The regulation of new and emerging e-cigarette, heated-tobacco and nicotine products will be one of the central topics of discussion at the COP10-MOP3 international tobacco control conferences next year, said Adriana Blanco, head of the World Health Organization Framework Convention on Tobacco Control (FCTC), in a virtual press conference on Nov. 14, reported ECigIntelligence.
Speaking from the WHO headquarters in Geneva, Switzerland, Blanco said that proposals to create more stringent rules and health guidelines to govern new tobacco and nicotine product use will be prioritized at the COP10 (10th Conference of the Parties to the WHO FCTC) and the MOP3 (third session of the Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products), which will now take place in Panama next year.
Last week, the WHO postponed COP10 to 2024 due to security issues for attendees and no new date has been announced.
As tobacco harm reduction continues growing in influence, it is also facing many obstacles.
By Stefanie Rossel
Regulatory policies, industry standards and medicinal licensing were among the themes tackled during the May 23–24 ENDS Europe Conference in Amsterdam.
Many countries, including New Zealand and England, aim to be “smoke-free” by 2040, a term generally defined as less than 5 percent of the population lighting up. However, according to speakers at the event, most of these countries are unlikely to achieve their goals due to prohibitionist policies, such as incremental increases in purchase age, reductions in tobacco sales outlets or ultra-low-nicotine requirements.
The country most likely to achieve smoke-free status is Sweden, according to the conference participants. By helping smokers switch to less harmful alternatives, such as snus, it is living proof that tobacco harm reduction (THR) is a more effective strategy than prohibition to reduce tobacco-related illnesses.
Noting that millions of smokers don’t want to quit, Christopher Snowdon, head of lifestyle economics at the Institute of Economic Affairs in the U.K., presented an alternative, pragmatic and realistic smoke-free plan that includes a wide range of reduced-risk products (RRPs), such as snus, nicotine pouches, e-cigarettes and heated-tobacco products (HTPs), and focuses on educating consumers and fostering innovation. To put an end to misinformation about RRPs, Snowdon proposed the introduction of public information campaigns and cigarette pack inserts informing consumers in a band-neutral manner about the benefits of switching to less risky products.
He also asked for better regulation, including advertising, tank and bottle sizes and nicotine limits. For HTPs and nicotine pouches, Snowdon proposed proportional tax and regulation and independent research. He warned policymakers against overregulation, naming e-cigarette taxes, flavor bans or indoor vaping bans as examples. Anything that makes vaping, HTPs, snus or nicotine pouches less appealing will make smoking relatively more appealing, he cautioned.
More Challenges Ahead
Regulations, however, continue to mount. Ciprian Boboi, founder and board member of the Independent European Vape Alliance, provided an overview of upcoming EU laws that will affect the nicotine sector. The Battery Regulation, which will be adopted in June or July this year, stipulates that the batteries in portable devices must be removable and replaceable by the user. For disposable vapes, the new rules mean a de facto ban from January 2027. The Tobacco Products Directive (TPD), which is in revision until 2025/2026 and projected to be implemented by 2027/2028, may encourage the spread of flavor bans (which are already in force in five member states), plain packaging and advertising bans.
The Tobacco Excise Duty Directive (TED), to be implemented by 2025, is expected to include vaping. The Packaging and Packaging Waste Regulation requires all packaging to be recyclable by 2030. Plastic must contain a minimum percentage of recycled material. Provisions are likely to apply to packaging used by the vaping industry, including e-liquid bottles.
The upcoming TED, which aims to harmonize taxation of combustible cigarettes among member states based on the purchasing power parity index, was also the subject of a panel discussion. According to leaked information, the revised TED will tax e-liquids with a nicotine content of below 15 mg/mL (including zero nicotine liquids) at 20 percent, or €0.10 ($0.11)/mL, and those above 15 mg/mL at 40 percent, or €0.30/mL. HTPs will be taxed at 55 percent, or €91 per 1,000 sticks, nicotine pouches at 50 percent, or €120/kg, and other nicotine products at 50 percent, the latter two gradually over four years.
Panelists questioned the objective of the directive, arguing that if it was about health or nicotine, it was illogical to also tax non-nicotine liquids. By failing to follow the risk continuum, tax differentials would merely protect the cigarette trade and worsen the public’s already poor understanding of THR, according to panelists.
