Two e-liquid companies will be able to resubmit their marketing applications to the U.S. Food and Drug Administration following a court ruling, reports Bloomberg Law.
On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
In a dissenting opinion, Judge Catharina Haynes stated that the agency “properly fulfilled its statutory mandate by considering the relevant portions of Petitioners’ PMTAs and coming to a reasonable conclusion that marketing Petitioners’ products is not appropriate for public health.”
Oldham stated that the manufacturers dutifully spent untold millions “conforming their behavior and their applications to FDA’s say-so.”
“Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans.”
In an X post, Michael Siegel, a professor at Boston University School of Public Health, stated that the ruling “exposed” the FDA’s wrongful rejection of applications for flavored vapes, ultimately resulting in a “win for public health.”
Eric Heyer, a lawyer for e-liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make “a significant course correction by communicating with specificity” what companies must do to get approval.
“No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people,” Oldham wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. “And FDA’s regulatory switcheroos in this case bear no resemblance to square corners.”
It is expected that the FDA will seek a review of the decision by the Supreme Court of the United States, however, the justice department hasn’t made an official announcement.
Regulatory challenges and misinformation continued to test the vaping industry in 2023.
By VV staff
It remains a frustrating business environment. The vaping segment has survived despite setbacks in 2023 and continues growing as a global market. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers. The past 12 months could also be labeled the year of the great exodus as several vaping retailers and manufacturers went out of business. Despite the challenges, more and more former smokers continue to switch.
While several countries banned, enacted regulations or continued heavily regulating vaping products, the United States’ denials of numerous premarket tobacco product applications (PMTAs) had the greatest impact on the industry this year. The U.S. Food and Drug Administration’s ban on most products has allowed a black market of disposable vapes to become a multibillion-dollar industry. Disposable e-cigarettes account for almost 40 percent of the global vape sector, according to ECigIntelligence.
Critics have accused the industry of avoiding responsibility for the environmental damage caused by disposable vaping products while federal regulators have failed to pass measures that would make vaping components easier to recycle or more eco-friendly. Some regulations have been proposed to lessen the products’ environmental impact. For example, standards could be put in place requiring them to be reusable or mandating that manufacturers fund collection and recycling programs.
Disposable e-cigarettes currently account for about 53 percent of the multibillion-dollar U.S. vaping market, according to the Centers for Disease Control and Prevention, more than doubling in size since 2020. Several states, including New York and California, have extended product responsibility laws in place for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products. Without action, some experts say the devastating environmental impact could last for centuries.
Misinformation surrounding the vaping industry also continued to spread in 2023. Nearly half of cigarette smokers and young adult nonsmokers think that nicotine-based e-cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.
Another study found that there are also a lot of exaggerations and misinformation about vaping on social media. Some tweets exaggerate or distort claims about nicotine and addiction while others misinterpret scientific studies to promote vaping. There are also tweets that downplay the harmful effects of nicotine and promote its benefits, which are potentially problematic. Below is a month-by-month recap of the vaping industry’s biggest headlines in 2023.
January
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The upscale U.K.-based grocer Waitrose halts sales of single-use vaping products due to environmental concerns. The FDA says it will “decide within months” how to regulate legal cannabis (it still hasn’t). Vaporesso becomes the first open-system vaping device brand to obtain the ability to sell in the United Arab Emirates. The Netherlands bans flavors, and Belgium says it plans to restrict flavor names and vape devices. A 2022 article that claimed e-cigarette users faced the same cancer risk as combustible cigarette smokers is retracted by the World Journal of Oncology. Lawmakers in Taiwan ban vaping products. A U.S. district judge preliminary approves a $255 million settlement resolving consumer claims that Juul Labs deceptively marketed e-cigarettes.
February
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Hong Kong begins enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession. Bloomberg Philanthropies commits $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. Australia reschedules the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder. Connecticut sues five companies for selling delta-8 products. Alex Norcia resigns from Filter for a job at Altria. RAI Services Co. submits a citizen petition asking the FDA to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine-delivery system [ENDS]” products. Matthew Farrelly, former chief scientist and director of the Center for Health Analytics at RTI International, is named director of the FDA’s Center for Tobacco Products’ (CTP) Office of Science. The FDA files the first civil money penalties for illicit sales of ENDS products.
March
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Altria Group exchanges its entire investment in Juul Labs for a nonexclusive, irrevocable global license to certain of Juul’s heated-tobacco intellectual property. Altria also agrees to acquire Njoy Holdings for approximately $2.75 billion and asks the U.S. Federal Trade Commission (FTC) to drop its 2020 challenge to the company’s 2018 acquisition of a 35 percent share in Juul Labs. The FDA proposes new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of vaping and other tobacco products. RLX Technology reveals that its 2022 financial performance was heavily impacted by new industry regulations and e-cigarette taxes, along with Covid-related disruptions, in China. A U.S. federal judge throws out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored vaping and other tobacco products. The FDA updates its definition of “tobacco products” to include nontobacco nicotine products. Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal 5th Circuit Court of Appeals issues a stay. Argentina bans imports and sales of ENDS products. Former CTP Director Mitch Zeller joins the advisory board of Qnovia, a “platform pharmaceutical” company that is developing a prescription inhaled smoking cessation therapy.
April
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Malaysia removes e-liquid containing nicotine used in e-cigarettes and other vaping products from the country’s Poisons List of controlled substances. Greentank Technologies closes a Series B financing round worth $16.5 million with a “strategic investor group” that includes BAT-funded Canadian cannabis producer Organigram Holdings. Vuse’s U.S. market share rises from 41.5 percent while Juul’s declines to 26.1 percent. Altria’s youth marketing suit in California begins. The U.K. announces plans to give 1 million smokers free vaping starter kits to encourage them to give up tobacco products. Juul Labs settles youth marketing lawsuits with six states, bringing the total of state settlements to 45 states, with a combined price tag of more than $1 billion. Panama rejects a proposal to regulate vaping products. The High Court of Justice in London rules that Philip Morris Products’ patents protecting its tobacco-heating technology are valid. Delaware becomes the 22nd U.S. state to pass a recreational marijuana bill. Altria’s youth marketing suit in California begins.
May
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Australia announces that it will ban the importation of all nonprescription vaping products, including those that do not contain nicotine. R.J. Reynolds sends letters to several small vape shops threatening to sue them if the shops do not stop selling flavored vaping products. A U.K. report shows inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes. Logic Technology challenges the FDA’s marketing denial of its menthol vape products. Altria strikes a $235 million deal to end a California lawsuit alleging that the company marketed vaping products to youth. Flonq launches the world’s first fully recyclable vape device—the Flonq Plus-E. Yolonda Richardson succeeds Matthew Myers as president of Tobacco-Free Kids. The FDA issues “Import Alert 98-06” detaining new tobacco products such as e-cigarettes without marketing authorization at the border. Altria completes its purchase of Njoy.
June
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Hawaiian law makes shipping of vaping and other tobacco products valued at more than $10,000 a misdemeanor. ANDS launches Slix, a disposable vape that it says is 99.29 percent recyclable.
Bidi Vapor sends the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.
A federal appeals court rules that the FDA acted reasonably in denying Magellan Technology’s application to market flavored vaping products.
The FDA issues warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. Zanzibar bans the use and imports of vape products. The CTP announces that it has made significant strides in putting its Reagan-Udall Foundation recommendation-based plan for improvement into action.
July
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Juul Labs asks the U.S. International Trade Commission (ITC) to block sales and imports of the Njoy Ace vapor device, claiming that the product infringes several Juul patents. The FTC dismissed the complaint against Njoy parent Altria Group for its purchase of a 35 percent stake in Juul Labs after Altria’s pullout. New York City accuses Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. of racketeering for selling illegal flavored vapes. Jason Carignan moves to Chemular. The FDA gives the Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on the smoking behaviors of current adult smokers. Philip Morris International acquires Syqe Medical, an Israeli company, for an estimated $650 million. Juul Labs submits a PMTA to the U.S. FDA for the Juul2 system. China’s State Tobacco Monopoly Administration releases the guidelines for vape exports. A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research. The FDA sends more warning letters for Esco Bars and Elf Bar sales. China vape exports top $3.36 billion for the first half of 2023.
August
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Ukraine imposes a consumption tax on disposable vapes. Venezuela bans all vaping products. The Philippines passes a law forcing importers of raw materials for vaping products to seek special clearances to release shipments. High Light Vape, which sells a vape pen disguised as a highlighter, is lambasted by the media. Njoy asks the ITC to ban the import and sale of certain Juul products. New Zealand imposes new regulations to limit youth vaping. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates launches its shadow report on the World Health Organization’s failing tobacco harm reduction strategy. Juul Labs announces a company restructuring aimed at reducing operating costs. Romania bans flavors for heated-tobacco products. Suriname bans the sale of all vaping products. The U.S. Court of Appeals for the D.C. Circuit sides with Fontem U.S. in a ruling that the FDA failed to conduct a proper analysis before rejecting some vaping product marketing applications.
