Regulatory and legislative disparities with cannabis present challenges to P&T committees and health care providers
In summary
An article has recently been published that gives a summary of current federal and state cannabis laws and highlights the arising regulatory and legislative challenges. Cannabis is still considered a Schedule I drug at the federal level under the Controlled Substances Act but the FDA approval of Edioplex, a cannabidiol (CBD)-based epilepsy medication, has caused CBD to be ruled as a Schedule V drug by the Drug Enforcement Agency. The piece explains the implications of CBD approval, including the Farm Bill passed in 2018 and discusses the intricacies of maneuvering between federal and state drug regulations. Current laws, even at the federal level, show a shift towards the approval of cannabis products but there is still a long way to go.
The article also highlights and attempts to explain the difficulties that physicians, budtenders, and pharmacists in prescribing, licensing, and providing cannabis. Some states, not including Massachusetts, require that pharmacists provide cannabis so that they can properly advise patients about the risks and benefits of cannabis use. Massachusetts (MA), like many other states who have legalized medical cannabis, do not require budtenders at dispensaries to possess any prior medical knowledge, meaning that their advice on which strain or product a patient should try can be extremely under-informed and subjective. Patients in states like MA should take care to speak with their licensing physician or nurse practitioner about which cannabinoids or products would likely be best for them.
The study is available for review or download here
Association of marijuana laws with teen marijuana use- new estimates from the youth risk behavior surveys
In summary
Earlier this July a letter was published providing evidence that adolescent cannabis use may actually decrease post-legalization of medical and recreational cannabis. An analysis of Youth Risk Behavioral Surveys from the past two decades revealed that legalizing medical cannabis had little to no effect on cannabis use among adolescents in 8th and 10th grade but that legalization of recreational cannabis actually led to an overall decrease of adolescent cannabis use across the states. The authors hypothesize that the rate of adolescent use may decrease as illegal drug dealers are replaced by legal, regulated dispensaries. This evidence may prove compelling for the possible rescheduling of cannabis under the federal Controlled Substances Act.
Adolescent substance use, like that of alcohol, has been found to be detrimental to brain development. There have been varying results regarding the effects of adolescent cannabis use on brain development yet some caretakers are given special permission to administer cannabis-based products to children experiencing rare forms of epilepsy or other seizure disorders. Cannabis-based medications may be a more ethical and far less dangerous substance to administer to children so that they aren’t set up for a substance use disorder at a young age. Research focussed on adolescent cannabis use needs to be conducted for better regulations and to better advise the parents and pediatricians of adolescents who have accidentally consumed cannabis or need a cannabis-based medical intervention.
The study is available for review or download here
A friend of mine posted that during these times the marijuana industry has done more to keep people safe, inside their homes than our leaders have. Without opining on the intelligence of our leaders or their decisions, it is clear that she is at least partly right. The cannabis industry is playing a large role in people’s decisions to remain inside. Many people have reported using cannabis to get through the long days, and that it is the only thing keeping them cooped up inside. The days of “Netflix and Chill” are truly upon us.
The numbers also confirm this notion. Dispensaries from Alaska to Colorado have reported lines around the block, similar to those seen at supermarkets and drugstores around the country. Some are seeing a spike in sales of 33%, while others are reporting a 159% jump from the same time last year. One San Francisco dispensary reported having the biggest day of business since recreational sales began there in January of 2018.
Most noteworthy, however, has been the official treatment of dispensaries in this time when nonessential businesses are being forced to close across the country. One state after another is announcing that cannabis businesses are to remain operational. Nevada and Colorado both issued advisories to dispensaries on how to observe social distancing. New York encouraged businesses to allow patients to schedule appointments in an effort to limit overcrowding. Illinois also exempted dispensaries from the list of non-essential businesses that must cease operations. In San Francisco, the city initially didn’t list cannabis businesses as essential, and its health department asked dispensaries to shut down. However, after an outcry from the community and patients across the city, they reversed course and allowed cannabis businesses to remain open. Ultimately California announced that cannabis business was deemed “essential”, allowing them to remain open statewide.
