Author: Staff Writer

  • RELX Launches Infinity, Nano2 Vapes in Saudi Arabia

    RELX Launches Infinity, Nano2 Vapes in Saudi Arabia

    RELX International announced it has launched two e-cigarette products in Saudi Arabia. The move expands the vaping manufacturer’s Middle East presence where products are already available in the United Arab Emirates and Kuwait. The company also announced it plans to expand into the wider Middle East and North Africa (MENA) region this year.

    Saudi Arabia recently announced new regulations, similar to Europe’s TPD, following the EU standard for e-cigarette packaging and labeling which was introduced in Sept. 2020.

    “The MENA region is one of our category’s fastest growing markets, growing at a rate just short of 10 percent until 2024,” said Fouad Barakat, KSA general manager at RELX International. “Saudi Arabia is one of the region’s largest and most prosperous markets, hence the need for any brand to launch there if it wants to thrive and grow bigger.”

    The company introduced two products into the Saudi Arabian market. Both the RELX Infinity and Nano2 devices are available. The Infinity, RELX’s flagship product, comes with wireless charging and clicks into place with a built-in pogo pin. The charging case delivers up to three full charges with its dual system in just 45 minutes, according to RELX.

    The Nano2 is a disposable device which features a user-friendly design. “The RELX Nano2 offers RELX’s quality and technology standards at the lowest price point,” a release states. “This device is perfect if you’re a first-time e-cigarette user or if you’re looking for a compact and discreet vape pen.”

  • Geekvape to Build in Hong Kong-Macao Greater Bay Area

    Geekvape to Build in Hong Kong-Macao Greater Bay Area

    Geekvape officials at the signing ceremony for an intelligent manufacturing industrial park in the Guangdong-Hong Kong-Macao Greater Bay Area. (Photo: PRNewsfoto/Geekvape)

    Geekvape will invest CNY10 billion ($1.55 billion) in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) with the support of the Shenzhen Municipal Government.

    Over the next two years, the Chinese e-cigarette company plans to build a modern industrial park for intelligent manufacturing that will help customers address their needs for increased production capacity.

    Geekvape says it will be the first vapor company to build modular intelligent manufacturing facilities. By leveraging a connected intelligent manufacturing platform, the Internet of Things technology and big data, Geekvape says it will further improve product quality and services.

    “Geekvape has always been committed to helping improve human wellbeing and community development,” said Geekvape CEO Allen Yang in a statement.

    “Benefiting from the ideal economic, geographical and business conditions in the GBA, in tandem with the momentum in the intelligent manufacturing sector, we will build on our presence in the area to expand globally. Geekvape will provide our customers across over 70 countries and regions with better products and services enhanced by intelligent manufacturing and innovative technologies.”

     

  • RELX Warns Consumers of Growing Counterfeit Sales

    RELX Warns Consumers of Growing Counterfeit Sales

    Example of a fake RELX website selling unofficial RELX products

    RELX International has warned consumers against purchasing its products through unofficial or unlicensed websites. “It has recently come to the attention of RELX International that a number of unlicensed persons or companies are attempting to profit off of the good and responsible reputation of the RELX brand in a number of markets, including Australia and Philippines,” the company stated in a press release.

    “In addition to selling unlicensed and potentially fake products, these websites and social media channels have been disseminating a variety of unfounded claims about our products or e-cigarette products in general. RELX International only provides science-based information about our products and only sells products to adult smokers or vapers. Furthermore, RELX International never uses any cartoons or ‘kid-friendly’ images or videos in our branding.

    “RELX International established the Golden Shield Program in 2019 to help prevent the production and sale of illicit e-cigarette goods such as those mentioned above. With the goal of safeguarding adult e-cigarette users’ right to access quality products, members of RELX International’s Golden Shield Program utilize large amounts of data and other technologies to track down illicit e-cigarette products sold online and offline. The Golden Shield team actively works with online social media platforms, online e-commerce platforms as well as Customs authorities to eliminate illicit vaping products from the market.

