Category: This Issue

  • Best of Both Worlds

    Best of Both Worlds

    What makes the FAV different is both its new wicking technology and its state-of-the-art microchip technology.

    A new vaping product is slated to offer the cigarette-like flavor of combustibles with the ease of vaping.

    By Timothy S. Donahue

    It might be the most “wicked” thing to ever happen in the vapor industry. A new vaping device will enter the U.K. market this summer that brings together the taste and aroma of heat-not-burn products with the ease of use, mouthfeel and lowered risk offered by liquid-based vaping products. Developed by Avail Vapor founders James Xu and Donovan Phillips, the new FAV system hopes to be the ultimate transition device to trend combustible smokers toward less risky electronic nicotine-delivery system products.

    Xu and Phillips co-founded FAV Tech Hong Kong Limited with a leading Chinese hardware manufacturer to launch this new hybrid product, the FAV. What makes the FAV different is both its new wicking technology and its state-of-the-art microchip technology. Xu said the wicking is the first of its kind in the industry to use real tobacco leaf in the wick to help produce the tobacco flavoring in the atomized vapor. Xu uses proprietary patented technology to “sandwich” a layer of tobacco particulate in the cotton wicking used to absorb the e-liquid into the coil. The liquid is then atomized, and the heat releases the natural tobacco’s essence into the vapor as flavoring.

    National data shows that at least two-thirds of combustible smokers try to quit each year. During his time with Avail, Xu said that shopper survey data showed that of those two-thirds of users, only six percent converted completely to vapor. That left 94 percent that continue to use traditional tobacco cigarettes. There had to be a better way to transition combustible smokers.

    “It’s a scary experience for them to quit smoking because it’s a habit they form over many years. Any reason that they [combustible smokers] could find not to switch, such as it’s too complicated to use, it leaks or the flavor’s not there … They walk away from it or any other less harmful product,” explains Xu. “From the early days, we could see that there were certain ‘boxes’ that had to be checked to convert smokers. A convenient form factor, ease of use, but the one thing that was the most important was flavor.”

    This knowledge sent Xu and Phillips on their journey to develop the FAV. Heated-tobacco products offered the touch and feel of combustibles, but they were complicated to use, and many users rejected the flavor. E-cigarettes were easier to use, but none offered the combustible cigarette flavor profile that nearly mimicked traditional tobacco cigarettes. The industry often said that if such a device was ever marketed, it could be the missing piece to the puzzle of tobacco harm reduction.

    The chip embedded in FAV pods will not allow the device to be used without being activated at the store from which it’s purchased.

    “When the smoker is first attempting to quit, it needs to be a lateral move. Something that tastes like combustible cigarettes,” said Xu. “For the smoker, taste is very important.”

    Xu said the lightbulb moment happened when he was in China exploring factories with representatives of a global leaf supplier that explained how recon tobacco was created and used. Also known as homogenized tobacco recon (RTL), it was developed in the 1950s to save valuable raw material by combining remnants of virgin tobacco during production. RTL is a paper-like sheet approaching the thickness of tobacco laminae.

    “They explained how they make recon paper. And that’s when we began to wonder if we could use recon paper near the heating coil so it can release the aroma. We later started to research how we could incorporate pure leaf into the cotton wicking existing in e-cigarette coils,” Xu said. “We devoted the last 12 months to perfect the process. We use real tobacco particulate. We can make infinite combinations to mimic all the different cigarette blends by using different leaves. It’s an extremely difficult and unique process to blend tobacco with cotton. The tobacco is ‘sandwiched’ in between the cotton fiber.”

    The heat from the coil then releases the tobacco aroma into the vapor produced by the e-liquid passing through the cotton wicking and heating coil. The tobacco never burns, it just “heats” to release the flavor in the leaf blend mixed into the wicking. Xu said the concept is simple. To make it work, however, is quite the process.

    “This wasn’t something we could do ourselves. We needed the assistance of scientists to help us be able to identify what particle size and layering process would actually work,” Xu said. “This is a specialized, unique and proprietary process.”

    Technical response

    An exceptional quality of the FAV is that the e-liquid used in the device contains only 3 percent tobacco essence boosters. Typical disposable vaping products contain between 20 percent and 36 percent flavoring. Xu didn’t disclose what flavoring was used, only saying it had no added sugars and only “enhanced” the flavor produced by the tobacco in the FAV’s wicking. Xu said the added flavoring “mimics other aspects of a combustible cigarette’s flavoring.”

    Xu said that another innovation offered by the FAV is its microchip enhancement technology developed over many years with their Chinese partner. The chip embedded in FAV pods will not allow the device to be used without being activated at the store from which it’s purchased. This prevents any use unless the seller verifies the purchaser is of legal age to consume tobacco products. Xu acknowledges that there is little a manufacturer can do if devices are purchased by an adult, then given to an underage user (straw purchase). The technical enhancements, however, are aimed at combating underage nicotine consumption.

    “The device can’t be stolen from a store and then used. It also prevents counterfeit products from becoming available. Only legitimate FAV pods work with the FAV battery device. The cartridge (pod) comes in the factory setting but can be modified by the user. Some users may want the wattage a little higher to squeeze out that last little bit of e-liquid. They have that ability to do that but within certain limits,” Xu explains. “Because many app platforms don’t allow tobacco product apps, users will have to initially connect the device to their computer to alter any settings.”

    The device can also program puff counts for users who may be using the device to wean themselves off nicotine entirely. Xu said that the first version of the FAV will have a very limited set of options for users. “It’s going to be very limited because we need regulatory approvals on some options. However, the sky is the limit with the chip,” he said. “But if you tell me you want to quit smoking or vaping, we can program that. Today, you can have 100 puffs, tomorrow, 99; the day after tomorrow, 98. Everything can be stored in the chip.”

    The FAV device has also performed better on toxicology testing than other heated-tobacco products. Xu said the FAV is equal to if not better than typical e-liquids as well because of the lack of flavoring and sugars in the e-liquid. There is little introduction of tobacco-specific nitrosamines (TSNAs) (which comprise one of the most important groups of carcinogens in tobacco products) or harmful and potentially harmful constituents (HPHCs) that are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers.

    The device can also program puff counts for users who may be using the device to wean themselves off nicotine entirely.

    “There are minute TSNAs or HPHCs present. FAV tests better than heat-not-burn by a significant amount and surpasses most vapor product testing because our cartridges/e-liquid use little flavoring. Additionally, the amount of tobacco equivalent to a pack of cigarettes is 12.4 grams for [an estimated] 300 puffs,” explained Xu. “We use 0.05 grams of tobacco in our wicking. It’s only a small fraction of real tobacco compared to a pack of cigarettes that’s needed to give that authentic taste.”