September
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The U.K. Vaping Industry Association announces that it will exclude tobacco companies from its membership. Indonesia legalizes vaping. Esco Bars’ manufacturer files a lawsuit challenging the FDA’s import ban of its products. Vaporesso becomes the first licensed company to sell open systems in the UAE. New York opens state cannabis licensing to the public. The FDA sends warning letters to 15 companies that market products under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. A massive fire destroys U.K. e-liquid and hardware brand Dinner Lady’s factory. Ispire announces that its fiscal year 2023 saw a 100.4 percent and a 10.9 percent surge in cannabis and tobacco vaping product revenues, respectively. Healthier Choices Management Corp. sues R.J. Reynolds Vapor Co. seeking royalties from sales of its Vuse Alto vape pens, chargers and pre-filled liquid pods, alleging the products infringe a patent. The FDA imposes civil money penalties on 22 retailers for the illegal sale of Elf Bar/EB Design products.
October
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Philip Morris International unveils LEVIA, a zero-tobacco stick for use with its IQOS heat-not-burn device. A new study, E-Cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, finds that flavor bans boost sales of traditional combustible cigarettes. U.K. Prime Minister Rishi Sunak proposes a tobacco endgame plan. The U.S. Supreme Court declines to hear Avail Vapor’s arguments against the FDA’s regulatory authorization process. ECigintelligence reports that disposable e-cigarettes account for almost 40 percent of the global vape sector. The American Vaping Association ends operations; Greg Conley joins the American Vaping Manufacturers Association. The FDA declines to issue a marketing order for flavored Vuse Alto pods. Elf Bar changes its name to defy a U.S. import ban. Njoy files lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. Logic Technology Development loses a court appeal to halt the FDA’s ban on the company’s menthol-flavored pods. Czechia bans flavors for heated-tobacco products. Altria says a booming illegal disposable flavored vape market is causing a major decline in the sales of its authorized vaping products.
November
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Italy’s Regional Administrative Court of Lazio (TAR) suspends a decree that would make CBD oil a narcotic substance until Jan. 16, 2024. The global vaping market will reach $93.94 billion in value by 2030, registering a CAGR of 16.27 percent from 2022 to 2030, according to Straits Research. BAT announces a $90.5 million investment in Organigram. Ohio becomes the 24th U.S. state to allow adult marijuana use for nonmedical purposes. Research from the United Nations suggests that toys are a much larger contributor to electronic waste than vaping products. The FDA again sends warning letters to online retailers for selling disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava. The 10th Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control is postponed, officially due to unrest in the host nation, Panama.
Louisiana’s state Office of Alcohol and Tobacco Control releases a list of nearly 400 approved vape products for legal sale in the state. Juul Labs raises an estimated $1.3 billion in funding. Ispire Technology reports revenue of $42.9 million and gross profit of $6.9 million in the quarter that ended Sept. 30. The FDA increases the penalties for violations of federal nicotine product laws. PMI expands IQOS Iluma in the Middle East. New Zealand’s new coalition government announces a cancelation of the country’s controversial generational tobacco ban. The Foundation for a Smoke-Free World, which was originally funded by PMI, says it will no longer accept any monetary support from the nicotine industry. The WHO announces the dates for the resumed in-person sessions of COP10 for February 2024. Australia will ban imports of disposable vapes beginning Jan. 1, 2024. France plans to ban disposables by 2025.
December
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(Editor’s Note: This magazine went to press in December, so the month may be incomplete.) The FDA announces that it is now estimating that completion of PMTA reviews may be delayed as the agency considers the D.C. Circuit’s opinion in Fontem U.S. v. FDA, affirming in part and vacating and remanding in part MDOs for certain vaping products. U.S. House lawmakers demand information from federal officials on what they are doing to stop the influx of kid-appealing electronic cigarettes from China. Mexico’s Supreme Court of Justice rules that the presidential decree banning the sale of e-cigarettes is unconstitutional. The FDA announces that it has filed civil money penalty complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products. France’s National Assembly unanimously approves a bill to ban single-use electronic cigarettes. Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent. Guam proposes rules to stiffen the fees and penalties for vape sales to minors.
Looking ahead
It’s impossible to predict what the vaping industry will look like by the end of 2024. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild.
The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand. More importantly, innovation should continue to thrive outside the U.S.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, predicted at the end of 2022 that the FDA’s policy on vaping products would continue to be characterized by regulatory paralysis and the search for the least politically controversial regulatory option, and the industry wouldn’t hear rulings on many PMTAs until 2024 or later. He was correct on both counts.
Looking forward to 2024, Conley told Vapor Voice that the vaping industry should expect a turbulent ride, particularly in the United States. He predicts that the most significant hurdle remains the FDA’s CTP.
“Under the current leadership of Brian King, the agency’s stance toward vaping products has become even more antagonistic despite a drop in youth vaping to its lowest levels in a decade,” said Conley. “This tension is heightened by ongoing court cases that might force reforms within the CTP, but these changes are likely to be met with considerable internal resistance and intransigence.
“Those in the industry should not be naive. The regulatory landscape in the U.S. for vaping businesses, regardless of their size, is likely to get worse before it gets better. This is a hard truth we need to brace for.”
Beyond the federal level, a critical challenge will continue to come from state governments and major tobacco companies like Altria and R.J. Reynolds. The rise of synthetic nicotine-containing disposable vaping products, which are impacting cigarette sales and the vapor market shares of the major tobacco companies, is leading to a push for state-level PMTA registries, according to Conley.
“In essence, these bills seek to deputize state regulatory agencies to behave as mini-PMTA enforcement divisions. The true effect of these registries is to ban all products that submitted their PMTAs after September of 2020. In plain English, this means nearly every disposable vaping product on the market becomes illegal to sell,” Conley explains. “Such measures have already been implemented in Alabama, Oklahoma and Louisiana, leading to a disruption in the market dynamics. Law-abiding retailers and average adult consumers are suffering as a result.”
Globally, Conley predicts that the vaping industry will continue to go up against well-funded prohibitionist campaigns spearheaded by organizations bankrolled by Michael Bloomberg. However, there’s a silver lining: The evidence supporting regulation over outright bans continues to grow.
“I’m cautiously optimistic that we’ll see countries in Latin America and Southeast Asia begin to revisit their previous, misguided policies. Regrettably, however, the anti-disposable furor is likely to get even more heated in Europe,” said Conley. “For adult consumers looking for hassle-free nicotine consumption, there’s never been a better time than now. The market has evolved tremendously in terms of product quality and variety. However, the picture is starkly different for businesses in the vaping industry. Until there is real reform that regulates the products adults want, like flavored disposables, being successful in this industry may require risking your livelihood and potentially your freedom.”
Conley said the industry must remain vigilant because regulatory challenges, particularly in the U.S., coupled with global policy shifts and market dynamics suggest that the industry’s path will be rocky in the short term. “The hope is for a future where nicotine control policies are grounded in harm reduction principles rather than mirroring a drug war,” he said. “However, we’re currently seeing a trend that veers toward the latter.”
Control of the U.S. cannabinoid market will be fueled by lobbying and lawsuits in 2024.
By Rod Kight
During the past six months, I have repeatedly been asked to predict what will happen with the U.S. Farm Bill. This is because the Agriculture Improvement Act of 2018, better known as the “2018 Farm Bill,” expired at the end of September. “Will it change?” “Will hemp be outlawed?” “Will I still be able to sell [insert THCa, delta-8 THC, D9 gummies, etc.]?” “What can we do to ensure that hemp remains legal?” Although I routinely discuss this with lobbyists and associations, the fact is that no one knows what will happen with the next Farm Bill.
Fortunately, that issue will not be decided for almost another year, which is plenty of time for the rapidly expanding hemp industry to grow even bigger.
(a) Extension.—Except as otherwise provided in this section and the amendments made by this section, notwithstanding any other provision of law, the authorities (including any limitations on the authorities) provided by each provision of the Agriculture Improvement Act of 2018 (Public Law 115–334; 132 Stat. 4490) and each provision of law amended by that act (and for mandatory programs at such funding levels), as in effect on Sept. 30, 2023, shall continue, and the authorities shall be carried out, until the later of—(1) Sept. 30, 2024; or (2) the date specified in the provision of that act or the provision of law amended by that act.
President Biden is expected to sign the act.
