The Food and Drug Administration (FDA) issued an update to Congress this week on the status of rulemaking for CBD.
While the process remains ongoing, the agency announced that it is actively exploring pathways to allow for the marketing of cannabidiol as a dietary supplement and is developing enforcement discretion guidance. It will also be reopening a public docket to solicit additional scientific information about the risk and benefits of the cannabis compound.
After hemp and its derivatives were federally legalized under the 2018 Farm Bill, FDA was mandated under separate appropriations legislation passed late last year to provide an update on its regulatory approach to CBD within 60 days. That deadline passed last month, but the report and a supplementary notice were made public on Thursday.
“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions,” the agency told lawmakers. “Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”
FDA has previously issued warnings to CBD companies that make unsubstantiated claims about the therapeutic potential of the non-intoxicating compounds, and it said it remains concerned about such practices and will continue to take enforcement action against such businesses.
The agency reviewed what’s known about CBD—acknowledging that data was limited “because cannabis-derived CBD was a Schedule I controlled substance” prior to hemp legalization. The roadblocks to research caused by marijuana’s ongoing restrictive Schedule I status is something legalization advocates have long pointed out.
“Thus, limited systematic data exist to inform our approach,” FDA wrote. “As more data on CBD become available, we will be able to refine—and, perhaps in some cases, revise—our thinking and approaches.”
The report notes that there are means to develop FDA-approved drugs based on CBD, as has been done for one prescription medication to treat severe seizure disorders, but it stressed that “CBD is not a risk-free substance” and could impact liver health and have adverse interactions with other drugs. Further, the agency said it is concerned about mislabeling and the presence of adulterants in unregulated products.
That said, FDA said it is “actively evaluating what and how much data would be sufficient to support a conclusion that CBD can safely be allowed in dietary supplements under certain conditions.” To expedite the process, it is also “evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rulemaking.”
“Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities based on the known risks to public health. As we move forward, FDA intends to continue taking action to address violations we identify that put the public at risk.”
There are a number of questions that FDA is considering as it continues to develop regulations for CBD products.
“1. What happens if you use CBD daily for sustained periods of time?
2. What level of intake triggers the known risks associated with CBD?
3. How do different methods of exposure affect intake (e.g., oral consumption, topical, smoking or vaping)?
4. What is the effect of CBD on the developing brain (such as children who take CBD)?
5. What are the effects of CBD on an unborn child or breastfed newborn?
6. How does CBD interact with herbs and botanicals?
7. Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?
8. Are there differing safety concerns for use in certain animal species, breeds, or classes?
9. Are any residues formed in edible tissues of food producing animals?”
While CBD is not currently allowed to be marketed as a dietary supplement, FDA wrote that it “has the authority to remove this exclusion through rulemaking.” Answering these questions—through the reopened public docket as well as discussions with government partners—will help facilitate that process. The docket will remain open “indefinitely” for stakeholders to submit relevant information to assist in the rulemaking process, it said.
“We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements,” FDA said.
“Given the significant public interest in the potential for CBD dietary supplements, as well as the extent to which many such products are available on the market, FDA has been taking a highly proactive approach to analyzing relevant safety questions. Rather than waiting for data to be submitted, we have been actively working to identify and review all available data to understand the risk profile of CBD and the potential for CBD to be safely included in dietary supplements, under certain conditions of use.”
But allowing CBD to be sold as a dietary supplement creates certain concerns, it said. For example, dietary supplement makers are not regulated in the same way as, say, pharmaceutical companies, and so that would “limit our ability to provide systematic and comprehensive oversight over all CBD products.”
To fill the gap in product-specific information about CBD, FDA said it will set up a system for proprietary data to be submitted to the agency in the hopes that the process “will enable responsible industry participants to share relevant information with FDA about specific products, which could help inform appropriate regulatory steps.”
Another notable component of the report concerns CBD vaping products. The agency said such products increase the risk of toxicity issues and could also appeal to youth. It emphasized that CBD vaping items cannot be marketed as a drug without FDA approval.
“We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” FDA said in a separate notice for the public on Thursday. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”
We’re seeing CBD being marketed in a number of different products & understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons. Aside from one prescription drug, no other CBD products have been evaluated/approved by FDA.
— Dr. Stephen M. Hahn (@SteveFDA) March 5, 2020
Though FDA has consulted with government partners at the federal, state, local and international levels, it has yet to do so for tribal entities. The agency stands “ready to do so,” the report states, adding that FDA plans to host a call with state public health officials on CBD safety issues.
FDA said it has received feedback inquiring about whether “full spectrum” or “broad spectrum” hemp products that contain CBD are allowed to be marketed. There’s a lack of clarity to that end because, as the agency noted, while such terms generally indicate that the products are not CBD isolates, some contain high levels of the compound.