    Xu said the FAV is expected to hit the European market this summer. The FAV is already TPD certified. The device has a 2 mL capacity with a 20 mg nicotine e-liquid mixed in a PG/VG base. It will come in three different tobacco flavors, and each flavor will have a menthol counterpart. Xu said he has submitted the FAV to Canadian authorities as well and expects to be able to enter that market sometime this year.

    Concerning the world’s largest vaping market, Xu said he does want to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration. He does, however, want to wait until the FDA gets the PMTA process in order and is clearer on what it expects from a vaping product to receive marketing approval. Xu said the FDA’s failure is costing the U.S. economy, limiting the technology of less risky tobacco products in the U.S. market and, most importantly, costing the lives of millions of smokers who want to quit but are unclear of the benefits of using less risky products.

    “We identified the European market for our initial product launch. The FDA has this ludicrous regulatory environment. Initially, we were thinking about releasing FAV in the U.S. and manufacturing it in the U.S. This would have brought jobs and the first vaping hardware production to the Unites States,” said Xu. “We just couldn’t make it work because of the U.S. regulatory landscape. Because of the uncertainty with FDA regulation, we had no other choice but to choose production outside the U.S.”

    There is one problem, however, that Xu hopes will never be solved: Focus group test panels seem to love the FAV. “The biggest problem we have right now is when we do a focus group test panel, and our testers are actual current combustible cigarette smokers, they don’t want to give me the FAV back,” he joked. “They just keep telling me, ‘This is exactly what we’ve being looking for.’ That’s a good problem; those individuals smoking combustible cigarettes don’t want to give it back. Maybe this is the unicorn device that makes the transition to less risky products easier.”

  • Better Late Than Never

    Better Late Than Never

    The major complaint against the proposed U.S. rules for vape manufacturing is that they took too long.

    By Maria Verven

    The U.S. Food and Drug Administration published a new set of proposed requirements for tobacco and vape product manufacturers in March 2023 with the goal of ensuring product consistency and ostensibly protecting public health. But vape industry experts say the new rules should have come out years ago. And for most vape manufacturers, it’s simply too late.

    The FDA held a public hearing on April 12, and stakeholders can still comment on the proposed rule until sometime this fall before the regulatory agency issues the final guidance. In the meantime, Vapor Voice spoke with several industry experts to gather their perspectives.

    Minimizing the risks

    The proposed requirements apply to all manufacturers of nicotine vaping products and tobacco products designed for consumer use, whether complete and sealed in packaging or simply their parts or components. Applied to the manufacture, design, packing and storage of these products, the rules are designed, among other things, to ensure product consistency and prevent contamination with foreign substances.

    “While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

    Key aspects of the proposal affecting vape manufacturers cover product design and development controls, manufacturing specifications, potential contamination and the traceability of components, ingredients and materials. Any inconsistencies between e-liquid product labeling and the actual nicotine concentrations are also addressed in the proposed rule.

    Finally, the rule includes what corrective actions the FDA will take for products that fail to meet these specifications, such as issuing a recall for incorrectly produced products that have already been distributed.

    What took so long?

    The FDA’s proposed rule was at least 10 years in the making. Sometime in 2012, a group of 13 tobacco manufacturers submitted to the FDA a list of recommendations for good manufacturing practices—a system for ensuring that products are consistently produced and controlled. The following year, the FDA created a public docket to obtain input on the recommended regulations for good manufacturing practices that had been submitted by the tobacco companies.

    And in 2017, an expanded group of manufacturers submitted proposals following the FDA’s 2016 Deeming Rule, which brought vaping manufacturers and products under the FDA’s jurisdiction, according to Patricia Kovacevic, general counsel for Cryomass Technologies Inc. A nicotine/cannabis regulatory consultant, Kovacevic has over 20 years’ experience in legal and regulatory affairs.

    “Tobacco product manufacturing practices (TPMPs) are not unexpected or new to the industry,” Kovacevic said. “Most reputable manufacturers already have a quality management system in place and design their manufacturing facilities to comply with the general principles of current good manufacturing practices (CGMPs).

    “The 2023 proposed rule on TPMPs is consistent with the manner in which the FDA regulates the practices, design and construction of personal hygiene products,” she said. As early as 1969, the FDA established CGMPs for foods as well as dietary supplements, infant formula and the like, added Kovacevic.

    This is a positive step in the right direction, both for the industry and the FDA, agreed Azim Chowdhury, a partner with Keller and Heckman LLP. Chowdhury advises domestic and international corporations on regulatory compliance with the FDA, focusing on vapor, nicotine, tobacco product and cannabis/CBD regulation.

    “This proposed rule is long overdue,” Chowdhury said. “This proposed rule should have come out years ago following the industry-proposed TPMPs that were submitted back in 2012. The vapor industry in particular has been in dire need of this type of regulation, which can only benefit public health.”

    In essence, the principles are not substantially different from other FDA-regulated industries, Kovacevic said, adding that some manufacturers also comply with ISO quality standards, the world’s best-known quality management standards for companies of all types and sizes.

    “It’s important to understand that TPMPs do not impose a certain product or manufacturing facility design or even dynamic of reporting,” Kovacevic said. “TPMPs are not prescriptive. They allow great latitude to manufacturers; thus, they should not be a great burden to be implemented.”

    As with all CGMPs, the common components are documenting procedures for business operations and outcomes, ensuring that personnel are appropriately trained, work procedures are followed and a document trail is created. This allows manufacturers to design the day-to-day practices for maintaining their equipment and facilities to maximize product quality, cleanliness, consistency and employee safety.

    TPMPs and PMTAs

    While the general reaction to the FDA’s proposed rule is positive, frustrations remain that the FDA has already banned most vaping manufacturers through the premarket tobacco product application (PMTA) process. Large manufacturers (with 350-plus employees) will be subject to the TPMP rule as soon as it is finalized, according to Chowdhury. Smaller companies have four years after the effective date to meet the requirements.

    “However, the question is will the small vape industry even be around in four years?” Chowdhury said. “The way things are going with the PMTA process and FDA enforcement, it seems that only the larger players will survive to see the implementation of this rule.”

    “As it became evident from the vast number of PMTAs that were denied or refused to file, small manufacturers and even some of the large ones did not meet FDA’s expectations regarding premarket review of vaping products and are consequently out of business for now,” Kovacevic said.

