For the second time, the U.S. House of Representatives passed the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, a bill that would end the federal prohibition on cannabis by removing it from the list of banned controlled substances. The bill is expected to face strong headwinds in the Senate, however.
The bill that passed the House with 220 “yea” votes to 204 “nay” votes would end the federal ban, but leave legalization up to the states. The legal marijuana industry generated $25 billion in sales last year, a 43 percent increase over 2020, and is expected to hit $65 billion in 2030, according to Forbes.
House Majority Leader Steny Hoyer said this is an important issue because the majority of Americans want cannabis to be legal. He also said that he used to support tough-on-marijuana policies earlier in his political career. “I was a supporter of the war on drugs, I’ve been here a long time… but it’s not a gateway drug, I’ve been convinced of that,” said Hoyer. “Marijuana has been legalized in 40 percent of our states, and medical marijuana is legal in 36 states. This is not out of the ordinary, this is something Americans tells us is an appropriate thing to do.”
Cannabis is legal for adult-use in 19 states and for medical use in 36 states. This bill would end the federal ban, but leave legalization up to the states. The MORE Act is thought to have an uphill battle in the Senate. The last time the House passed the bill the Senate did not take it up to a vote.
There are also competing bills within the House. Nancy Mace, the freshman Representative from South Carolina’s coastal swing district spanning Charleston to Hilton Head, introduced the States Reform Act, a bill that would end the federal government’s 85-year prohibition on marijuana, last year. Her bill, the first comprehensive Republican version to end cannabis prohibition, is expected to have its own hearing in April. Mace voted no on the MORE Act.
The flavor ban bill introduced in Illinois would also ban flavored THC vaping devices. Senate Bill 3854, introduced in January, is currently in committee. Any flavored flavored vaping product, including heat-not-burn systems and tobacco chew, would be banned.
Credit: Kurgu 128
The bill provides “that (1) “tobacco product” includes products containing tetrahydrocannabinol and products containing a mixture of tetrahydrocannabinol and nicotine, and (2) “tobacco retailer” includes dispensing organizations and dispensing organization agents, as those terms are defined in the Cannabis Regulation and Tax Act. Creates a presumption that a tobacco product, related tobacco product, alternative nicotine product, or solution or substance intended for use with electronic cigarettes is a banned product, solution, or substance intended for use with electronic cigarettes if it has or produces a characterizing flavor.”
A consumer advocacy group says the measure could do more harm than good. Elizabeth Hicks, U.S. Affairs analyst with the Consumer Choice Center, said enacting a flavor ban for vaping products will push adult consumers to switch back to smoking combustible tobacco at a time when smoking cigarettes has been trending down in Illinois, according to KPVI.
“About 12% of adults in 2020 reported smoking, however, if this bill passes, we can certainly expect that number to increase,” Hicks said. “This ultimately will lead to increases in smoking-related healthcare costs, which are already costing Illinois taxpayers over $1.9 billion annually,” Hicks said.
The state of Illinois passed two laws last year aimed at making it harder for minors to access vaping products. The first law (Senate Bill 512) prohibits the use of cartoon characters, video game characters, and popular children’s media from advertisements for e-cigarettes. It also makes it harder to buy vaping products online. Buyers will now have to use a credit card or check in the buyer’s name.
The second law (Senate Bill 555) amends the Substance Use Disorder Act to include vape shops. Adding vape shops allows the Illinois Department of Human Services to do compliance checks on the sale of e-cigarettes according to the minimum purchasing age of 21.
Turning Point Brands is embracing next-generation tobacco and alternative products by taking calculated risks.
By Timothy S. Donahue
It’s hard to argue the success of Turning Point Brands (TPB). In business since 1988, during the past decade, the company has been turning the typical tobacco business model on its head. It is involved in almost all aspects of the industry, generating nearly $450 million in sales every year. From its iconic brands like Zig-Zag to its more recent investments in the growing legal cannabis industry, TPB is turning heads.
Headquartered in Louisville, Kentucky, USA, TPB’s business includes three operating segments. Its main line of revenue comes from its “smoking” segment, which includes the rights to the Zig-Zag brand in the U.S. and Canada, according to Scott R. Grossman, TPB’s vice president of corporate development. Zig-Zag is one of the oldest, most recognized “other tobacco products” (OTP) and cannabis accessory brands. “Founded over 150 years ago, Zig-Zag holds the No. 1 share of both rolling papers and wraps in North America, and its products can be found in more than 200,000 retail outlets,” says Grossman. “Given that Zig-Zag generates roughly 40 percent of TPB’s revenue and a majority of our operating income, the brand and its growth initiatives are a major focus for us.”
TPB’s second segment is “smokeless,” which is predominantly the Stoker’s brand, a leading player in the moist snuff tobacco and chewing tobacco markets. The company also owns the Beech-Nut brand and a diverse collection of other chewing tobacco products. Another compelling segment of the TPB operation is its new generation of products (NewGen), which covers the company’s electronic nicotine-delivery system (ENDS) and cannabis brands.
NewGen includes an assortment of brands serving multiple industry segments, such as TPB’s business-to-business (Vapor Beast) and business-to-consumer (International Vapor Group) distribution platforms and its new product engine, Nu-X Ventures. The company has online platforms under brand names such as VaporFi, South Beach Smoke and DirectVapor. TPB also owns the e-liquid brand Solace and within its NewGen segment includes recent minority investments in the emerging cannabinoid space, including brands such as Old Pal, Dosist, Docklight and Wild Hemp.
TPB was one of the first traditional tobacco companies to publicly announce its foray into the legal cannabis market. That decision came under the leadership of TPB’s former president and CEO, Larry Wexler, who retired from the company and was succeeded by Yavor Efremov on Jan. 11. “Larry took the company public in 2016 as an OTP business, and over the next five years, he successfully drove significant initiatives to drive value, including the investment in new talent to drive TPB forward,” says Grossman. “We’ve been strategically focused on introducing new products to serve both B2B and B2C customers across on-premise retail and online channels.”