The global novel nicotine market is currently worth an estimated $56 billion, according to Marija Obradovic, head legal analyst at ECigIntelligence. Vape products are the predominant category in North America whereas HTPs are leading in Europe, the Middle East and Africa region and the Asia-Pacific region.
Nicotine pouches are steadily growing but face a fragmented regulatory framework in the EU. In several countries, among them Estonia, the Czech Republic and Sweden, they are regulated, with some states imposing packaging restrictions and requiring health warnings. In Bulgaria and Austria, there is a tax on modern oral nicotine products. For HTPs, a flavor ban will enter into force this October. Obradovic said the regulation will likely lead to more illicit markets, especially in eastern European countries bordering non-EU countries where flavors are not banned. Meanwhile, the number of herbal consumables for HTPs with or without nicotine, a totally unregulated market, has been growing.
Regulatory Approaches
When it comes to regulatory policies for RRPs, there are three approaches, as independent consultant Patricia Kovacevic explained. Regulatory science-based policies rely primarily on premarket notification with some elements of product science or standards. The EU TPD notification scheme is an example of this approach. Advantages of this stance include faster and more accessible market entry and a more diverse range of manufacturers, importers and products. Due to distinctions among national legislation, however, consistent success of electronic nicotine-delivery systems (ENDS) as a consumer product is impeded, and the approach does not include an element of scientific communication of the risk continuum. As flavor bans show, it is not always science-based.
By contrast, regulatory policies based on product science authorize market entry upon scientific review, including a comparative risk profile of products. The unit-by-unit review prevails in the U.S. under the Tobacco Control Act. While the approach is protective of the individual and, to some extent, public health, and robust science will eventually lead to a favorable outcome, it is a time-consuming, prohibitively complex, expensive and anticompetitive process that results in a limited number of products concentrated with a few large players, likely resulting in deceleration in harm reduction, according to Kovacevic.
The third approach—no effective premarket requirements—is followed by a dwindling number of countries. It allows easy market access but is not protective of public health. There are no standards and no oversight of product ingredients or functionalities. A regulatory approach that best serves THR, Kovacevic summarized, would include proportional and science-based product design, ingredients and manufacturing standards, reasonable liberties to communicate with adult consumers and would consider distribution, retail and age verification.
Regarding the future of global ENDS regulation, this November will see the 10th conference of the parties (COP10) to the World Health Organization Framework Convention on Tobacco Control (FCTC), to be staged in Panama. Jeannie Cameron, CEO of JCIC International, told the audience about the mechanisms behind the gathering’s decision-making, which takes place by consensus, not vote, and what to expect from the meeting. As the COP10 Bureau, the body that will be writing the agenda, consists of representatives of six countries, most of which have banned vaping, a pro-THR approach is unlikely.
Key issues on the FCTC agenda will likely include bringing novel nicotine products into the FCTC remit, a redefinition of smoke that includes aerosols, restriction of nicotine delivery and bans on nicotine salts in vaping products. COP10 will also discuss nicotine addiction, environmental issues and illicit trade.
As only governments have a say at the meeting, they will have to determine their views beforehand. Cameron recommended that to prepare for Panama, business and consumer advocates should contact small business and health committee members of Parliament, respectively, while political advocates should coordinate with like-minded countries.
Making Adjustments
In a presentation, Marina Murphy, director of scientific and medical affairs at ANDS, demonstrated that nicotine is not the evil substance anti-THR advocates make it out to be.
There is evidence that nicotine, an alkaloid like caffeine, could have a neuroprotective effect, she noted. Murphy pointed out that in nicotine product regulation, lawmakers apply widely varying standards, with cigarettes being regulated based on what comes out and e-cigarettes being regulated on what comes in, for example. With the WHO promoting nicotine flux—the rate at which nicotine flows from the mouth end of an e-cigarette per puff second—as a new regulatory target, she said it is time for the industry to reframe nicotine.
Righting misperceptions derived from flawed science can be helpful in this regard. Rosalia Emma, assistant professor at the Department of Clinical and Experimental Medicine at the University of Catania, reported on the Replica project at the Center of Excellence for Acceleration of Harm Reduction (COeHAR), in which researchers between 2019 and 2022 replicated the most relevant international studies and unequivocally demonstrated the reduced toxicity of e-cigarettes and HTPs. With Replica 2.0, a new phase of research has started this year, which repeats a study by Fetterman that suggested that flavorings in tobacco products induce endothelial cell dysfunction.