    “The vaping industry has tried in vain for more than a decade to work with the FDA on sensible manufacturing standards only to be ignored while the agency recklessly vilified nicotine vaping,” said Gregory Conley, president of the American Vaping Association. “While the FDA’s proposed requirements are a step in the right direction, the larger issue of the PMTA process disproportionately affecting smaller manufacturers and limiting market diversity must be addressed.”

    “The FDA needs to strike a balance between ensuring public health and maintaining a diverse and competitive market,” he said. “Without PMTA reform, there won’t be many companies left to be impacted by this proposed rule. It’s highly likely that vaping product manufacturers that received marketing orders under the PMTA pathway already have rather robust quality systems. So, complying with TPMPs will not represent a meaningful burden to them.

    “These regulations do not appear to differ a great deal from what would already be contemplated in a PMTA. But if the FDA’s Center for Tobacco Products does not reform itself, the real-world impact of this rule will be small, as companies with PMTAs will have no issue meeting just about any standard the FDA issues,” he said, adding that he wouldn’t recommend any manufacturer put themselves on the FDA’s radar at this junction.

    Kovacevic agreed. “Compliance with TPMPs, when effective, should not require a massive effort for responsible manufacturers, who by now should have a robust quality management system,” she said.

    Monica Schick, CEO and regulatory consultant with North Guide Solutions, predicted that the new rules could impact the industry financially. Smaller companies that are holding onto their market share with the rise of illicit products might need to increase their price points to add quality processes and/or testing requirements, according to Schick.

    “My concern is are we bringing out the cart when we are sending the horse to slaughter? With illicit products still being marketed and sold and open systems getting continuously MDOed [marketing denial orders from the FDA], what will be left to hitch this cart to?” she asked. “I would like to see this as FDA’s attempt to work with the industry and possibly see some increase in the number of legal products on the market.”

    Feelm research lab

    What about foreign manufacturing?

    The FDA’s new regulations will also apply to Shenzhen and other foreign-based e-cigarette manufacturers, although just how they will exercise enforcement is in question as the FDA currently doesn’t conduct regular foreign tobacco product manufacturing site inspections.

    “Unlike domestic manufacturers, this rule does not require foreign manufacturers to register their establishments, submit a product list or be subject to regular biennial inspections,” Chowdhury said. “However, FDA’s unified agenda of upcoming rulemakings indicates the agency may soon propose another rule that extends the Tobacco Control Act’s registration and product listing requirement to foreign establishments,” he said.

    The TPMP rule also highlights the FDA’s existing authority under Section 801(a) of the Federal Food, Drug and Cosmetic Act to refuse the importation of tobacco products that are manufactured, processed or packed under unsanitary conditions, are adulterated or misbranded and/or are forbidden or restricted in sale in the country where they were produced or exported, Chowdhury explained.

    Chowdhury said he doesn’t believe the FDA has ever exercised its authority under this provision to deny entry of imported vapor products, such as open-system devices or nontobacco-flavored vapes that are prohibited from domestic sale in China, as this would require the agency to evaluate imported tobacco products not only with respect to the FDA’s own rules but also on the importing country’s applicable laws and regulations. That could prove to be highly inefficient and impractical.

    “Furthermore, provisions concerning unsanitary conditions and adulteration/misbranding suggests that the FDA’s overall intent may be to control the quality of tobacco products rather than the specific legal status of tobacco products in their country of manufacture,” he said. “That said, members of Congress, public health groups and even Big Tobacco have been pressuring FDA to find a way to prevent illegal and counterfeit disposable vapor products from continuing to enter the country.

    “The TPMP rule could be highlighting that FDA already has the ability to accomplish this.”

    Final ruling could take years

    A final rule could take at least a year or more. First, the FDA needs to address all the comments from industry stakeholders. And even after that, it’s likely the final rule will be similar if not outright identical to the proposed rule, predicted Kovacevic.

    Chowdhury expects that thousands of comments will be submitted over the next six months, which the FDA will need to review carefully before finalizing the rule. “All in all, this rule will likely take at least one [year] to two years to become final. While it won’t directly impact pending PMTAs, companies should be reviewing this rule carefully and bolstering their existing practices to ensure compliance,” he said. “We now know what FDA expects.”

    “It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market,” Conley said. “Our recommendations for the FDA include reconsidering the PMTA process, as its current review standards will shutter most legally operating manufacturers.

    “We also want the FDA to focus on how to support smaller manufacturers that are committed to producing high-quality, compliant products. The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications Inc., a public relations and marketing firm specializing in the vapor industry.

  • More to NJOY

    More to NJOY

    As Altria sheds the burden of Juul, its leaders are hoping investors ‘Njoy’ the company’s new outlook.

    By Timothy S. Donahue

    It would have been hard to imagine less than five years ago. In September of 2018, Juul had a U.S. vapor market share of 72 percent. By mid-March of this year, Juul’s market share had plummeted to 25.6 percent and continues to drop. Meanwhile, R.J. Reynolds Vapor Co.’s Vuse products have grown from single digits to a more than 47 percent market share during the same period.

    Altria, Juul Labs’ largest minority shareholder, had to do something. Juul’s baggage of lawsuits for youth marketing and ongoing battle with the U.S. Food and Drug Administration over marketing denial orders just became too much to bear. After devaluing its $13 billion investment in Juul Labs to less than $250 million earlier this year, Altria stated that it would exchange its entire minority investment in Juul Labs for a nonexclusive global license for some of Juul’s heated-tobacco intellectual property to potentially boost its IQOS heated-tobacco products. It then did something that surprised no one in the industry.

    The next day, Altria Group announced it had entered into an agreement to acquire Njoy Holdings for approximately $2.75 billion in cash. Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for IQOS. In less than a week, Altria went from vaping product purgatory to owning the best vaping product on the market with a U.S. marketing order, the Njoy Ace. In total, Njoy Holdings has received six of the 23 marketing orders granted by the FDA as of this writing for the entire vaping product category, including pods, disposables and open systems.

    The other major factor in purchasing Njoy is the product didn’t come with the stigma tied to youth vaping, according to Altria CEO Billy Gifford. Speaking during an investor call, Gifford said that his company evaluated Njoy’s marketing practices and national survey data regarding underage use of Njoy tobacco products.

