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.
Marijuana Businesses Could Get Federal Disaster Relief Funds Under New Congressional Bill
Marijuana businesses impacted by recent natural disasters or that have experienced financial distress due to the coronavirus pandemic would be eligible for federal relief programs under new legislation introduced in the House of Representatives and Senate on Thursday.
Because cannabis remains federally prohibited, the Small Business Administration (SBA) has explicitly denied the industry—and businesses that work indirectly with it—access to its relief programs like other markets. That means, for example, marijuana farmers in states like California and Oregon that have seen their crops destroyed by wildfires are fully dependent on state and local assistance.
The new Small Business Disaster Relief Equity Act would resolve that problem, stipulating that disaster- or COVID-related services, grants, loans and tax benefits that are made available through federal agencies or congressional legislation cannot be denied to cannabis businesses solely because of the nature of their work, as long as it is in compliance with state law.
What’s more, the bill states that the the heads of federal agencies that administer disaster relief such as SBA “shall, to the greatest extent practicable, allow State-legal cannabis businesses to retroactively apply for such disaster assistance.”
Sens. Ron Wyden (D-OR) and Jeff Merkley (D-OR) and Reps. Earl Blumenauer (D-OR) and Peter DeFazio (D-OR) filed the companion bills.
“Cannabis businesses in Oregon hurt by the blazing wildfires or any other disaster shouldn’t be shut out from federal relief simply because the federal government is stuck in yesteryear,” Wyden said in a press release. “These legal small businesses employ thousands of workers and support our struggling economy. If they need federal support, they should get it. Full stop.”
SBA recently confirmed to Marijuana Moment that while it opened a disaster relief loan program for Oregon businesses damaged or destroyed by the wildfires, the cannabis industry isn’t eligible. People working in the state-legal market whose primary residences were impacted could still apply, however, but not if they conduct their business from home.
Blumenauer, cochair of the Congressional Cannabis Caucus, said that many marijuana companies in his state “have faced catastrophic disruptions because of wildfires.”
“There’s no reason why these legitimate businesses shouldn’t have access to the federal support meant to help businesses survive unprecedented disasters,” he said. “Our legislation will help ensure these businesses and their workers are not left behind.”
According to the Oregon Liquor Control Commission, 20 percent of marijuana businesses in the state were encouraged to evacuate due to the fires. Regulators are also asking cannabis business owners to fill out a survey so they can get a better sense of how extensive the damage is.
As of this week, seven cannabis business have been destroyed by the fires and at least a dozen have been damaged, Oregon Live reported.
“Whether you’re for or against state-legal cannabis, we can all agree that families in all of our communities are struggling to keep the lights on and stay afloat during this turbulent time—and that they need and deserve support,” Merkley said. “That includes thousands of small business owners, workers and their families who rely on state-legal cannabis businesses for their livelihoods.”
“We have to make sure those families won’t be shut out from critical assistance that can make a real difference,” he said.
The timing of the natural disasters in Oregon isn’t ideal, either, as consumer demand for marijuana products has been up amid the pandemic. In July, the state broke its record for cannabis sales, with about $106 million in medical and recreational cannabis purchases. Oregon’s Office of Economic Analysis said in a report on Wednesday that “since the pandemic began, the increase in recreational sales have been more than 30 percent above forecast.”
Blumenauer in April led a letter with 34 bipartisan members of Congress calling on House leadership to include language in COVID-19 stimulus legislation to allow marijuana businesses to access federal disaster relief. He followed up by filing standalone legislation—the Emergency Cannabis Small Business Health and Safety Act—that would address the problem specifically when it comes to coronavirus relief.
Wyden similarly led a letter with nine other senators in April, asking the chamber’s leadership to extend federal assistance to the cannabis market. Civil rights groups and industry stakeholders have also made these calls to action in recent months.