Yavor Efremov
Bump in the Road
Being a business with major assets in ENDS comes with challenges. TPB was one of the first major companies to receive a marketing denial order (MDO) from the U.S. Food and Drug Administration after the agency’s Sept. 9, 2021, deadline to decide on premarket tobacco product applications (PMTAs). Convinced that the FDA’s decision was unjustified, TPB immediately filed a legal challenge. Before the lawsuit made its way through the courts, the FDA rescinded the MDO it issued to TPB. The term “Fatal Flaw” was used by the FDA for PMTA submissions that lacked certain studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The Fatal Flaw standard is obviously one that departs from the pre-September 2020 guidance. In fact, it’s in direct conflict with that guidance. It’s helpful that [our MDO] was rescinded and that the agency admitted it had not reviewed certain [TPB] studies,” explains Paul Blair, TPB’s vice president of government affairs, adding that TPB made the decision to file suit because there was information that the regulatory agency overlooked in its review process. TPB wasn’t unique in that respect; however, the agency didn’t look at specific study data for several businesses.
“[The rescission] is an important recognition that our denial was not related to nitpicking over data. The science we submitted about transitioning combustible cigarette consumers to our products in particular … It was an oversight. And that’s helpful not only as we try to navigate the process moving forward but also because it doesn’t seem it was an attack on the body of our application generally,” explains Blair. “We maintain that we provided data that is sufficient for the agency to authorize the marketing of our PMTAs. It’s fair to say, though, there’s not a publicly announced standard for the approval process, whether it’s for open system products, closed system products, flavors and, honestly, even tobacco and traditional flavored products.”
That’s what Blair believes the FDA is doing now; the agency is probably reviewing its communications plan on how to reassess the PMTA process and come to some conclusions on deciding on a standard for authorizing products. Traditionally, the FDA would engage in good faith conversations with businesses trying to get products approved and offer some clarity on what information the agency needs. According to critics, the FDA’s Fatal Flaw analysis for ENDS products proved this isn’t the case anymore.
Paul Blair
Embracing Change
Unlike most traditional tobacco companies, TPB isn’t shy about its cannabis investments. The company’s management team and its board have embraced legalization, according to Grossman. Currently, 37 U.S. states have legalized medical cannabis and 18 have approved it for recreational use. During the past few years, the company has invested in several cannabis operations. In 2021, TPB completed an $8 million strategic investment in Old Pal Holding Co., a cannabis lifestyle brand, and an $8.7 million strategic investment in Docklight Brands, a consumer products company led by its anchor brands Marley Natural and Marley CBD. In 2020, TPB entered into a long-term distribution and profit-sharing arrangement with Wild Hempettes, the Texas-based manufacturer of Wild Hemp Hempettes brand smokable CBD, and made a $15 million strategic investment in the global cannabinoid company Dosist.
Grossman says that while every investment needs to be able to stand on its own, TPB’s strategy is focused on finding highly synergistic companies that strengthen the current TPB platform. Old Pal is a good example of how its strategy is being deployed—Old Pal sells roll-your-own (RYO) cannabis products with rolling papers inside the packaging. “Zig-Zag has historically been mainly focused on the convenience store channel, so this investment enables TPB to further accelerate growth in under-indexed stores such as dispensaries and head shops while supporting the growth of Old Pal,” says Grossman.
In August, TPB made its first move into the international market by increasing its stake in ReCreation Marketing, a Canadian distribution company with ties to Canada’s recreational cannabis culture. In December, ReCreation Marketing rebranded as Turning Point Brands Canada. “TPB Canada has a number of proprietary branded products in its portfolio, and we are exploring strategies to leverage that proven model and its portfolio to increase distribution within the U.S.,” says Grossman. “We are one of a select group of established companies—especially public companies—that are actively looking to deploy capital in the cannabinoid space. Historically, we’ve been predominately focused on brands given our expertise, but we’re exploring many verticals within the cannabinoid sector. Our pipeline is very healthy, but at the same time, we have to remain highly disciplined with how we spend our time and capital.”
It’s not just vaping and cannabis products in TPB’s future. In July, the company acquired certain cigar assets of Unitabac. The acquisition was for a portfolio of cigarillo products and all related intellectual property, including cigarillo non-tip, homogenized tobacco leaf, rolled leaf and natural leaf cigarillo products. “The cigar business is a $2.5 billion wholesale business in the United States. We’ve historically participated in that market, but we didn’t have the scale necessary to be really competitive. The Unitabac acquisition allows us to further extend into the cigar market,” says Grossman. “You’ll see a number of initiatives with that asset rolling out natural leaf products and other cigar assets, both under the Unitabac portfolio of brands as well as extending it to Zig-Zag.”
Scott Grossman
Facing Uncertainty
The FDA will soon have a new leader (Biden’s appointee, Robert Califf, had yet to be confirmed at press time). The FDA’s Center for Tobacco Products (CTP) will also have a new leader; its current director, Mitch Zeller, plans to retire in April. Blair says that the individuals in those positions will have a significant role to play in determining how the agency and CTP will work with stakeholders and communicate policies about how those regulations will go into effect. The FDA, he says, doesn’t have any previous experience regulating vaping products, so there is going to be a lot of action, reaction and learning along the way.
“It’s not as if Congress explicitly wrote how the approval or denial process might look. In fact, they didn’t write the details,” says Blair. “At least [the FDA is] thinking about the process, and they’re thinking about the consequences. But there is this opportunity beyond vapor product PMTAs in 2022 for a future generation of products to have some certainty because at the end of this, whether it’s because of litigation, because it’s further issued guidance, because it’s approvals or denials, there will be a pathway for companies and a better understanding of how the process works.”