    “We believe Njoy has taken a responsible approach to marketing its products. According to the 2022 National Youth Tobacco Survey, Njoy-branded products are not included among the top usual brands among middle school and high school e-cigarette users. Additionally, Njoy is developing access restriction technology for its devices to further address underage use,” explains Gifford. “Our consumer research indicates that once consumers try Njoy Ace, it is a competitive product for both smokers and vapers. After trying the authorized nonmenthol Ace variant, 19 percent of surveyed smokers and 27 percent of surveyed vapers indicated that they would definitely buy the product.

    “The Ace results were on par with the post-trial findings for Vuse Alto nonmenthol and better than those for Juul nonmenthol. We observed similar post-trial results for the Ace menthol variants when compared to Vuse Alto and Juul menthol products. This encouraging research supports our belief that Ace is a compelling proposition.”

    The FDA said that it authorized Njoy’s products because they were found to meet the appropriate for the protection of public health standard as, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.

    Further, data provided by Njoy demonstrated that participants who had used only the authorized Njoy Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.

    Additionally, the FDA considered the risks and benefits to the population as a whole, including users and nonusers of tobacco products and, importantly, youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.

    Open access

    Altria has the ability to take Njoy products to the top. Gifford said that a large number of tobacco consumers are not currently aware of nor have access to the Ace vaping system. Njoy’s Ace, the most technologically advanced FDA-authorized vaping product, is currently available only in an estimated 33,000 stores. Altria services more than 200,000 U.S. stores. Njoy’s sales force is fewer than 50 people. Altria has 1,600.  

    “As a result, total U.S. retail share for Ace pods in 2022 was only 3 percent. Yet, we know that Ace has performed better in stores where it’s visibly merchandised and has consistent distribution. In the top 5 chain accounts where Ace competes with Vuse Alto and Juul, the weighted average share for Ace is approximately 11 percent,” Gifford said. “We believe we can responsibly accelerate U.S. smoker and competitive vaper adoption of Ace in ways that Njoy could not as a standalone company.”

    During the session, Bonnie Herzog, managing director with Goldman Sachs, questioned whether Altria would need to reposition the Njoy brand or change its strategy considering the brand’s relatively small share of the market. After all, several devices have done very well in the market and then disappeared or lost their position. Chris Growe, with Stifel Financial Corp., wanted to know what made the Ace device so unique. Could the Ace device develop another level of brand loyalty it had yet to reach? Gifford said Altria has an extensive relationship with retailers that its “sales force has built over decades.” It’s all about consumers having better access.

    “You’re going to see loyalty in these new spaces that we experience in the tobacco category. When you see the consumer, they’re trying various products. They’re looking for products that satisfy their unmet needs and desires, and once they find a satisfying product, it’s up to us to build a brand around that. I think when you look at Njoy, and I’d reference you back to the consumer research, it was both smokers looking to transition and how they rank the products in the marketplace as well as existing vapers, people that have already converted, and their preference there,” Gifford told the investment advisers.

    “I think you see that we believe this is a strong asset because not only does it bring certainty around the authorization but the consumer is telling us they have preference for this product over some of the other products in the marketplace. That’s the way we think about it and are extremely excited to, again, have that base IP, have a product ready in the marketplace, but then be able to develop on it as we move forward,” Gifford said.

    Gifford told Priya Ohri-Gupta, with Barclays, that prior to closing the deal, Altria would offer none of its services to Njoy but that after closing, Njoy would experience all of the assets Altria has at its disposal. “Our sales force, our regulatory team, our government affairs team, all of that would be available subsequent to close,” said Gifford.

    Gifford said that in the next few years the company expects the FDA will complete marketing determinations on the remaining premarket tobacco product applications, including those filed for synthetic products. He said he also hopes the agency will implement the suggestions from the Reagan-Udall Foundation report.

    Altria expects the vaping market to remain “in flux” until the FDA goes through the enforcement process and removes unauthorized products from the market. Over the next 10 years, U.S. volumes will grow at a single-digit compounded annual growth rate, Gifford predicted.

    After the Njoy acquisition is finalized, Altria will have a compelling portfolio of products and technology across the three largest smoke-free categories, according to Gifford. In the vaping segment, the company will fully own the only FDA-authorized, pod-based product on the market. In oral tobacco, it owns the largest brand, Copenhagen, and holds 100 percent of the global rights to On!, one of the fastest-growing nicotine pouch brands in the U.S. last year.

    “We have differentiated new products in development. And in heated tobacco, we have the majority-owned joint venture with JT Group for the U.S. commercialization of the next-generation Ploom device and Marlboro heated-tobacco sticks,” said Gifford. “We [also] have full ownership of an exciting heated-tobacco capsule technology, which we will discuss further at our Investor Day.”

    Gifford also explained that the Juul IP rights deal is centered on the Ploom device and the capsule technology. He told Herzog that Altria viewed the technology as “very interesting,” and it allows Altria to put it “in the toolkit” of its product developers. That would give Altria the ability to market the new product anywhere around the world. “Our focus, of course, would be the U.S. because that’s the biggest opportunity we see in products,” said Gifford.

    When asked when new heated-tobacco products using the newly acquired IP would make it to the U.S. market, Gifford’s answer became lost in translation. Deciphering the double talk quickly, Herzog ended the conversation by clarifying Gifford’s answer, saying, “OK. So, in a few years. Appreciate it. Thank you.” Gifford did not disagree with Herzog’s assessment.

  • Vaping in Ireland

    Vaping in Ireland

    Vaping is beginning to take hold in Ireland’s smaller cities, but combustibles are still king in Dublin.

    By Timothy S. Donahue

    Going on a trip to Ireland, I had expectations. I thought the vaping community would be small and just learning about new products coming to market. No. That wasn’t how it was at all. In Ireland, and I imagine it’s the exact same thing one could witness across the entire European Union, people understand that vaping is better than smoking combustibles. Many former cigarette smokers, an estimated 200,000, have already made the switch.

    According to a 2021 survey from Eurobarometer, Ireland has the highest rate of people who use e-cigarettes in the European Union at, 7 percent, while the EU average is 2 percent. There seemed to be a lot of vapers across Ireland. Media reports suggest that Ireland has a youth vaping problem. When a vape shop owner in Dublin was asked about this, he said that the people who vape are mostly former smokers, but there are youth who would have started smoking combustible cigarettes that instead started vaping.

    This was evident in Killarney, a town of 15,000 in southwest Ireland. It also has about 1.7 million tourists per year. College kids were vaping here. They were also smoking combustible marijuana. They were also drinking at noon on Tuesdays and Wednesdays and so on. It’s Ireland. Drinking is sort of a thing. I asked a few students if they would be smoking combustible cigarettes if vaping didn’t exist. The answer was an overwhelming yes. It’s university; nicotine use is a thing too. Just two years ago, everyone smoked combustibles. 