This means that we will not likely have a new Farm Bill until the fall of 2024. Given that the 2018 Farm Bill is the basis for the hemp cannabinoid market, which Whitney Economics recently reported has a demand of $28.4 billion (more than the marijuana industry and on par with the craft beer industry), maintaining status quo for another year is a good thing for the industry.
Rod Kight
In addition to an additional window of time to continue its progress of bringing cannabis to people in the U.S., the extension will allow hemp companies to expand their sales and operations internationally. This is because hemp can cross borders, and many current hemp products meet the emerging standards set by countries who are creating cannabis programs.
This does not mean that the hemp industry will take a break from politics. In fact, the reality is quite the opposite. There is a growing dispute, known as the “Cannabis Civil War,” between the hemp and marijuana industries. At stake is control over the rapidly expanding and lucrative market in cannabinoids and cannabis products. I use the term “cannabis” in this context as a generic botanical term to encompass both federally legal hemp and federally illegal marijuana. In addition to intensive lobbying efforts by both sides of the cannabis industry, there have been a number of important decisions in recent lawsuits.
For this reason, I will spend the rest of this article discussing important rulings in four recent lawsuits filed by hemp companies and hemp organizations against various states regarding laws and rules that they contend violate state and/or federal law. My firm has worked with the hemp plaintiffs in some of these lawsuits.
Additionally, I will discuss the landmark ruling in a trademark dispute between two private parties that addressed the legal status of delta-8 tetrahydrocannabinol (D8 THC) and a decision by the Georgia Court of Appeals regarding D8 THC in the context of a criminal seizure. These cases appear to be the tip of the proverbial iceberg in the Cannabis Civil War, and I anticipate several more to follow.
BioGen v. State of Arkansas. In this case, several Arkansas hemp companies filed a lawsuit against the state, seeking an injunction prohibiting enforcement of Senate Bill 358, enacted on April 11, 2023, as “Act 629” (the Act). This bill criminalized all hemp products “produced as a result of a synthetic chemical process” and “[a]ny other psychoactive substance derived therein.”
The hemp companies argued that the Act is preempted (i.e., superseded) by the federal 2018 Farm Bill and that its provisions are unconstitutionally vague and thus void. The U.S. District Court agreed and entered an injunction barring enforcement of the Act. In its ruling, the court made three important findings: (1) the Act is preempted by federal law under the principle of “conflict preemption,” (2) the Act is preempted by federal law under the principle of “express preemption,” and (3) the Act is unconstitutionally vague and thus void.
Maryland Hemp Coalition Inc. v. Moore. The Maryland hemp industry sought an injunction prohibiting the enforcement of Maryland Code Ann. Alc. Bev. §36-1102, known as the Cannabis Reform Act (CRA), “against any person who was already lawfully in the business of selling hemp-derived products prior to July 1, 2023.”
In an expansive ruling in favor of the Maryland hemp industry, the Washington County Circuit Court found that “the interests of [the hemp industry] plaintiffs are not ‘merely academic, hypothetical or colorable,’ but rather, they are interests of survival, prosperity and, indeed, of life, liberty and property.”
In its ruling, the court addressed the issue of “whether the strict and exclusive licensing scheme under the CRA and as applied to the hemp industry is a valid exercise of legislative prerogative.” In finding it is not a valid exercise, and thus prohibiting enforcement of the CRA against the state’s hemp industry, the court ruled that the CRA “creates a monopoly that unfairly excludes many from their right to continue, or enter, a profession of their choosing, all to the detriment of the public.”
The Washington County Circuit Court went on to state that “[b]ased on the evidence and argument offered thus far, the court cannot find a rational basis to support the exclusive and exclusionary licensing scheme that has put plaintiffs out of their legitimate businesses.”
In short, the court found that the CRA creates an illegal monopoly, it unlawfully puts legitimate hemp companies out of business, and it is a “severe” and “Draconian” licensing scheme that fails to “actually benefit the communities found to have been impacted.” It also noted that the plaintiffs were not challenging the health and safety portions of the CRA.
Northern Virginia Hemp and Agriculture LLC v. the Commonwealth of Virginia. Several Virginia hemp companies sought an injunction prohibiting enforcement of SB 903, which state lawmakers enacted “in response to the growing concerns regarding delta-8 and other adulterated hemp products on the market.” The restrictions placed on hemp products by SB 903 are dramatic enough to destroy most of the state’s hemp industry.
The hemp company plaintiffs argued that SB 903 was preempted by federal law, namely the 2018 Farm Bill. The hemp companies made two preemption arguments. The first was based on federal and state definitions of hemp, and the second was related to the ability of Virginia hemp processors to ship or transport hemp through the commonwealth. The U.S. District Court found that these arguments failed, and the court denied the request for an injunction. Consequently, SB 903 is currently in effect.
The Travis County District Court ordered the DSHS to “remove from its currently published Schedule of Controlled Substances the most recent modifications of the definitions to the following terms: ‘*(31) tetrahydrocannabinols’ and ‘*(58) marihuana extract’ and any subsequent publications of the same (if any) until further order of this court.”The court further “enjoin[ed] the effectiveness going forward of the rule stated on DSHS’s website that delta-8 THC in any concentration is considered a Schedule I controlled substance.” Consequently, D8 THC is not a controlled substance in Texas.
AK Futures LLC v. Boyd Street Distro LLC.Unlike the cases summarized above, this case did not arise from a lawsuit filed by hemp companies. Rather, it arose in the context of an intellectual property dispute between the two private parties. The plaintiff, AK Futures (AK), makes vaping products. It sued Boyd Street Distro (Boyd) for infringing on its trademark and copyright rights by selling a fake version of its “Cake”-branded vaping products that contain D8 THC.
In an unusual defense, Boyd argued that AK’s case should be dismissed because its trademark rights were unenforceable based on its position that D8 THC is illegal under federal law. In ruling for AK, the U.S. Court of Appeals for the 9th Circuit upheld the injunction issued by the lower court, ruling the 2018 Farm Bill legalized the D8 THC products. Specifically, the 9th Circuit held that D8 THC is not a controlled substance under the plain and unambiguous text of the 2018 Farm Bill and that it fits within the legal definition of “hemp.”
The court also found that the method of manufacture is irrelevant. Since most D8 THC is produced through an isomerization of cannabidiol rather than an extraction from the plant, this portion of the ruling is particularly notable.
Elements Distribution v. State of Georgia. This case arose out of a criminal seizure in which the plaintiff, Elements Distribution LLC (Elements), sought the return of business records, money and products from law enforcement. In February 2022, Gwinnett County, Georgia, law enforcement officers executed a search warrant upon a warehouse owned by Elements and seized business records, currency and edible and nonedible products containing D8 THC and D10 THC.
The warrant was issued based on the affidavit of a law enforcement officer that Elements had violated OCGA §16-13-30(b), which prohibits the possession of a controlled substance with the intent to distribute by possessing and selling products containing D8 THC and D10 THC. In ruling that Elements was entitled to a return of the seized items, the Georgia Court of Appeals found that the warrant authorizing the seizure was not supported by probable cause.
The state argued that even though D8 THC and D10 THC are not themselves controlled substances, edible products containing them are controlled substances unless those products also meet the definition of “hemp products” under OCGA §2-23-3 of the Georgia Hemp Farming Act. The court found the state’s argument to have “no merit” and ordered the state to return the items it seized from Elements.
As the cases above demonstrate, there is a growing body of case law regarding the legal status of hemp and hemp products, particularly D8 THC. Of note is an emerging trend by hemp companies to sue state agencies regarding laws and regulations that severely restrict distribution of the products they sell.
The 2018 Farm Bill, which is the foundational federal law regarding the legal status of hemp, has just been extended to Sept. 30, 2024. Meanwhile, the Whitney Economics report discussed at the beginning of this article found that total demand for hemp-derived cannabinoid products exceeds that of the marijuana industry and is on par with the craft beer industry.
The latter report and extension of the 2018 Farm Bill means we can expect to see the Cannabis Civil War—and lawsuits regarding hemp products—continue in 2024.
Based in Asheville, North Carolina, USA, Rod Kight is a world-renowned attorney in the cannabis industry.
The European Parliament, in full assembly, adopted a report recognizing the role of vaping in aiding smoking cessation. This comprehensive adoption by the Parliament marks a pivotal moment in the fight against smoking-related illnesses, according to an emailed World Vaper’s Alliance release.
The report, a part of the Parliament’s broader initiative on non-communicable diseases, acknowledges vaping as an effective method for smoking cessation and may also set a new direction for health policies within the EU.
The move follows the EU’s Subcommittee on Public Health (SANT) endorsement on Nov. 7. However, the initial recommendation by the SANT to limit vaping in certain public areas remains a point of contention.