Because not all states have made similar moves, the Marijuana Policy Project, a cannabis legalization organization, penned a letter to all governors urging them to declare medical cannabis businesses “essential” and ensure that they remain open during this crisis. The letter is signed onto by several reputable organizations and can be found in its entirety here:
Think about what all of this means. States are not only declaring dispensaries to be essential businesses, but they are putting out guidelines as to how to expand remote services, maintain good business practices, and safely deliver cannabis to the consumer. Just a few years ago, this would have been unimaginable. The notion of deeming a dispensary to be an “essential business” would have seemed laughable from a governmental perspective. The thought of advising them on how to remain operational in a time of crisis seems even less likely.
In this time when everything seems chaotic, it is important that we take time to reflect on the good in our lives. It is important to remember the blessings we have and to appreciate the times we are living in. The cannabis industry remains young, but it seems to have established itself as a legitimate industry in the minds of our leaders. This is something that should not be taken for granted. I encourage all to take a moment to think about this and appreciate how far we’ve come.
Year 2019 was an up and down year for the cannabis industry. As the year comes to a close, let us take some time to reflect on what transpired during this transitional period for the cannabis industry. Hopefully, a detailed look at what happened may shed some light on what is ahead in 2020.
First, public opinion on cannabis has continued to rise. For the first time, poll results suggested that more than two-thirds of Americans support legalization. Such a pervasive, bipartisan, agreement for a fundamental change in the law is rare, and is a true reflection of the state of the industry now, and where the industry is headed.
Riding along with public opinion, Congress saw more movement towards full legalization than in any single year prior. The list of cannabis-related bills that were introduced in Congress this year tops 15, covering topics from banking to immigration. Most noteworthy among those bills are the MORE Act, a comprehensive legalization bill that passed its committee in the House, and the SAFE Banking Act, which passed the full House by a landmark 321-102 bipartisan vote. At the same time that these provide an optimistic outlook for the federal regime, no actual progress has been made in Congress, largely because the Republican-led Senate remains staunchly opposed to reform (google “Mitch marijuana machete” for an idea of Mitch McConnell’s recent activities relating to drug policy reform).
The executive branch has not been without movement either. President Trump does not have the traditional hard-lined anti-cannabis stance that some Republican leaders espouse. He campaigned on a platform of not interfering with states’ ability to manage their own medical and adult-use programs. He has publicly stated his support for the States’ Act, a bill that would essentially codify the same, leaving enforcement up to the states. Under Trump, the FinCEN continued its policy of allowing banks to do business with the cannabis industry, assuming that the Suspicious Activity Report (“SAR”) requirements were being followed. There are also no known examples of DEA or other federal law enforcement actions taken against operators lawfully operating under state law.
At the same time, the executive branch has made moves against the legalization movement. In 2018, then-AG Sessions rescinded the Cole Memorandum, signaling that the feds were looking into increasing enforcement against cannabis businesses (Thankfully Sessions is no longer a part of the administration, as his views are notoriously more anti-legalization than Trump’s). Just last week, as Trump signed the yearly spending bill into law, he attached a vague statement reserving the right to enforce federal law even in the face of full state-law compliance. Overall the federal government has progressed, albeit slowly, in the right direction.
Many states had significant progress towards legalization in 2019. Illinois became the 11th state to fully legalize adult-use, while Hawaii, New Mexico, and North Dakota decriminalized. We now stand with 33 states having passed a robust medical program, a full two-thirds of the union. Bills were proposed in more than two dozen states, some to expand existing frameworks, and others to create new ones. Just this week Alabama’s legislature’s commission recommended legalizing for medical purposes, a stark shift from the traditional views thought to be widely-held in the deep south. Overall the trend is clearly moving towards more states joining the legalization team, some quicker than others.
Though 2018 set a high bar for the hemp/CBD industry in terms of significant reform, Year 2019 arguably topped the significant progress of the 2018 Farm bill. In October, the USDA published its interim final rule, providing much-needed guidance to the hemp community. It created a federal framework for hemp farmers, creating registration, licensing, and testing requirements. It also allowed states to create their own systems, and many of the largest states for hemp farming are doing just that. FinCEN, the same treasury bureau that regulates banking for marijuana businesses, announced in December that banks may do business with the hemp industry without having to adhere to the SAR reporting requirements like those doing business with marijuana.