    Not anymore. Vaping is the way today. Many said they even have their parents, who were two-pack-a-day to three-pack-a-day smokers, vaping now. The older folks like the simplicity of the pods. The younger group likes the flavor varieties in disposables. Walking the streets of downtown, you could witness vapers from a variety of age groups and economic backgrounds. Flavors are also extremely popular.

    “The older folks want the tobacco taste first,” a college student said. “Now, they vape a while, and they don’t want that taste; my mom loves the watermelon now. She’s stopped smoking cigarettes completely and now just vapes. She used to smoke two packs a day.” Watermelon is the favorite flavor in Ireland, followed by Blue Ice, a straw poll of shops in Killarney and Dublin has confirmed.

    Ireland had no age restrictions on the purchase of vaping products until recently. In November of 2022, the country’s minister for health, Stephen Donnelly, and the minister for public health, Frank Feighan, received government approval to introduce additional restrictions on the sale and advertising of nicotine inhaling products, such as e-cigarettes.

    Under the new proposals, the sale of e-cigarettes and related vaping products became prohibited from self-service vending machines, from temporary or mobile premises and at places or events for children. In addition, advertisements for e-cigarettes are now prohibited on public transport, in cinemas and near schools.

    At the time the proposal was announced, Feighan said the legislation was necessary because tobacco smoking continues to kill approximately 4,500 people in the island country each year. “We recognize that nicotine inhaling products are used by some adult smokers to assist them to quit tobacco smoking,” he said. “However, we are clear that these products are of no benefit to our children and young people or to nonsmokers, and that is why we are taking this action.”

    All Irish and EU vaping devices and e-liquids are regulated by the Tobacco Products Directive 2. The Tobacco Products Directive regulates nicotine strengths, bottle sizes and ensures that communications about products are factual and clear. The ingredients that make up all Irish regulated vaping products must be provided to the Health Service Executive, with detailed information, including chemical studies and risk assessments.

    These regulations act as an important barrier to any products that do not adhere to EU standards entering the Irish market and can be contrasted sharply with the absence of similar regulations in the U.S. and elsewhere, according to Vape Business Ireland (VBI), the largest vapor industry trade association in Ireland.

    Credit: TS Donahue

    VBI is advocating the Irish government to consider more evidence-based policymaking decisions, which in turn will allow for more evidence-based regulation of vaping products in Ireland. The trade group wants the government to “deliver effective, evidence-based and balanced regulation of vaping products,” according to its leadership.

    There were at least four vape shops in Killarney. None of the owners would speak to me on the record because they said they aren’t “trying to call attention to themselves.” The truth is probably more along the lines of the massive distrust of the media that Ireland has. Owners probably believed I didn’t just want to know about vaping in Ireland and what types of products were popular and that I instead had more dubious plans for this article.

    One shop attendant, Karen, said that most of her customers are college-aged; however, many of them were buying combustibles from her store until vaping became more popular in the country around 2020. She thinks youth are going to experiment with things like drinking, drugs and nicotine and that if there are safer ways to consume these products, government regulations shouldn’t hinder their availability.

    According to the Global State of Tobacco Harm Reduction (GSTHR), the overall smoking prevalence in Ireland has decreased since 2006. More than 23 percent of the adult population in Ireland are current smokers, down from 29 percent in 2006. This means there are now approximately 893,778 smokers in the country. An estimated 26 percent of men still smoke combustibles, and for women, the figure is an estimated 21 percent.

    In Ireland, there are 265,500 vapers in the country, giving an adult vaping prevalence of 6.7 percent, according to the GSTHR. There is a requirement to ensure that vape packaging contains a health warning and vaping devices can be purchased without a prescription. There are no legal restrictions on their use in public places. Heated-tobacco products cannot be marketed, and the situation is “quite complicated” for snus. While it is illegal to import snus for trade or to buy the product online, it is possible to import it for personal use.

    In Dublin, it seemed that combustibles were still king. A short walk around the city, and there are cigarette smokers everywhere. There were also cigarette butts littering the streets everywhere we walked. Places like Temple Bar, an insanely popular tourist neighborhood littered with drinking establishments where few true Dubliners visit anymore, hundreds of people were smoking cigarettes and marijuana openly, and vapers could be seen mixed in the crowd but in much lower numbers.

    There are an estimated 50-plus vape shops in Dublin; however, it seemed like a lot more. Still, no vape shop owner or employee would speak with me on the record. Vaping products could also be found at many discount shops that sold everything from shampoo to clothing throughout Ireland.

    There was even a vape shop in the small fishing village of Howth, a suburb of Dublin. While we only went to see Dublin and various places around County Kerry where Killarney is situated, it wasn’t hard to find vaping products anywhere we visited. One cab driver told me that he was sure everyone in Killarney drank and used nicotine in some form or another and that vaping is definitely more popular than combustible cigarettes in the small town.

    Overall, the rising popularity of vaping in Ireland can’t be denied. The harm reduction benefits of vaping are widely known, and even many cigarette smokers told Vapor Voice they wanted to quit combustibles and have or would try vaping products to try to end their compulsion to smoke cigarettes. It’s quite the contrast to the United States, where many doctors still believe nicotine causes cancer and are skeptical of the harm reduction benefits of vaping.

  • Mixed Messages

    Mixed Messages

    Credit: Onticello

    The head of the FDA’s Center for Tobacco Products sent mixed messages during a recent public event.

    By VV staff

    When the American Vapor Manufacturers (AVM) Association announced it had secured a Q&A session with the Brian King, the industry was taken by surprise. It was the first time King, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), would speak with vaping industry advocates publicly and answer questions from the audience. Surprisingly, King was quite candid. He did shy away from certain questions, however, and some of his responses were questionable.

    Brian King

    Youth e-cigarette use was first declared a national epidemic in December 2018 by then U.S. Surgeon General Jerome Adams. King said the “FDA has not used that terminology” (epidemic) in its “most recent estimates” of youth use. However, during a hearing of the House Oversight Subcommittee on Economic and Consumer Policy in 2021, then acting FDA Commissioner Janet Woodcock was asked if Juul Labs was “the e-cigarette company most responsible for creating this epidemic.”

