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An Update on Missouri Legalization & Taxes

By Abraham Finberg, Simon Menkes, Rachel Wright
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Some states, like California, Colorado and Washington, have welcomed cannabis with open arms while others have taken a while to come to the party (or haven’t gotten there yet). Missouri, whose licensed sales only began in October 2020, is one of the late arrivals.

Perhaps it’s in the nature of the people of the Show Me State to wait for proof that something is a good thing rather than being early adopters. Even Missouri’s nickname came into being as a statement of skepticism when Missouri Congressman Willard Duncan Vandiver, in an 1899 speech in Philadelphia, said, “Your frothy eloquence neither convinces nor satisfies me. I am from Missouri. You have got to show me.” (Not surprisingly, perhaps, Missouri’s state animal is the Missouri Mule).

Missouri legalized the use of medical cannabis on December 6, 2018. Compared to many other states, Missouri’s definition of what constitutes medicinal use is more tightly defined. For example, most medical cannabis states allow “anxiety” as an acceptable condition for a prescription; Missouri does not.1

Current Status of Adult Use Cannabis

St. Louis, Missouri

Missouri is now locked in a battle to legalize adult use cannabis, with the group Legal Missouri 2022, among others, working hard to put the measure on the ballot this year. At the same time, Representative Ron Hicks (R) is pushing to legalize recreational purchases with his Cannabis Freedom Act. “I want the legislature to be able to handle it so that when there are problems and things need to be changed, it can be changed,” Hicks said.2 Missouri Governor Mike Parson (R), who has been against recreational usage, has stated he would “much rather have the legislators have that discussion out here and see if there is a solution other than doing the ballot initiative.” Parson added, “If it got on the ballot, it’s probably going to pass.”3

Cannabis Business in Missouri: Only Cost of Goods Sold Deduction

Missouri has maintained its state tax code to be in conformity with Section 280E of the Internal Revenue Code, which disallows deductions and credits for expenditures connected with the illegal sale of drugs, stating:

No deduction or credit shall be allowed for any amount paid or incurred during the taxable year in carrying on any trade or business if such trade or business … consists of trafficking in controlled substances (within the meaning of schedule I and II of the Controlled Substances Act) which is prohibited by Federal law.4

This is true for both corporation5 and individuals6 in Missouri.

Governor Mike Parson recently vetoed a bill to eliminate conformity with I.R.C. Section 280E. Eliminating conformity would have lowered the tax burden on medical cannabis businesses, and increased Missouri’s competitiveness.7

State Sales and Cannabis Taxes

Missouri taxes retail sales at 4% of the purchase price.8 In addition, Missouri taxes retail sales of medical cannabis another 4% of the retail price.9,10 The medical cannabis tax is collected by dispensary facilities who then remit it to the Department of Revenue using Form 5808.11

Tax compliance is burdensome in Missouri, with dispensaries having to file returns monthly, even when they have no tax to report.12 Missouri also doesn’t allow cannabis businesses to pay their taxes in cash.13

No Tax on Tax

It’s important to note that Missouri doesn’t charges sales tax on cannabis tax nor cannabis tax on cannabis tax (unlike high-tax states like California). Under Missouri’s law, the tax is “separate from, and in addition to, any general state and local sales and use taxes that apply to retail sales.”14 Under Missouri’s sales tax law, “ Tax collected as a part of a sale should not be included in gross receipts.”15 Missouri has not specified whether the medical tax constitutes tax collected as a part of a sale; however, its regulations state that gross receipts from the sale of cigarettes do not include the amount of the sale price that represents the state cigarette tax.16 If the medical tax is analogous to the cigarette tax, gross receipts from the sale of medical cannabis likely excludes the amount paid as medical cannabis tax.

If the Legislature-Sponsored Cannabis Freedom Act Passes

If the Cannabis Freedom Act passes, Missouri will have a number of additional interesting changes. The bill would only allow for double the number of current medical cannabis licensees to serve the adult use market. It would also allow for people with non-violent convictions to petition the courts to have their record expunged (cleared).

Adult Use Taxes

The Act would allow the Department of Revenue to set an adult-use tax of up to 12%. There would be no such tax on medical cannabis sales.17

Normal Tax Deductions Allowed for Businesses

Licensed businesses would also be able to make tax deductions with the state up to the amount that they’d otherwise be eligible for under federal law if they were operating in a federally legal industry.18

Amendment Added to Act

In a move seen by many as a bid to derail the Cannabis Freedom Act, Representative Nick Schroer (R) amended the Act to bar transgender women from accessing no-interest loans for women- and minority-owned cannabis businesses, adding that only women who are “biologically” female would be eligible for the benefit. In the end, this addition may have the effect of scuttling the bill.19

Multiple Efforts to Place Cannabis on the Ballot

Even if the Act doesn’t pass, there are multiple efforts to place cannabis before the voters, including one by Representative Shamed Dogan (R), the group Legal Missouri 2022, which got medical cannabis passed by voters in 2018, and Fair Access Missouri.20

 Comparison to Neighboring Oklahoma

Oklahoma, like Missouri, has not legalized the use of recreational cannabis, only medical cannabis. Also, Oklahoma taxes sales of tangible personal property (except newspapers and periodicals) at 4.5%, which is close to Missouri’s 4%.21 Tax is imposed on gross receipts or gross proceeds.22 Gross receipts (or gross proceeds) = Total amount of consideration, whether received in cash or otherwise. Credit is allowed for returns of merchandise.23

Oklahoma taxes retail medical cannabis sales at 7% of the gross amount received by the seller.24 Like Missouri, it has not specified any exemptions from the medical cannabis tax. Oklahoma’s medical cannabis tax base is the same as Missouri’s. Oklahoma’s medical tax rate is higher than Missouri’s. Therefore, Missouri’s tax treatment of medical cannabis is even better than Oklahoma’s.