“We are actively seeking information from individual manufacturers, trade groups, and others regarding the processes by which ‘full spectrum’ and ‘broad spectrum’ hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products,” it said. “Such information will be critical to informing our evaluation of the regulatory status of such products.”
These efforts are in line with our mission to protect the public, foster innovation & promote consumer confidence. We’re committed to working efficiently to further clarify our regulatory approach – using science as our guide & upholding our rigorous public health standards.
— Dr. Stephen M. Hahn (@SteveFDA) March 5, 2020
The agency also acknowledged a separate congressional mandate to conduct product sampling of CBD products on the market to determine the extent to which there is contamination or adulteration. It said it is actively developing a plan to accomplish that within the 180-deadline set in last year’s spending legislation.
“As this report outlines, we have made progress, but there are still areas where timely attention is needed,” FDA said. “Ultimately, we remain steadfast and committed to working with all stakeholders to ensure the protection and promotion of public health. This is especially so with respect to our government partners at the federal, state, local, territorial, tribal and international levels.”
While the report does not offer much in the way of policy updates and largely describes ongoing efforts to develop CBD rules, FDA does appear to be heeding the opinion of lawmakers and stakeholders who have repeatedly implored the agency to provide a pathway for marketing of the compound.
Relatedly, the newly installed commissioner of FDA said last week that given the widespread availability and interest in CBD, it would be a “fool’s game” to ban them.
Read the full FDA report on CBD below:
Photo by Kimzy Nanney.
Federal Judge Gives Arkansas Marijuana Legalization Activists A Boost With Signature Gathering Ruling
Activists behind a marijuana legalization initiative in Arkansas are seeing glimmers of hope that they will be able to qualify for the November ballot despite serious setbacks caused by the coronavirus pandemic.
A federal judge ruled on Monday that the secretary of state must accept signatures that were not collected in-person or notarized, as has been required by existing policy, because of excessive burdens that imposes on campaigns amid the health crisis. Legalization advocates say the temporary injunction, which comes before a final ruling, gives them confidence their measure can qualify ahead of a July 3 deadline to submit signatures.
Now people can download, print and mail in signed petitions—significantly bolstering the chances the legal cannabis campaign can make up for the petitioning deficit created by stay-at-home orders and social distancing requirements enacted due to the COVID-19 outbreak.
In the April lawsuit that brought about the federal injunction (which was not filed by legalization activists but by another initiative campaign), plaintiffs also made the case that full-scale electronic signature gathering should be permitted. U.S. District Judge P. K. Holmes empathized with that request in his order, noting that in many scenarios outside the ballot process, officials have recognized the validity of digitally signed documents—including in legal proceedings he oversees.
“It is not that electronic signatures cannot similarly be determined to be genuine. In fact, electronic signatures are commonplace and accepted for all manner of official business, and not only by the State, but by this Court,” he said. “Counsel for Plaintiffs and the Secretary of State electronically signed the briefing on this very motion, and the Court has electronically signed this opinion and the order.”
However, the judge said there must be a balance that takes into account the state’s interest in ensuring the validity of signatures and so he’s doubtful the final ruling will provide for digital signatures.
In any case, the court’s temporary injunction bodes well for the marijuana reform campaign, Arkansans for Cannabis Reform, which says it was on the path to qualifying before in-person signature gathering was suspended. Melissa Fults, executive director of the group, told Marijuana Moment in a phone interview on Wednesday that she’s confident the new policies will help the initiative get placed before voters.
“I am still confident. We’re going to give a hard push these next four-and-a-half weeks—hoping and praying that we get signatures and get them turned in and get on the ballot,” she said. “And I think it’ll pass once it gets on the ballot.”
Arkansas voters approved a medical cannabis ballot measure in 2016.
As the state begins the process of reopening, Fults said the campaign will also be engaging in limited in-person collection with enhanced safety mechanisms in place, as well as “drive by” gathering for people to sign the initiative from their vehicles.
In order to make the ballot, the group needs to submit about 90,000 valid signatures from registered voters by July 3. Fults said they’ve collected roughly 20,000 so far, and so these last five weeks will prove critical.
Under the proposal, adults 21 and older would be able to purchase and possess up to four ounces of cannabis flower and grow up to six plants and six seedings.
A minimum of one dispensary must be licensed per county, and there must be at least 30 shops per congressional district.
Tax revenue from marijuana sales would first go toward implementation. After that, 60 percent would be used to fund public pre-K and after school programs and 40 percent would fund the operations of the University of Arkansas for Medical Sciences.
Another campaign that was working to put cannabis legalization on the state’s ballot told the Arkansas Democrat Gazette on Tuesday that it is ending its effort for the year and will shift its focus to 2022. An Arkansas True Grass spokesperson said “we weren’t able to do any of our spring events” because of the virus, leaving them without an opportunity to qualify.
