest or in the interest of justice. Additionally, the relevant information and views in the administrative record were adequately considered when we denied the Original Petition.”
Here are the other reasons that FDA said it wouldn’t be accepting the petition for reconsideration:
—Citizen petitions aren’t supposed to be used to force enforcement action by FDA.
—Laws prohibiting the marketing of unapproved over-the-counter drugs are “unambiguous” and so classifying cannabis and THC as negative monographs would not, as DWI argued, clarify their legal status.
—FDA has an arsenal of communications tools to convey its concerns about the public health risks of marijuana; therefore, it disagreed that “undertaking the monograph rulemaking process is a necessary, effective, or efficient way to communicate to the public” about such risks.
—Although DWI said the inclusion of other substances that it claims are less harmful than marijuana as negative monographs demonstrated a need to add marijuana, FDA replied that inclusion on the list “does not necessarily mean that therapeutic categories and active ingredients that are not included in negative monographs pose comparatively more or less serious potential risks to the public health.”
“While we appreciate the safety and public health concerns that motivate your requests, the Reconsideration Petition does not persuade us to modify or overrule the Original Petition Response,” FDA concluded. “We have not found that granting the Reconsideration Petition would be in the public interest or in the interest of justice. Additionally, the relevant information and views in the administrative record were adequately considered when we denied the Original Petition.”
Though FDA’s response to the petition is far from an endorsement of cannabis or its derivatives, it signals that the current administration is not interested in entertaining bad faith attempts to disrupt the legal industry.
That said, the agency has made clear that it will continue to take enforcement action against marijuana and hemp companies that make unsanctioned claims about the therapeutic potential of their products. Most recently, it sent a warning letter to CBD company Curaleaf for selling “unapproved products with unsubstantiated therapeutic claims,” causing the company’s stocks to plummet.
At the same time that FDA is working to hold cannabis businesses accountable, it is also working to develop regulations for hemp-derived CBD, which was federally legalized under the 2018 Farm Bill. Earlier this month, the agency said it was speeding up its rulemaking process amid growing pressure from industry stakeholders and policymakers.
Read FDA’s full letter rejecting the further restricting of marijuana below:
Photo courtesy of Mike Latimer.
Bipartisan Lawmakers Tell DEA To Let Researchers Study Marijuana From Dispensaries
A bipartisan coalition of lawmakers from the House and Senate sent a letter to the Justice Department on Friday, requesting a policy change allowing researchers to access marijuana from state-legal dispensaries to improve studies on the plant’s benefits and risks.
The letter, led by Rep. Harley Rouda (D-CA) and Sen. Brian Schatz (D-HI), cites feedback from federal health agencies, which have said that existing restrictions on cannabis have inhibited research. One problem in particular is that there’s only one federally authorized manufacturer of research-grade marijuana.
While the Drug Enforcement Administration (DEA) said that it is in the process of approving additional manufacturers, it’s been more than three years since they first announced that applications for more growers would be accepted and, more recently, the agency said it would have to develop alternative rules to approve proposals that have been submitted.
“At the same time, the status quo does not address a barrier to research raised by both [the National Institutes of Health] and [the Food and Drug Administration],” the lawmakers wrote in the new letter. That barrier is a ban on researchers being able to obtain marijuana from dispensaries.
“Both agencies recommended that researchers should be able to obtain cannabis from state-legal sources,” the letter states.
Today, @SenBrianSchatz and I sent a bipartisan letter to AG Barr, urging the DEA to amend current policies to improve research on cannabis.
It’s time to bring our drug research policies into the 21st century.https://t.co/bfpPUhUvQf
— Rep. Harley Rouda (@RepHarley) December 6, 2019
Further, the lawmakers said that there are “problems in industry development of licensed drugs with data from products obtained from third-parties, such as the University of Mississippi.”
“In many states, cannabis law and regulations already provide for licensing of industrial manufacturing activities, and products are available for medical use in those states, but not for research leading to FDA licensure,” they wrote.