    She answered that it does “appear” to be the case. The title of the FDA’s own press release was “An Epidemic Continues: Youth Vaping in America.” A 2018 FDA focus group study conducted by the agency reported that “‘epidemic’ ads [had a] perceived effectiveness score of 4.17 out 5.0.” King defended the agency’s youth-oriented anti-vaping ads, which he said were “rigorously evaluated” before and after they aired and were effective at reaching teenagers. King ignored that the ads continue to use the FDA’s approved youth vaping “epidemic” terminology.

    “So, I believe you’re thinking about the CDC [U.S. Centers for Disease Control and Prevention]. And FDA has not used that terminology to view the most recent estimates of youth use. I will say that I’m an epidemiologist by training, so I’m fully cognizant of the definition of an epidemic, which is unprecedented increases over what you’d expect at baseline,” said King. “That said, I think, no, that science has shown a decline in the number of youth users. And that’s a good thing. Over the past couple of years, we have seen [a] decline since the peak in 2019. It’s still too high.

    “Since I’ve started, I have not [used the term]. I’m not aware of any of my staff. But as far as I’m aware, we have not used the term. It’s ultimately up to respected individuals. There’s certainly disagreements among epidemiologists. Like there is in any discipline, you’re going to find people disagree.”

    It should be noted that King’s disdain for vaping is well-documented. King is credited with creating the term “e-cigarette or vaping product use-associated lung injury,” or EVALI. The term was used by the CDC for the lung injuries caused by the 2019 spread of illicit THC cartridges tainted with vitamin E acetate during King’s tenure at the CDC. The name suggested that nicotine vaping products (e-cigarettes) were responsible for at least 70 deaths attributed to black market THC products. No nicotine vaping device has ever been associated with an EVALI death or any death; however, King and the CDC have never tried to correct the misinformation.

    The event was moderated by AVM Vice President Allison Boughner and its director of legislative and external affairs, Gregory Conley. When the moderators asked King if the FDA had ever identified a single nicotine vaping product, not an illicit THC cartridge (referencing EVALI deaths), that could be more hazardous than combustible smoking, King dodged the question.

    “I would say that at present, we evaluate the merits of evidence that has been submitted to this agency. In terms of applications and science on their products, at present, we have authorized 23 e-cigarette products or devices that we have found and that benefits outweigh the risks,” he explained. “And we’ll continue to do that. The onus is on the applicants to submit that information. And we’re fully open to evaluating that information and then making an informed scientific decision.”

    Being more direct, moderators asked King if vaping products are far less hazardous than smoking cigarettes and if that is something consumers should know. “I would agree with the statement that if an adult smoker were to transition completely from a cigarette to an e-cigarette, that would be a benefit to their health, yes,” King responded. Moderators then questioned whether it was ethical to mislead the public, letting people believe that vaping isn’t safer than smoking cigarettes.

    “Although we know that in general, e-cigarettes have lower risks than a conventional cigarette, there’s a broad class, and there’s a lot of different factors that can influence the extent of risk. And so it’s not just a simple statement that every single e-cigarette is going to be lower risk,” King said. “There are different factors that we have to consider, particularly when it comes to risks to vulnerable populations like kids.”

    Fighting misinformation

    Credit: Vadim Pastuh

    King acknowledged that vaping has been effective at helping smokers quit smoking. He added that the FDA and CTP don’t want people using combustible cigarettes. Combustible products introduce 7,000 chemicals and 70 carcinogens into users. However, the misinformation surrounding vaping products is massive. King acknowledged that he is “fully cognizant” of the misperceptions.

    “I am wholly open to enhanced efforts by the Center for Tobacco Products to message not only on the continuum of risk but also misperceptions related to nicotine,” he said. “But again, the devil is going to be in the details there in terms of making sure that we have scientifically defensible messages and that we’re delivering it to the target population, which is adult smokers, and not inadvertently delivering it to the unintended populations where there’s consequences, including youth.”

    The FDA’s fight against misinformation is confusing at best. For the last several years, former CTP Director Mitch Zeller and several CTP employees have repeatedly stated in public that correcting misperceptions surrounding vaping and nicotine are part of the CTP’s agenda. King seemed to imply that little had been done so far in accomplishing that goal. He said that little had been done, and that was due to competing priorities at the CTP.

    “When you have a finite number of resources and people, you have to prioritize what you do to have the greatest impact. And so, I will say that for my part, coming into this position, there’s four key tenants that I am adhering to, and that’s strong science, stakeholder relations, communications and health equity,” King said. “And so, obviously, the stakeholder relations and communications are pivotal to this. In terms of my prioritization, I think it’s important that we engage with people, hear them out, but also use science to inform our communication strategies moving forward. It’s not that we haven’t done this work before but it’s just where prioritization is moving forward. And I can tell you that we’re working on it.”

    Concerning misperceptions and the FDA’s message in the public arena, moderators questioned King on the FDA’s advertising. FDA ads have portrayed vapers as being possessed by demons or shapeshifting metal dragons, and vaping will cause huge parasites to crawl through your skin. None of these things have ever been reported as being true. King said that the agency does a “rigorous evaluation” both before and after the implementation of any of its campaigns, and all of the FDA’s youth-centric campaigns have very targeted strategies to reach that target population.

    “We cognitively test them and do science in the beginning, and then we evaluate them on the back end. And that science has shown demonstrably that there is a beneficial impact. That said, I think that we’ve got opportunity for better public engagement on our campaigns,” he said, which didn’t really provide a clear answer to the question. “That is a critical component of our work. We don’t function in silos, and we want the opportunity to engage, but we’ve got to give people that opportunity. And if they’ve got data, if they’ve got evidence to demonstrate that a certain message or a certain target audience is going to be problematic in terms of the campaign, we welcome it.”

    Illicitly speaking

    confusedBans on consumer goods haven’t worked well historically. Prohibition of alcohol and marijuana led to massive black markets for those products. U.S. states that have enacted tobacco flavor bans, such as Massachusetts, have seen a huge increase in black markets. King said this depends on how an illicit source is defined. He added that any vaping or other tobacco product on the market that does not have FDA authorization is considered illegal, and anyone selling those products is operating in the black market.

    “In terms of our enforcement and compliance strategy, we’re committed to taking action to address those that are violating it. And that can take a broad spectrum of action, whether it’ll be warning letters all the way up to civil money penalties as well as injunctions,” he said. “But we have an obligation to enforce the law. And that’s what we will do. That is what Congress has told us to do. And so we’re committed to continuing to do that. But in addition, we’re also working to make sure we get efficiencies and ramp up our efforts around reviewing applications.”

