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.
Businesses That ‘Indirectly’ Work With Marijuana Industry Ineligible For Federal Coronavirus Loans
It’s not just state-legal marijuana retailers and growers that stands to miss out on federal relief loans amid the coronavirus outbreak. In addition to that restriction, which the federal Small Business Administration (SBA) confirmed last month, a wide range of businesses that indirectly service the cannabis industry are also ineligible under recently enacted legislation.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which the President Trump signed last month, provides for a Paycheck Protection Program that offers a significant amount of forgivable loans to companies with 500 or fewer employees. Cannabis businesses—as well as ancillary firms that contribute to them with products or services—are specifically excluded from those benefits, however.
In a notice about the draft rules of the CARES Act, SBA points to a document from last year outlining businesses that are generally ineligible for its programs. One section describes how “Businesses Engaged in any Illegal Activity” can’t receive federal loans.
“SBA must not approve loans to Applicants that are engaged in illegal activity under federal, state, or local law,” it states. “This includes Applicants that make, sell, service, or distribute products or services used in connection with illegal activity, unless such use can be shown to be completely outside of the Applicant’s intended market.”
“Because federal law prohibits the distribution and sale of marijuana, financial transactions involving a marijuana-related business would generally involve funds derived from illegal activity,” it continues. “Therefore, businesses that derive revenue from marijuana-related activities or that support the end-use of marijuana may be ineligible for SBA financial assistance.”
To that end, it’s no surprise that businesses such as dispensaries and cultivation facilities would be excluded. But it’s also the case that a large class of companies that indirectly work with the cannabis industry could also lose out on the benefits.
An ineligible “indirect marijuana business” is defined by SBA as “a business that derived any of its gross revenue for the previous year (or, if a start-up, projects to derive any of its gross revenue for the next year) from sales to Direct Marijuana Businesses of products or services that could reasonably be determined to aid in the use, growth, enhancement or other development of marijuana.”
SBA provides specific examples of such companies. The list includes “businesses that provide testing services, or sell or install grow lights, hydroponic or other specialized equipment, to one or more Direct Marijuana Businesses; and businesses that advise or counsel Direct Marijuana Businesses on the specific legal, financial/accounting, policy, regulatory or other issues associated with establishing, promoting, or operating a Direct Marijuana Business.”
Businesses that sell paraphernalia like bongs or pipes intended for cannabis use are also ineligible for the loans, SBA said.
However, the agency said its interpretation of an indirect cannabis business doesn’t extend to companies that provide general services such as plumbing or tech support for laptops that marijuana firms use, for example.
The penalty for submitting an application for the relief loans with fraudulent information is up to five years in prison and up to a $250,000 under one federal statute. Another statute makes it punishable by imprisonment of up to two years and a maximum $5,000 fine. Finally, if the application was submitted to a federally insured institution, the penalty is up to 30 years in prison and up to a $1 million fine.
“As a starting point, it is incredibly unfair that state-legal cannabis companies are not eligible for these SBA loans,” Josh Kappel, founding partner at Vicente Sederberg, told Marijuana Moment. “These companies pay Social Security and Medicare taxes, unemployment taxes, and, of course, federal corporate taxes. In every way, they deserve to be treated like any other business when it comes to these emergency loans.”
“It is even more egregious when the SBA determines, not by law but by its own regulations, that companies will be ineligible for loans if they derived any revenue in the previous year from selling products or services to state-legal cannabis companies,” he added. “In a state like Colorado, when you consider law firms, accounting firms, advertising and marketing firms, HVAC companies, lighting companies, and on and on, there are literally hundreds of small businesses that could be deemed ineligible.”
Advocates are pushing for Congress to add language to future coronavirus-related spending legislation to free up access to SBA services for state-legal marijuana businesses. But it remains to be seen whether that will materialize.
Eleven senators did recently send a letter to leadership in a key committee asking that they add a provision allowing marijuana businesses to access federal loan services in an upcoming annual spending bill, however.