At the same time, the hemp/CBD industry skyrocketed in 2019. We saw an explosion of CBD products, and the industry is now estimated to be worth $4 billion. Tinctures, edibles, lotions, balms, you name it, someone has put CBD in it and made money this year. There remains so much uncertainty about the legalities of the market, and many have taken advantage of this “Wild West” atmosphere to quickly seize market shares, without guaranteed continuity once enforcement occurs. Year 2019 was not without foreshadowing of enforcement, however. In November, the FDA sent out warning labels to several companies that were selling CBD products. The letters go into detail regarding the various items being sold and analyzed how each company was violating various laws. Although the FDA hasn’t actually seized anyone’s assets or froze any bank accounts, they are clearly watching and thinking about doing it.
A really interesting piece of news swept the nation this year. At the beginning of November, the NYPD posted a picture of two officers posing with “106 pounds of marijuana that was destined for our city streets”, bragging about its success. Only one problem… it was all legal hemp, with certifying papers and all. The NYPD quickly dropped all the charges, and recently returned the hemp to the owner. This incident also highlights a significant issue with the hemp industry, in that it comes from and has all the outward appearance of marijuana, leading to confusion and enforcement problems. Until law enforcement agencies are properly trained, this type of incident is likely to repeat itself.
Year 2019 also took its toll on many cannabis companies. Large companies like Eaze and MedMen had to lay off many employees, as the actual returns were less than what their projections anticipated. Many stocks took big hits in 2019, for the same reasons. The projections for the industry have been huge, and are likely accurate, but are also likely skewed because of the nature of the industry. There is still a large “traditional” market in existence, which continues to dwarf the legal one. While some have come out of the shadows, progress remains slow because of the monumental taxes, regulations, and difficulties associated with being a fully-legal operating cannabis company.
WHAT ABOUT 2020?
The year 2020 is upon us. The cannabis industry is not going anywhere. It will continue to grow and mature as the year goes on. We aren’t going to see any reversal of the general trend towards legalization. At the federal level, I don’t believe that 2020 will see a single cannabis bill passed and enacted into law, and certainly nothing like full legalization. The country is not ready for it yet, as many of the industry leaders remain staunchly opposed for two reasons. First, there remains distrust and skepticism that is leftover from the reefer madness days. Many politicians still feel that marijuana is a gateway drug to other substances, and until they are convinced otherwise will stay opposed. Second, and more sinister perhaps, legalization denotes trouble for industries like alcohol, tobacco, and pharmaceuticals, all of whom stand to lose significant market shares once cannabis replaces these vices as people’s substance of choice. Lobbyists for these industries continue to work tirelessly to oppose legalization, and members of Congress are still forced to follow. Until these issues change, we must wait for full legalization.
At the state level, change will happen, and rapidly. Already several states seem poised to have recreational programs on the ballot, in states where it is almost certain to pass. These include New Jersey, New York, North Dakota, Minnesota, Vermont, and Pennsylvania, all of whom will pass legalization by years end. More states will join the medical bandwagon, leaving perhaps one or two states with absolutely no cannabis legalization framework.
Public opinion will continue to positively increase and have more of an impact on the industry. If in 2019 we finally hit 66%, I predict that Year 2020 will have us hit 75%. As the younger generation grows up, and as the older one retires and fades away, the numbers will continue to rise. At the same time, science continues to develop, as new studies are coming out nearly every week showing another beneficial use of the cannabis plant. At the same time, organizations like CED Foundation and The IJCA continue to run awareness campaigns and spread the word, adding to the number of people who are exposed to ideas and understanding of the plant’s many uses. More studies and more awareness, reaching even more people, means more backing for legalization.
Hemp is poised for a huge gain in 2020. With the federal regulations in place, the industry now has definitive guidance on the government’s position. While CBD as medicine remains a tricky subject, certainly hemp’s use as a tobacco alternative, a plastic alternative, textiles, fabric, and other industry uses will skyrocket. I also believe that 2020 will see the FDA, DEA and USDA will work out some of the kinks with using CBD as an active ingredient, providing helpful guidance to an industry running around like a headless chicken. Once that occurs, again, the industry will expand rapidly, as more certainty from the government will allow more companies to enter the market.