“There is a need for a greater diversity of cannabis products so that research on benefits and risks reflects the realities of what consumers and patients are using. NIH and FDA have strongly recommended streamlining the process for conducting research and product development activities with cannabis and other Schedule I substances, and that the DEA take action to assure that interpretations of processes and policies are universally applied in local DEA jurisdictions.”
The lack of chemical diversity in the federal government’s cannabis supply has been repeatedly pointed out. One study found that the research-grade cannabis is more similar to hemp than marijuana in commercial markets.
To resolve the research issues, the coalition made two recommendations: 1) to amend internal policy “so as to allow researchers with Schedule I licenses to obtain cannabis-derived products from state authorized dispensaries for research purposes” and 2) issue guidance clarifying that hemp researchers do not need a DEA license to obtain and study hemp because it was federally legalized under the 2018 Farm Bill.
The letter requests a response from DEA by December 20.
A total of 21 members of Congress signed the letter, including Sens. Kamala Harris (D-CA) and Cory Gardner (R-CO), along with Reps. Earl Blumenauer (D-OR), Barbara Lee (D-CA) Matt Gaetz (R-FL) and Joe Kennedy (D-MA).
“Our nation’s cannabis research laws are archaic,” Rouda said in a press release. “Forty-seven states have legalized some form of cannabis consumption—we must ensure our federal agencies and other licensed institutions can comprehensively study the benefits and risks of cannabis products.”
“I thank Senator Schatz, and my colleagues on both sides of the aisle, for joining me to make this common-sense request,” he said. “It’s time to bring our drug research policies into the 21st century.”
Attorney General William Barr received a similar letter from lawmakers about the need to expand the number of federally authorized marijuana cultivators in April.
Read the lawmakers’ full letter on expanding marijuana research below:
Oregon Activists Begin Signature Gathering For 2020 Drug Decriminalization Initiative
Oregon activists have begun collecting signatures for a statewide initiative to decriminalize possession of all drugs.
Three months after petitioners quietly submitted the proposed ballot measure—titled the “Drug Addiction Treatment and Recovery Act” (DATRA)—the signature gathering process has started, with organizers deployed to Portland to raise support.
A long road lies before the activists, who need to collect 112,020 valid signatures from voters in order to qualify for the 2020 ballot. Funding and polling will decide whether they mount a full push for the decriminalization measure in the months to come.
To that end, their efforts are being helped by David Bronner, CEO of the soap company Dr. Bronner’s, who told Marijuana Moment on Thursday that he will be investing $250,000 in the decriminalization campaign. An additional $500,000 will go to a separate Oregon initiative to legalize psilocybin for therapeutic purposes.
The Drug Policy Alliance (DPA), which backed Oregon’s successful marijuana legalization initiative in 2014, is also supporting this new effort to make low-level drug possession an infraction punishable by a $100 fine with no jail time, rather than a misdemeanor. It remains to be seen how involved in the campaign DPA will be, however.
Peter Zuckerman, a chief petitioner for the decriminalization initiative, told OregonLive on Thursday that it’s not guaranteed that the campaign will proceed and that much rides on how much money the group can raise, whether there’s public support for the reform move and how staff recruitment comes together.
He said the main thrust of the measure is to take a “health-based approach to drug addiction rather than a criminal justice-based approach.”
The proposal caught the attention of Oregon’s teachers’ union, which said that it supports decriminalizing drug possession but wrote in a comment submitted to the secretary of state in October that it was not taking an official position because it’s concerned about another provision that would shift cannabis tax revenue away from schools.
DATRA would make it so most of that revenue would be used to fund addiction treatment programs.
At the same time that activists are collecting signatures and weighing whether to move ahead with the broad decriminalization initiative, another advocacy group is pushing for a measure to legalize psilocybin for therapeutic use, allowing individuals to receive treatment with the psychedelic fungus at licensed health facilities. The group launched its signature drive in September.
Advocates in Portland are also hoping to advance a local measure to decriminalize psilocybin and other psychedelics such as ayahuasca and ibogaine.