Blair says that overcoming the challenges of getting a PMTA approved will be stepping stones toward determining how the company approaches the future regulation of other products, such as cannabis. He says there is a real opportunity for TPB to play a critical role in the future of cannabis regulation and policy. “I think our action is going to be guided by our business’ experience as a regulated tobacco business. There are other tobacco businesses that have cannabis interests or investments, but there aren’t many that are willing to publicly engage in the way that ours is as an advocate for legalization, as an advocate for appropriate regulations. There needs to be a balance of consumer protection with entrepreneurship and opportunities in the investment space.”
Grossman says the future of TPB is to align itself with the growth of the cannabinoid industry and possibly make more direct cannabis investments outside its current portfolio. “We are concentrated on trying to learn and execute on a variety of cannabinoid initiatives,” he says. “Although we’ve historically focused on brands, we are deeply embedded in the sector and are actively studying many verticals across value-added products and services, brands and distribution. We believe the U.S. cannabis market will exceed $50 billion over the next five to 10 years, which we clearly think will benefit TPB over the long term.”
Timothy Donahue is the managing editor
of Vapor Voice. Since helping start the magazine in 2014, he has become an
expert and well-respected voice in the rapidly evolving
vapor industry. Tim spends much of his time on the
road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind
are valuable assets to the industry’s diverse audience.
A growing number of countries are considering embracing legalized marijuana to boost their economies.
By Timothy S. Donahue
Marijuana is a moneymaker. To help combat slowing economies caused by the Covid-19 pandemic, many countries are considering legalizing marijuana. Currently, only Canada, Georgia, Mexico, South Africa and Uruguay, plus 18 U.S. states, two U.S. territories, the District of Columbia and the Australian Capital Territory in Australia have some form of legal marijuana. More recently, Germany, Luxembourg, Costa Rica and the U.S. are working to legalize marijuana on a national level.
In November, the leaders of Germany’s incoming governing parties announced that they had reached a formal agreement to legalize recreational marijuana and “promote broader drug policy harm reduction measures” when they take power. “We are introducing the controlled supply of cannabis to adults for consumption in licensed stores,” the parties said in a 118-page agreement. “This controls the quality [of marijuana], prevents the transfer of contaminated substances and guarantees the protection of minors.”
Currently, the personal possession of marijuana is decriminalized in Germany, and there is a medical cannabis program for residents. However, this proposal seeks to establish a regulated market for adult-use marijuana. The joint government will also review the social impact of legalization four years after implementation, according to the agreement.
“When it comes to alcohol and nicotine prevention, we rely on increased education with a special focus on children, adolescents and pregnant women,” the agreement states. “We are tightening the regulations for marketing and sponsoring for alcohol, nicotine and cannabis. We constantly measure regulations against new scientific findings and use them to align health protection measures.”
Competing with Germany to be first to legalize in Europe is its neighbor Luxembourg. The country’s ministers of justice and homeland security in October unveiled a legalization proposal, which will still require a vote in Parliament but is expected to pass, according to Marijuana Moment. Luxembourg’s rules focus on legalization within a home setting. Parliament is expected to vote on the proposal in early 2022, and the ruling parties are friendly to the reform.
In Mexico, medicinal use of cannabis products became legal in June 2021. World-renowned cannabis attorney Rod Kight says that Mexico is moving along rapidly in the implementation and understanding of the new rules, though a bit chaotically. He said that he expects to see more movement on marijuana laws in the country during its next legislative session.
“Medical cannabis is lawful in Mexico, and regulations were published earlier this year,” he said. “With respect to adult-use cannabis, the Supreme Court ruled that laws prohibiting the personal use and consumption of cannabis are unconstitutional. However, it remains unlawful to engage in commercial cannabis transactions. We anticipate that an adult-use bill will be passed in 2022.”
A top Mexican senator says that there’s agreement among key legislative leaders of multiple parties to prioritize marijuana legalization legislation this session, according to Marijuana Moment. Senate Majority Leader Ricardo Monreal Avila of the ruling MORENA party made the comments following a meeting of the Political Coordination Board. He said that the panel “agreed to prioritize cannabis laws” among other issues like cybersecurity, according to a translation.
During a recent trip to Costa Rica, Vapor Voice visited several stores that sold marijuana components, such as pipes and grinders, but no one was selling the product itself. This is because the rules in Costa Rica are confusing. While technically marijuana is illegal, there are no statutory penalties for the possession and use of marijuana. Selling marijuana, however, is illegal and punishable by up to 10 years in prison and/or fines.
To help combat this confusion and truly embrace the growing number of global marijuana tourists, like Mexico, Costa Rica is considering legalizing recreational marijuana. This would allow marijuana to be purchased in stores and allow the country to tax the product. Last year, Costa Rica’s Congress approved the legalization of marijuana for medicinal purposes despite opposition from conservative groups and President Carlos Alvarado.
Instead of taking up the required second debate, lawmakers sent the bill to the Constitutional Chamber of the Supreme Court for legal review, similar to the route Mexico took toward legalization as well. The second debate is expected early next year and would still require a signature from Alvarado.
The Costa Rican law only allows for the production and processing of cannabis but does not regulate its recreational use. However, the vote represents the most concrete action Costa Rica has taken toward legalizing cannabis products while noting the “significant economic potential” of legalizing the sale of cannabis. “It is a market of billions of dollars, and Costa Rica could be part of it,” said lawmaker Zoila Rosa Volio, who introduced the bill. He said Costa Rica was in a prime position to reap the “benefits of growing and exporting hemp and marijuana plants.”