“It’s ridiculous that legal businesses here in Oregon are being denied critical wildfire aid because of outdated policies handed down from Washington, D.C.” DeFazio said. “Cannabis businesses employ thousands across Oregon and are a vital economic engine for our state. This important legislation will ensure that these businesses are eligible for the same aid as every other business impacted by the 2020 wildfires.”
Read text of the marijuana disaster relief bill below:
Photo courtesy of Philip Steffan.
Congressional Research Service Analyzes Marijuana Expungements And Cannabis Immigration Issues
The Congressional Research Service (CRS) released new two reports on marijuana policy—one dealing with the immigration implications of federal prohibition and the other looking at expungements provisions in pending legislation to deschedule cannabis.
For the immigration-focused report published last week, CRS outlined how being convicted of a marijuana crime, admitting to using cannabis (even in a legal state) or working in the marijuana industry can carry four “key consequences” for non-citizens. They can be deemed inadmissible to the U.S., deported, lose immigration relief benefits and be denied naturalization.
The threat of inadmissibility for state-legal cannabis activity even extends to people who simply invest in the market, CRS said. The report makes a point of reiterating several times that just because something is legal under state law doesn’t mean there are carve outs in federal immigration statutes.
There are also immigration relief benefits that individuals could lose out on because of marijuana-related activities. They include the “waiver of certain criminal inadmissibility grounds, cancelation of removal, voluntary departure, withholding of removal, protection under the Convention Against Torture, asylum, Temporary Protected Status (TPS), and Deferred Action for Childhood Arrivals (DACA),” the report states.
With respect to naturalization restrictions, CRS points out that the Trump administration in 2019 issued a memo clarifying that having a cannabis conviction or admitting to working in the marijuana industry “can bar an individual from establishing [good moral character], even if the marijuana-related activity did not violate applicable state or foreign laws.”
CRS also recognized in the new report that legislation to federally deschedule marijuana—the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act—would help resolve the immigration dilemma, as the bill “would prohibit the denial of any immigration benefit or protection to aliens who have participated in any marijuana-related activity.”
The MORE Act was initially expected to be scheduled for a House of Representatives floor vote this week, but following pushback from certain Democratic lawmakers who felt it would look bad to advance the bill before approving additional COVID-19 relief, it was postponed. Now it’s expected to receive a vote later in fall, likely after the election.
In a separate report also released last week, CRS looked specifically at the MORE Act’s expungement provisions.
The bill would mandate that federal district courts expunge the records of individuals with federal marijuana convictions within one year of the bill’s enactment. It would also allow individuals with cannabis-related convictions to petition courts to have their records cleared prior to the one-year review period.
The Capitol Hill research office noted that federal marijuana convictions represent just a small fraction of the country’s total cannabis convictions, with most being carried out at the state, county and local levels. Relatively few federal cases are for possession alone; most are for trafficking-related charges. According to the U.S. Sentencing Commission, cannabis trafficking convictions are on the decline, with fewer than 2,000 cases occurring last year.
“The expungement provision in the MORE Act could raise several issues for policymakers,” CRS said. “The legislation would only address expungement of criminal records related to federal marijuana offenses; it would not provide relief from convictions for marijuana offenses in state courts.”
But CRS also floated potential solutions such as providing “an incentive for states to adopt uniform laws regarding the expungement of convictions for state level marijuana offenses.”
“For example, Congress may place conditions on federal criminal justice funding, such as the Edward Byrne Memorial Justice Assistance Grant (JAG) program, or provide funds to states to help them implement expungement programs. Congress may consider providing guidelines to states on how to structure their expungement programs,” the report states.
CRS also noted that while the courts could be compelled to expunge records, the bill doesn’t address the fact that certain private companies harvest data on arrests and convictions when they’re publicly available.
“Policymakers might consider whether federal courts should be required to send lists of criminal records that would be expunged under the MORE Act to private background check companies in their respective districts to notify them of the expungement,” the report said.
CRS has dedicated significant time to exploring cannabis policy issues lately. Earlier this month, for example, it released a separate report that identified multiple problems caused by conflicting federal and state marijuana laws.