Note, however, that Oklahoma has made it explicit that there is no tax-on-tax. “The 7% gross receipts tax is not part of the gross receipts for purposes of calculating the sales tax due, if the tax is shown separately from the price of the medical marijuana.”25

Oklahomans appear to be far more favorably disposed towards cannabis than Missouri, however. 2021 cannabis sales per person in Missouri was approximately $34, while Oklahoma boasted an impressive $210 per person, besting even California, which had $111/per person in cannabis sales.26

The Hidden Opportunity

Although Missouri only began licensed sales in October 2020, the state’s monthly sales has shown a strong upward curve. By the end of June 2021, monthly sales were just above $16 million. That number had shot up to $29 million per month for December 2021, and almost $37 million for April 2022.27 Patient enrollment is also increasing significantly.28

The best move, many experts believe, is to get into the medical market now, before the inevitable happens and adult use is approved. Competition is low at the moment, due to the lack of medical licensed dispensaries in the state. Although obtaining a license can be difficult, the current lack of competition, as well as the opportunity to gain a foothold in the cannabis industry before recreational purchases are approved, could provide a 10 times revenue increase from current medicinal sales levels.

Tyler Williams, founder of St. Louis-based Cannabis Safety and Quality and one of the St. Louis Business Journal’s 2021 40 Under 40, is optimistic about the future of Missouri cannabis. The state, he says, has been left “with only a few cannabis growers and manufacturers with a head start over the impending recreational market that is likely to come within the next couple of years.”29

The Bottom Line

The State of Missouri’s treatment of legal cannabis has been mixed, but the demand for the product by many residents of the state is unquestioned. If an entrepreneur has the foresight to get involved before all the wrinkles of legalization have been resolved, there is a possibility for very strong return on investment.

References

  1. https://health.mo.gov/safety/medical-marijuana/how-to-apply.php
  2. https://www.marijuanamoment.net/missouri-lawmakers-approve-gop-led-marijuana-legalization-bill-in-committee/
  3. https://www.stltoday.com/news/local/marijuana/parson-not-taking-sides-as-fight-over-marijuana-legalization-heats-up-in-missouri/article_2fbe3b03-14b0-54c6-940c-130b672a949e.html
  4. In the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §801–971 (1970)
  5. Mo. Rev. Stat. § 143.431.
  6. Mo. Rev. Stat. § 143.091.
  7. https://blog.tenthamendmentcenter.com/2021/07/missouri-governor-vetoes-bill-to-eliminate-state-conformity-with-irs-section-280e-for-marijuana-businesses/
  8. Mo. Rev. Stat. § 144.020.1(1).
  9. Missouri Amendment 2, approved by voter ballot Nov. 6, 2018, effective Dec. 6., 2018, § 1(4)(1).
  10. Missouri Amendment 2, § 1(4)(4).
  11. Missouri Amendment 2, § 1(4)(1).
  12. Ibid.
  13. Ibid.
  14. Missouri Amendment 2, § 1(4)(4) (emphasis added).
  15. Mo. Code Regs. Ann. tit. 12 § 10.103-555(3)(A).
  16. Mo. Code Regs. Ann. tit. 12 § 10.103-555(3)(M).
  17. https://www.marijuanamoment.net/missouri-lawmakers-approve-gop-led-marijuana-legalization-bill-in-committee/
  18. Ibid.
  19. Ibid.
  20. Ibid.
  21. Okla. Stat. Ann. tit. 68, § 1354.
  22. Okla. Stat. Ann. tit. 68, § 1352(12)(a).
  23. Okla. Admin. Code § 710:65-19-89(a).
  24. Okla. Stat. Ann. tit. 63, § 426.
  25. Okla. Admin. Code § 710:65-19-216(d).
  26. https://mogreenway.com/2022/03/07/medical-marijuana-sales-in-missouri-continue-strong-trend/
  27. https://health.mo.gov/safety/medical-marijuana/pdf/dispensary-cumulative-sales.pdf
  28. https://www.benzinga.com/markets/cannabis/21/06/21594575/missouris-cannabis-market-what-investors-and-entrepreneurs-need-to-know
  29. Ibid.
Soapbox

How Do You Know You’re Right? qPCR vs. Plating

By Dr. Sherman Hom
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Cannabis testing to detect microbial contamination is complicated. It may not be rocket science, but it is life science, which means it’s a moving target, or at least, it should be, as we acquire more and more information about how the world we live in works. We are lucky to be able to carry out that examination in ever increasing detail. For instance, the science of genomics1 was born over 80 years ago, and just twenty years ago, genetics was still a black box. We’ve made tremendous progress since those early days, but we still have a long way to go, to be sure.

Much of that progress is due to our ability to build more accurate tools, a technological ladder, if you will, that raises our awareness, expertise, and knowledge to new levels. When a new process or technology appears, we compare it against accepted practice to create a new paradigm and make the necessary adjustments. But people have to be willing to change. In the cannabis industry, rapid change is a constant, first because that is the nature of a nascent industry, and second because in the absence of some universal and unimpeachable standard, it’s difficult to know who’s right. Especially when the old, reliable reference method (i.e. plating, which is basically growing microorganisms on the surface of a nutritional medium) is deeply flawed in its application to cannabis testing vs. molecular methods (i.e., quantitative polymerase chain reaction, or qPCR for short).