In contrast to the Fetterman study, COeHAR’s preliminary results show no significant differences in cell viability between PG/VG and PG/VG with vanillin. Reviewing recent literature about emission characterization, Sebastien Soulet, an engineer at Ingesciences, concluded that the contested studies used devices with high power and low airflow. He said that the condition of use should be investigated by researchers as there was a lack of information in many commissions and committees, including those that put together the FCTC’s nineth report, or the SCHEER report.
Compared to other age-restricted consumer products, such as combustible cigarettes or alcohol, vape products face a stronger regulatory, often prohibitionist stance, mainly because of the flavors involved—although these are also common in alcoholic beverages, according to speakers at the Amsterdam event. To make their products less prone to attack, panelists argued, the industry should behave more responsibly in the design and description of their products to prevent them from attracting youths. It should also develop a nomenclature to rule out violations, they suggested.
Rather than raising taxes on vape products, regulators should step up enforcement against retailers selling to youth, according to speakers. No longer subject to EU requirements, the U.K. should also consider allowing larger tank sizes, they suggested. This would make vapor products less appealing to youth due to higher prices.
The Flavor Issue
The conference also tackled the issue of flavors. In her Tobacco Products Prevalence Study, Andrea Patton, behavioral epidemiologist and head of prevalence research at the Centre for Substance Use Research, modelled the impact of an ENDS flavor ban on U.S. youth and adult users, developing two scenarios. Under the first, the U.S. Food and Drug Administration would ban all flavors except tobacco; under the second, the agency would ban all flavors except tobacco and menthol.
According to the study, the first scenario would result in a 31 percent reduction of vaping among current adult cigarette users while the second scenario would yield a 21 percent reduction. In both scenarios, participants stated that they would start using tobacco. Flavor, Patton concluded, was the main driver for quitting cigarettes. By contrast, only 5 percent of youths said that they vaped only because of flavors; the main reasons cited for vaping were anxiety, stress or depression. A flavor ban would thus not affect youth use as intended, according to Patton, who also stressed the importance for studies on youth use to look beyond the brand level.
Citing research by Konstantinos Farsalinos, Michael Landl, director of the World Vapers’ Alliance, explained the importance of flavors. Most vapers, Farsalinos’ work showed, use flavors other than tobacco. Over time, they will get “flavor fatigue” and hence need a variety of flavors. Flavor bans, he argued, won’t work as they make vaping less attractive to smokers, imply a never-ending “war on drugs” mentality and drive consumers to the black market.
In Estonia, where flavors have been banned since 2020, 58 percent of vapers still use flavors, he said—a real-life experience the Netherlands should have considered before enacting a similar ban. A flavor ban wouldn’t prevent youth uptake either, Landl argued, as most adolescents consumed nicotine for relief of psychological stress. To solve this problem, he asked politicians to improve the socioeconomic conditions and create better opportunities for disadvantaged adolescents.
Richard Young, principal toxicologist at Bibra Toxicology Advice and Consulting, identified aspects that vape manufacturers need to consider when carrying out assessing their products under TPD rules. He recommended getting a toxicologist involved early in the process—doing more extensive toxicity assessments, comparing acceptable levels or thresholds of toxicological concern for each ingredient to appropriate consumer exposures and documenting hazard and risk assessment clearly.
What THR Also Means
Credit: Smithers
Three speakers shared their personal experiences with THR. Tom Gleeson, trustee of the New Nicotine Alliance Ireland, related how he, a smoker of 35 years, successfully quit within two days 12 years ago by trying an early vape product.
Flora Okereke, head of global regulatory insights and foresights at BAT, said that to her, a better future is to use and enjoy nicotine with little or no health impact, which she described as an achievable goal. Okereke made clear that leaving cigarettes, the cash cow for the tobacco industry, to an uncertain future was a bold step for a cigarette manufacturer. She called on the industry to unite and send a unified message to policy regulators. The industry, Okereke said, needed to use COP10 as an opportunity to shape where the industry will be heading.
Liam Humberstone, technical director at Totally Wicked, described his company’s strategy to deal with the waste created by disposable vapes. According to Nielsen, the U.K.’s single-use vape market was worth £1.12 billion ($1.38 billion) in May 2023, corresponding to 200 million pieces sold each year. In addition, there are an estimated 300 million illegal products.