Photo courtesy of Brian Shamblen.
Oregon Marijuana Sales Spike Could Continue As Consumers ‘Permanently Adjust Their Behavior’ Following COVID
Record-setting Oregon marijuana sales continue to be a bright spot in the state’s coronavirus-slowed economy, state analysts reported this week, but a convergence of unknowns—including the end of federal coronavirus relief and a possible rise in cannabis prices due to devastating wildfires—could still mean a rocky road ahead for consumers.
“Marijuana sales continue to be strong,” Oregon’s Office of Economic Analysis wrote in a quarterly revenue forecast published on Wednesday. “Since the pandemic began, the increase in recreational sales have been more than 30 percent above forecast.”
The increase tracks with other more established cannabis markets, such as those in Colorado, Washington and Nevada, which have also seen “strong gains” since the pandemic, the office said. “There are a number of likely reasons for these higher level of sales and expectations are that some of these increases will be permanent.”
Analysts also expressed a rosier outlook on the future of the state’s marijuana market than they did in last quarter’s report, which acknowledged a spike in sales since the pandemic began but concluded that business was eventually “expected to mellow” as incomes fell and bars reopened. Officials now forecast Oregon will see “somewhat more” in sales than previously projected.
The state has recently seen a string of record-setting months for cannabis sales. Over the summer, monthly cannabis sales had averaged more than $100 million, according to an Oregon Liquor Control Commission (OLCC) report.
The projected uptick in sales will mean an extra $30 million in marijuana tax revenue for the state during its two-year budget period ending in 2021. Total adult-use cannabis taxes for that period are now forecast to end up at more than $276 million.
“Factors leading to increases in sales include higher incomes due to federal support, increased stressors in everyday life, reductions in other forms of entertainment or recreational opportunities, and simply more time on one’s hand be it due to a COVID-related layoff, or increased working from home,” the report said.
“A key question is now that the federal aid is gone and other entertainment options return in the months ahead, will some of this increase in sales in recent months subside?” the Office of Economic Analysis wrote in the new report. “In a recent meeting of our office’s marijuana forecast advisory group, the broad consensus was that yes, some of these sales will come off, but not entirely so. And the longer the pandemic lasts, the more likely customers will permanently adjust their behavior as they become accustomed to their new routines and buying patterns.”
For now, the bulk of the increases appear to be driven by existing consumers. While “indications are that the customer base is broadening some as the market grows due to more users trying an increasingly socially acceptable product and ongoing converts from the black market to the legal market,” the report said, the increase “is more likely to be due to larger or more frequent sales to existing consumers than due to more consumers alone.”
“One item to watch moving forward are prices,” analysts wrote. “In recent years the supply of marijuana has greatly outstripped the demand, leading to lower prices. This is great news for consumers. Given that marijuana is a normal good, lower prices have led to larger quantities sold. But now that demand has increased, while supply has held steady, and with the potential impact of the wildfires right as growers are prepping for harvest, this balance in the market may shift… As such, it may be that prices rise, or at least not decline like they have in recent years.”
As far as tax revenue goes, any price increase would likely lead to more money for the state, “as the decline in quantity sold is not large enough to outweigh the price impact,” the report said.
How cannabis revenue is spent would also be affected by a drug decriminalization ballot proposition, Measure 110, that voters will decide in November. While the initiative isn’t expected to change the amount of taxes collected, it would redirect marijuana tax funds to expand drug treatment programs. “Whether current programs receiving marijuana tax revenue would ultimately see budgetary impacts,” analysts said, “would remain up to the Legislature should voters approve the measure this fall.”
Measure 110, which broadly seeks to reframe problem drug use in medical rather than criminal terms, is one of two key drug-reform measures on Oregon’s ballot in less than six weeks. The other would legalize the therapeutic use of psilocybin, the main psychoactive ingredient in psychedelic mushrooms. That measure would be the first of its kind in the U.S., although Canada has recently granted some patients immunity from that country’s prohibition on psilocybin.