Michael Landl, director of the WVA, said the full adoption of the report by the Parliament is a step forward and underscores a significant shift in recognizing vaping’s positive impact on public health.
“We now call on the European Commission to align with this perspective, as it represents the collective voice and decision of the Parliament, the direct representatives of EU citizens,” he said. “Listening to this voice is not just a matter of policy but of democratic responsibility.
“While we welcome the Parliament’s endorsement, the proposed restrictions on vaping in public spaces are concerning. Such measures could inadvertently hinder smokers’ transition to a less harmful alternative.”
Most young New Zealanders support the law to progressively ban smoking, which was recently abandoned, reports RZN, citing the results of an international study.
The new coalition government plans to repeal changes to the Smokefree Environments and Regulated Products Act that would have barred the sale of cigarettes to anyone born after 2009, among other measures.
A Canadian-based international study shows 79 percent of New Zealanders aged 16 to 29 favored the ban.
A similar share supported a reduction in the number of shops which could sell tobacco, while 68 percent wanted manufacturers to have to take nicotine out of cigarettes.
The International Tobacco Control Policy Evaluation Project investigates attitudes to smoking across several countries. The most recent research was supposed to provide a baseline for New Zealand before the law came into effect.
“Our overseas colleagues are incredibly disappointed and devastated as we are because the tobacco research world has been really looking to New Zealand,” said co-author Jude Ball from Otago University.
By contrast, the Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA) expressed its support for the decision to repeal the generational tobacco ban.
“CAPHRA applauds the government’s decision to prioritize harm reduction strategies,” said the group’s executive coordinator, Nancy Loucas. “We believe that vaping and other harm reduction tools can play a significant role in helping smokers quit, and we are pleased to see the government recognizing this.”
The organization said it also shares the government’s concerns about the potential for a black market to develop if the sale of tobacco is overly restricted.
“A regulated market is always preferable to an unregulated one, where product safety cannot be guaranteed,” Loucas added.
New industry figures, collected by online vape retailers representing around 43 percent of the U.K. market, have revealed that significant numbers of older adults are users of disposable and flavored vapes, which are the focus of a government consultation to address the issue of youth vaping that will close on Dec. 6.
The industry warns that any moves to ban single use vapes and flavors, which have been key drivers in the decline of smoking to record low levels in the U.K. over the last two years, will have catastrophic consequences for the nation’s public health and will effectively end any chance of creating a smokefree generation in the near future.
The data collected from the last quarter sales by four of the country’s leading online retailers, representing nearly a quarter of the U.K. market, revealed that:
The most popular flavor category amongst middle-aged adults (35-44 and year olds) was “fruit” flavors, followed “treats and desserts”
Highest proportion of tobacco flavor use is in the over-55 age category
Menthol flavors and tobacco flavors are significantly less popular amongst middle-aged adults
The average age of adult disposable users is 39
The latest adult vaping statistics follow a survey conducted by One Poll earlier this year, which revealed that 83 percent of vapers said that flavors helped them quit smoking, with one in three saying that a ban on them would lead them back to conventional cigarettes, which would represent around 1.5 million former smokers.
Why should 4.5 million adults who have spent years trying to kick a habit that kills some 250 people a day, and have managed to do so through vaping, be at risk of having their lifeline taken away?”
“These statistics show what we in the industry already know—that the very flavors and single use vapes that are now under scrutiny by the government as it looks to tackle youth vaping are a lifeline for former adult smokers,” said Dan Marchant, co-owner of online retailer Vape Club, which contributed to the demographic sales data.
“The legitimate vaping industry completely recognizes the need to deal with youth vaping but it shouldn’t involve any wholesale bans, as this will affect the adults who depend on them. There is already a ban on vapes for under 18 year olds as it is illegal for retailers to sell devices to minors. That’s why the industry is calling for greater enforcement of the existing law, on-the-spot fines of up to £10,000 ($12,631) per offence and the introduction of a retail licensing scheme to weed out the rogue traders.”
“Why should 4.5 million adults who have spent years trying to kick a habit that kills some 250 people a day, and have managed to do so through vaping, be at risk of having their lifeline taken away?” asked UKVIA’s Director General John Dunne.
“If the government goes down the path of banning single use vapes and/or flavors a return to smoking amongst current vapers will be very much on the cards, bringing with it catastrophic consequences for the public health of the nation and wrecking any chances of the government’s smoke free ambition. The only winners from any potential bans on the vaping industry are the tobacco industry and illicit markets, something that no one in their right mind wants to see.”
A new systematic review conducted by the Center of Excellence for the acceleration of Harm Reduction on the available scientific research showed no difference in respiratory parameters in human clinical tests on the respiratory effects of electronic nicotine delivery systems (ENDS) use in participants who smoke tobacco cigarettes.
In their study “Respiratory health effects of e-cigarette substitution for tobacco cigarettes: a systematic review,” the researchers analyzed 16 studies from 20 publications. They found that the large majority of the studies showed no difference in respiratory parameters. According to the authors, this indicates that electronic nicotine delivery systems substitution for smoking likely does not result in additional harm to respiratory health.
One of the problems the researchers found during their evaluation is that many studies were not of sufficient duration for observing any harmful or beneficial effects because these may take time to manifest. In fact, the researchers observed a general low quality of the studies included in the review, with 10 of 16 studies rated at high risk of bias.
In light of the findings of no change in respiratory function plus the presence of reporting spin bias, the researchers call for long term studies that include diverse participants and to assess smoking behavior and history. Furthermore, they note that exclusive ENDS use and dual use with cigarettes should be identified as separate categories for analysis and findings. They also stressed that additional studies are necessary to assess the potential benefits or risks of e-cigarette substitution for tobacco cigarette smoking.
Tobacco harm reduction (THR) took center stage during this year’s GTNF conference in Seoul.
By VV staff
Nearly 300 delegates from around the world gathered in Seoul for the annual Global Tobacco and Nicotine Forum (GTNF) from Sept. 19 – 21. The delegates encompassed a variety of backgrounds including public health professionals, consumer advocates, financial analysts, and prominent regulators such as Brian King, the director of the Center for Tobacco Products at the U.S. Food and Drug Administration. This year’s theme was “Change the Conversation, Change the Outcome” which promoted the open exchange of information and ideas between public health experts, government representatives, the industry and investors.
Attendees of GTNF discussed several issues currently confronting the nicotine industry, with a special focus on lessening the harms brought on by tobacco use. Behind the success of the GTNF is a strong belief that deepening the conversation about tobacco, nicotine and public health can lead to more informed views and decisions by all stakeholders. Previous events took place in Washington DC (2022 and 2019), London (2018); New York (2017); Brussels (2016); Bologna (2015); West Virginia (2014); Cape Town (2013); Antwerp (2012); Bangalore (2010); and Rio de Janeiro (2008). The following stories are a small selection of the keynote speakers and panels presented during the GTNF 2023 event.
Keynote: Eve Wang, executive director of Smoore International and vice president of Shenzhen Smoore Technology Co.
The vaping industry is young at only 20 years old. However, Eve Wang, executive director of Smoore International and vice president of Smoore Technology, said the industry isn’t going to get much older if it doesn’t find a way to balance innovation and social responsibility. Wang should know. She has been in the industry for more than 17 years.
“We are at a very critical path for the vapor industry,” she said. The vapor industry has grown rapidly over the past 20 years, with large growth in the first 10 years followed by the past 10 years seeing more regulation in markets like the U.S., Europe and China as products have evolved to be more compact and portable, usability has improved with technology evolution, open systems have evolved to pod mods and disposables have grown in variability.
Wang cited Frost and Sullivan data from March of this year, which showed that as of last year, the vapor industry made up a $52 billion dollar market, nearly double what it was in 2018. “There is no doubt the market is fast growing with huge potential,” she said.
With large growth comes media attention, as Wang noted, highlighting headlines that called for bans and restrictions, overwhelmingly regarding disposables.
She then posed the question “What can we do for sustainable growth?” She broke this up into two categories that Smoore uses to address this issue: consumer experience and environmental impact, what she called “vaping efficiency.”
“Vaping is not perfect,” she said. “It’s far from being perfect. Yes, it’s new, it’s complex.”
To address this, Wang explained that Smoore looks at it as two major aspects—atomization efficiency and power efficiency, and each aspect has a different approach. Without going into minute detail, she described atomization efficiency as improving the utilization of e-liquid and power efficiency as increasing energy density and reducing battery size.
“Do we have answers to all the challenges?” she asked. “I’m afraid it’s too early to tell. And if I may be the real Eve, I would say, no, we don’t have the answers.” She urged the industry to keep innovating and for every player to take their responsibility seriously.