Dr. Sherman Hom, Director of Regulatory Affairs at Medicinal Genomics

Plating systems have been used faithfully for close to 130 years in the food industry, and has performed reasonably well.2 But cannabis isn’t food and can’t be tested as if it were. In fact, plating methods have a host of major disadvantages that only show up when they’re used to detect cannabis pathogens. They are, in no particular order:

  1. A single plating system can’t enumerate a group of microorganisms and/or detect specific bacterial and fungal pathogens. This is further complicated by the fact that better than 98% of the microbes in the world do not form colonies.3 And there is no ONE UNIVERSAL bacterial or fungal SELECTIVE agar plate that will allow the growth of all bacteria or all fungal strains. For example, the 5 genus species of fungal strains implicated in powderly mildew DO NOT plate at all.
  2. Cannabinoids, which can represent 10-30% of a cannabis flower’s weight, have been shown to have antibacterial activity.4 Antibiotics inhibit the growth of bacteria and in some cases kill it altogether. Salmonella species & shiga toxin producing coli (STEC) bacteria, in particular, are very sensitive to antibiotics, which leads to either a false negative result or lower total counts on plates vs. qPCR methods.
  3. Plating methods cannot detect bacterial and fungal endophytes that live a part or all of their life cycle inside a cannabis plant.5,6 Examples of endophytes are the Aspergillus pathogens (A. flavus, A. fumigatus, A. niger, and A. terreus). Methods to break open the plant cells to access these endophytes to prepare them for plating methods also lyse these microbial cells, thereby killing endophytic cells in the process. That’s why these endophytes will never form colonies, which leads to either false negative results or lower total counts on plates vs. qPCR methods.
  4. Selective plating media for molds, such as Dichloran Rose-Bengal Chloramphenicol (DRBC) actually reduces mold growth—especially Aspergillus—by as much as 5-fold.This delivers false negative results for this dangerous human pathogen. In other words, although the DRBC medium is typically used to reduce bacteria; it comes at the cost of missing 5-fold more yeast and molds than Potato Dextrose Agar (PDA) + Chloramphenicol or molecular methods. These observations were derived from study results of the AOAC emergency response validation.7
  5. Finally, we’ve recently identified four bacterial species, which are human pathogens associated with cannabis that do not grow at the plating system incubation temperature typically used.8 They are Aeromonas hydrophila, Pantoea agglomerans, Yersinia enterocolitica, and Rahnella aquatilis. This lowers total counts on plates qPCR methods.

So why is plating still so popular? Better yet, why is it still the recommended method for many state regulators? Beats me. But I can hazard a couple of guesses.

A yeast and mold plate test

First, research on cannabis has been restricted for the better part of the last 70 years, and it’s impossible to construct a body of scientific knowledge by keeping everyone in the dark. Ten years ago, as one of the first government-employed scientists to study cannabis, I was tapped to start the first cannabis testing lab at the New Jersey Dept. of Health and we had to build it from ground zero. Nobody knew anything about cannabis then.

Second, because of a shortage of cannabis-trained experts, members of many regulatory bodies come from the food industry—where they’ve used plating almost exclusively. So, when it comes time to draft cannabis microbial testing regulations, plating is the default method. After all, it worked for them before and they’re comfortable with recommending it for their state’s cannabis regulations.

Finally, there’s a certain amount of discomfort in not being right. Going into this completely new area—remember, the legal cannabis industry didn’t even exist 10 years ago—we human beings like to have a little certainty to fall back on. The trouble is, falling back on what we did before stifles badly needed progress. This is a case where, if you’re comfortable with your old methods and you’re sure of your results, you’re probably wrong.

So let’s accept the fact that we’re all in this uncharted territory together. We don’t yet know everything about cannabis we need to know, but we do know some things, and we already have some pretty good tools, based on real science, that happen to work really well. Let’s use them to help light our way.

References

  1. J. Weissenbach. The rise of genomics. Comptes Rendu Biologies, 339 (7-8), 231-239 (2016).
  2. R. Koch. 1882. Die Aetiologie der Tuberculose.  Berliner Klinische Wochenschrift, 19, 221-230 (1882). 
  3. W. Wade. Unculturable bacteria—the uncharacterized organisms that cause oral infections. Journal of the Royal Society of Medicine, 95(2), 91-93 (2002).
  4. J.A. Karas, L.J.M. Wong, O.K.A. Paulin, A. C. Mazeh, M.H. Hussein, J. Li, and T. Vekov. Antibiotics, 9(7), 406 (2020).
  5. M. Taghinasab and S. Jabaji, Cannabis microbiome and the role of endophytes in modulating the production of secondary metabolites: an overview. Microorganisms 2020, 8, 355, 1-16 (2020).
  6. P. Kusari, S. Kusari, M. Spiteller and O. Kayser, Endophytic fungi harbored in Cannabis sativa L.: diversity and potential as biocontrol agents against host plant-specific phytopathogens. Fungal Diversity 60, 137–151 (2013).
  7. K. McKernan, Y. Helbert, L. Kane, N. Houde, L. Zhang, S. McLaughlin, Whole genome sequencing of colonies derived from cannabis flowers & the impact of media selection on benchmarking total yeast & mold detection tools,  https://f1000research.com/articles/10-624 (2021).
  8. K. McKernan, Y. Helbert, L. Kane, L. Zhang, N. Houde, A. Bennett, J. Silva, H. Ebling, and S. McLaughlin, Pathogenic Enterobacteriaceae require multiple culture temperatures for detection in Cannabis sativa L. OSF Preprints, https://osf.io/j3msk/, (2022)

One Month In: New Jersey Market Starts Growing

By Cannabis Industry Journal Staff
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Just over a month ago, a handful of dispensaries in New Jersey began selling cannabis to adults over the age of 21. The state issued licenses for adult use sales to seven alternative treatment centers (ATCs), otherwise known as medical cannabis businesses already established in the state. In total, thirteen dispensaries in the state started selling cannabis to adults over 21.