Kight said that the developments in Costa Rica are encouraging. The approved bill authorizes the production, industrialization and commercialization of medicinal cannabis and hemp. “Under the bill, low-THC hemp and nonintoxicating hemp products are lawful generally, and high-THC cannabis will be approved for medical use,” Kight explains. “President Carlos Alvarado approves of hemp but is an opponent of high-THC cannabis. His office controls the legislative agenda, which means that a final vote on the law may not occur in the short term.”
In the United States, federal regulation of marijuana has been introduced numerous times and always failed. As more states legalize marijuana, however, the federal government is under pressure to decriminalize marijuana and remove it from its listing as a Schedule I drug, which are considered “substances or chemicals [that] are defined as drugs with no currently accepted medical use and a high potential for abuse.” While a large swath of the U.S. has legalized marijuana, it is still a highly debated argument at the federal level.
The most recent attempt to decriminalize marijuana is the States Reform Act, which would deschedule, regulate and tax cannabis products with a novel federal excise tax design—based on quantities and predefined categories, not dissimilar from how the federal government taxes alcohol and tobacco.
Introduced by Representative Nancy Mace, the bill would impose a tax of 3 percent on the removal price (cost when leaving the manufacturer or a bonded warehouse) of cannabis products. That’s significantly lower than the rates suggested in the other bills introduced this year to deschedule and tax cannabis: the MORE Act (8 percent rate) and the Cannabis Administration and Opportunity Act (CAOA, 25 percent rate), according to Ulrik Boesen, an analyst with the Tax Foundation.
“Arguably, the biggest impact on existing cannabis businesses would not be a new federal tax. Today, due to its Schedule I status, cannabis products cannot cross state borders, and as a result, all products must be grown, processed, sold and consumed within state borders,” states Boesen. “Descheduling would create a national market where products grown in Oregon can be processed in Colorado and sold in New York. This would revolutionize markets in states, which, given the federal prohibition, are currently able to discriminate against interstate commerce. Descheduling would mean that state laws can no longer do so as it would violate the Dormant Commerce Clause of the U.S. Constitution.”
Mace’s bill establishes six taxable categories and instructs that the secretary of the treasury can create more if needed:
cannabis flower (454 grams);
cannabis pre-rolls (100 grams);
cannabis extracts (20 grams);
cannabis vape cartridges (10 grams);
edibles (20 units); and
topicals and cosmetic products (20 units).
In a blog post, Boesen states that the creation of categories avoids some larger issues associated with price-based taxation as it guarantees that comparable products are taxed at the same rate regardless of price. “Under a pure price-based tax design, an expensive THC-containing chocolate bar would be taxed at a higher rate than a cheap THC-containing chocolate bar—even if they contain the exact same amount and quality of THC,” he writes. “Taxing the value of the product is not an excise tax’s job—capturing value should be left to sales and income taxes.”
Michelle Minton, a senior fellow at the Competitive Enterprise Institute, said that while it certainly has room for improvement, Mace’s bill is a solid starting point for “truly bipartisan legislation” that could finally end America’s prohibition of marijuana products. The MORE Act, introduced in House in May by Rep. Jerrold Nadler, would also decriminalize marijuana.
Specifically, the MORE Act also removes marijuana from the list of scheduled substances under the Controlled Substances Act and eliminates criminal penalties for an individual who manufactures, distributes or possesses marijuana. However, Minton says that Mace’s bill, unlike the MORE Act, would set a national minimum age for cannabis purchasing at 21.
“This would be enforced in the same way as the national minimum age for buying alcohol: by withholding federal transportation funds to states with a lower minimum age than the federal standard,” she writes in a blog post. “However, Mace’s proposal includes an exemption for states that allow minors to access medicinal cannabis for therapeutic purposes. The SRA bill would also grandfather in state medical cannabis products, allowing them to be sold in interstate commerce without prior federal approval.”
The dangling carrot for countries seeking to legalize marijuana is the amount of potential tax revenue the sales of marijuana can bring. For example, sales of marijuana in Colorado, one of the first U.S. states to legalize recreational marijuana, has resulted in buoyant tax revenues, according to media reports. In 2019, Colorado collected more than $302 million in taxes and fees on medical and recreational marijuana. Sales in the state totaled over $1.7 billion.
Nationwide, marijuana sales in the U.S. were $12.2 billion in 2019 and are projected to increase to $31.1 billion by 2024, according to a report from Arcview Market Research and BDS Analytics. Should marijuana become legal on a federal level, the benefits to the economy could be exceptional: A report from cannabis analytics company New Frontier suggests that federally legalizing marijuana could generate an additional $105.6 billion in aggregate federal tax revenue by 2025. It also predicts the impact of federally legal marijuana at the federal level could generate 1 million jobs by 2025.
Legalizing cannabis could bring Germany annual tax revenues and cost savings of about €4.7 billion ($5.34 billion) and create 27,000 new jobs, according to a survey by the Institute for Competition Economics at the Heinrich Heine University in Duesseldorf and commissioned by the German hemp association. The European market is projected to grow to €3.2 billion by 2025, up from €403 million at the end of 2021, according to the European Cannabis Report by the research firm Prohibition Partners.
Kight says legalization just makes sense. Whether in a large country like the U.S. or smaller countries such as Costa Rica and Mexico, the economic boost that legalized marijuana could bring is an economic gamechanger. “We seem to be at a tipping point for cannabis legalization, which appears inevitable in the U.S., most of Europe, much of Latin America and other parts of the world. The only real questions are when and what the various regulatory regimes will look like,” Kight says. “Countries that legislate quickly and thoughtfully should reap the benefits of increased tax revenue and lower crime rates.”
The U.S. House Judiciary Committee approved a bill Thursday that would decriminalize and deschedule marijuana by a vote of 26-15. The move ended a two-day markup period in which the panel also approved a series of bipartisan measures designed to lower drug prices.