    When questioned whether he had concerns about the black market continuing to grow, King said the CTP is committed to continuing to review premarket tobacco product applications as quickly as possible to guarantee a clear pathway to a marketing order. He’s also equally committed to making sure that the regulatory agency enforces the law. He says he’s committed to continue to implement the law.

    “This is what Congress has told us to do. We have specific authorities that we are responsible for, and in my job as the director [of the CTP], I have to make sure that we exercise those authorities, and toward that end, I don’t think we’re perfect,” said King. “I think we’ve got opportunity for improvement. I think that there’s always [an] opportunity for improvement. We acknowledge that. I think we can do some things better, and from our part, I’m happy to continue to move us into the next chapter of the center to make sure that we’re engaging people in a meaningful way.”

    On the enforcement front, King was asked why only small businesses bore the brunt of FDA action. King said that the CTP does not have a policy against small business and that its enforcement compliance actions have been taken against small and large businesses. However, one participant explained, many small businesses don’t have the finances to hire lawyers to petition the courts to fight the FDA. They also question whether the FDA would ever approve open-system products, which are mostly sold by independent vape shops.

    “We’re committed to enforcing the law. I will say that some of the recent actions in terms of the civil money penalties and also the injunctions were a result of companies that did not obey the law after repeated warnings. And there are many small businesses that are obeying the law and have submitted their applications and have gone through the process,” said King. And so it’s certainly possible. I will say that for our part, we’re committed to continuing to explore opportunities where we can better provide information to applicants to make sure that the process is as flexible and straightforward as possible.”

    A bad taste

    During the open question session, one participant questioned whether the FDA would ever approve a flavor other than tobacco. The business owner wanted to know if the FDA intended to have an outright ban on flavored products or any open system with potential for flavored e-juice options. King said the CTP does not have an outright ban on flavored products, but the onus is on the applicants to submit the evidence to demonstrate that the benefits among adult smokers outweigh the risks to youth.

    “So, there is no de facto policy within this center that would prevent the authorization of a flavored e-cigarette. But I will say that with continued high rates of youth use, the onus is high to make sure … to demonstrate that benefit to adult smokers,” King said. “But it’s not impossible. We’ve seen the authorization of several products already, all tobacco flavored, but we are certainly open to applications on flavored products.

    “And if the science demonstrated that there was a net benefit compared to the risk, we would authorize it. And so that’s my take-home here [that] there’s no blanket policy against flavored, but we’ve got to follow the science, and at present, we have not got sufficiently strong evidence that demonstrates that the flavors are needed for the adult smoker to quit.”

    King was also asked about memos submitted to the U.S. Court of Appeals for the 3rd Circuit but an attorney for Logic Technology showed that King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists. King said that that was an “erroneous description” of what occurred. It was not an overrule.

    “In this case, there was [an] initial assessment of that science, and then there was further scientific discussion. And I am a scientist by training. I have been for many, many years. And we sat down and discussed the merits of the available science that was presented,” explained King. “And after the discussion of that science and those merits, the determination was made that the applicant did not meet the standard.”

    A recent report published in the journal Addiction examined e-cigarette use in England among young adults between 2007 and 2018. That study concluded that 18-year-olds to 24-year-olds who use e-cigarettes did not use vaping as a gateway to smoke combustible cigarettes. King was asked about the study and whether he believed a “gateway effect” existed despite evidence that one did not. King responded that there’s still a strong body of evidence that suggests that the gateway does exist, but it’s dependent on a variety of different factors.

    “[It’s] certainly not conclusive evidence, but there’s moderate evidence to demonstrate that [a gateway exists]. But you also have to look at the net impact of the science. And so I’ve said publicly many times that you do have some gateway effects. We’ve seen that through the past study and others, but that doesn’t mean that every single kid who’s using an e-cigarette is going to go on to smoke,” King explained. “There’s a variety of factors that impact that. So I caution folks against definitive statements like that, that every person is going to transition who uses the product. It’s certainly happening. But when you look at the net effect, we’ve definitely seen a decline in overall e-cigarette use.”

    In the end, King said that the one thing people should realize is that he’s the type of person who speaks plainly and honestly. He doesn’t have the stereotypical characteristics of a civil servant. “If there’s anything that folks know about me, it’s I aim to be the most nonbureaucratic bureaucrat that you’ve ever met, and that involves just straight-shooting. And so, if we can do better, I want to know about it, and we can definitely enhance the communication on that front,” explains King. “So, I would say more to come, but the science is going to drive it. And we’re at the initial stages in informing what effective messages are most critical to reach the target audience without unintended consequences.”

  • Quitting is Easy

    Quitting is Easy

    Credit: Ivelin Radkov

    It seems to be very difficult for many politicians and think-tankers to change their minds.

    By George Gay

    Ever since they were mentioned in a Guardian newspaper leader in the U.K. in February, I have been fascinated by sea squirts. These tiny creatures start off as eggs and then develop into tadpole-like entities that swim around seeking a suitable rock or piece of coral on which to make their homes for life. But this is the good bit: Once they have attached themselves to their homes-for-life, they no longer need to swim or seek out suitable habitats, so they devour their own brains.

    The rest of their lives is spent blissfully drawing in sea water through one orifice, removing the nutrients they need and then squirting out what they do not want through another orifice—all without having to contemplate tricky meaning-of-life questions.

    Do these little creatures remind you of anything or anybody? To me, their way of life mirrors that of many politicians and employees of ideologically rigid “think tanks.” I mean, once these people have swum away from home, school or university and attached themselves to their political party or ideology of choice, they no longer need their brains, just a couple of orifices, one of which takes in information that is scanned for the nutrients that will feed their political or ideological prejudices and the other to squirt out the indigestible, inconvenient facts.

    You might laugh at this, or you might find it outrageous, but it would explain something that to me is otherwise inexplicable: the fact that it seems to be enormously difficult for many politicians, think-tankers and people in thrall to the aforementioned to change their minds.

    It is not unusual to hear a person who has always voted for a particular political party to say, while acknowledging that their party has been in power for years and proved itself to be incompetent, corrupted and lacking ideas, that they will continue to vote for it because “imagine what another party would have done if it had been in power during the same period,” something that, obviously, cannot be known. This is your individual as a sea squirt, operating to her full potential with two orifices while comfortably attached to her easy chair.

    In a similar vein, there is no end of people willing to tell you that tobacco smoking is the worst thing that anybody could do, but who will then add that, nevertheless, “can you imagine the awful things that vaping could usher in in the long term.” These two-orifice people look for nothing new, listen to nothing new and say nothing new.