The seven companies awarded adult use licenses were Ascend, Curaleaf, GTI, Acreage, Verano, Columbia Care and TerrAscend. The state’s roll out created a lot of controversy over allowing already established, larger medical cannabis businesses and multi state operators to begin adult use sales before smaller businesses and social equity applicants get licensed.

Sales totals in the first month of New Jersey’s adult use market

Earlier this week, the New Jersey Cannabis Regulatory Commission (CRC) held a public meeting where regulators discussed progress, sales totals so far, conditional license applications and more. According to the meeting notes, between April 21 and May 21, retailers in New Jersey did $24,201,875 in cannabis sales with 212,433 transactions. During the meeting, regulators considered 46 conditional license applications and four testing lab license applications.

According to NJ.com, six new dispensaries were awarded licenses to begin adult use sales. Of the six new retail locations, Curaleaf opened their Edgewater location to adult use customers and Ayr Wellness received approval to begin adult use sales at all three of their medical locations in Eatontown, Union and Woodbridge. Ascend and TerrAscend also received approval to begin adult use sales act their locations in Montclair and Lodi, respectively.

About two weeks ago, the CRC testified before the state’s Senate Judiciary Meeting to share progress on the legal cannabis market, just over a year after the CRC was established. Jeff Brown, executive director of the CRC, discussed the agency’s goals and some challenges ahead of them. Brown says the CRC will be focusing on additional rules for adult use, modernizing the medical rules, enforcing regulatory compliance and information sharing in the near future. He also mentioned a couple challenges the industry is currently facing that they wish to address, including: expanding access to capital for entrepreneurs , removing impediments to finding real estate, educating municipalities to open up opportunities for applicants and ensuring medicinal cannabis access is unimpeded by recreational sales.

“We have made great strides in all of these efforts, and when we look at how New Jersey compares against other states, we fair pretty well,” Brown told lawmakers. “Beginning recreational sales on 4/21/22 was an important milestone. But it doesn’t mark the end of the process, it marks an important step in a multi-year effort to establish New Jersey as the premier cannabis market on the East Coast.”

AOAC Launches Cannabis Proficiency Testing Program

By Cannabis Industry Journal Staff
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In a press release published this week, AOAC International announced it has partnered with Signature Science, LLC as the test material provider for the new AOAC Cannabis/Hemp Proficiency Testing program. What makes this proficiency testing (PT) program so unique is that AOAC will be the only PT provider to offer actual cannabis flower as the matrix.

This month, the pilot round with twenty cannabis testing labs begins with hemp-only samples being shipped in early May. The first live round of the PT program is scheduled for November of this year and will offer participating labs the choice of cannabis flower samples or hemp samples.

The program will include one sample for cannabinoid and terpene profiles, moisture and heavy metals, as well as a second sample for pesticide residue testing. According to the press release, mycotoxins will be added to the mix soon.

The new PT program was developed by stakeholders involved with the AOAC Cannabis Analytical Science Program (CASP), including state regulatory labs, industry labs, state and federal agencies and accreditation bodies. Shane Flynn, senior director of AOAC’s PT program, says the program is a result of scientists coming to them with concerns about testing in the cannabis space. “AOAC has a long history of bringing scientists together to address emerging topics, so when stakeholders came to AOAC with their concerns and need for quality proficiency testing in the cannabis industry, AOAC acted,” says Flynn. “Stakeholders noted the analytical differences in testing cannabis versus hemp and had specific concerns around it and asked for a program that would provide actual cannabis samples in addition to hemp. This is truly a program that was created by the stakeholders, for the stakeholders.”

AOAC says they plan on introducing microbiology to the PT program, with microbial contamination tests in both cannabis and hemp samples. They are also considering adding additional matrices, like chocolate and gummies.

Signature Science is an ISO 17043 accredited proficiency test provider that also has a DEA-licensed controlled substances lab, making them an ideal candidate to partner with AOAC for the PT Program. They entered into a 3-year MoU with AOAC for the program. Their team developed and validated methods used to create the samples for the PT program at their DEA-licensed lab in Austin, Texas.

Steep Hill Expands to Vermont

By Cannabis Industry Journal Staff
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Steep Hill, the company that started the first cannabis testing laboratory in the United States, today announced their expansion into Vermont. Their licensee, Steep Hill Vermont, is the first lab in the state to receive pre-approval from the state, according to a press release.

The leadership team is made up of CEO Kos Parulekar, Dr. Mark Scialdone, chief scientist and Callie Chapman, who will be the lab director. Parulekar previously held management roles at General Electric and The World Bank.

Dr. Scialdone will be speaking at the Cannabis Quality Conference & Expo. Click here to learn more. Dr. Scialdone worked at DuPont for eighteen years before joining the cannabis industry and becoming an expert in plant oil extraction, analysis and natural product chemistry. Dr. Scialdone is a member of the ASTM D37 cannabis committee, the NCIA testing policy working group and is a founding member of the cannabis chemistry subdivision at ACS. “We chose to partner with Steep Hill because of their breadth of experience from opening multiple cannabis testing labs across the country that are considered the gold standard for quality results, rapid turnaround time, and impeccable customer service,” says Dr. Scialdone. “Vermont has long had the status of the Humboldt County of the East having a long tradition in cannabis, so opening a testing lab here makes sense on many levels.”