Totally Wicked promises consumers it will take back any device of any brand, even illegal vapes. Products are recycled through some of the country’s few authorized treatment facilities, as their batteries are hazardous waste that needs separating. He pointed out that reducing, reusing and recycling makes sense—a lithium-ion battery, for instance, can be recharged 150 times to 300 times—but is not yet widely practiced. Concrete steps and appropriate regulations are needed to improve the situation, he claimed.
New Technologies
One way to accelerate THR is to offer licensed e-cigarettes on prescription. According to Ian Fearon of WhatIF? Consulting, doctors could prescribe vapes instead of less effective nicotine-replacement therapies. The best places for the medical licensing pathway, according to Fearon, are the U.K. and the U.S. Pete Lomas, managing consultant of product realization at Broughton, explained in detail what it takes to develop an ENDS product for medicinal licensing.
The ENDS Conference also highlighted innovative technologies. Stefanie Scheffler, scientist at the Fraunhofer Institute for Toxicology and Experimental Medicine, presented a novel device for standardized e-liquid testing. Capable of producing a defined and adjustable temperature, the prototype eliminates the influence of the vaping device on aerosol emissions and creates more safety for the user, independent from the e-cigarette used.
Scientific Horizons Consulting launched a new puff-recording ENDS that allows researchers to assess real-world user behaviors in real time. According to the company’s principal scientist, Xiang Gao, a two-month observation study revealed that users had vastly varying, complex and nonlinear puff behavior patterns.
The U.S. states that have banned or heavily restricted vaping product sales have seen increases in combustibe cigarette sales, according to the latest research. The study titled “Impact of Banning Electronic Nicotine Delivery Systems on Combustible Cigarette Sales: Evidence from US State-Level Policies,” said cigarette sales increased by up to 7.5 percent in one state that imposed a full ban on electronic nicotine delivery systems (ENDS).
Credit: Wire Stock
According to the study, published in the medical journal Value in Health, found that a full ban on ENDS was associated with increased cigarette sales of 7.5 percent in Massachusetts and banning non-tobacco flavored ENDS was associated with a minimum of a 4.6 percent increase in cigarette sales among the US states outlawed most flavors (Massachusetts, Washington, and Rhode Island).
ENDS are considered by many to be an alternative nicotine product for adult smokers, and banning them may have unintended consequences, according to the authors of the study. “Cigarette sales in states banning ENDS were significantly higher than would have been observed otherwise,” researchers Yingying Xu, Lanxin Jiang, Shivaani Prakash, and Tengjiao Chen stated in the study, adding that commercial sales data provided the evidence that banning e-cigarettes was associated with increased sales of traditional cigarettes.
The authors looked at cigarettes sales data in 2020 following the start of restrictions on vaping in several states in the U.S. in the fall of 2019 that were imposed in several states following the outbreak of the e-cigarette or vaping product use-associated lung injury (EVALI), which was caused by illegal THC products and not nicotine vaping products.
The researchers also stated that the results “highlight and quantify potential unintended consequences” of ENDS sales restrictions, and the study’s results should be considered in the future as part of public health impact analyses of such policies.
“Additional research is also needed to investigate the impact on spatial spillover effects, illicit markets, and other scenarios that may arise in response to ENDS restrictions. Furthermore, the long-term impact of ENDS sales bans on ENDS and cigarette sales, as well as the distal public health outcomes, will need to be studied as additional data become available,” the report states.
South Africa’s National Treasury has outlined a proposal on the taxation of electronic nicotine delivery systems (ENDS), reports BusinessTech.
Credit: Skórzewiak
Among other measures, the agency is considering taxes on hardware and e-liquids, with higher-nicotine products attracting higher levies than low nicotine varieties.
While the market for ENDS is still in its infancy in South Africa, the National Treasury expects it to grow. The agency says it wants to learn from the experience of other countries where growth of ENDS has raised concerns about underage consumption. The agency said it is also aware of concerns about the potential of ENDS to undermine global tobacco control efforts and public health.
Vaping products are covered neither by South Africa’s Tobacco Products Control Act nor by the country’s Medicines Act. The government has proposed the Control of Tobacco Products and Electronic Nicotine Delivery Systems Bill in which it hopes to regulate vapor products in a similar way as cigarettes.