    “The Golden Shield team has already helped authorities launch 28 criminal cases related to the illegal production and sale of illicit or copyright-infringing e-cigarette products. Over 77,000 websites and over 6,000 social media accounts have been taken down due to the Golden Shield team’s efforts, and 550,000 illicit products have been removed from the market.

    “Moving forward we are committed to getting even more counterfeit products off the market.”

    The release lists all the official RELX websites as well as provides an email address to confirm third-party websites that are selling authentic RELX products.

  • FDA Not Expected to Include ENDS in Menthol Ban

    FDA Not Expected to Include ENDS in Menthol Ban

    Photo: makcoud

    The U.S. Food and Drug Administration is unlikely to incorporate electronic nicotine-delivery devices (ENDS) into its proposed rulemaking to ban menthol cigarettes and flavored cigars, according to Azim Chowdhury and Neelam Gill.

    Azim Chowdhury

    Writing on the Food and Drug Law Institute’s website, the Keller and Heckman attorneys say that doing so would only further complicate a rulemaking that is already poised to receive hundreds of thousands of comments and will likely be litigated once final.

    On April 29, 2021, the FDA announced that it will initiate a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year.

    In its announcement, the FDA did not mention ENDs, which come in a wide variety of nontobacco flavors and have been the subject of much debate.

    Chowdhury and Gill believe Congress is more likely to defer to the premarket tobacco product application (PMTA) process rather than intervene and legislate a flavored ENDS ban. All ENDS products require FDA marketing authorization through that process.

    But while a federal ban on flavored ENDS seems unlikely while FDA reviews the science and the manufacturers’ arguments, these products continue to face the threat of prohibition at the local level, according to the attorneys.

    Many state and local authorities and attorneys general are pushing for bans or have requested the FDA to deny PMTAs for flavored ENDS. New York, New Jersey, Rhode Island and Massachusetts have already banned the sale of flavored ENDS while Maryland, California and Connecticut are considering similar measures.

  • CTFK Urges FDA to Deny All PMTAs for Flavored Vapes

    CTFK Urges FDA to Deny All PMTAs for Flavored Vapes

    Photo: Brian Jackson

    The Campaign for Tobacco-Free Kids (CTFK) reiterated its call for banning all flavored vapor products following the U.S. Food and Drug Administration’s denial of marketing applications for about 55,000 flavored e-cigarette products.

    While welcoming the FDA decision, the CTFK noted the denial involved only a small percentage of the flavor products under review by the FDA. “

    “The FDA’s action covers just a fraction of the more than 6.5 million tobacco products for which the FDA has received marketing applications, and it does not include any e-cigarette brands with a significant market share or that are most popular with kids, such as Juul, the number one youth brand,” CTFK President Matthew L. Myers wrote in a statement.

    “Today’s action will be effective in reversing the youth e-cigarette epidemic only if FDA also denies the applications for all flavored e-cigarettes (those with flavors other than tobacco), as well as high-nicotine products like Juul that put kids at risk of addiction.”

    According to the 2020 National Youth Tobacco Survey, 3.6 million kids use e-cigarettes, including nearly one in five high school students. The CTFK blames flavored e-cigarettes for this situation. Eighty-three percent of youth e-cigarette users report using flavored products, and 70 percent of youth users say they use e-cigarettes because of the flavors, according to the organization.

    “To protect our kids and end the youth e-cigarette epidemic, the FDA should not authorize the sale of any flavored or high-nicotine e-cigarettes,” wrote Myers.

    The FDA must decide whether to grant marketing applications for e-cigarettes by Sept. 9.

  • FDA Denies Marketing Orders for 55,000 Vapor Products

    FDA Denies Marketing Orders for 55,000 Vapor Products

    The U.S. Food and Drug Administration issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products today. In a press release, the regulatory agency determined that the premarket tobacco product applications (PMTAs) for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence they appropriately protect public health.