“While we would like to see loans available to all cannabis companies, the SBA, at the very least, should immediately modify its regulations to remove the prohibition on COVID-19-related loans to ‘indirect marijuana businesses,'” Kappel said. “Countless jobs and small businesses could be at risk if they do not.”
Because hemp was legalized under the 2018 Farm Bill, businesses that sell the crop or those that indirectly service those companies are eligible for federal relief programs—a point SBA stressed in a recent blog post.
Photo courtesy of Philip Steffan.
CBD Prescription Drug Is No Longer A Federally Controlled Substance, DEA Says
The Drug Enforcement Administration (DEA) has removed a marijuana-based medication from the list of federally controlled substances.
GW Pharmaceuticals announced on Monday that Epidiolex, a prescription drug it developed that’s derived from cannabis and used in the treatment of epilepsy, had been taken off Schedule V of the Controlled Substances Act. Effectively immediately, the CBD medication is no longer a controlled substance, the company said.
That means individuals will be able to more easily obtain Epidiolex. GW said in its notice that it will “begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.”
After that point, state reporting requirements under prescription drug monitoring programs will no longer be applicable. Like many non-controlled drugs, people will still need to get a prescription from a doctor, but those prescriptions will be valid for up to a year and can be transferred among pharmacies.
“This notification from DEA fully establishes that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” Justin Gover, CEO of GW, said in a press release. “We would like to thank DEA for confirming the non-controlled status of this medicine.”
“Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy,” he said.
The Food and Drug Administration (FDA) approved the medication in 2018. DEA said it would be placed in Schedule V, rather than Schedule I like marijuana and its derivatives.
FDA pushed back in a letter to the agency, arguing that CBD carries minimal risks and has established health benefits and so it shouldn’t be controlled at all. DEA replied that international treaty obligations warrant its control, albeit in the least restrictive category of Schedule V. FDA then said that if that changed, the agency should “promptly” revisit its status as a controlled substance.
Last year, the World Health Organization clarified that CBD containing no more than 0.2 percent THC is “not under international control.”
Meanwhile, FDA is in the process of developing regulations for hemp-derived cannabidiol products that aren’t approved as medications following the 2018 Farm Bill’s legalization of the crop and its derivatives. The agency said in a report to Congress last month that the rulemaking process is ongoing, but it is actively exploring pathways to allow for lawful sales of the cannabis compound as a dietary supplement, and it’s developing enforcement discretion guidance for products that are currently on the market.
Photo by Aphiwat chuangchoem.
Delaware Officials Allow Medical Marijuana Delivery Amid Coronavirus Outbreak
Home delivery of medical marijuana may soon be available to patients in Delaware under an emergency program being rolled out by state regulators. It’s yet another step designed to ensure safe access to medical cannabis products while limiting the risk of coronavirus transmission.
Delivery from one company, Columbia Care, which has locations in Wilmington, Smyrna and Rehoboth Beach, is expected to begin as soon as this week, regulators confirmed to Marijuana Moment on Friday. The program is being allowed under Delaware’s state-of-emergency declaration, although regulators intend to allow deliveries to continue even after the COVID-19 pandemic stabilizes.
“The Office of Medical Marijuana is not establishing this as a convenience option,” Paul Hyland, director of the state Office of Medical Marijuana, said via a spokesperson, “but as a stop-gap system to allow homebound and the most vulnerable patients to obtain products safely.”
Hyland added that there are “a number of steps to be completed” and “no firm date has been set” on when deliveries will begin, “however Columbia Care is looking to launch delivery” this week.
Columbia Care representatives didn’t immediately respond to a request for comment, but its website says it is “proud to be the first medical marijuana company in Delaware to deliver products to patients and designated caregivers.”
The program could eventually expand to other dispensaries in the state, such as Fresh Delaware and First State Compassion. Those other operators “can participate” in the delivery program, Hyland said, “however at this time, they were not in a position to accommodate delivery in the time necessary to respond to the current situation.” Neither company responded to requests for comment on Friday.