Chapman is a chemical engineer who previously worked for Autumn Harp as their head of cannabis product development. “Working with the State of Vermont, our laboratory plans to expand cannabis testing services, while offering quick turnaround times and educational resources for cultivators, manufacturers, and other industry participants,” says Chapman. “Our goal is to be a key partner in the success of the Green Mountain State’s adult use market and continue to grow our industry.”

Just a few months ago, in December of 2021, Steep Hill announced their expansion into Illinois. In March of 2019, the company expanded into New Jersey through their partnership with Green Analytics East.

Cannabis Banking: The Ins, the Outs & the Unknowns

By Tamara L. Kolb, Amy Bean, Caitlin Strelioff
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As the legal cannabis market expands, banks and nonbank financial institutions (NBFIs) across the United States continue to explore how to safely provide banking and other financial services to cannabis-related businesses (CRBs) and other CRB ecosystem players. At the same time, these organizations are taking into account changes they might need to consider relative to their Bank Secrecy Act ( BSA), anti-money laundering (AML) and related compliance programs. 

Regulatory conundrum

The Controlled Substances Act (CSA) identifies the cannabis plant and all its derivatives as a Schedule 1 controlled substance. Schedule 1 controlled substances have a “high abuse potential with no accepted medical use,” and they cannot be “prescribed, dispensed, or administered.” Because cannabis remains classified as a Schedule 1 controlled substance, the CSA “imposes strict controls on possession, manufacturing, distribution, and dispensing” of cannabis.

Under the Money Laundering Control Act of 1986 (MLCA) and the BSA as amended, covered banks and NBFIs are prohibited from providing financial services to businesses that are engaged in illicit activities. Because federal law prohibits the distribution and sale of cannabis, financial transactions involving CRBs are therefore deemed to be transactions that involve funds derived from illegal activities.

As of Feb. 3, 2022, 18 states, two territories, and the District of Columbia have enacted legislation to regulate cannabis for adult use. Thirty-seven states, the District of Columbia and four territories have approved comprehensive, publicly available medical and cannabis programs. Eleven states allow for the use of low-THC, high-CBD substances for medical reasons in limited situations or as a legal defense.

The growing divide between federal prohibition and state legalization of the cannabis industry creates a precarious position for federally regulated banks and NBFIs with the main concern involving exposure to legal, operational and regulatory risk. The situation begs the question: How might the federal government and regulators pursue and prosecute players in the legal cannabis industry?

The current economic trajectory predicts that retail sales of legal cannabis products in the U.S. will surpass an estimated $41.5 billion annually by 2025, and many banks and NBFIs are eagerly awaiting the federal green light to do business with CRBs without fear of prosecution or legal ramifications.

From 2018 forward, Congress has made several attempts to pass legislation that would protect CRBs when cultivating, distributing, marketing, and selling cannabis products in their state-legalized form. These efforts to declassify cannabis-related activity as a specified unlawful activity have thus far been unsuccessful.

The House passing the MORE Act back in 2020

Passage of the Secure and Fair Enforcement Banking Act of 2021 (SAFE Banking Act) and the Marijuana Opportunity Reinvestment and Expungement Act of 2021 (MORE Act) would enable banks and NBFIs to provide financial services to CRBs. The SAFE Banking Act would provide a safe harbor for banks and NBFIs that provide financial services to CRBs. The MORE Act would deschedule cannabis from the CSA entirely.

Questions to ask

Banks and NBFIs interested in providing financial services to CRBs should ask these questions:

  • Do we adequately understand our risk, and what are the implications for our organization? How should we augment our risk assessment process and our controls?
  • To what extent are we willing to accept the risk of banking CRBs? Do we have the ability to identify CRB customers, and if so, do we have any?
  • How should we advise the board of directors about setting risk appetite?
  • What customer due diligence (CDD) and enhanced due diligence (EDD) will we need to safely continue with existing customers and onboard new ones?
  • How will we monitor for unusual and suspicious activity? What will be the alerting and judgmental criteria?
  • How will our resource needs change so that we stay abreast of new processes and controls?

Risk appetite considerations

In order to determine whether to accept or prohibit CRBs, banks and NBFIs should identify the level of acceptable risk they are willing to take on. Several key components need to be considered, such as:

  • The board of directors’ stance on legal cannabis, given that good governance recommends and regulators expect that the board sets risk appetite
  • Cannabis laws in states within the customer footprint and the impact on customers’ communities
  • Risk profile, customer base, geographic location, products, and services
  • Relationship with regulators and any recent deficiencies or weaknesses in the BSA and associated compliance programs
  • Ability to implement appropriate controls and staffing

 Developing a strategic road map

If the decision is made to bank CRBs, banks and NBFIs should perform an assessment of compliance maturity for existing BSA/AML program processes and controls to identify potential gaps and develop a strategic road map that helps the organization achieve its vision for future state compliance and sustainable operations. 

A well-developed and well-articulated strategic road map visualizes what actions or key outcomes are needed to help organizations achieve their long-term goals. When creating the road map, banks and NBFIs need to demonstrate a keen understanding of their desired strategy, outcomes, markets, and products for onboarding and banking CRB customers. Specifically, banks and NBFIs need to define and explain how desired outcomes and business strategies create risk and exposure.

In addition to a road map, banks and NBFIs should develop and document a detailed risk-based approach that is aligned to the organization’s risk tolerance to determine necessary compliance steps when banking CRB customers.

