Category: CBD

  • Hong Kong Bans all CBD Products Beginning Feb. 1

    Hong Kong Bans all CBD Products Beginning Feb. 1

    Credit: Proxima Studio

    Hong Kong announced that it will ban all products containing cannabidiol (CBD) beginning on Feb. 1. CBD will be added to the Dangerous Drugs Ordinance (DDO) and will join over 200 substances already listed in the ordinance (including fentanyl, ketamine, heroin, and many psychoactive compounds, eg lysergamides).

    CBD will be added with the already covered “cannabinol and its tetrahydro derivatives (THC); and their 3-alkyl homologues.” Following this change, anyone who possesses or consumes CBD faces up to seven years in jail and fines of up to HK$1 million ($128,000). Manufacturers of CBD may also face life imprisonment, according to Lexology.

    While many users around the world have been promoting the anxiolytic and pain-relieving properties of CBD, Hong Kong’s Security Bureau has taken the view that such claims “lack authoritative scientific proof”. This directive appears to be in line with the ban imposed in China last year for the use of CBD in cosmetic products.

    From the Government reports it remains unclear as to whether other cannabinoids (e.g., CBG, CBDV, CBC, etc.) will be included in the ban. However, from the Narcotics Division memorandum in November, the main concern of the Government appears to be with CBD products that may contain some THC, either “through decomposition or conversion”, and the lack of international regulations for such products.

    “It does appear that with better international regulation and scientific data it is conceivable that the policy around CBD may change again in the future,” the authors write. “Therefore, given that there are no restrictions in Hong Kong for pursuing patent protection for CBD and related technologies, it remains prudent to maintain patents and pending applications in Hong Kong for CBD-related innovations should the position in Hong Kong change, as we have seen in other countries in the region, such as South Korea, Malaysia and Thailand.”

  • Google to Allow Limited CBD Advertising in 3 Markets

    Google to Allow Limited CBD Advertising in 3 Markets

    Credit: NMann77

    In a sudden change of policy, Google will allow the advertising of hemp and topical CBD products in California, Colorado and Puerto Rico under an update to its policies on “Dangerous Products and Services and Healthcare and Medicines.”

    Google did not make clear why it is restricting the advertising to the three distinct markets, according to Hemp Today.

    Advertising for CBD for internal human consumption remains off limits, the company said, including those for “supplements, food additives, and inhalants.” Also, masthead advertising on YouTube (owned by Google), which appears at the top of the page in the main feed across all devices, is not available to hemp and CBD products, under the policy revisions.

    Google also said pharmaceuticals approved by under the Food and Drug Administration (FDA) may now also be advertised in those jurisdictions. That part of the rule change will benefit only one producer, Jazz Pharmaceuticals, whose high-CBD Epidiolex is the lone such product approved by the agency to date. Epidiolex is prescribed for severe seizure disorders in children. It was approved by the FDA in 2020.

    The changes take effect Jan. 20. Advertisers can request certification with Google starting on that date, when an application form will be published.

    Google said it has contracted with LegitScript, a Portland, Oregon-based internet and payments compliance company that provides certification in high-risk industries, as a clearinghouse to determine products’ advertising eligibility. Only products that pass muster with LegitScript can be promoted on Google platforms.

    Those seeking certification to advertise on Google must provide samples of their products or THC testing and provide LegitScript with third-party certificates of analysis, according to Google.

  • Lifted Made Recoups $630,000 for Clogged Vapes

    Lifted Made Recoups $630,000 for Clogged Vapes

    The CBD brand Lifted Made, a subsidiary of LFTD Partners, has entered into an agreement with its third party disposable vape device manufacturer that will allow Lifted Made to recoup just over $1 million of the losses associated with clogged disposable vape devices.

    The defective devices were recognized by Lifted Made during Q3 2022.

    The unnamed overseas disposable vape device manufacturer has agreed to write-off $630,000 currently owed to it by Lifted Made for previously delivered disposable vape devices, and to give credits to Lifted Made against future purchases totaling $370,047 at the rate of $185,023 for each of years 2023 and 2024, according to a press release.

    Nick Warrender, CEO of Lifted Made, and vice chairman and COO of LFTD Partners, said that the company had an excellent relationship with the manufacturer of its disposable vape devices.

    “Their willingness to share the losses we experienced during Q3 due to the discontinued clogged 2mL vape devices has really demonstrated to us what a good partner they are. We look forward to a very bright future with them,” Warrender said. “The new, award-winning 3mL disposable vape devices have been really well received by our customers. We are extremely excited about 2023 and all the things we have in the pipeline going into the new year.”

  • U.S. FDA Could Drop CBD Guidance ‘Within Months’

    U.S. FDA Could Drop CBD Guidance ‘Within Months’

    Credit: Sofia

    The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.

    After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.

    In an interview, Janet Woodcock, the FDA’s Deputy Commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.

    However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.

    Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.

    CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

    The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.

    In recent months, the FDA posted warning letters to at least nine companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.

    In 2021, The FDA told Charlotte’s Web Holdings Inc., one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.

    The FDA has not approved any CBD-based products for use as dietary supplements. The only CBD-based product the FDA has approved is Epidiolex, a prescription medication used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in children two years of age and older.

  • FDA Warns 5 Companies for Marketing CBD Edibles

    FDA Warns 5 Companies for Marketing CBD Edibles

    Credit: Simone

    The U.S. Food and Drug Administration today posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).

