The head of the U.S. Department of Agriculture (USDA) again indicated that the Drug Enforcement Administration (DEA) had an outsized influence on its proposed rules for hemp, stating that the agency “really didn’t like the whole program to begin with.”
During a hearing on USDA’s budget before the Senate Appropriations Committee last week, Agriculture Secretary Sonny Perdue was pressed on restrictive provisions of USDA’s interim final rule for hemp, specifically as it concerns the limited THC threshold allowed in the crop.
Sen. Jeff Merkley (D-OR) said the 0.3 percent THC limit is arbitrary, and it’s not necessary to distinguish hemp from marijuana.
Perdue said that was “certainly true” and he added that USDA “fought for a little more flexibility of widening those standards,” but it was constrained by congressionally approved statutes and faced pushback from other federal agencies as it attempted to loosen restrictions.
“You may know also in the regulations, we had some pushback from DEA,” the secretary said, noting for the second time this month that the agency stood opposed to implementing a domestic hemp program in the first place. He previously called out DEA for its role in shaping restrictive rules for the newly legal crop in a House hearing.
Watch the conversation below, starting around 46:45:
“We made a few modification as we were able to under the legal statutes in our interim final rule. This is a new and unusual crop, as you understand, and we’ll be very open to ongoing comments as we go forward about what those other flexibilities,” he said. “But our hands were constrained many times by the interagency process of other people weighing in.”
Sen. Patrick Leahy (D-VT) quickly followed up to say that he shares Merkley’s concerns and he urged Perdue to “continue working with us to get it right.”
Later in the hearing, which was first reported by Hemp Industry Daily, Merkley again brought up hemp and asked the secretary whether it would be fair to characterize the interim final rule as a “draft plan” given the evolving nature of the regulations. He cited USDA’s recent decision to temporarily lift certain testing requirements as an example of that fluid approach.
“I would think you would” be able to characterize it as a draft, Perdue replied. “The problem is, on an interim final rule, as our lawyers have explained to me, once it’s set, unless they’re minor changes in that, you can’t change it until you go to the notice of proposed rulemaking. I would functionally say it’s a draft plan.”
“This is a very unique crop as you know. We were learning as we were going and we tried to nail it best we could,” he said. “We had some pushback as I indicated in other agencies, but I would think your characterization of a draft is a good one.”
Watch the conversation below, starting around 1:31:30:
The senator also inquired about the possibility of allowing certain states to continue to operate under the more limited research-focused provisions of the 2014 Farm Bill, as opposed to the 2018 version that contains what industry stakeholders describe as problematic provisions. As it stands, states and tribes are able to use the earlier version for the 2020 growing season.
Perdue said that his “preference would be to resolve the issues from our federal rule, if we can, by that 2021 growing season.”
“If we cannot, I will be absolutely as flexible as the law allows in order to perpetuate the 2021 under the state rules of 2014 in that area if we can’t resolve the main issues that the states that had those 2014 laws resolved,” he said.
Perdue added regulators at the department will “continue to look at things that we feel like we can do under the guise of the interim final rule to match up with where the states were in their ’14 rules in order to reconcile any differences and resolve those.”
“Our goal was to have really all the states under the federal umbrella, but we understand why some states chose not to,” he said.
In the meantime, USDA has continued to approve regulatory plans submitted by states and tribes. In the most recent round, Georgia and Montana had their plans signed off on, raising the total number of approvals to 10 ten states and 12 tribes.
Photo courtesy of Pixabay.
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.