Specifically, the following activities should be considered when developing a CRB banking program that meets regulatory expectations:

  • Identifying BSA/AML control gaps related to CRB risk identification and mitigation and formulating a plan to address them
  • Updating a board-approved policy framework
  • Updating detailed operating policies and procedures
  • Planning for capacity, developing job descriptions, and onboarding new personnel
  • Training for all three lines of defense, senior management, and the board
  • Developing and documenting a phased or full approach to acceptance of CRB customers
  • Developing and documenting a CRB program oversight policy

CRB risk framework

A three-tiered CRB risk framework first proposed in 2016 has quickly become the cannabis industry standard. The framework has evolved and expanded comprehensively to consider many types of CRBs, and evolving legal systems continue to refine the framework.

This framework is intended to help banks and NBFIs differentiate types of CRBs and their corresponding risks, and it separates CRBs into three tiers and details risks for each tier. The following exhibit summarizes the approach:

Risk framework by tier

Level Risk
Tier 1 Direct
Tier 2 Indirect with substantial revenue from Tier 1
Tier 3 Indirect with incidental revenue from Tier 1

Source: CRB Monitor

Even the most conservative of risk appetites equivalent to outright prohibition is not devoid of significant risk considerations. Residual risk frequently encompasses a large number of indirect connections in the total CRB ecosystem. Common examples are printers, lawyers, accountants, landlords, and even utilities and taxing authorities, and all of these are subject to regulatory scrutiny and, importantly, visibility to law enforcement. Also, policies to prohibit or restrict will be audited and examined for compliance, and exceptions will require explanations.

This panorama necessitates expertise and prudence in identifying and evaluating risks within the many layers of CRBs. For example, consider a bank or NBFI that banks a CRB’s employee or vendor. If a bank fails to properly implement controls that would allow it to identify and mitigate risk associated with banking CRBs, it will be susceptible to severe violations of the BSA, including civil money penalties, criminal penalties, and regulatory enforcement actions. 

Implementing necessary precautions

A well-developed road map should consider and implement the following activities:

  • Understanding the most current state and federal cannabis laws and regulations to ensure the bank or NBFI’s compliance
  • Understanding the local, state, or tribal program to ensure CRB customers are compliant with the program
  • Implementing a CRB risk assessment
  • Implementing executive approval practices for direct CRBs
  • Developing adequate risk ratings (possibly through a risk-based, tiered approach) and corresponding monitoring for CRB customers that includes:
    • Integrating various customer onboarding and AML solutions at both onboarding and periodic levels
    • Scheduling regular reviews to include recurring enhanced due diligence, site visits, and transaction monitoring
    • Monitoring for suspicious activity, including red flags, via open sources for adverse information about the CRB customers and related parties such as beneficial owners
  • Performing adequate CDD and EDD that will validate that the CRB-offered products, services, and programs are compliant with most current state laws and regulations by:
    • Collecting appropriate documentation as evidence of compliance, perhaps including a comprehensive onboarding questionnaire, beneficial ownership information, and contracts for the growing, harvesting, transporting and processing of the product
    • Reviewing applications and supporting documentation used to obtain a legal cannabis state license
    • Understanding the normal and expected activity of the organization’s CRB customers and their product usage
  • Developing adequate training programs and governance and oversight programs to address this customer type by:
    • Updating existing policies and procedures to review inherent risk presented by banking CRB customers
    • Updating annual training for employees
  • Auditing initial program design and periodic operational effectiveness

Moving forward cautiously

The ins, outs, and unknowns of cannabis banking are complex, and they require banks and NBFIs to be extremely vigilant with current policy and aware of new developments. Overall, the idea of creating a cannabis program might seem like a daunting task, but with appropriate guidance and care, organizations can provide services in compliance with laws and regulations.

Crowe disclaimer: Qualified organizations only. Independence and regulatory restrictions may apply. Some firm services may not be available to all clients. Given the continued evolution and inconsistency of various state and federal cannabis-related laws, any company should seek competent legal advice relating to its involvement in the cannabis industry, including when considering a potential public offering as a cannabis-related company.

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FDA Issues First Warning Letters for Delta-8 THC

By Cannabis Industry Journal Staff
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In an unprecedented move, the U.S. Food & Drug Administration (FDA) has issued warning letters today to companies selling products containing delta-8 THC. In total, the FDA sent out five warning letters to companies for violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Image from the FDA’s consumer update on Delta-8 THC

The violations include illegal marketing of unapproved delta-8 THC products as treatment for medical conditions, misbranding and adding delta-8 THC to food products. Back in September of last year, the FDA published a consumer update on their website, seeking to educate the public and offer a public health warning on delta-8 tetrahydrocannabinol, otherwise known as delta-8 THC.

Delta-8 THC is a cannabinoid that can be synthesized from cannabidiol (CBD) derived from hemp. It is an isomer of delta-9 THC, the more commonly known psychoactive cannabinoid found in cannabis. Delta-8 THC does produce psychoactive effects, though not quite as much as its better-known cousin, delta-9 THC. Many regulators and industry stakeholders are increasingly concerned about the rise in popularity of delta-8 products, namely because of the processing involved to produce it. Delta-8 THC is often synthesized using potentially harmful chemicals.

The FDA has a history of sending a lot of warning letters to companies marketing CBD products inaccurately and making drug claims. Earlier this year, they sent a number of letters to companies claiming that CBD can cure or prevent Covid-19.