“As long as the conversation goes on, we are confident that together we can make the best outcome. It could be this year; it could be next year; it could be in the next five years.”
Keynote: Brian King, Director of the U.S. Food and Drug Administration’s Center for Tobacco Products
GTNF 2023
When Brian King speaks, people come to listen. The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) director’s keynote address was easily the most attended session of GTNF 2023. King’s speech served as an overview of the current state of the CTP and an outline of the center’s main priorities over the next few years.
King said that the CTP has made considerable progress in reducing combustible cigarette smoking in the United States, which he contends as one of the most remarkable public health achievements of the past century. He hopes that those declines continue, given that “we do know” that combustible smoking is responsible for the overwhelming burden of death from using combustible tobacco.
Tobacco use continues to cost the U.S. government a considerable amount of money—to the tune of $600 billion per year from both direct healthcare costs and lost productivity, according to King. He said there are important human health benefits as well as financial benefits for regulators to continue to focus on reducing combustible use in the United States. As a part of this focus, the CTP is continuing to make inroads when it comes to premarket tobacco production application review.
“As folks are aware, we do have a new director of our office of science who has jumped in headfirst to continue to fiercely lead our 550-plus scientists on application review …. We have processed 99 percent of those and continue to finalize the remaining 1 percent. I’m hopeful that in the coming months and years, we will get back to what was intended to be a premarket approval process,” said King. “In the meantime, we have authorized 23 e-cigarettes, all tobacco flavored. So, it is possible. We have had successful authorizations. But again, I can’t reinforce enough the importance of providing that sound and robust science to inform on potential authorization.
“And it is possible, as you can see. There will be more authorizations in the future, but it’s important that we have that science to support those decisions. As I noted earlier, we also continue to fold in the nontobacco nicotine work into our broader portfolio around regulation. We did receive a million applications, which I don’t think anyone anticipated. I will say that we are making great numbers. We are 99.9 percent through with the review of those. I will say that 100 percent is very imminent.”
King said that when it comes to products that are illegally on the market (having received a marketing authorization and are not currently under review by the CTP), the CTP is mindful of the importance in exercising all authorities that it has to ensure that people are complying with the law. He said that the FDA has given retailers the information they need to comply with the law through a list of authorized products (the 23 products that have been authorized for sale). The CTP also continues to ramp up efforts in terms of training, education and outreach across the supply chain, particularly to retailers.
“We also continue to do surveillance inspection investigations. This is something that occurs on a daily basis. We have arrangements with all 50 states and territories to continue to do investigations. We have issued many warning letters for flavored disposable e-cigarettes, which we know are particularly popular for youth,” said King. “There’s been a variety of blitzes that have occurred monthly throughout the summer. I will say there are more to come. We are going to continue to conduct those blitzes and making sure that we are routinely monitoring, particularly with a focus on those products that we know have high youth appeal.
“On balance, we are also continuing to do work around issuing import alerts. I was a little tickled by all the attention that the import alert on Elf Bar got. That’s nothing new, folks. We’ve been doing that for many years. It was suggested it was something seismographic, but we’ve been doing import alerts for quite some time. And we do use those as, again, another tool in our toolkit to make sure that we are addressing not only the products that are already in the country but preventing illegal products from entering the country.”
As of Sept. 31, the FDA has issued over 1,200 warning letters for online investigations. For manufacturers, the CTP has sent more than 800 warning letters, with more than 750 letters for e-cigarettes. Beginning earlier this year, the FDA also issued the first civil money penalties against manufacturers for violations for illegal e-cigarette sales. He said civil money penalties will remain a part of the CTP’s tools to combat illicit sales.
“We also issued the first six injunctions in coordination with the Department of Justice. I got a lot of flak for that as well about enlisting the Department of Justice. And I will remind folks that the FDA doesn’t have an independent litigation authority. If folks do not comply with the law, we will escalate further as has been evidenced by these actions, which again are going to be part of our broader portfolio moving forward,” said King. “Everyone is going to be held accountable across the supply chain. We do want to make sure that we address the bad actors in a meaningful way. We also continue to pursue no tobacco sale orders among retailers as well. This has traditionally been issued for underage sales. But again, we’re committed to using the full scope of our authorities granted through Congress.”
King added that education is also a priority for the CTP. The center is ramping up efforts to address misinformation in the continuum of risk for nicotine products. He mentioned that he recently wrote a commentary where he highlighted the importance of opportunities and considerations for addressing misperceptions in nicotine. “There is science that exists in that there are misperceptions around the continuum of risk and also nicotine. And so, we do have opportunities that are present, but we have to follow the data-driven pandemic-based approach,” he explained. “That said, I’m putting my money where my mouth is …. We’re working with the National Institutes of Health for a funding opportunity to get more data on public health communication messaging about the continuum of risk.
“And as noted in that funding announcement, we’re looking for data both for the target population, which is called smokers, but also unintended populations, particularly youth. This is several million dollars on an annual basis, and we look forward to that kickstarting and getting data to inform our work.”
King said the CTP will also continue to gather input from the industry and the public. The CTP is creating a new office within the Office of the Center Director and is looking to hire a new director for Policy and Partnerships. “That posting is public,” he said. “And I’m looking forward to seeing those who have applied and getting someone in that seat to meaningfully oversee the product regulation portfolio across the center, particularly as we get that strategic plan in place.”
During the closing of his address, King said that he continues to be big on communication and stakeholder engagement. He expects to provide the industry with more opportunities for communication with the CTP. “I know that you’ll see in the future an evolution of our messaging. Both through our press releases, our social media and our [overall] messaging to make sure that we are clearer, simpler and more digestible,” he said. “I’ve been a bureaucrat for many years, but that doesn’t mean that I can’t communicate effectively with the general public. I think we can do better. I know we can do better.”
Panel: Innovating Products for the Future
GTNF 2023
Discussing the future of innovation in nicotine products is complicated. The industry is innovating at lightning speed, especially in batteries and atomization. However, manufacturers don’t often want to discuss innovations in progress because competition in the next-generation nicotine-delivery segment is fierce. It’s not uncommon for a company to launch a new innovative design only to see its IP stolen and used in counterfeit products.
During the panel “Innovating Products for the Future,” moderator Eve Wang, executive director of Smoore International and vice president of Shenzhen Smoore Technology Co., questioned five industry experts about how they imagine the future of the vaping industry. The participants agreed that innovation would continue boosting the harm reduction potential of next-generation nicotine-delivery products. Surprisingly, they all willingly shared interesting insights into new product innovation.
Tao Cui, director of innovation, strategy and compliance at Innokin Technology, said that future vaping products will likely be more individualized, more efficient and more intelligent. He also said that products will continue to become less harmful. He said the heating element is especially an area that will see more innovation.
“In a perfect scenario, you can control the temperature as low as possible and also precisely control it. And, if you have a much, much less harmful substance, we combine both together, then we have a less harmful product,” he said. “In the future, I would say the products will be more individualized because no one product fits 1 billion people. In the future, your product may adapt to your habits. The product may know if you need more [puffs] in the morning, in the afternoon, today or tomorrow.”
Cui outlined some potential solutions for sustainability-related issues, including the use of research and development. He proposed that countries that have successfully controlled youth usage could offer insight; they could accomplish this by better regulating flavor names and packaging.
James Kuang, chief scientist and head of the Life Science Institute at ICCPP, parent to Voopoo vaping products, stated that the innovation of products is needed to balance user experience, harm reduction and environmental protection. “Yes, we should develop some [better batteries] and [e-liquid bases] for that. “We talk about the effective battery …. Can we do something for our environment by developing different [e-liquids]? I say if we can develop some new type of [e-liquid base] … for example, can we use some nature-sourced alcohol? …. Another solution, I think, is a water-based solution. In my opinion, a water-based [solution] may be the best product for the future.”
Fadi Maayta, president and co-founder of Alternative Nicotine Delivery Solutions (ANDS), stated that the next stage of innovation should be aimed at protecting consumers—especially nonsmokers and ex-smokers—and youth. He noted that it was the responsibility of the industry to ensure it was on the right path to responsible growth. He said that artificial intelligence (AI) could play for both the industry and regulators by helping to better analyze data concerning consumers and product use.
“I know many companies that invested in applications to link [AI] to the device to tell the consumer how many puffs they took, what’s the health risk. All these apps failed. I don’t see consumers really using it, to be realistic,” said Maayta. “It will help consumers to get more data. It will help companies and factories [know where] to locate and know how to get the right product for the consumers through using that engine but also externally for the regulators and policymakers to get data about these products. It might help in tracking as well, track and trace for the product.”