Credit: EKKAPON
The measure, sponsored by Judiciary Chairman Jerrold Nadler, passed the chamber last year but stalled in the GOP-controlled Senate, according to rollcall.com. Senate Majority Leader Charles E. Schumer proposed a similar measure in July, sparking hopes among advocates that the legislation would finally make it into law.
The bill would decriminalize and deschedule cannabis, and implement a federal tax on marijuana products to fund grants for communities hardest hit by the nation’s war on drugs. The bill would also allow most individuals convicted of nonviolent cannabis offenses to expunge their records, with the exception of those considered to be “kingpins,” or those who helped oversee a criminal drug ring.
The outlook for final passage is still uncertain. Schumer and co-sponsors, including Sen. Cory Booker, have not yet formally introduced their draft bill, and Congress is currently consumed by a debate to pass trillions of dollars in spending on infrastructure and social programs, including a first-ever e-cigarette tax.
In a stern reminder to its citizens that vaping and cannabis products are illegal, Taiwan law enforcement and health officials arrested five people in the city of Taipei last week. Taipei police stated that they had broken up a criminal organization, whose members have been accused of selling vaping products containing cannabis extracts, according to the Taipei Times.
“After surveilling the premises for several days, police officers carried out a raid at a motel in Taipei’s Wanhua District last week, in which 94 vaping cartridges and 23 pouches of unknown powdered material were seized,” the story states. “Preliminary lab testing revealed that the cartridges contained cannabidiol (CBD) and tetrahydrocannabinol (THC), the main active ingredients in cannabis. The pouches contained ketamine, which is a controlled substance.”
A 25-year-old woman allegedly led the criminal ring. One modified handgun, 11 bullets and an undisclosed amount of cash were also seized. Investigators said that Liu’s group had been selling the vaping cartridge oil for the past year and has profited an estimated NT$10 million ($359,544) in illegal proceeds.
The suspects face charges of contravening the Narcotics Hazard Prevention Act and for possession of illegal firearms in contravention of the Controlling Guns, Ammunition and Knives Act. Ring members allegedly promoted their products to youth via social media and online platforms.
The CBD and THC oil were branded as “Cookies,” “Sherbet,” “Dream,” “Skywalker” and other names. Officials at the Ministry of Health and Welfare yesterday said that e-cigarette and related vaping devices have not been approved in Taiwan, and their use therefore is illegal, regardless of their contents.
CBD in pharmaceutical products has received approval for medicinal use in Taiwan, when prescribed by a physician and the request is approved by authorities. However, general sale of CBD is not permitted. Such products can contain THC at less than 10 parts per million, but would otherwise be scheduled as a Class 2 illegal drug, officials said.
International cannabis attorney Rod Kight discusses minor cannabinoids and the growing cannabis market.
By Timothy S. Donahue
The questions kept coming. When Vapor Voice published an article on Delta-8 THC and other minor THC products in its last issue (see “High Expectations,” Vapor Voice, issue 3, 2021), it seems readers had more questions concerning newly marketed cannabinoids than the story answered. To gain more insight into the state of the current overall global cannabis market, we went to one of the best resources in the business.
In the cannabis industry, there may be no attorney more renowned than Rod Kight. While his firm is based in Asheville, North Carolina, USA, Kight currently spends much of his time in Mexico. His experiences with marijuana started when he used it during chemotherapy treatments in 2011. It had such a positive impact on his recovery that he decided he was going to focus on cannabis law. He wanted others to have the access that offered him such a profound experience.
“It’s kind of funny because I was practicing in North Carolina, which is a prohibition state. I got licensed in Oregon and kind of dove head-in to the laws regarding cannabis. It was right around the time that the 2014 Farm Bill came out that legalized, at the federal level, cannabis for the first time in almost a century,” Kight said. “We started getting calls about CBD. And like any good lawyer, I thought I would do some research and see what the laws and regulations were concerning CBD.”
He did not find much. He said he found nothing on CBD derived from hemp. The only federal restrictions on cannabinoids were centered on the source of the product. If the cannabinoids are derived from marijuana, then they are illegal controlled substances because marijuana is defined as the plant and all its parts. The legal definition is so broad that technically speaking, chlorophyll from a marijuana plant is a controlled substance.
Anything derived from a hemp plant, however, is legal, provided it has less than 0.3 percent Delta-9 THC. “All of the hemp plant’s parts are legal. So, if you get CBD or another cannabinoid from hemp, then it is not a controlled substance. I carved that out and began writing about it,” Kight explained. “We started to get more and more calls, more and more clients … things just went from there. That’s now called the Source Rule, and that was the first thing that kind of put me and the law firm on the map.”
Credit: Rod Kight
When Congress wrote the 2014 Farm Bill, lawmakers specifically stated that hemp is a cannabis plant with no more than 0.3 percent Delta-9 THC. Kight says the law could have easily been written as 0.3 percent of “any” THC. There are 30 known THC isomers. “They singled out that one cannabinoid and had to have some reason for doing so. We don’t know what reason that is. It could be good, bad or otherwise. But it took a special effort to say ‘Delta-9’ and call that out versus just ‘THC,’” says Kight. “The result is that all forms of THC with the exception of Delta-9—no more than 0.3 percent—have been removed from the controlled substances list.”
Another concern is that the U.S. Drug Enforcement Agency (DEA) views Delta-8 as a synthetic form of THC, which is illegal. Kight says the agency is correct in saying synthetic THC is illegal; however, he explained that it is not entirely clear whether Delta-8 produced from CBD qualifies as a “synthetic” form of THC under U.S. law since no generally accepted legal definition of the term “synthetic” exists.