Lastly, I think 2019 brought some valuable lessons to the industry. The way the projections did not turn into reality, and the hits that many businesses had to take, give us some really important lessons. Caution is urged when investing in an industry plagued by burdensome regulations and strong financial incentives not to join the legal market. The “traditional” market remains the elephant in the room. The likelihood of real enforcement crackdown is low, because of limited resources, sheer numbers, and the probability that any enforcement would result in really bad press. Because investors have now been warned, the industry’s growth will slow. We will continue to see startups join the market, but perhaps on a smaller scale.
I hope that this discrepancy between projections and sales will also be a lesson for our legislatures. They need to come up with solutions that create subsidies for those coming out of the shadows so that states can see the actual revenues they hoped for. They may have to accept several billion in illegal sales as water under the bridge. They may have to lower tax rates to incentivize people to legitimize their operations. They may have to lessen the licensing requirements, making it easier and cheaper for those interested in joining to actually do so. The specific decisions are theirs to make, but they need to get creative about solving this problem.
Overall 2019 was a successful year for the industry. Even the downsizing and financial hits taken will prove to be valuable in the long run. Just like getting out of bed too fast can result in injury, an industry that expands too rapidly can result in harmful consequences.
Benjamin Caplan, MDWHAT 2019 HAS TAUGHT US ABOUT WHAT 2020 WILL LOOK LIKE: PROCEED WITH CAUTION
Cannabis wasn’t always a taboo topic. Hemp, a variety of the Cannabis Sativa plant, has a rich history in the United States as being a valuable and versatile crop. Hemp was booming as a “cash crop” because not only was it useful in a range of industries, but it was also very easy to grow. The fiber from the plant has many uses, ranging from textiles and clothing to sails for rafts, rope, and paper. In fact, the Declaration of Independence was originally drafted on hemp paper! Unfortunately, with the passing of the 1937 Marijuana Tax Act that lumped all cannabis in the same group of regulated narcotics and the rise of inexpensive synthetic fibers in the 1950s, hemp’s popularity took a sharp decline. It wasn’t until 2018 the United States removed hemp as a Schedule 1 substance. Now, the plant is surging in popularity again for its many uses, especially the extraction of CBD for states that do not have any medical cannabis sales available.
What: Laws and regulations about growing cannabis in MA
Cannabis has earned the name “weed” for good reason. While careful allotments of light, humidity, soil, and nutrients affect its health and potency, cannabis is a resilient plant, built to thrive even in the harshest conditions. With its natural flexibility, cannabis growth can be an enjoyable hobby for people who are interested in growing their own medicine, either for the pleasure of attending to a growing plant or the joy of saving from the costs of dispensary products.
There are regulations and firm restrictions in place for how many plants can be grown in a home and any potential impact on visibility to neighbors. In Massachusetts, each adult may grow up to six plants, themselves, and no more than 12 plants per household with more than two adults. The plants must be grown in a secure, preferably lockable location, and they may not be visible from a public place.
It’s also important to know that just because it is legal for adults to grow cannabis, landlords and private living facility operators like nursing home or assisted living facilities often have the final say on the cultivation of cannabis on their property.
In general, gardening has been associated with reducing stress, depression, and anger. Considering these benefits, and the positive effects that cannabis medicine offers, once the crop is ready to be cured, cultivating one’s own cannabis is quite an attractive option.
Of note: Cannabis consumed from a home grow should still be lab-tested. Cannabis is a plant especially skilled at absorbing micronutrients (and micro-toxins) from its environment. Even when grown in “organic” soils, undesired contaminants can seep into the plants. Lab testing facilities exist and are easily accessible in all states with legal medical cannabis, and typically cost anywhere from $0 to $100 dollars for basic testing of final plant products.
The House of Representatives, or more accurately the House Judiciary Committee, announced this week that they will be holding a markup for the MORE Act on Wednesday, November 20th. The Marijuana Opportunity Reinvestment and Expungement Act (“MORE Act”) is a comprehensive legislative bill to completely overhaul the cannabis laws of the federal government. The revolutionary bill may be voted on the same day, and if it passes, the focus will shift to the Senate to pass the same.
The MORE Act has several key points. First, and most
importantly, it removes cannabis from the Controlled Substance Act. It
completely eliminates the criminal laws prohibiting cannabis at the federal
level, while leaving room for states to create their own legal framework.
Second, it creates a pathway for expungement and resentencing for existing marijuana
convictions.