When it comes to eco-friendly products, Maayta claimed that a rational vision of environmental sustainability involves four distinct pillars. The first pillar is the product. Manufacturers should use the right elements … cardboard, biodegradable silicon and biodegradable plastics. The second pillar is showing that your claims of eco-friendliness are provable—that they can be substantiated.
“If you want to claim that your product is recoverable and recyclable, and your product can be recycled to 99 percent, whatever—you [had] better be careful. You are in a very controversial industry, and every word will be tracked,” he said. “You better [be able] to substantiate every word, every percentage, everything you say about the recyclability and the probability of the product.”
The third pillar is that if you market an eco-friendly product, you need to have a program to support recycling. The collection of these products is important. “Make it simple … because consumers need simplicity,” he said. “You used to have a cigarette and a lighter. That’s it. You are giving them an electronic device. They don’t want to have a headache there.”
The fourth element is regulation. Maayta said regulators should be involved in investing in approving sustainable products and possibly incentivizing recycling programs. He criticized manufacturers that aggressively market products that appeal to youth. He criticized regulators for not doing more to remove the “bad players” from the market because it’s leading to good manufacturers being replaced by the black market.
Cherry Pan, managing director of consumer and marketplace insights at Altria, said that as the industry moves toward more “eco-friendly” products, the term needs to be better defined. Pan said that the environment should be a concern for all manufacturers. She also suggested that manufacturers could play a more innovative role in the design of eco-friendly products.
“First, how to define eco-friendly … that means you’re 100 percent recycled or 50 percent recycled or 30 percent? …. Or does it mean that we use vaping products that are less harmful than cigarettes? This also means it’s eco-friendly,” Pan explained. “We will make about 150 to 200 new products every year [not necessarily that make it to market] with our army engineers. We have about 150 engineers. So we also must make products which we [consider] eco-friendly because we can recycle it, maybe 70 [percent] to 80 percent. We use some degradable materials. The percentage we use is higher [than many other products]. We want to make removable batteries.”
Ryan Selby, CEO of Generative AI Solutions and executive chairman at The Modern Nicotine Co., said that innovation will not bring about a one-size-fits-all solution for consumers. It’s going to take a comprehensive approach to create choices for consumers through innovation. However, he doesn’t know what the next best thing is.
“I do think we need to keep our eyes on the future and look at there’s some big changes coming down in terms of the virtual and augmented reality experiences,” Selby said. “In the oral space, looking at opportunities for creating more personal nicotine experiences that have a lower [third-party] impact as well as lower the impact on the environment.”
Selby also said that AI could be beneficial in providing consumer insight and in helping find innovative ways to restrict youth access. He said AI can aid the nicotine industry by helping to reduce harm by analyzing data. Regulators may even be better able to understand the consumer experience.
“I think this is a tremendous opportunity for AI in this space to help feed in massive amounts of data set and tease out some of these interactions between devices … looking at opportunities for combining substances and devices in a way that can reduce the harms associated with [use],” said Selby. “I think there is tremendous promise with large data sets and the ability of AI to tease out some hidden secrets in there that can help us to continue moving in the right direction.”
Panel: Talking Nicotine: Perception vs. Reality
GTNF 2023
From a public health perspective, the misperceptions and misunderstandings surrounding nicotine are incredibly frustrating, according to David Sweanor, adjunct professor of law at the University of Ottawa, who moderated the GTNF panel on the public perception of nicotine. Science has proven that it is the delivery system [combustible cigarettes], not the nicotine itself, that causes the deadly diseases suffered by cigarette smokers.
Sweanor said Sweden was an excellent example of a country where the use of different delivery systems, such as snus, led to massive decreases in the number of combustible cigarette smokers. Sweanor said it would be a major benefit to public health if the industry would or even could do more to educate consumers, public health groups and legislators about the facts. He emphasized that people can only make as good a decision as the information available to them allows.
“We already knew from the work of Michael Russell that people smoked to get nicotine, but they died from the smoke. Nicotine wasn’t the problem. It was the delivery system that was the problem,” Sweanor explained. “We’ve known that for 50 years. And we’ve seen examples from places like Sweden where people can move to an alternative product and have disease rates that are massively lower than what you see elsewhere. In fact, looking at the long-term users of a product called snus, it is very hard to find anything to distinguish their disease risks from those people who don’t use any tobacco or nicotine product at all.”
The first speaker was Carolyn Beaumont, a general practitioner, educator and founder of SmokerHealth Telehealth and Medical Nicotine Scripts who for the last three years has been prescribing vaping products to cigarette smokers in Australia. She said that there is an outpouring of need and frustration and even fear from the many smokers that she works with. Under Australia’s strict vaping rules, vaping products are only allowed through prescription, and there are only a few products legally allowed to be prescribed. She presented several quotes from former smokers showing how vaping had changed their lives for the better.
“They really want their stories to be heard …. Smokers want to be heard—not judged—supported, and advocated for. And as I said before, they’re also very fearful that if they can’t get their vape, they will return to smoking, and that seems true as well,” said Beaumont. “I guess for those of you who are not sure how successful vaping is in [supporting] smoking cessation, it’s very effective.”
There were several quotes presented, including one from a patient who said there was a history of cancer in their family. “I am very reluctant to take up smoking again. I haven’t touched a cigarette in close to three years now, and I feel wonderful,” the patient stated, according to Beaumont. “My sense of taste and my smell has returned. Fitness has improved. So, I thank you for the service you provide for us ex-smokers to be able to vape instead of [smoking] those dirty cigarettes.”
The next speaker, Delon Human, president of Health Diplomats, a healthcare advocacy group, said that misperceptions surrounding nicotine were causing people to die. “At the heart of nicotine misperception lies an issue that we are wasting unnecessary lives,” Human told attendees. “We are allowing the misperception of nicotine to lead to disease. And that is a time that we absolutely have to take hold of the stakeholders, who can change those perceptions.”
He also stated that the World Health Organization’s failure to differentiate between tobacco and nicotine, combustibles and noncombustibles, has caused the spread of misinformation among the organization and government and nongovernment organizations it influences. “If you read WHO documentation …. On the one hand, nicotine is part of the WHO list of essential medicines. Nicotine as part of nicotine-replacement therapy as prescribed by physicians and health professionals for smoking cessation,” said Human. “And on the other hand, there’s an all-out war on nicotine. What has happened over the years, over the last 50 years, is that the so-called war on tobacco has changed into the war on nicotine.”
Human also noted that there is a serious amount of misperception surrounding nicotine among physicians and consumers. He mentioned a recent study from the Foundation for a Smoke-Free World that found that on average, nearly 77 percent of doctors mistakenly believe nicotine causes lung cancer, and 78 percent believe it causes atherosclerosis. While on average 87 percent of doctors at least moderately agree that helping patients quit smoking is a priority, lack of training and nicotine knowledge adversely impacts quitting and harm reduction advice, according to the study.
“It found that 58 percent of those respondents thought that [nicotine] caused cardiovascular or heart disease, which again shows you that the level of misconception is not only dangerous, it’s sick …. It’s 2023 and so simple of a situation, but suddenly physicians have a complete misconception of what nicotine is,” he said. “In our own study in 5 countries, we [found that among] GPs [general practitioners], there was a persistent belief that nicotine is the most awful aspect of smoking. Nicotine causes cancer, and nicotine causes heart and lung disease.”
Human pointed out the positive outcomes of correcting misconceptions about nicotine, including improved health for smokers and lower smoking rates. He proposed that medical professionals should receive new training on the effects of nicotine and the advantages of tobacco harm reduction. Human said that companies should also refrain from marketing to youth and keep up with the research and development of new reduced-harm products.
“In terms of physicians, what can they do for misperceptions to be corrected? No. 1, training needs to be updated to the 21st century. Doctors need to know that nicotine does not cause cancer. It’s a crime for doctors to think that nicotine causes cancer or heart disease or lung disease in a way that they perceive it now, so correct the training,” he said. “No. 2, make sure that doctors understand what harm reduction is. Harm reduction is really part of everyday medical life. That’s what we do in medical practice. You’re trying to reduce the harm.”
Hiroya Kumamaru, cardiovascular surgeon and vice director of AOI International Hospital in Japan, said that in his country, there is also a wide misperception among physicians that nicotine is harmful. He argued that the industry needs to think about how best to educate regulators on understanding the effects of nicotine and the risks of different delivery systems. “Many, many … GPs are thinking that nicotine is quite harmful itself [in Japan], and we have to educate them somehow. Thinking about how we can [address] this issue, I tried to have a small meeting in the Swedish embassy about four years ago to educate not only physicians but also media and governmental officers to understand the concept of harm reduction in tobacco, in smoking,” explained Kumamaru. “But it was still difficult because some of the physicians, even [ones that] were working in a university hospital or working in the Ministry of Health, were saying that smoking is a sin …. They didn’t care about the difference [between] vapor and cigarette smoking. Because they say nicotine drug dependency is a very bad agent. We have to think once more to educate these people to understand.”