“To be clear, there’s not a special listing for ‘synthetic’ THC. It just says that THC is a controlled substance and that includes synthetic forms of THC … it’s totally accurate. However, the Farm Bill provides an exception. It specifically removed hemp from the controlled substances list, including all of its cannabinoids, extracts, derivatives and isomers. That more specific and recent law trumps the general older law, which is the Controlled Substance Act (CSA).” Legally speaking, this is referred to as the doctrine of “lex specialis,” which means that “the more specific controls over the general. In other words, the Farm Bill exempts hemp-derived Delta-8 THC from the CSA.”
Delta-8 THC and its cousins are not like the synthetic cannabinoids, such as K-12 and Spice, that pushed the DEA to ban synthetic THC, according to Kight. He says that those K-12/Spice synthetics are not anything like the THC molecule. In fact, technically speaking, they are not synthetic forms of THC. Rather, they are best understood as analogs of THC. These fall under the Analogue Act, a section of the CSA passed in 1986. It allowed any chemical “substantially similar” to a controlled substance listed in Schedule I or II to be treated as if it were listed in Schedule I, but only if it is intended for human consumption and has a stimulant, depressant or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the controlled substance.
Delta-8 does not have the same effect on the body as Delta-9 THC. “Synthetics are typically very strong and potent, whereas Delta-8 is up to 10 times less potent than Delta-9 THC,” he said. “That’s a long way of saying that those are compounds that are created in a laboratory. They don’t resemble THC. Delta-8 is a natural compound that the cannabis plant produces and is much less potent than Delta-9 THC.”
Preventing precedent
Another question that arose following our previous article centered on the recent arrests of some Georgia vape shop owners for selling Delta-8 products. The Newnan Times-Herald reports that county authorities were tipped off that a store was illegally selling THC products. An undercover officer bought gummies from the store, and law enforcement tested the product for THC. They tested positive for THC. However, the tests the officers used in the field cannot differentiate between Delta-8, Delta-9 or any other THC, or if the products contained more than 0.3 percent of THC.
While several states have laws, regulations or official agency-level legal positions banning Delta-8 THC, Georgia does not. “Could this case set a precedent for other vape shop owners if they are found guilty?” a reader asked.
Kight says one only needs to look to the state statute for an answer. If the state’s hemp laws mirror the federal law, like (the laws of) many states do, then Delta-8 is a legal product. “If a judge were to be persuaded that it was illegal, however, that could create precedent,” said Kight. “Other states could look to Georgia’s ruling, and that could be very detrimental if the prosecution wins.”
The bigger problem with the Georgia case is the testing protocols, according to Kight. Most state crime labs don’t test to differentiate between different types of THC. To convict someone, you have to prove beyond reasonable doubt that they have committed a crime. The best a crime lab can usually do is identify THC. Depending on the particulars of the case, this may not be sufficient.
“There’s all sorts of forms of THC that are lawful. So, meeting its burden of proof to convict is much more difficult for a prosecutor now that hemp is lawful,” explains Kight. “A related issue is when crime labs test products using heat, which is known as gas chromatography. Since THCA [the acid form of the THC molecule] transforms into Delta-9 THC when heated in a process called decarboxylation, this is problematic. THCA in cannabis begins to decarboxylate at approximately 220 degrees Fahrenheit after around 30 [minutes] to 45 minutes of exposure. That amounts to evidence tampering, namely, converting one piece of evidence into another. … I hope that criminal lawyers will address this issue when it arises.”
Banning cannabinoids is not the way to regulate them, according to Kight. He says lawmakers need to understand that prohibition is a failed concept. Not only does it waste resources, it also drives products that are desired by the public into the underground black market, which results in additional problems, according to Kight. Banning a product means regulators lose the ability to regulate the safety of these products. “They are washing their hands on the ability to regulate them and collect taxes,” Kight says. “Prohibition also incentivizes people who would otherwise operate legitimate legal businesses to participate in an illegal black market.”
Businesses need to understand the laws surrounding cannabis products because they are consistently evolving. There are a lot of U.S. Food and Drug Administration regulations regarding labeling and the manufacturing processes. Importantly, no one should be making medical claims about their products. “You need to understand the laws,” Kight said. “Secondly, you need to be willing to dig in and understand the science so that when you look at a certificate of analysis and an ingredient list, you know what that means so that you’re not pumping out products to the public that may be dangerous.”
Kight said that he expects the FDA to start regulating CBD products in the next 12 months to 18 months. He isn’t sure if those regulations will encompass all cannabinoid products. Currently, several bills dealing with regulating CBD are floating through Congress. For example, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 has been in the Subcommittee for Health since early February.
This bill would allow the use of “hemp, cannabidiol (i.e., CBD) derived from hemp, or any other ingredient derived from hemp” in a dietary supplement, provided that the supplement meets other applicable requirements. Currently, the FDA’s position is that CBD products may not be marketed as dietary supplements.
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Kight said that he also expects the market to consolidate as federal regulators enact rules for the industry. This will be good for some businesses and bad for others. “Companies that are attractive to the bigger companies will either enter into joint ventures or be acquired. Additionally, smaller companies that fill a niche that some of these larger conglomerates cannot fill will fare well,” said Kight. “But for companies that don’t fill a specific niche and also are not going to be appealing as a merger acquisition target, they’re going to struggle once a lot of consolidation occurs.”
Marijuana markets
Marijuana is growing globally. Numerous nations have or are considering legalizing cannabis products. Kight says that global markets are a “moving target” and changes typically do not happen overnight. In December 2020, the United Nations’ drug policymaking body recognized the medicinal and therapeutic potential of marijuana. Following a 2019 World Health Organization recommendation, the U.N. Commission on Narcotic Drugs removed cannabis from the strictest drug tier, Schedule IV, of the 1961 Convention—where it had resided alongside heroin for decades.