The bill was introduced for public comment in 2018, but remains in a draft form.
According to 2021 study commissioned by the Vapor Products Association of SA, the vapor industry in 2019 contributed ZAR2.49 billion to South Africa’s GDP while paying ZAR710 million in taxes. More than 350,000 South Africans use vapor products.
In August, the U.S. Food and Drug Administration issued 29 warning letters to firms it says were manufacturing and selling unauthorized electronic nicotine delivery system (ENDS) products. The agency advised the companies that selling products which lack a marketing authorization is “illegal and therefore they cannot be sold or distributed in the U.S.” The companies did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline.
Credit: Андрей Яланский
While each of these 29 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 268,000 products, according to the FDA.
In a first for ENDS products, two of the warning letters went to companies for selling after their PMTAs were not accepted. “Both Vapor Boss, LLC, and Kaleidoscope Custom Vapor Lounge, LLC have continued to sell ENDS products after receiving “Refuse to Accept” (RTA) determinations from the agency following submission of their premarket tobacco applications,” the FDA stated. “These are the first warning letters issued for an application that was submitted by the Sept. 9, 2020 deadline that subsequently received a RTA determination.”
Companies who receive an RTA determination must remove any products currently on the market or risk enforcement action by FDA, according to the agency. Companies may resubmit a complete application for these products at any time, however the products may not be marketed unless they receive a marketing granted order.
FDA also issued the first warning letter to a company that submitted premarket applications for some, but not all, of its products. The company (Maduro Distributors d/b/a The Loon) submitted a premarket application covering 18 products, but it manufactures and sells additional products not covered by the premarket application and thus lacking premarket authorization.
From January through August 2021, FDA has issued a total of 169 warning letters to firms selling or distributing more than 17 million unauthorized electronic nicotine delivery system (ENDS) products and that did not submit premarket applications by the Sept. 9 deadline, according to the agency.
On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.
A coalition of 31 U.S. states and territories has penned a letter the U.S. Food and Drug Administration (FDA) to asking the agency to ban all flavors other than tobacco, limit nicotine levels and restrict the marketing of all electronic nicotine delivery system (ENDS) products. The group wants the regulations to also apply to oral nicotine products such as pouches, gum and lozenges.
Credit: Balint Radu
Led by New York Attorney General Letitia James, the group’s letter to the FDA argues that the FDA must address the epidemic of youth use of ENDS products by imposing restrictions and age verifications on traditional and digital marketing tactics aimed towards youth, according to a press release. The group claims that e-cigarettes and oral nicotine products have not received marketing authorization from the FDA, as required by federal law.
“Flavored nicotine products attract kids to dangerous, habit-forming products that only jeopardize their health,” said James. “New York has taken important steps to protect our kids by banning non-tobacco flavored vapor products and limiting the sale of e-cigarettes, but the FDA must also do its part to curb the youth nicotine epidemic. The health and wellbeing of our kids is our top priority and the federal government must act now.”
The FDA must make a decision by Sept. 9 on whether to allow nicotine products to stay on the market through its premarket tobacco product application (PMTA) pathway for any ENDS product that submitted the application by Sept. 9, 2020. The group’s proposed restrictions would require the FDA to deny approval for most products.
The coalition argues that banning candy, mint, fruit, and menthol flavors, is essential to eliminating the appeal of the products to youth consumers. Other signatories to the letter are the attorneys general of Idaho, Illinois, Nebraska, North Carolina, and Tennessee. Additional states joining the letter include Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Guam, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Utah, Vermont, Washington, and Wisconsin.
James has a long history of challenging the ENDS industry. In April 2019, she led a coalition of seven states in urging the FDA to take stronger action in addressing “the scourge of e-cigarette use among youths” by taking proposed measures such as strengthening guidance, beginning enforcement earlier and banning online sales of e-cigarettes.
Later that year, James filed a lawsuit against the electronic cigarette company JUUL Labs for deceptive and misleading marketing of its e-cigarettes, which “contributed to the ongoing youth vaping epidemic in New York state.” In December 2020, James ordered dozens of retailers across New York state to immediately stop selling e-cigarette products to underage customers and to stop selling flavored vaping products in violation of New York state law.