Kumamaru said Japan has seen a historic decline in the number of combustible smokers because of the rise of heated-tobacco products. He said more than half of the combustible market has disappeared in just a few years. He also agreed that the industry could accomplish more if more were done to battle misinformation.
“We’re still stuck with this problem of it. People and regulators can only make as good a decision as the information available to them allows us. And people believe that using nicotine is about sin rather than about health. If people don’t understand that [combustible cigarettes, not] nicotine causes cancer, what can you do? …. Millions of Americans who are able to move between the [various harm reduction] products never had the information that one product is very likely to kill you and [that] the alternative product is massively less hazardous.”
Mohamadi Sarkar, a fellow of scientific strategy and analysis and regulatory affairs at Altria Client Services, told attendees that the science on nicotine is not new. He said that even though many mistakenly believe that vaping is just as dangerous or even more so than smoking combustible cigarettes, there is a plethora of evidence to show that vaping contains fewer harmful chemicals than cigarette smoke.
“We often hear that ‘Well, these products have not been on the market long enough, so there is no long-term epidemiology.’ We don’t need it. What we do know is that cigarettes have 70,000 chemicals. Seventy of them are carcinogens and linear, cardiovascular and respiratory toxins,” he explained. “On the other hand, smoke-free products like e-vapor or [heated-tobacco products] are nicotine-positive and have far fewer chemicals.”
In the end, all the speakers agreed that the industry could do more to battle the misinformation surrounding reduced-risk products. The vaping industry needs a unified voice. “We need unified goals for all the stakeholders to communicate …. We know that education works. Education has changed perceptions,” said Sarkar. “We need immediate action.”
Panel: Reasonable Responsibility
GTNF 2023
Youth use is everyone’s responsibility. It’s also the name of the GTNF panel that focused on how to balance preventing youth use with helping combustible cigarette smokers move toward less risky nicotine products. The panel’s moderator, Stacy Ehrlich, partner at Kleinfeld Kaplan and Becker, encouraged panelists to debate whether abstinence is a realistic or appropriate goal when attempting to combat youth use.
“Hopefully, speakers will address that and whether and how to communicate with youth and children about relative risks and progress. I think an interesting question is: Are youth an unintended population for these communications?” said Ehrlich, referring to the U.S. Food and Drug Administration’s acknowledgment that e-cigarettes are less harmful than combustible cigarettes. “Should we be communicating with underage individuals about consumer risk?”
All the panelists were given the opportunity to make a short presentation. Jasjit Ahluwalia, professor of behavioral and social sciences and professor of medicine at the Center for Alcohol and Addiction Studies at the Brown University School of Public Health and Alpert School of Medicine, said that tobacco addiction is a pediatric disease and noted that many diseases resulting from tobacco use were effectively human caused, such as chronic obstructive pulmonary disease, as 95 percent of cases were the result of tobacco use.
He also stated that youth use of tobacco and nicotine was unethical as young people are uninformed consumers. However, he noted that communicating risk to this group was complicated. He said that tobacco prevention campaigns are key.
“This is something that we know [is] important to effectively educate youth,” said Ahluwalia. “I’m mindful of the importance of the issue of spillover … this is, again, a careful area where I think it’s important that we’re mindful of what the impact is on the intended population and mitigating risk for the unintended population, which in this case, I believe is adult smokers that you want to make sure that they’re not scared away from using an e-cigarette that could potentially be beneficial for them to transition completely from combustibles.”
Ahluwalia also highlighted the vast amount of misinformation that had been communicated through anti-vaping/smoking campaigns, noting the role of the media in misrepresenting the science behind vaping products. He stated that the industry needed to focus on innovating safer and better products. He also called for the FDA to approve new smoking cessation medications. Lastly, Ahluwalia stated that a goal of zero youth use was unrealistic and unreasonable.
Brian King, director of the FDA Center for Tobacco Products, explained that youth prevention continued to be a critical part of the FDA’s portfolio since nine out of 10 adult smokers started smoking below the age of 18. He noted that the youth were using a variety of different products, with the use of e-cigarettes being particularly prominent.
“Youth prevention is a key component of FDA’s portfolio … we do see kids using a variety of different products. But right now, the focus is primarily on e-cigarettes,” explained King. “We’ve seen an evolution within even that product class as well, which I think is important for us to consider as we talk about what the inherent risks of these products are, particularly when it comes to dependency. That said, although we’ve seen declines in e-cigarette use, which again, we’ve noticed, is a good thing, among the kids who are currently using e-cigarettes, we’re seeing increased signs of dependency.”
King said the FDA is held by the standard of being “appropriate for the protection of public health.” This is not like the other centers at the FDA, such as the Center for Drug Evaluation and Research (CDER), which has a “safe and effective standard.” In therapeutics, the CDER wants products to be safe for people to use but also effective at treating the ailment.
“When it comes to tobacco products, the U.S. Congress has given us appropriate for the protection of public health, where we have to weigh the benefits and the risks. That said, the risks are typically focused on youth initiation. And we have made decisions based on that,” King told attendees. “The primary reason you’re seeing a variety of negative actions that have been taken on e-cigarettes is because of the prominent youth use of these products. It certainly is possible to mitigate that risk. For example, we know that youth have very little [interest in] tobacco-flavored e-cigarettes, which are the products that have been authorized to date because that benefit of adults has been able to outweigh the risk of kids.”
Colin Mendelsohn, general practitioner and founding chair of the Australian Tobacco Harm Reduction Association, said that current vaping policy is largely driven by fears over youth vaping. The scientific evidence of vaping is being overlooked. He stated that children should not vape or smoke; however, he acknowledged, it is inevitable that some will. Mendelsohn argued that most youth vaping was experimental, with frequent vaping being rare.
“I think policy around e-cigarettes is largely driven by youth [and] flavor. And I think it should be driven by the evidence, not by emotion and moral values,” he said. “What I’m going to talk about is actual evidence, or at least the best evidence we have today. Kids shouldn’t vape or smoke. They shouldn’t be using alcohol or useless drugs. Of course, they do lots of things they shouldn’t do.”
Mendelsohn said his research showed that only 3 percent of children who had vaped were frequent vapers, with half of those also being smokers. This evidence, he said, showed that vaping was not a gateway to smoking. He said that the opposite was true, and vaping was diverting kids away from smoking combustible cigarettes.
“I think we all agree that vaping is not a significant gateway to smoking. If there were a significant gateway, we would expect to see smoking rates going up. And of course, they’re going in the opposite direction. In the U.S., when vapes became popular, smoking rates continued to decline. In fact, they declined faster than they ever had compared to the historical period before 2013 since vaping became available.”
Stefanie Miller, vice president of external engagement at Juul Labs, said one of the reasons why she wanted to join Juul Labs is that she gets to say that Juul has a problem with youth use. “We don’t need to skirt around that. So I’m going to talk to you about what this company has done to successfully deal with youth using the product,” she said. “We took what we consider a three-pillar approach … it has been a productive initiative that we’ve taken …. It’s limiting underage appeal, restricting underage access and enforcing against third parties, enforcing against illicit products.”
Miller said Juul Labs is also using technology and innovation to help in the company’s fight against youth use. However, Juul Labs is also looking at how initiatives that are put in place to prevent youth use impact adults making the switch from combustible cigarettes. “We’re also considering what these interventions would do to make it potentially more difficult for an adult smoker to have access to a less harmful product, which is not the goal of our company,” said Miller. “We’re trying to walk this really careful line, both from the innovation but also the point-of-sale intervention along these three lines.”
Many of the questions coming from the audience were directed at King concerning the FDA premarket tobacco product authorization process. For example, Fadi Maayta, the CEO and co-founder of Alternative Nicotine Delivery Solutions (ANDS), a Dubai-based vaping product manufacturer, asked King to explain why the agency does not do more to incentivize law-abiding players. The FDA’s current penalty framework, he argued, penalizes good and bad players alike.
King said he understood Maayta’s frustration. There are numerous good players in the vaping industry that don’t have the issues of youth uptake, he acknowledged. The reality, however, is that the U.S. Congress wrote the Tobacco Control Act and prescribed very specific processes that the agency is required to do by law, said King.