Here’s a status update on other drug policy reform efforts throughout the country:
Activists in Montana and Nebraska have resumed signature gathering with new safety measures in place for campaigns to legalize adult-use marijuana and medical cannabis, respectively.
In Arizona, the organizers of a legalization effort asked the state Supreme Court to instruct the secretary of state to allow people to sign cannabis petitions digitally using an existing electronic system that is currently reserved for individual candidates seeking public office. That request was denied but in March the campaign expressed optimism that they had amassed enough signatures to qualify anyway.
Separate Oregon campaigns to decriminalize drug possession while significantly expanding substance misuse treatment and to legalize psilocybin mushrooms for therapeutic purposes recently submitted more than enough raw signatures to qualify for ballot access, though they must still be verified.
Activists in Washington State are continuing to work on a drug decriminalization and treatment measure.
Washington, D.C. activists behind a psychedelics decriminalization campaign are more confident that they will be able to make the ballot after the District Council voted in favor of a series of changes to signature gathering protocol.
A federal judge recently ordered Ohio officials to accept electronic signature submissions to place local marijuana decriminalization measures on the ballot—a decision that could potentially have positive implications for a statewide legalization campaign in the works.
California activists had hoped to get a measure to legalize psilocybin on the state’s November ballot, but the campaign stalled out amid the coronavirus pandemic.
A California campaign seeking to amend the state’s cannabis law asked for a digital petitioning option, but state officials haven’t signed on.
A campaign to legalize cannabis in Missouri officially gave up its effort for 2020 due to signature collection being virtually impossible in the face of social distancing measures.
North Dakota activists said they plan to continue campaign activities for a marijuana legalization initiative, but it’s more likely that they will seek qualification for the 2022 ballot.
Idaho medical cannabis activists announced that they are suspending their ballot campaign, though they are still “focusing on distributing petitions through online download at IdahoCann.co and encouraging every volunteer who has downloaded a petition to get them turned in to their county clerk’s office by mail, regardless of how many signatures they have collected.”
Prior to the COVID-19 outbreak and stay-at-home mandates, measures to legalize marijuana for medical and recreational purposes qualified for South Dakota’s November ballot.
The New Jersey legislature approved putting a cannabis legalization referendum before voters as well.
And in Mississippi, activists gathered enough signatures to qualify a medical cannabis legalization initiative for the ballot—though lawmakers also approved a competing (and from advocates’ standpoint, less desirable) medical marijuana proposal that will appear alongside the campaign-backed initiative.
Read the federal judge’s order on Arkansas signature gathering below:
Scientists And Veterans File Lawsuit Challenging DEA’s Marijuana Rescheduling Denials
The Drug Enforcement Administration (DEA) is facing yet another marijuana-related lawsuit—and this time, researchers and veterans are challenging the agency’s denial of prior cannabis rescheduling requests.
The Scottsdale Research Institute (SRI) filed suit last week in the U.S. Ninth Circuit Court of Appeals, asking for a review of DEA’s scheduling determinations in 2020, 2016 and 1992. In all cases, the agency denied the petitions, citing statutory obligations to maintain the status of cannabis as a Schedule I drug under the Controlled Substances Act.
Petitioners are taking exception to the basis of those denials, raising questions about DEA’s reliance on scheduling standards that they feel are arbitrary and misinterpret federal law. In particular, they are seeking reviews of the agency’s claims that marijuana must be strictly scheduled because, the government has claimed, it has no currently accepted medical value and has not been proven to be safe.
They also argue that another statutory policy DEA says necessitates marijuana being strictly controlled is unconstitutional.
“The reason we’re filing this is because, ultimately, the research has been impeded,” Matt Zorn, an attorney representing SRI in the case, told Marijuana Moment. “We’re trying to get the administration to remove those roadblocks.”
In terms of valid therapeutic value, the agency has said there are five criteria that a substance must meet, including the reproducibility of the drug, the existence of controlled studies establishing safety and efficacy and “whether the drug is not accepted by qualified experts.”
Lawyers representing SRI argued in a filing that the test “has no basis in the statute, is contrary to the statutory text, structure, history, and purpose, departs from the original understanding of the statute and rests on flawed and outdated case law.”
Further, they said DEA’s determination that there’s a “lack of accepted safety for use of marijuana under medical supervision” is wrong because it “misconstrues the statute and is arbitrary, capricious, and contrary to law because the agency has improperly imported a clinical efficacy requirement.”
In its past denials of rescheduling petitions, the agency has asserted that marijuana can only be placed in either Schedule I or II. But the attorneys said the statute justifying that determination is “an unconstitutional delegation of legislative authority” that “violates core separation of powers principles” by granting the attorney general authority to schedule drugs on his or her discretion based on an interpretation of international treaty obligations.