Several recent studies have found that banning flavored vaping products boosts sales of combustible cigarettes and youth use. If vapor product sales were restricted to tobacco flavors, one-third of U.S. vapers between the ages of 18 and 34 would switch to smoking combustible cigarettes, according to at least three known studies.
A research initiative on the potential harmful effects of electronic nicotine delivery systems (ENDS) by Chemical Insights, an institute of Underwriters Laboratories and Georgia State University’s School of Public Health are now underway. The collaboration will characterize airborne particulate aerosols and volatile organic chemicals released during e-cigarette use and determine human exposure levels and toxicity for users and bystanders, according to a press release.
Essentra Scientific Services’ new laboratory is dedicated to testing electronic cigarettes.
“With a focus on public health and safety benefits, our research findings will identify specific particles and chemicals that infiltrate the lungs of a user so that steps can be taken to reduce human health risks,” said Marilyn Black, vice president and senior technical advisor with Chemical Insights.
The release states that one contributing factor to youth use of ENDS is the perception that ENDS are a safer alternative to cigarettes and other traditional tobacco products. “However, a series of studies have proven pulmonary toxicity in e-cigarettes and a link to negative impacts on adolescents’ respiratory health,” the release states. “ENDS lags in product safety testing for numerous proprietary liquids and aerosol delivery methods available in the expanding marketplace.”
The study will reportedly provide scientifically sound data to inform policy makers, healthcare providers, manufacturers and consumers of potential health risks and approaches for product usage and label warnings to educate consumers of potential respiratory hazards, according to Roby Greenwald, assistant professor in the School of Public Health and co-principal investigator of the study. “We’re looking at multiple liquids and aerosol delivery methods that are readily available to better understand toxicity and their impact on human health.”
The U.S. Food and Drug Administration is currently evaluating the harm-reduction potential of vapor products through its premarket tobacco product application (PMTA) process. The regulatory agency has stated that ENDS are safer than combustible tobacco products, but do not come without risk.
Research findings will begin to be released in fall 2021.
Ukrainian lawmakers passed a new law today prohibiting the use of electronic nicotine-delivery systems (ENDS) in public places as well as advertising, sponsorship, and promotion of e-cigarettes. The law also bans the sale of flavored e-liquids other than tobacco flavors.
In its report on vaping, published on Tuesday, the WHO speaks approvingly of the 32 countries where the sale and use of vaping devices is banned. In those 32 countries, people are still free to use combustible tobacco products, which data shows is responsible for more than 7 million deaths each year globally, according to the U.S. Centers for Disease Control and Prevention (CDC).
“Eighty-four countries still have no bans or regulations to address ENDS, leaving them particularly vulnerable to the activities of the tobacco and related industries,” says the report, which was funded by Bloomberg Philanthropies, the foundation started by American billionaire and former New York City mayor Michael Bloomberg.
Not coincidentally, Bloomberg has been appointed the “WHO Global Ambassador for Noncommunicable Diseases and Injuries”—a largely honorary title granted in recognition of the money he spends on tobacco control and other health policy efforts, according to the WHO.
Tobacco harm reduction advocates and vaping industry representatives denounced the WHO report as “nonsensical and dangerous.”
“The WHO has a long-standing anti-vaping stance and this latest attack on a sector that is literally saving millions of lives worldwide flies in the face of scientific evidence, common sense and harm reduction,” said John Dunne, director general of the U.K. Vaping Industry Association (UKVIA) in a statement.
“This report demonstrates that, sadly, the WHO still doesn’t understand the fundamental difference between addiction to tobacco smoking, which kills millions of people every year, and addiction to nicotine, which doesn’t,” said John Britton, professor of epidemiology at University of Nottingham.
A coalition of 23 organizations have written a letter to the U.S. Food and Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration (SBA). The SBA had recommended companies seek a court order to allow vaping manufacturers to keep products on the market while their premarket tobacco product application (PMTA) submissions are being reviewed.
Credit: Tanasin
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. All products must be removed from market on Sept. 9, 2022 without FDA approval, according to a court order.
The coalition letter, organized by the Americans for Tax Reform (ATR) acknowledged that FDA promised to exercise discretion in enforcement, stating that “this does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.”
The letter also argues that there “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The coalition states that the only way to avert a disastrous outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The full letter and list of signatories can be read here.