“That said, the intent is not to penalize everyone … but we do have to follow the law in terms of implementing the regulations that have been required by us. And that includes a premarket tobacco product process and a rigorous scientific assessment …. We also have to enforce the law, and we are a free market paradigm. So there’s no safe harbor. If you don’t have authorization, your product is subject to enforcement compliance,” explained King. “That said, are there opportunities to streamline those processes? Absolutely. And that’s what we’re looking at. There are efficiencies that I think we can gain by looking at our processes to make it more streamlined moving forward.”
Panel: Research and Innovation Update
GTNF 2023
Regulations in the nicotine industry should change as products become more innovative and less harmful. Unfortunately, that is unlikely to happen in many markets. During a panel discussion updating attendees on research and innovation, moderator Mohammed Agrabawi, senior director of corporate affairs and communications at ANDS, discussed approaches in the Middle East where governments have imposed high taxes on vaping products.
“I want to take you to the reality where I come from, from the Middle East, where most of the countries are imposing taxes that are 100 percent and 200 percent on vaping products. You can buy a pack of cigarettes [for one-fifth the cost of a disposable vape] …. Don’t you think that governments are part of suppressing innovation and investment in that part because of fiscal and regulatory frameworks?” Agrabawi asked. “Yes, absolutely. And the reason for this is clear. One of the things that Sweden did really, really well is price taxes on a continuum of risk. The lower the risk, the lower the tax.”
For Agrabawi, this clearly demonstrated that government regulation can suppress innovation.
Also on the panel, Tim Andrews, director of Consumer Issues at Americans for Tax Reform and the Tholos Foundation, cited several historic examples of innovation being demonized that would later go on to save lives—he suggested next-generation nicotine products are another example of this. He also stressed the need to better communicate the scientific research on nicotine products and their benefits.
Andrews believes there are better ways to deal with the uptick in youth vaping. “There’s an old saying that goes, ‘Children see and children do,’” he said. “A simple switch or a simple button to activate this product will not prevent [youth use].” Andrews suggested that youth prevention can’t just be simple, such as technology requiring a user to push a button three times. And future solutions will probably incorporate AI or Bluetooth. However, an immediate impact could be made if more was done to fight the black market.
“I would say that unethical retailers … they sell illicit products, and they sell to minors as well. So illicit vaping is a gateway to smoking and vaping rather than legal companies. And if we look into the illicit market, they don’t check IDs, they don’t use [legitimate sales] practices because they’re an illicit company,” explained Andrews. “If you shut down all of the legal products and move it to the black market, it’s going to be worse because we’re unregulated; we don’t know what’s in there; they’re going to sell to kids. You don’t have any safeguards.”
Kang Yu, head of the Research Institute at Hangsen International Group, outlined how her employer has been establishing a framework of harm reduction that will help test new products and produce safer ones. She delivered a comprehensive presentation outlining Hangsen’s strategic evolution within the realms of scientific research and innovation. Yu underscored the organization’s steadfast dedication to enhancing consumer safety by elaborating on their initiatives pertaining to harm reduction.
Yu pointed out that the industry is still young and has a promising future. Yu also commented on the potential of nicotine salts. She emphasized that nicotine salts are a critical component of e-liquid formulations and have a decisive impact on product taste and feel.
“Pure and high-quality nicotine salts can significantly enhance the overall sensory experience, providing consumers with a superior user experience. While benzoate salts have gained popularity in the market, they have limitations in reproducing certain specific taste profiles, such as sour fruits, non-sour fruits, toasted and tobacco flavors,” she said. “Other acids that can be used for salt formation, such as acetoacetate, lactic acid and citric acid, offer unique and rich flavor characteristics once they form salts. For example, acetoacetate can enhance the authenticity of fruit flavors.”
Shawn Long, president of the Zinwi Research Institute, Yunnan, and director of Zinwi Tobacco, said his company has been focused on reducing the harm of their e-liquid products. He said the company has set up advanced safety assessments and a tobacco flavor evolution platform that allows conventional tobacco smokers to find an e-liquid flavor that mimics the brand of combustible cigarettes they are trying to transition away from.
A major reason that Zinwi’s e-liquid has an enhanced flavor profile is the company’s Atomization Technology Research Center, which has self-developed nicotine salts and the sweeteners used in the e-liquids to ensure the highest quality of those components of the e-liquid formula, according to Long. The company also requires each component of its e-liquids to have the highest levels of quality and purity.
Marlen Nazarov, chief technology officer at Alfabet Labs, identified two main challenges in the e-cigarette industry: sustainability and youth access to vapes. On youth access, he suggested the solution is to make the product look less attractive with minimalist packaging, minimal colors and no flavors. He also agreed that additional solutions to challenges with youth use will likely involve AI.
“Innovation should be directed toward the key challenges in the market. So basically, there is no one solution for everything. It’s a really big challenge,” said Nazarov. “For youth use, it’s two parts. The first part is to make the colors less attractive, use conservative packaging without any fruits, etc. For the devices, it’s the same, just a simple white or black device without any images.”
Rex Zhang, strategy director at Shenzhen Smoore Technology Co., discussed what he sees as the two main challenges to the vaping industry: user experience and sustainability. On youth vaping, he outlined how child protection must be more advanced to stop children from using vapes. Zhang detailed Smoore’s advancements in sustainability and vaping efficiency. The company, he said, had reduced the amount of lithium materials in its vaporizers and increased the lifespan of its products, thus fewer products will be discarded.
Zhang also added the drive behind Smoore’s innovations. “I think the solution of best fit for society is a balance solution between regulations and user experience,” he said. “Smoore’s mission ‘Atomization Makes Life Better’ aligns very well with this objective to continue to work on the R&D, improving it for bettering people’s life.”
BAT has begun selling heat sticks made from nicotine-infused substances such as rooibos tea to counter an incoming EU ban on flavored heated-tobacco products, according to Reuters.
Health experts have warned that the safety of the new products is unclear.
BAT has launched heat sticks containing nicotine-infused rooibos tea rather than tobacco in nine European markets, including Germany and Greece. The company plans to roll the product out globally.
BAT stated that the move will provide “adult nicotine users and smokers with the widest possible range of reduced-risk products.”
“Anything that burns or is vaporized … and inhaled into the lungs, probably will cause some effects,” said Erikas Simonavicius, a research associate at King’s College London, of the unknown risk factors of the tea-infused heat sticks. Tobacco companies have not yet published any research showing the health implications of rooibos or other zero-tobacco heat sticks, said Simonavicius.
BAT is the first big tobacco company to publicly state what its zero-tobacco sticks are made from. The company declined to comment on whether it had conducted research on the health implications of the product.
Philip Morris International plans to roll out a zero-tobacco stick later this year, according to statements made during the company’s investor day in September. PMI declined to comment on what the product is made from or its health implications.
According to Jacek Olczak, PMI CEO, the company’s product could avoid the regulatory scrutiny of tobacco products.
According to BAT, its new zero-tobacco heat sticks are not subject to EU tobacco rules, meaning the company can sell its sticks in flavors even after a ban on flavored heated-tobacco products is implemented later this month.
“The obvious advantage these new products should provide is a way to keep menthol and flavor varieties on the EU market,” said Owen Bennett, a Jefferies analyst.
Experts do not think the regulatory advantages will last long, however, according to Bennett and Phil Gorham, senior equity analyst at Morningstar.
“The next generation of regulation is going to target nicotine,” Gorham said.
The Netflix documentary Big Vape: The Rise and Fall of Juul will premiere on Oct. 11. Netflix states the docuseries is “a scrappy electronic cigarette startup becomes a multibillion-dollar company until an epidemic causes its success to go up in smoke.”
Helen Redmond of Filter wrote that she was prepared to hate-watch the docuseries, directed by R.J. Cutler, in her review of the show.
“The name alone pissed me off because of its implied conflation of Juul, which is not a tobacco company, with ‘Big Tobacco.’ The trailer is a feverish montage of talking heads and voiceover accusing the company of being ‘wildly irresponsible,’ photos of hospitalized patients with bloody chest tubes, and a clip of James Monsees, one of Juul’s founders, being called ‘a marketer of poison to young people’ at a congressional hearing,” she wrote.
She also states that she “was happily shocked” when the series presented a alternate viewpoint.
The docuseries is based on TIME journalist Jaime Ducharme’s book, Big Vape: The Incendiary Rise of Juul.
The vaping industry is young at only 20 years old. However, Eve Wang, executive director of Smoore International and vice president of Smoore Technology, said the industry isn’t going to get much older if it doesn’t find a way to balance innovation and social responsibility. Wang should know. She has been in the industry for more than 17 years.
The Netflix documentary Big Vape: The Rise and Fall of Juul will premiere on Oct. 11. Netflix states the docuseries is “a scrappy electronic cigarette startup becomes a multibillion-dollar company until an epidemic causes its success to go up in smoke.”