“[T]he statute outsources regulatory power to create domestic criminal law to international organizations and subordinates domestic law to treaty obligations, conventions, and protocols,” the suit states. “Then, it entrusts the Attorney General, a member of the executive branch, to execute non-self-executing international treaty obligations, providing him no intelligible principle, instructions, standards, or criteria whatsoever against which to measure what ‘he deems most appropriate.’ This is unconstitutional.”
Stephen Zyskiewicz, who filed the handwritten 2020 rescheduling petition that is central to the new suit’s claims, is not a party to the case. Instead, several military veterans, as well as SRI and its principal investigator Sue Sisley, are the plaintiffs.
“Marijuana’s schedule I status and DEA’s determinations hinder SRI’s clinical research—the very clinical research that DEA requires under its unlawful interpretation of 21 U.S.C. § 812(b)(1)(B) to consider removing marijuana from schedule I—in several key respects,” the lawsuit states. For example, the scheduling status has meant that “SRI has had to delay FDA-approved clinical trials to investigate the safety and efficacy of smoked marijuana in treating breakthrough pain in terminal cancer patients.”
This isn’t SRI’s first time taking the feds to court over their marijuana decisions. The institute, which is among several dozen applicants to become a federally authorized manufacturer of cannabis for research purposes, successfully forced DEA to issue an update on the status of their application processing and then got the Justice Department to hand over a “secret” memo that DEA allegedly used to justify a delay in deciding on those proposals.
“What has been animating all of these lawsuits is that we can’t get the research done,” Zorn said. “The ideal result is that we stop filing lawsuits and the administration decides it wants to support cannabis research. But until that happens, we’ll be in the courts.”
Meanwhile, a public comment period recently ended for proposed rules that DEA published as part of its attempt to expand the number of authorized cannabis manufacturers. Many advocates made the case that marijuana research should not be the purview of DEA at all and should instead be handled by a federal health agency.
DEA could also find itself being challenged over its marijuana scheduling decisions in the U.S. Supreme Court in a separate case. After an appeals court dismissed a lawsuit because the plaintiffs said they wouldn’t push for rescheduling through administrative channels, attorneys in the case said they will soon request that the nation’s highest court take it up.
Read the new lawsuit challenging DEA’s marijuana rescheduling denials below:
Photo by Aphiwat chuangchoem.
USDA Approves Hemp Plans For U.S. Virgin Islands And Four Indian Tribes
The U.S. Department of Agriculture (USDA) announced on Wednesday that it has approved hemp regulatory plans from a U.S. territory and four additional Indian tribes.
The U.S. Virgin Islands is the first territory to have its proposal accepted. USDA also signed off on plans from the Cheyenne River Sioux Tribe, Chippewa Cree Tribe, Lac Courte Oreilles Band of Lake Superior Chippewa Indians and Red Lake Band of Chippewa Indians.
That brings the total number of approved plans across states, territories and tribes to 47.
USDA has been signing off on hemp plans on a rolling basis since the crop and its derivatives were federally legalized under the 2018 Farm Bill. Earlier this month, Massachusetts joined the list of states where proposed regulations for hemp have been approved.
The department said in a new notice that it “continues to receive and review hemp production plans from states and Indian tribes.”
While the agency released an interim final rule for a domestic hemp production program last year, industry stakeholders and lawmakers have expressed concerns about certain policies it views as excessively restrictive.
USDA announced in February that it will temporarily lift two provisions that the industry viewed as problematic. Those policies primarily concern testing and disposal requirements. The department declined to revise the THC limit, however, arguing that it’s a statutory matter that can’t be dealt with administratively.
Agriculture Secretary Sonny Perdue has said on several occasions that the Drug Enforcement Administration influenced certain rules, adding that the narcotics agency wasn’t pleased with the overall legalization of hemp.
Meanwhile, the Food and Drug Administration (FDA) is still in the process of developing regulations for CBD. It sent an update on its progress to Congress in March, explaining that the agency is actively exploring pathways to allow for the marketing of the cannabis compound as a dietary supplement and is developing enforcement discretion guidance.
An FDA public comment period was reopened indefinitely for individuals to submit feedback on CBD regulations.
Amid the coronavirus pandemic, hemp industry associations pushed for farmers to be able to access to certain COVID-19 relief loans—a request that Congress granted in the most recent round of coronavirus legislation.
However, USDA said last week that hemp farmers are specifically ineligible for its Coronavirus Food Assistance Program. While the department initially said it would not reevaluate the crop’s eligibility based on new evidence, it removed that language shortly after Marijuana Moment reported on the exclusion.
Hemp farmers approved to produce the crop do stand to benefit from other federal loan programs, however. The department recently released guidelines for processing loans for the industry.
Photo courtesy of Brendan Cleak.