    The products from JD Nova Group, Great American Vapes and Vapor Salon subject to this action are non-tobacco-flavored ENDS and that include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. The FDA states the products didn’t provide enough benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels” of youth use of such products.

    Credit: Stan Cuic

    “Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said acting FDA Commissioner Janet Woodcock. “Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”

    According to the TMA/Vapor Voice PMTA Tracker, Vapor Salon submitted 327 flavors in four sizes and 12 nicotine strengths covering approximately 47,108 submissions. Great American Vapes was also captured by the TMA/Vapor Voice PMTA Tracker with 150 flavors, including the Dr. Cola flavor mentioned in the CTP’s MDO release.

    The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health, according to the agency. The agency noted that “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” The FDA stated that there is the possibility that other types of evidence may exists that could be adequate if sufficiently robust and reliable. However, because the evidence was absent in these applications, the FDA issued MDOs.

    The agency will continue to review other PMTAs for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth. If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.

    The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. Although the agency has issued other negative actions for some applications, this is the first set of MDOs the FDA has issued for applications that have reached the substantive scientific review portion of premarket review.

    According to the release, the products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement. The MDOs announced today do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration.

    Credit: FDA

    “Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products. Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”

    The agency also stated that the scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises “unique considerations.” While menthol-flavored ENDS are not included in the these current FDA decisions, the regulatory agency stated that its reviews will “similarly examine whether the evidence in the application demonstrates a benefit to existing adult users that outweighs the known youth use” of ENDS products.

    The American Lung Association commented via Twitter that it stands “firmly with the science that no flavored tobacco products are appropriate for the protection of public health, and all should be removed.”

    Greg Conley, president of the advocacy group American Vaping Association, said the three companies targeted by FDA had minimal market share and chastised the agency for going after “low-hanging fruit.” Conley also stated via Twitter that its not a foregone conclusion that all or most pending flavored e-liquid applications will be rejected before the agency’s Sept. 9th deadline. He  stated that how the FDA will handle products from manufacturers that submitted requests for extensions and have attempted to supplement their PMTAs are still unknown.

    “The FDA never intended to fairly regulate open-system vape products. From the 2014 draft release of the agency’s Deeming Rule until today, the Center for Tobacco Products has looked forward to the moment it would eliminate the ‘wild west’ of the independent industry,” stated Conley.

    Scott Gottlieb, who served as FDA commissioner during the Trump administration, blamed e-cigarette manufacturers for their predicament, saying “many companies had ample time, and the benefit of guidances that we issued, to provide a path toward compliance, so they could demonstrate their value as tools that could help current smokers quit combustible tobacco. Many of them chose to fight the laws Congress enacted, and the FDA, and they didn’t invest in demonstrating the public health benefits that they asserted.”

    The FDA has until Sept. 9, 2020 to make a decision on the remaining estimated 2.5 million PMTAs.

  • Illinois Passes 2 Laws to Prevent Youth Access

    Illinois Passes 2 Laws to Prevent Youth Access

    The state of Illinois passed two new laws this week 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.

    Credit: Sharafmaksumov

    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, according to B100. The legislation also allows underage individuals to test retailer’s compliance under the supervision of law enforcement as a part of a compliance check without violating tobacco laws.

    You must be 21 in Illinois to buy e-cigarettes. Illinois Governor J.B. Pritzker signed the two bills into law on Tuesday. Both Senate Bills 512 and 555 will go into effect on January 1, 2022.

    “This legislation will make our communities healthier places to live, and most importantly, will save lives. I’m proud that Illinois is taking yet another step toward protecting the health and safety of our young residents from tobacco and e-cigarettes and I want to thank Attorney General Raoul, our partners in the General Assembly, as well as the advocates and organizations for their work to make these laws possible,” Pritzker said in a statement.