The U.S. currently has bills in both the House and the Senate aimed at national legalization for Delta-9 THC products. The Cannabis Administration and Opportunity Act (CAOA) aims to withdraw laws and federal penalties on marijuana. If passed, the legislation would also expunge nonviolent federal cannabis-related criminal records and let states make their own marijuana laws.
The CAOA proposal builds upon the recent Marijuana Opportunity Reinvestment and Expungement (MORE) Act passed by the U.S. House of Representatives. The CAOA expands beyond the MORE Act by proposing a “moon-shot effort to address drugged driving and multi-substance impairment, establishing strong cannabis health and safety standards” under the FDA, and leveraging the expertise of the Alcohol and Tobacco Tax and Trade Bureau within the Department of Treasury to regulate industry practices.
The U.S. cannabis industry grew 32 percent in 2020; and by 2025, it is estimated that the industry could have nearly $45.9 billion in annual sales, according to Grandview Research. Kight says legalization is probably closer at the federal level than many realize, most likely within the first term of the Biden administration.
“Whether that’s 12 [months] or 36 months from now … I think we’re going to see it during that time period,” he said. “We don’t know what form it’ll take, but it’s probably going to either be removing marijuana and THC from the controlled substances list altogether, which is really what should happen, or they’re going to be scheduled in a different way. Most likely, we will continue to have state-by-state regulation within the paradigm of federal legalization; some states will be really liberal, and some states will be really conservative.”
Internationally, Uruguay and Canada were the first countries to legalize marijuana. Several other countries are attempting to follow suit. However, many nations have signed onto treaties that make marijuana and THC illegal. Hemp is also defined differently from country to country, especially in the EU. In Switzerland, it is a 1 percent THC cap, whereas some other countries in the EU have a 0.2 percent cap, according to Kight. Countries have recently been more open to legalizing hemp, and that trend is expected to continue.
“We’re beginning to see producers in certain countries where hemp can be grown inexpensively being shipped to other countries where it can’t be produced inexpensively but where there’s a higher market price and demand. For instance, South America is known for being able to cultivate large tracts of hemp, especially in countries like Uruguay and Colombia, he says. “They want to deliver it to the EU where it’s a lot more expensive, there’s a large demand and people willing to pay more.”
In France, a court case made the decision for the country to legalize CBD products. France’s highest court ruled that CBD—including CBD flower—are legal in the country. The decision referenced last year’s KanaVape judgement in which a European court ruled that the French authorities had acted unlawfully in prosecuting two businessmen who imported CBD flowers from the Czech Republic in 2014, citing that CBD is “not a narcotic.”
The European court said France cannot ban any CBD that’s produced lawfully in the EU. If a product is produced lawfully in one EU country, it must be allowed in all EU countries. “France is changing its laws right now. Spain has got to change,” said Kight. “We are going to see this happen across Europe. These countries are working toward or just coming into compliance.”
One of the biggest stories currently in cannabis reform is Mexico. In late June, Mexico’s Supreme Court declared unconstitutional the prohibition of personal marijuana use in the country, clearing a path to legalization. Mexico’s lower house passed a legalization bill in March, but it is still awaiting legislative approval in a gridlocked Senate.
The Supreme Court of Mexico determined that the laws in Mexico prohibiting the personal use of cannabis is unconstitutional, according to Kight. Mexico has a “really important clause that the U.S. doesn’t have” called The Right to Free Development of Personality. The Mexican constitution protects the individual’s right to be unique and independent.
In several cases, marijuana advocates argued that the state cannot infringe upon that right when the consequences of marijuana consumption—be they positive or negative—only affect the individual who chooses to use the drug. “The Mexican Supreme Court agreed and determined that laws prohibiting cannabis use for personal use violated that constitutional provision,” Kight said.
Under Mexican law, its Supreme Court must rule on an issue five separate times (separate cases) for a decision to have precedence or value. The same process was how same-sex marriage was legalized in Mexico in 2014. The first cannabis case was brought by four members of the Mexican Society for Responsible and Tolerant Consumption in 2015. After the fifth separate marijuana decision was handed down in 2020, the court ordered the Mexican Congress to change the criminal laws prohibiting the use of cannabis.
Mexican lawmakers then failed to meet the Supreme Court’s April 2021 deadline to end marijuana prohibition after spending months going back and forth on a legalization bill that passed both chambers of Congress in differing forms. “There was an expectation that the Senate would again ask the court for an extension, but that did not take place. The Supreme Court of Mexico then entered a ruling that nullified the Mexican laws prohibiting cannabis use, and so we’re kind of in the Wild, Wild West now,” Kight explains. “That’s never happened for any subject under Mexican law, much less cannabis. Now the Congress is under the gun to enact laws and regulations.”
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Future focus
Overall, cannabis markets are expected to continue to grow globally. According to Market Watch, the global cannabis market size is expected to reach $118.9 billion by 2027 and is valued at approximately $20.6 billion in 2020. It is anticipated to grow with a healthy rate of more than 28.5 percent from 2020 to 2027. Regulation is coming, and many countries will likely regulate cannabis similar to the way tobacco products are regulated.
To help secure the future of the industry, businesses currently selling or manufacturing products using minor cannabinoids need to regulate themselves and produce and/or market only high-quality products using legitimately sourced and tested ingredients, says Kight, adding that one bad product can reverberate through the industry. Business owners should also be actively engaged with regulators.
“There are a lot of cannabis products out there that are not regulated. They might have contaminants in them that harm people, and we don’t want that,” he says. “I think it’s really important that industry players make sure they’re only dealing in high-quality, safe products. And they need to let their representatives in government know how important hemp is to them, including all of its cannabinoids.”
The U.S. Food and Drug Administration on Wednesday told Charlotte’s Web Holdings Inc. that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.