FDAlogoAccording to Janet Woodcock, M.D., principal deputy commissioner at the FDA, they are getting more and more concerned about the popularity of delta-8 THC products sold online. “These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” says Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The FDA sent warning letters to the following companies selling delta-8 THC products:

  • ATLRx Inc.
  • BioMD Plus LLC
  • Delta 8 Hemp
  • Kingdom Harvest LLC
  • M Six Labs Inc.

2022 Cannabis Extraction Virtual Conference

By Cannabis Industry Journal Staff
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2022 Cannabis Extraction Virtual Conference

Sponsored by Hardy Diagnostics

View On-Demand Now

Click here to see all available CIJ events and webinars

Agenda

The Future of Cannabis Concentrates: in Hydrocarbon Extraction & Manufacturing

  • Michelle Sprawls, Director of Science, CULTA

This presentation delves into closed loop hydrocarbon extraction, what products can you make with this type of extraction method, advancements for manufacturing and new techniques.

Hardy Diagnostics Sponsored TechTalk

  • Jessa Youngblood, Food and Beverage Market Coordinator, Hardy Diagnostics

Extraction Optimization Through Artificial Intelligence

  • Dr. Markus Roggen, President & Chief Science Officer, Delic Labs

Attendees can expect to learn about:

  • Data is the basis for optimization, but which data is important and how to collect it.
  • What system exist for extraction optimization?
  • What is Bayesian Optimization, and how does it work?
  • What are the best parameters for extracting average cannabis?

How the Notorious CO2 Became a Superhero: SFC for Green Cannabinoid and Terpene Purification

  • Jason Lupoi, Ph.D., Director of Laboratory Operations, Thar Process

Attendees can expect to learn:

  • Assessment of the ways in which SFC can be used to purify cannabinoids as well as remediate THC from hemp products such that they are compliant with the Farm Bill.
  • The use of SFC for removing unwanted contaminants from product batches or chemical conversion processes such as those used in making delta-8-THC
  • The application of CO2 extraction and SFC for terpene refinement.

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The Rise of a New Market… And a New Consumer

By Christiane Campbell
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The adult beverage industry, like any other category of consumer branded products, is driven by trends. If you’re old enough to remember Bartles & Jaymes wine coolers, you probably also remember Zima and Smirnoff Ice, and more recently “healthy” options like Skinny Girl and Michelob Ultra. The sensation that was craft beer saw many brands being acquired by Big Alcohol so that while the brands remain, ownership and production have changed significantly. Gin, tequila and vodka have had their moments in the sun and the current market is undeniably saturated with what is probably the largest current trend – hard seltzers. However, with the seltzer craze waning, many are wondering what’s next. And with the growing sober/California sober trends, some are betting it is cannabis-infused beverages.

Cannabis-infused beverages offer both an alternative method of consumption of cannabis and are also an attractive alternative to alcohol. Infused beverages are more appealing to the new demographic of casually curious cannabis consumers. i.e., consumers that may not be interested in smoking a joint or vaping, but are comfortable micro-dosing from a can or bottle, as they would a seltzer or beer. The same type of consumer may be moving away from alcohol consumption to eliminate hangovers or other negative health effects.

The emerging market and curious consumer group present an enormous opportunity right now for cannabis-infused beverage brands. Of course, with opportunity and growth come challenges. And while cannabis-infused beverages face a host of legal and regulatory challenges relative to sourcing, manufacturing, packaging, labeling, shipping, marketing, distribution and sale, one of the most critically important business assets to address at inception is the brand.

Lines are Blurring, Gaps are Being Bridged

The U.S. cannabis market is currently a geographic hamburger. Hear me out: Geographically, you have a relatively mature market out west and a relatively new and growing market along the east coast. These are the buns. You have a mixed bag in between, with some states coming online and allowing medical or adult use cannabis use and others that have not yet embraced any form of legalization. The landscape has lent itself to the development of regional brands, such that brands that are so similar they might otherwise confuse consumers, have been able to co-exist in different regions without issue, or because there is little to no trade channel or market overlap. Similarly, adult beverages and cannabis have historically been separate verticals, with an arguably low likelihood that a consumer would assume a particular cannabis product and adult beverage product emanate from the same source.

A drink additive, made by Splash Nano, that uses nano emulsion technology

However, lines are blurring and gaps are being bridged. Walls are breaking down. The increasing number of states coming online with legalized cannabis, and the proliferation of multi-state operators (MSOs), means that cannabis brands can grow to be more than siloed regional brands. This will inevitably lead to brands that previously co-existed bumping into one another and there’s bound to be some pushing and shoving. The advent of infused beverages likewise bridges the gap between cannabis products and alcoholic beverages. While the respective industries were not historically per se related, competing, or overlapping, now you’ve got infused beverages that bridge the gap between the two, and traditional alcohol brands (e.g., Boston Beer Company, Molson Coors, Lagunitas, Pabst.) entering the market (albeit under different brands). This makes a strong argument that cannabis and alcohol (or, more generally, adult beverages) are within each other’s logical zones of expansion, for purposes of a likelihood of confusion analysis.

The growing pains infused beverage brands will experience are analogous to those craft beers saw in the 2000 – 2010s. Many craft brewers had catchy, cheeky names and brands that contributed to their ability to engage consumers and develop a following, but failure to clear and protect the brands prior to launch detracted from the brands’ market values. Localized use prior to expansion also led to many brands bumping into one another and stepping on each other’s trademark toes. This was significant as the brands sought investment dollars or an exit strategy, making clear that the brand itself contributed heavily to valuation.

Mitigating Risks and Overcoming Challenges: Search and Protect 

The risks and challenges can be significantly mitigated and/or overcome with proper preliminary clearance searching and assessments, and by seeking and obtaining state or federal protection for the brand or brands, to the extent possible.