Hyland said patients won’t need to take any additional steps to register for Columbia Care’s delivery service. “It will work the same way as in-store pick-up currently works for Columbia Care,” he said, “through an option on their website.”
In a blog post Friday that broke news of the delivery program, the Delaware chapter of NORML, a leading cannabis advocacy organization, said it was “thrilled” by the development and urged officials to implement the plan quickly.
“Some patients may not drive and many do not have an authorized caregiver,” the group wrote. “Ordering online with pick up options isn’t enough when a vast majority of patients are now homebound with little resources to facilitate those services. By definition, medical patients are the most at risk and we should be doing everything we can to ensure their safety.”
Laura Sharer, the director of Delaware NORML, had urged the state last week to allow delivery options for patients who needed it. She cheered the move in an email to Marijuana Moment on Friday. “This is historic advocacy action,” she wrote. “To have expressed an urgent need an have it quickly met is not something that has happened within (Delaware’s medical marijuana) program before. I truly applaud our state officials for stepping up to meet patients’ needs.”
Sharer said that she understands Columbia Care plans to make delivery available for orders of $50 or more and will charge a $10 delivery fee. Patients will be able to place orders online or by phone. “As of now, there are no other requirements or extra steps for the patients,” Sharer said, although she stressed that delivery “is a new process and I anticipate they may adjust if needed.”
NORML in its blog post asked patients to continue to use existing curbside-pickup options if they’re able, which will minimize demand on delivery drivers and help them service the state’s most vulnerable patients. “Please be mindful that for many patients this will be their *ONLY* option,” the group wrote. “If you can facilitate the online ordering with pick up option safely, please continue to do so and save this service for those who need it most.”
“I would like to convey that this one center will not be able to meet the demands of the 12,000+ current patients” in the state, Sharer said on Friday, adding that she hoped more dispensaries will soon offer delivery. “I would urge patients to only facilitate this service if they must, reminding that some patients are homebound and this would be their only option.”
Delaware NORML also provided Marijuana Moment with recent email correspondence between activists and Delaware regulators, who wrote in the emails that they began working on a delivery plan in late March.
“Last week we started working with Columbia Care to start a delivery service,” Alanna Mozeik, a policy head at the state Department of Health and Social Services, wrote in a message on Wednesday. “Not all of the vendors are on board at this time, but Columbia Care has the digital infrastructure already in place and they are working diligently to develop the other necessary processes and procedures so that this can occur safely.”
As Mozeik explained in an earlier email to NORML, Delaware law doesn’t expressly forbid cannabis delivery. Prior to the coronavirus pandemic, however, the state hadn’t put together a formal process to evaluate and approve delivery proposals. “While the governing statute does not prohibit delivery, OMM (the Office of Medical Marijuana) would still require compassion centers to submit a plan for delivery implementation for review,” she wrote on March 26.
In the email to Marijuana Moment on Friday, Hyland, the director of Delaware’s Office of Medical Marijuana (OMM), said that his office plans to “create a more defined delivery program” going forward.
“Once the (state of emergency) is over, the Office of Medical Marijuana will work to create the proper regulatory and operational framework to standardize delivery across the program,” he said. “Prior to the impacts of COVID-19, the Office of Medical Marijuana was already in initial discussions with compassion center vendors on how to operate a delivery service in Delaware. This planning phase is on pause until the pandemic is over, but at that time the OMM will create a more defined delivery program.”
Nearly all U.S. states with legal cannabis programs have deemed retail outlets essential businesses and allowed them to remain open, with one notable exception being Massachusetts, which has shuttered adult-use cannabis businesses and allowed only medical dispensaries to remain open. Many states have also relaxed regulations in order to allow for curbside pickup, designed to improve social distancing, although only a handful of states currently allow delivery.
In Colorado, regulators last month issued that state’s first delivery license to The Dandelion, a Boulder dispensary operated by the company Native Roots. The store began medical marijuana deliveries last week but for now can deliver only to Boulder and the nearby town of Superior.