Exhibitors react to the industry’s first trade show since the Covid-19 pandemic struck in March of 2020.
By Timothy S. Donahue
The vaping industry has a lot of trade shows and conferences every year. So, when the Covid-19 pandemic struck in March 2020, it was a big change. Gone were face-to-face meetings and the networking opportunities the events offer to business owners. Many businesses saw sales slump and profits nosedive. Coupled with other regulatory requirements, the pandemic caused many businesses to close.
That’s what made this year’s Tobacco Plus Expo (TPE) trade show so special. After being postponed nearly four months, many retailers said they had surpassed their sales goals for the entire show on the first day. TPE attendees said it was a good feeling being able to fist bump clients and talk about the industry in person instead of through a Zoom conference. The TPE felt like the beginning of a much-needed return to normal.
Held May 12–14, an estimated 2,500–3,000 people visited the TPE on the opening day of the three-day event. According to security staff, approximately 4,000–5,000 attended overall. Every morning, several hundred attendees waited at the entrance to see the more 350 exhibitors. The show was moved to May from its typical January date due to the pandemic and was also the first major trade show to be held at the Las Vegas Convention Center (LVCC) since it closed in March of 2020.
Dan Bilzerian (right), owner of the cannabis company Ignite
Even professional poker player Dan Bilzerian, owner of the Ignite cannabis brand, made an appearance. “Honestly, I’m excited to be back,” Bilzerian said. “This industry is really set to take off again.” When asked about Ignite sales at the show during the second day of the event, Bilzerian said the numbers looked good. “We hit our sales target for the show on our first day,” he said. “We’ve had an excellent response.”
Many exhibitors said that the show had exceeded expectations. Rich Zagari, a sales representative for Bantam Vape, said they were unsure of what the show would be like considering it was the first industry trade show in over a year. “We didn’t know what the response was going to be, but there’s a lot of people here,” he said during the second day of the show. “Yesterday was great and today’s already shaping up to be even better. When you’re seeing customers come up to the booth, having conversations and placing orders, it makes a difference. It’s good to be back doing business face-to-face.”Zachary Kestenbaum, VP of sales for The Beard brand, said that while he was hoping for a bit more foot traffic this year, for his company the TPE was more about getting facetime with distributors, vape shops and other industry players. “I enjoy face-to-face sales more than phone sales, anything of that nature,” he said. “I think it’s much better to conduct business outright. In that regard, the show has been a great success.”
Some exhibitors initially questioned whether the show would be able to bring in foot traffic at all. Andy Lucas, director of sales for Ripe Vapes, said with the influx of restrictions, such as the premarket tobacco product application (PMTA) requirements for the U.S. Food and Drug Administration and the recent placement of electronic nicotine-delivery systems (ENDS) under the Prevent All Cigarette Trafficking (PACT) Act, alongside the issues brought about by Covid-19, he was a little hesitant about exhibiting.
“Actually, it’s been pretty good. It’s been more like a traditional show, especially for a big show like this. You got all these organizations with tobacco and the hemp industry, the e-liquid industry; it has really lived up to the hype surrounding its opening,” said Lucas.
Jakob Gutierrez, product specialist for JustCBD, said he was happy to be back in Las Vegas. The attendees were also ready to spend money. While he had hoped for even more buyers to visit the TPE, JustCBD had received more orders by Day 2 of TPE than the company had gotten at the last couple of shows it attended, according to Gutierrez. “People keep stopping by and loving our products,” he said. “People are absorbing it, taking it and just asking us for more. We keep providing high-quality products, and our customers keep coming back.”
There was a noticeable reduction in the number of nicotine vaping companies showing on the floor. The impact of PMTA and PACT Act regulation was evident. There were only an estimated 16–18 e-liquid vendors, including Coastal Clouds, BLVK E-liquid and Fresh Farms. There were an estimated five to seven hardware manufacturers, including Mi-One Brands, Myle, NJoy and Inspire, and most of them produced their own brands.
There was also a noticeable reduction in international participants, said Tony Riva, CEO of TD Distribution Co., the parent to the Hi-Drip e-liquid brand, which was also exhibiting. Normally, there are at least 20–30 exhibitors from China alone; this year, there were only a few Chinese brands present, and the booths were manned mostly by U.S.-based personnel.