  • Snowplus Taking Steps Towards Middle East Expansion

    Snowplus Taking Steps Towards Middle East Expansion

    The Middle East is a fast-growing market for vapor products. According to Mordor Intelligence, a market research firm, the Middle East and Africa vapor market is forecast to reach $485 million by 2025 with a growth rate of 9.74 percent during the forecast period (2021-2026). In a press release, vapor manufacturer Snowplus announced it is taking its first steps towards expanding into the Middle East market by attending the World Vape Show 2021 (WVS) in Dubai from Sept.19-21.

    Snowplus Alien X

    “Snowplus has seen a remarkable growth increase of 350 percent since late 2019 despite being faced with numerous challenges during the Covid-19 [pandemic] and is now looking towards more growth opportunities in the Middle East,” the release states. “The vaping company has secured lucrative partnerships with leading companies in their local market of China as well as regional offices around the world. These partnerships were made possible thanks to Snowplus’ quality products, the reliable support the company offers their partners, and strategic long-term investments.”

    The WVS is the first international vaping industry trade show to be held in the United Arab Emirate’s (UAE). Organizers say the show promises to attract some of the world’s most prominent vaping brands. Snowplus will be unveiling its latest device line: the Alien Series (Alien Air and Alien X). “The Alien lineup sits at the intersection of cutting-edge technology and unique, sophisticated design,” the release states. “Visitors will be able to catch a glimpse of the future of vaping through the Alien devices displayed at the Snowplus booth.”

    Snowplus also produces the Snowplus Pro, Snowplus Lite and Snowplus Go, as well as a series of flavored pods. Snowplus co-founder and head of overseas markets, Derek Li, said the company is excited for Middle East vapers to experience Snowplus’ products first hand. “We believe the Middle East market will be important for us and we’re ready to invest in creating partnerships to make it happen,” Li said.

  • England: Number of Young Smokers Up During Lockdown

    England: Number of Young Smokers Up During Lockdown

    Photo: marjan4782

    The number of young adults who smoke in England rose by about a quarter in the first lockdown, reports The Guardian, citing new research from University College London (UCL) and the University of Sheffield said. At the same time, the number of people who quit smoking nearly doubled across all groups.

    “The first lockdown was unprecedented in the way it changed people’s day-to-day lives. We found that many smokers took this opportunity to stop smoking, which is fantastic,” said Sarah Jackson, the lead author and a principal research fellow at UCL.

    “However, the first lockdown was also a period of great stress for many people, and we saw rates of smoking and risky drinking increase among groups hardest hit by the pandemic.”

    While the widespread belief that smoking and drinking relieved stress could be a factor in the apparent increased prevalence among people aged 18 to 34 years, the researchers pointed out that their data did not indicate what the causes may be.

    Doug Mutter

    Doug Mutter, director at U.K. vaping specialist VPZ, warned that the country is now in danger of missing its 2030 smoke free targets.

    “Smoking statistics are continuing to rise as the pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups,” he said.

    “There has been a lack of funding and joined up strategy to tackle smoking and we are now sleep-walking into another public health crisis with a new generation of smokers being consigned to an early death or serious disease.

    Mutter pointed to a new report from Royal College of Physicians Tobacco Advisory Group, which backs vaping as an effective treatment for tobacco dependency and recommends that it should be included and encouraged in all treatment pathways.

    A VPZ consumer survey from September 2020 found that among the 14,000 smokers served:

    • 25 percent of people said they were unable to buy their vaping products because of store closures.
    • 26 percent of smokers said they has increased the number of cigarettes they smoked during lockdown
    • 65 percent of people claimed they received no advice during lockdown of the best ways to quit smoking, through either NHS or online resources.
    • 58 percent of people said they did not feel healthier coming out of the initial lockdown.
    • 45 percent of people said their mental health was affected during the lockdown.
  • Responsible Action

    Responsible Action

    Credit: Mex Chriss

    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.

    Credit: Jose

    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.”

    Credit: Stock Photo Pro

    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.”