The bill goes further. It authorizes a 5% sales tax on cannabis sales, creating a fund that will be used to ameliorate the negative effects of the War on Drugs, create incentives for small businesses, and to support disadvantaged and marginalized people and communities.
Everyone that I’ve spoken to agrees that this bill is long
overdue. The negative effects that our nation’s marijuana laws have caused are
too numerous to mention. Cannabis’ medicinal and therapeutic uses are undeniable,
and it’s about time that Congress does something about it.
But while the introduction of the bill may be cause for
celebration, and while it may even have the support to pass the House, we are
still far away from this bill becoming law. This is because unlike the
Democratic-controlled House, the Senate is run by Mitch McConnell and the
Republicans. Mitch famously stated that he won’t support marijuana
legalization, even as he pushed for the legalization of hemp. The SAFE Banking
Act, a far less controversial bill allowing financial institutions to do
business with the legal cannabis industry, has completely stalled under Mitch’s
watch. Mitch visited with industry leaders last month, but there is not much
optimism that he will bring the SAFE Banking Act bill to a vote in the near
future. While that bill remains tabled, it seems extremely unlikely that the
MORE Act would ever get any traction.
Unfortunately, we are still a long way away from full federal legalization. While the list of states with medicinal and/or adult-use programs seems to increase from month to month, Washington lags behind. As long as we have presidential candidates calling cannabis a “gateway drug”, and leaders who still call it “Reefer”, cannabis will be federally illegal for years to come.
Benjamin Caplan, MDThe US House of Representatives may vote on CANNABIS Legalization this week: Here’s why it doesn’t matter!
Starting with the 2014 Farm Bill, and continuing with the 2018 Farm Bill, we have seen a dramatic shift in the landscape governing hemp. Prior to 5 years ago, hemp production was entirely illegal, as the Federal government handled industrial hemp the same as it handled high-THC marijuana. It was an established Schedule 1 controlled substance, entirely illegal to grow, harvest, or possess.
As awareness has grown, and the true benefits of the hemp plant have become more widely understood, the federal government has passed legislation to decriminalize hemp. However, although it is no longer considered a controlled substance, the questions about the process and regulatory requirements abound. This is because all plants grown in the United States are highly regulated by the United States Department of Agriculture, or the USDA, which has a complex framework of licensing, reporting, and general requirements for every specific product grown in the country.
Last week, the USDA published the draft of its regulations
for the hemp industry. Since the 2018 farm bill, we have been living in the
“wild west” for hemp. As promised, the USDA released its rules in time for
farmers to get legal and licensed for the 2020 season. However, this
long-awaited release has been met with mixed results.
Many lawmakers and industry leaders are happy that the
federal government has finally put out regulations for hemp. First, they see
this as a dramatic shift from the era of prohibition, alone a cause for
celebration. Others see the certainty that we are going to have regulations put in place means that the industry will start to
grow and develop at a much faster pace. It is certainly true that the future is extremely
bright for hemp. But other farmers and individuals have expressed concerns with
some of the regulation’s details.
The “0.3% THC” limit, which delineates the difference
between legal “hemp” and illegal “marijuana”, may be too stringent for some
growers. They report that a mature hemp plant will have a THC content that will
vary from day to day, including some spikes over the 0.3% limit. The new
regulations require strict testing to be done prior to harvest, and if the
resulting THC content is too high, the entire crop must be destroyed. This may
cause farmers to harvest before true maturity, leading to a decrease in the
potency or effectiveness of the CBD derived from such a harvest.
The regulations also allow the states to develop their own plans
and submit them for approval. Some are concerned that some states may try to
infringe on the interstate commerce occurring there, which could cause all
kinds of problems and complications for the industry. Still others are worried that
the method for disposing of “hot crops” requires just a little too much DEA
involvement, which could also cause disruption or have a chilling effect on
growth.
It is clear that these regulations are a good step in the right direction. It’s also clear that this is just the beginning, and there is still plenty of room for improvement. The USDA announced a 60-day window for submitting public comments, and then they will consider any suggestions, and then publish a final rule in the future. I encourage you to read the regulations or a summary of them. I encourage you to think about how you would be affected by these rules, and what suggestions you may have. Speak to an expert about how you can do your part to improve the landscape of the industry for the future.