Bronner wrote in a blog post that the decriminalization and therapeutic psilocybin legalization campaigns are “already coordinating closely and conserving resources on the statewide signature drive.”
He told Marijuana Moment that “we see this as the perfect one two punch in Oregon, legalizing psilocybin therapy that has so much promise for treating drug addiction, at the same time Oregon shifts to a treatment not jail approach.”
“And 100 percent confident it’s coming together,” he said.
All of this comes amid a national movement to decriminalize psychedelics, with activists in almost 100 cities across the U.S. considering pushing for reduced penalties for substances such as psilocybin and ayahuasca. Decriminalize Nature, which is aiding in and tracking these efforts, is also receiving donations from Bronner, he said.
Decriminalization is also gaining traction on the national stage, with two presidential candidates—South Bend, Indiana Mayor Pete Buttigieg and Rep. Tulsi Gabbard (D-HI)—voicing support for the policy change. Former Housing and Urban Development Secretary Julián Castro, another candidate, recently said that he’s open to broad decriminalization, while entrepreneur Andrew Yang backs decriminalizing opioids.
North Dakota Activists Submit Measure To Legalize Marijuana In 2020
North Dakota activists submitted a measure to legalize marijuana for adult use to state officials on Thursday, an organizer confirmed to Marijuana Moment.
Legalize ND, the group behind the proposed statutory initiative, delivered the measure to the secretary of state’s office. It’s expected to be validated within days, after which point petitions will be distributed to collect signatures in support of qualifying for the 2020 ballot.
It’s been about a year since organizers began working on the measure, which would allow adults 21 and older to possess and purchase cannabis for personal use. The proposal is more narrowly tailored than a legalization initiative from the same organization that voters rejected in 2018, however.
The previous version didn’t include any restrictions on cultivation or possession, and it didn’t involve a licensing scheme. By contrast, the new measure would prohibit home cultivation, limit possession to two ounces, impose a 10 percent excise tax and establish a regulatory body to approve licenses for marijuana businesses.
“One of the largest complaints from last time was the mantra of ‘poorly written,'” Legalize ND’s David Owen told Marijuana Moment in a phone interview. “They targeted the lack of legal experience from our team and they targeted a lack of ‘qualified lawyers’ to be drafting language that would go into the state’s statutory law.”
But he said he’s confident the campaign will be successful this time around, in part because they spent months drafting the language with the North Dakota Legislative Council.
Asked what he’d say to voters still on the fence about legalization, Owen replied that it would depend on what their initial concerns were:
“If it’s a concern over home grow, well it’s simple, we don’t have that anymore. If it’s a concern of people having too much, we have a reasonable possession limit now—in their eyes, I still think possession limits are fundamentally arbitrary, but they wanted a possession limit so we have that now. If people go, ‘well what about the quality of the language?’ I can point to how it’s literally written by Legislative Council, so either every attorney who works for the state of North Dakota is incompetent or this is well written.”
In order to qualify for next year’s ballot, the group must collect 13,452 valid signatures from voters before July 6, 2020.
“I think the most important thing isn’t what it would do, but what it would stop from happening,” Owen told local radio station KFGO on Wednesday. “We currently have a system where people are unable to find a job because of a criminal record, we have a system where people are continuing to get marijuana charges and lose their housing, we have families being separated because of parents losing custody over their children for marijuana charges. That all stops when this is legalized.”
Listen to Owen’s radio interview about the new marijuana ballot measure below:
Internal polling that received outside funding, which Owen said cannot be publicly released because of the wishes of the donor, shows the initiative is “slightly ahead” among voters.
In an earlier interview with Marijuana Moment in February, Owen said that it’s “very probable that we can do it” this time around, but much of that depended on the extent to which opposition campaigns are involved and how much funding outside groups are able to offer.
Currently, North Dakota has a medical cannabis program, and the governor signed legislation in May decriminalizing low-level marijuana possession.
Photo courtesy of Philip Steffan.