“The international community that is normally present at this show just isn’t here this year. That’s obviously due to the Covid restrictions and complications of international travel,” he said. “That’s having an impact on sales, I think. But business is good. We are just trying to navigate the changing regulatory environment and new policies that have been put in place.”
Regulatory concern
Before the show, exhibitors were concerned about what impact the PACT Act would have on show sales. The rule requires a manufacturer to gather data from customers to file the mandatory monthly reports with native, state and local governments disclosing the identity, address and product received for all customers as well as remit any excise taxes owed.
“As a best practice, it’s our priority to collect licensing information upfront from any new customer and we were glad potential buyers came to the show prepared,” said Zagari. “They had copies of these documents on hand or emailed them right away.”While many companies have already stopped using the United States Postal Service (USPS) because the PACT Act prevents the USPS from mailing ENDS products to customers, the rules have not yet taken effect. At the time of writing, the USPS had yet to publish the finalized rule. Lucas said Ripe Vapes had a large following for online sales. However, Ripe Vapes has ended all direct-to-consumer sales because of the PACT Act and now only conducts B2B sales in the U.S. “It was a difficult decision,” he said. “In the end, it was the right one to make.”
Zagari said Bantam plans to ship through USPS until the final rules go into effect. “We are working to identify alternative shipping options, which will help us continue online consumer sales once the USPS final rule is published,” he said. “It’s our goal to ensure our customers always have access to our high-quality, flavor-filled e-liquids that are in compliance with all regulatory requirements.”The PACT Act’s definition of ENDS is so broad that it includes vape-able hemp cannabis products too. JustCBD only sells cannabis products and felt that they were “suckered in” to the ENDS definition, according to Gutierrez. The company has filed an exemption with the USPS, but that exemption will not be considered until after the final rule goes into effect. “It seems like we are jumping through a lot of hoops to sell a legal product that has nothing to do with nicotine or tobacco,” Gutierrez said.
Beyond the PACT Act, TPE exhibitors and attendees remain concerned about the PMTA process and the full impact of FDA regulation on the vaping industry. Numerous companies, including major industry players like Dura Smoke, My Freedom Smokes, Logic and Vape Wild, have gone out of business, merged with other companies or ended all online sales.
Kestenbaum said that as the market condenses and regulation pushes players from the market, naturally sales to the companies that remain would increase. The recent release of the list of manufacturers that have submitted PMTAs has also served a guidance for vape shop owners. Companies cannot now claim they have submitted a PMTA without having done so.
“So many companies were saying, ‘We’re going through PMTA. We’re doing it. We’re doing it,’ and they weren’t. I think we are starting to see many of those companies drop out of the industry, said Kestenbaum. “We’re trying to run everything by the book … I feel like we’ve gotten burned for doing that because there were a lot of companies that were not. The PACT Act, PMTAs, these aren’t all bad. Let’s clear out the lawless, let’s get a little bit more organized and allow the ones doing the right thing to continue.”
Lucas said Ripe Vapes submitted only one PMTA for its VCT flavored e-liquid. The company has a considerable international business, so its other popular flavors, such as Key Lime Cookie, are still available outside the U.S. “Our attorney said, ‘Look, your best chance … the way this is going to go, looking at it from a cost standpoint, take your No. 1 e-liquid and just roll with it,’” said Lucas. “Some of these guys are trying 10, 15 or 20 flavors. They may get it if they have enough money, and there’s a couple of guys in this industry that probably do have enough money.”
Another concern is that the FDA has been taking its time in reviewing PMTAs, according to Lucas. He doesn’t see a path for the regulatory agency to complete reviews on the more than 6 million PMTAs submitted by the 1-year deadline (Sept. 10, 2021).
“We find it kind of hard to believe they’re going to have this done by next year. That’s what my next question is: What happens? Do they give you an extension? I think the industry is going to force them to make some decisions because you’re putting us through this,” explains Lucas. “The submittal alone for us was huge. So, when you’re spending all this money, you want some results. … It’s going to be an interesting thing as that deadline approaches.”
Bantam Vape has received a filing letter for its submitted products, according to Zagari. He said that the company hopes to hear back from the FDA soon but is preparing for the likelihood that the agency will not complete all reviews come September. “We are working to better understand our options and in the meantime, we are continuing to monitor FDA communications and actions.”
TPE 2022 will be held Jan. 26–28, 2022, in Las Vegas.