Quatreau CBD infused sparkling water

Of course, clearance searches and assessments come with their own challenges, as does federal protection. With respect to clearance searches, these typically look at U.S. federal and state trademark databases. These resources are not sufficient for purposes of clearing a proposed cannabis brand. Many brands are not recorded at the federal or state level and indeed may not even show up in a basic search engine. An appropriate search looks at social media resources like Instagram, Twitter, Facebook and known cannabis resources like Leafly and Weedmaps. Additionally, the scope of the search should exceed cannabis products and services and at least look at alcohol and merchandise. Adoption and use of a brand for a cannabis-infused beverage is high risk if that brand is similar to a prior existing alcohol brand. A current example is Cointreau’s taking aim at Canopy’s adoption and use of QUATREAU for an infused beverage.

A U.S. federal trademark registration presents its own unique challenges, but is incredibly valuable and beneficial to a brand since it provides the owner with a nationwide presumption of ownership and validity in a trademark, and can also secure priority for the owner with a constructive first use in commerce date that is years before actual use of a mark begins. The U.S. Trademark Office categorically denies protection of brands that violate its “lawful use” rule, and will treat as per se unlawful any applied for mark that covers marijuana, or that covers foods, beverages or pharmaceuticals that contain CBD. With respect to brands that cover products containing THC, since it is federally scheduled, use of the brand would violate the Controlled Substances Act (CSA). With respect to brands that cover CBD or products containing CBD, these may be lawful pursuant to the Farm Bill and the U.S. Trademark Office’s subsequent allowance of marks that claim CBD “solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis,” however under the Food Drug Cosmetics Act (FDCA) it is currently federally unlawful to introduce CBD – even if it fits the definition above – into foods or beverages.

Even if cannabis is not specifically claimed in a trademark application, cannabis brands have a natural gravitation toward names and logos that can do some of their marketing for them, and announce to the world they cover cannabis. This increases the chances that a trademark application for the brand will get push-back from the U.S. Trademark Office, and if not at the initial review stage, then at the point in time when the brand must submit to the U.S. Trademark Office a sample of (lawful) use of the applied-for mark. While this all sounds like bad news for cannabis-infused beverages, all is not lost.

There are typically ancillary and federally lawful products and services cannabis companies offer under their brands that can be covered in a U.S. federal trademark application, and arguments to be made that registered protection of a brand for the ancillary items should be sufficient to enforce against third parties using the same or confusingly similar brands in their space. Some cannabis brands’ lawful ancillary products are actually product lines (e.g., beverages) offered under the same brand that contain no cannabis. Others may be more causally related, like online forums and blogs. The former is closer to the actual product, and the latter would be more beneficial to a brand that is inherently stronger and more distinctive. One note of caution: A trademark application and eventual registration that expressly disclaim cannabis (THC or CBD) may be difficult to enforce against a third party using the same or a similar mark on and in connection with cannabis. So, while there is a natural inclination to follow a U.S. Trademark Office request to disclaim coverage of cannabis, there may be enforcement consequences down the road.

The cannabis-infused beverage market is poised for explosive growth. The brands that survive – and succeed – will be those that position themselves for growth by clearing and buttoning up their brands as early as possible. The market leaders will be those that select strong and distinctive brands, with geographic and market space around them for growth and expansion; and those that protect and enforce their brands, to the extent possible, at the federal and/or state levels.

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FDA Warning Letters: Stop Claiming CBD Prevents COVID

By Cannabis Industry Journal Staff
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Once again, the U.S. Food and Drug Administration (FDA) has issued a number of warning letters to companies selling hemp-derived cannabidiol (CBD) products. This time around, the FDA sent these warning letters to companies that had statements on their website claiming CBD is an effective treatment or prevention of Covid-19.

In this latest round, the FDA sent a total of seven warning letters to:

Just some of the many hemp-derived CBD products on the market today
  • Greenway Herbal Products LLC
  • UPSY LLC
  • Functional Remedies, LLC dba Synchronicity Hemp Oil
  • Nature’s Highway
  • Heaven’s Organic LLC
  • Cureganics
  • CBD Social

Earlier this year, a slew of preliminary research studies went viral for shedding light on promising signs that certain cannabis compounds could help treat or prevent Covid-19. The conclusions from most of that research is: It is still too early to tell if any of these studies will show evidence of cannabis treating Covid-19, let alone if they mean cannabis products can be used as a treatment or preventative for Covid-19. However, the research is significant and we should keep an eye on any developments that come from those studies.

The hemp-derived CBD market has a history of clashes with the FDA over health claims. Since the Farm Bill legalized cannabis with less than 0.3% THC back in 2018, the hemp-derived CBD market has proliferated, with all sorts of companies seizing the opportunity. Jumping on the health and wellness trend, companies incorporated this messaging into their marketing campaigns. Over the past four years, the FDA has issued dozens and dozens of warning letters and threatened enforcement actions to companies making unsubstantiated health claims about CBD.

While CBD definitely does have medical benefits, such as being used as an anti-inflammatory or anticonvulsant, preliminary research alone is not enough to say it does. Products need to be approved by the FDA with a new drug application (NDA) in order to make those claims. Therefore when companies make unsubstantiated health claims about their CBD products, like claiming it can prevent Covid-19, they are violating the FD&C Act by marketing “unapproved new drugs” or “misbranded drugs.”

The bottom line is companies that are marketing CBD products need to ensure that their marketing materials and labeling comply with FDA requirements and avoid making unapproved drug claims.