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“While we disagree with FDA’s reasoning, believing we provided extensive and credible scientific evidence that supported a different outcome, this decision affirms the path to regulatory clarity must come from Congress,” Charlotte’s Web CEO Deanie Elsner said in a statement.
The company’s bid to sell its full-spectrum hemp extract with CBD as a dietary supplement won’t be considered because of the FDA’s own prior decision to treat CBD as a drug, according to a letter posted on the agency’s website Wednesday, according to Fortune. The FDA’s latest decision rested in part on its prior approval of Epidiolex, a CBD drug to reduce seizures, which the agency said precludes it from authorizing CBD for dietary purposes.
Even if the drug hadn’t been approved, though, the FDA said in the letter to Charlotte’s Web dated July 23 that it “has concerns about the adequacy of safety evidence” that the company submitted. The agency would have wanted more data on potential liver and reproductive toxicity.
The decision isn’t expected to impact sales of Charlotte’s Web products or prevent other companies from continuing to sell CBD products. The market for CBD products has already grown to more than $6 billion as consumers seek help with everything from relaxation to focus to better sleep, according to reports. While generally an unregulated market, the FDA will periodically crackdown on companies that try to make unsubstantiated claims about the health benefits of CBD products.
A difficult debate is brewing in the U.S. Senate. Majority Leader Chuck Schumer released draft legislation Wednesday to legalize marijuana across the country. The lawmaker was joined by fellow senators Cory Booker (D-N.J.) and Ron Wyden (D-Ore.) in proposing to withdraw laws and federal penalties on marijuana. If passed, the legislation would also expunge nonviolent federal cannabis-related criminal records and let states make their own marijuana laws.
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The Cannabis Administration and Opportunity Act (CAOA) would also help put an end to the unfair targeting and treatment of communities of color by removing cannabis from the federal list of controlled substances, according to a press release. “Ending the federal prohibition on cannabis is becoming increasingly urgent as more and more states continue to legalize adult and medical use of cannabis,” the release states. “Despite the fact that cannabis is illegal under federal law, the majority of Americans live in a state where cannabis is legal in one form or another and more than 90 percent of Americans believe it should be legalized for either adult or medical use.”
To date, the adult use of cannabis is legal in 18 states, the District of Columbia, the Commonwealth of the Northern Mariana Islands, and Guam; and 37 states, the District of Columbia, Puerto Rico, Guam, and the U.S. Virgin Islands have advanced laws to allow medical cannabis. Schumer said that this legislative proposal goes a step beyond legalizing cannabis by expunging federal non-violent marijuana crimes and allowing individuals currently serving time in federal prison for non-violent marijuana crimes to petition a court for resentencing. It will also establish a fund to reinvest in the “communities that were hurt by the War on Drugs and provide restorative justice” to communities of color.
“I am proud to introduce our discussion draft of the Cannabis Administration and Opportunity Act, a legislative proposal aimed at finally putting an end to the federal prohibition of cannabis and addressing the over-criminalization of cannabis in a comprehensive and meaningful way,” said Schumer. “The War on Drugs has too often been a war on people, and particularly people of color. Not only will this legislation remove cannabis from the federal list of controlled substances, but it will also help fix our criminal justice system, ensure restorative justice, protect public health, and implement responsible taxes and regulations.”
The cannabis industry, which employs over 320,000 workers and generated over $17.5 billion in sales in 2020, also presents a significant opportunity for economic empowerment, according to the release. The industry saw 32 percent growth in 2020; and by 2025, it is estimated that the cannabis industry could have nearly $45.9 billion in annual sales.
These proposals build upon the recent Marijuana Opportunity Reinvestment and Expungement (MORE) Act by the U.S. House of Representatives. The CAOA expands beyond the MORE Act by proposing a “moon-shot effort to address drugged driving and multi-substance impairment, establishing strong cannabis health and safety standards” under the Food and Drug Administration, and leveraging the expertise of the Alcohol and Tobacco Tax and Trade Bureau (TTB) within the Department of Treasury to regulate industry practices.
22nd Century Group has added strategic partnerships with expert commercial-scale plant breeders Sawatch Agriculture and Folium Botanical. The partnerships with these two northern hemisphere breeders add to the breeding capabilities that 22nd Century already has through its close partnership with Aurora Cannabis and another southern hemisphere-based breeder that will be announced shortly, providing 22nd Century year-round growing capabilities.
With decades of combined specialized alkaloid plant breeding and plant biotechnology experience, these expert breeders have proven next-generation technologies and innovations on breeding, commercial scale-up and cultivation, many of which are far beyond those of independent competitive breeders or in-house breeding in consumer product companies, according to 22nd Century Group. Under 22nd Century’s direction, proprietary plants will be developed with optimum levels of cannabinoids that meet high-quality standards when grown at commercial scale.
“We are thrilled to announce the addition of these world-class alkaloid-based plant breeding specialists to complement 22nd Century’s capabilities in our upstream value chain,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“Our four breeding partnerships complete our portfolio of comprehensive plant science capabilities, enabling the rapid creation and scale-up of stable, tailored, highly disruptive plant lines with predictable yields critical to the mass cultivation of hemp/cannabis, which will be absolutely necessary to meet the rapidly growing market demand for improved, stable genetics.
“We are giving growers a competitive advantage by substantially improving crop yield and optimizing the time that it takes to develop new lines to a two-year cycle, a reduction from the 7 to 10 years that would typically be necessary to create new lines using our proprietary capabilities.”
With today’s announcement of these expert breeding partnerships, 22nd Century says it has secured all key partnerships needed to maximize and support each of the segments of its cannabinoid value chain: plant profiling (CannaMetrix), plant biotechnology (KeyGene), plant breeding, commercial-scale plant cultivation and ingredient extraction/purification (Sawatch Agriculture, Folium Botanical, Aurora Cannabis, Needle Rock Farms and Panacea).