    These companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD. This could result in unintentional consumption or overconsumption of CBD.

    “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” the FDA stated in a release.

    Warning letters were sent to the following companies:

    The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm, according to the agency.

    “This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products,” the agency states.

    The warning letters also outline additional violations of the Food, Drug & Cosmetics Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

    “The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law,” the agency wrote. “Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

  • BAT Invests Nearly £50 Million in Charlotte’s Web

    BAT Invests Nearly £50 Million in Charlotte’s Web

    Photo: bukhta79

    BAT is investing £48.2 million ($57.4 million) in Charlotte’s Web Holdings. Based in Colorado, USA, and listed on the Toronto Stock Exchange, Charlotte’s Web offers cannabinoid extract wellness products.

    “The appeal of Charlotte’s Web is clear to us: a wide portfolio of high-quality products, strong brand equity, an extensive retail presence and robust B2C e-commerce platform serving a loyal U.S. consumer base, and a track record of in-depth scientific research,” said BAT Chief Growth Officer Kingsley Wheaton in a statement. “Our investment in Charlotte’s Web represents another step for BAT in our exploration beyond tobacco and nicotine,” Wheaton said.

    Last month, Charlotte’s Web became the first CBD company allowed to use the moniker “Official CBD of MLB.” Major League Baseball (MLB) said in June that it would allow teams to enter sponsorships with CBD marketers.

    Describing its relationship with MLB as a “multiyear, strategic partnership,” Charlotte’s Web issued 6,119,121 shares of its common stock to the sports organization—worth an estimated $4.4 million at the time.

    “This investment will provide Charlotte’s Web with funding that we anticipate will help unlock deeper and broader research and development that is key to our continued innovation, global footprint and the advancement of our intellectual property portfolio,” said Jacques Tortoroli, CEO of Charlotte’s Web.

  • Charlotte’s Web Signs First CBD Deal With MLB

    Charlotte’s Web Signs First CBD Deal With MLB

    Credit: Charlotte’s Web

    The first company to score a CBD sponsorship with Major League Baseball is Charlotte’s Web Holdings Inc. as distribution deals with Gopuff and Southern Glazers widen its playing field.

    Charlotte’s Web becomes the first CBD company that will be allowed to use the moniker “Official CBD of MLB.” The sports organization said in June said it would allow teams to enter sponsorships with CBD marketers.

    Describing its relationship with MLB as a “multiyear, strategic partnership,” Charlotte’s Web will issue 6,119,121 shares of its common stock to the sports organization—worth an estimated $4.4 million, according to media reports.

    In addition, the deal requires the company to make payments to MLB through Dec. 31, 2025.

    According to a Securities and Exchange Commission filing, Charlotte’s Web will pay an “aggregate rights fee of $30.5 million and a 10 percent royalty on the company’s gross revenue from MLB-branded products of the company sold after prior sales of all such branded products exceed $18.0 million.”

    Bottles of Charlotte’s Web’s new Sport Daily Edge line of CBD-infused gummies, oral sprays and topicals will carry MLB’s silhouetted batter logo.

    “Charlotte’s Web will have a premiere brand presence at MLB’s Jewel Events, including All-Star Week, Postseason and the World Series” through marketing, media and ballpark activations that connect to the league’s fan base of over 180 million Americans,” the company said in a news release.

    Also this month, Charlotte’s Web signed a distribution deal with liquor distributor Southern Glazer’s Wine & Spirits, which operates in 44 U.S. states, Washington D.C. and Canada.

    That followed a national partnership with food and beverage delivery platform Gopuff, which also carries CBD-infused products from Medterra, Mad Tasty, Daytrip and Recess.

    According to research from Brightfield Group, Charlotte’s Web was the leading U.S. CBD company in the second quarter in terms of dollar share, followed by Your CBD Store, Medterra, CBD American Shaman and cbdMD.

  • US FDA Warns Four for Illegally Selling CBD Products

    US FDA Warns Four for Illegally Selling CBD Products

    Credit: Anankkml

    The U.S. Food and Drug Administration (FDA) yesterday issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest.

    “While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply,” a press release states. “After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system.”

    The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. The regulatory agency states all other CBD products intended for use as a drug (i.e. making medical claims) are considered unapproved drugs and are illegal to sell.

    Some of the claims made by the companies in the warning letters refer to helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These claims, among others, establish the intended use of the products as drugs, according to FDA.

    The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

  • FDA Issues First Warnings for Illegal CBD, Delta-8 Products

    FDA Issues First Warnings for Illegal CBD, Delta-8 Products

    The U.S. Food and Drug Administration today issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (THC). The regulatory agency claims that the companies violated the Federal Food, Drug, and Cosmetic (FD&C) Act. It’s the first time the FDA has issued warning letters for products containing delta-8 THC.

    “Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products,” the agency stated in a release. “There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug.”

    The states that it has not evaluated whether “these unapproved drug products” are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns, according to the statement.

    “Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects,” the release states. “Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.”

    The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum and peanut brittle.

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

    The FDA recently published a consumer update expressing concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment, according to the agency.

    The FDA states that it is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.

    In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.

    “CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements,” the release states. “One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.”

    The FDA issued warning letters to:

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

    The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, according to the agency.

    The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

  • Eye of the Tiger

    Eye of the Tiger

    Photo: byrdyak

    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.”