    This resistance to doing things in new ways, even putting one foot in front of the other, was highlighted by John D. Barrow in The Book of Nothing when he quoted Francis Cornford. “Every public action, which is not customary, either is wrong, or, if it is right, is a dangerous precedent. It follows that nothing should ever be done for the first time.” Crazy as it might seem, this is where we are with vaping. Traditional tobacco products are customary, so they are OK, but vaping devices could set a dangerous precedent.

    It must have been the case that sea squirts or their relatives were in charge at Suring School in Wisconsin, USA, recently. According to a Vaping360 story relayed by Tobacco Reporter, Wisconsin legislators have had to propose a bill that would make certain invasive searches of students illegal.

    “The proposed law follows searches of students aged 14 to 17 last year in Suring, Wisconsin, in which the students were made to strip down to underwear in order for the superintendent to search for vapor devices,” the story reported. “The students were not told that they could decline the search, and parents were not informed until after the searches were completed.”

    At first, I found this story difficult to believe because it requires your accepting that somebody, or some people, thought that one way of protecting students, who might or might not have been carrying vapes, would be to humiliate them. They apparently thought that theirs was a proportionate response to student vaping.

    The students were 14 to 17, at a time of their lives that many find difficult to navigate, when they should be able to rely on the adults running their school to set an example of rational, humane behavior. Instead, they seem to have been confronted by adults obsessed with enforcing petty rules even to the extent of carrying out strip searches, which most people probably associate with prisons.

    I would suggest that even if those students vape for 50 years, it will do them less damage than the memory of being strip searched. I salute the legislators who are seeking to stop such incidents occurring again.

    An issue that seems to me to arise from the above story and one from Sheridan, Wyoming, USA, is that a lot of adults need to grow up. Their ideas on rules and discipline seem to be aligned with those of your average 13-year-old, which often tend to be inflexible. According to a Sheridan Media story relayed in TR, the city council in Sheridan was due to consider an ordinance pertaining to vaping and tobacco use by minors in the city.

    “Under the proposed ordinance, any minor [I assume, anyone under the age of 21] found possessing tobacco or electronic cigarettes (vaping devices) would be subject to a tiered system of fines through municipal court,” the story reported.

    Credit: Olly

    It’s none of my business, I suppose, because I don’t live in Wyoming, but, nevertheless, perhaps I could respectfully suggest that there should be some consultation on this. Perhaps the authorities might do well to draw on the expertise of people informed about comparative risks and gun laws in Wyoming, where I gather from the internet that just about anybody in the state who is above the age of 18 may carry a gun.

    As elsewhere, in clamping down on vaping devices, the authorities in Wyoming seem to be more concerned about things that people can protect themselves from, such as vaping, than about things that it is difficult if not impossible to protect themselves from, like being shot. At the outbreak of the Covid-19 pandemic, the World Health Organization seemed more intent on putting on an anti-tobacco/anti-nicotine conference than protecting us from a deadly virus that, unlike tobacco smoke, could and did sweep unseen across borders.

    By the way, the Centers for Disease Control and Prevention (CDC) rank Wyoming as having a firearm mortality rate of 25.9 per 100,000 people, which places it third highest, below Mississippi (28.6) and Louisiana (26.3). And, as another aside, this raises an interesting question about whether the CDC believes that gun ownership is a disease, but that is not for discussion here.

    Although, having said that, language does matter, according to Johanna Cohen, Bloomberg professor of disease prevention and director of the John Hopkins School of Public Health’s Institute for Global Tobacco Control. Cohen stars in a video that seems to be an advertisement for language purity by scientists and academics working in the field of opposing new-generation products (NGPs).

    It is a rather confusing video to my way of thinking because, while the voice-over makes the point that language evolves, Cohen seems not to be a Darwinist. She seems to lean toward genetically modified language, where such modifications are controlled by people such as her to avoid language developing adjectival diseases helpful to the tobacco industry.

    This all becomes rather silly in fact. At one point in the video, according to a piece by Alex Norcia writing in Filter magazine [I quote Norcia because, though I watched the video, I did not transcribe it], Cohen says that “words like ‘novel’ and ‘emerging’ are really misrepresentative by nature as a product is only new for so long.”

    I mean, come on, I know that a lot of people who like to go on about tobacco cannot resist dredging up the past, but what is she trying to do here, reignite the 1920s debate between Albert Einstein and Henri-Louis Bergson on the nature of time? As a bit of a diversion, is she seeking the illusive equation that will define for us the “now” moment? Cohen seems to want to set up an Academie Anglais when the object of the NGPs exercise should simply be to make it as easy as possible for those people who want to do so to switch from traditional combustible cigarettes to these less risky products.

    As always, if you want to make sense of something, it is best to seek out the experts, and by that, I don’t mean the scientists and academics. I mean the people who smoke and who use NGPs. At the bottom of a TR news report on the Filter piece, a viewer of the video was quoted as saying, “WE use these devices. WE define the terms. You need to stop talking and start listening.” Sixteen words that say it all.

    But Cohen is right in one way: Language is important, and those who support tobacco harm reduction (THR) should not be lulled into picking up and repeating whatever ideas the anti-tobacco/anti-nicotine activists put out. And there is a tendency to do this, especially within the tobacco industry, which is forever issuing mea culpas in an effort to curry favor with its enemies. One obvious example of this is the way in which just about everybody applies the word “addiction” to smokers and vapers without bothering to define what exactly is meant by addiction, something that I try to point up in another piece in this magazine.

    Another example can be seen in the otherwise useful World Vapers’ Alliance Policy Primer featuring case studies of the most successful countries that have embraced alternative products as a means of combating traditional smoking. It is unfortunate, in my view, that the primer at one point had this to say: “Quitting smoking is one of the hardest things to do, and smokers need all the support they can get instead of being stigmatized.”

    I find it hard to believe that anyone whose aim is to get people to switch from smoking to vaping would make this point, which I don’t think is even correct. For one thing, the hardest thing to do would vary from person to person, but it is easy to imagine that, for some people, obtaining a doctorate in quantum physics, playing Hamlet well, knitting a jumper with two arms in the right place, playing Wagner or listening to The Ring Cycle right through … might all come higher up the scale of difficulty than giving up smoking.

    I gave up smoking without recourse to any replacement or alternative products, and many of my peers did so, too, and I don’t for a minute believe that we were a particularly strong-willed bunch. Indeed, the figures showed that countless numbers of people did so at the same time.

    And even if this were not the case, I would find it difficult to understand under what circumstances any sensible person would try to encourage another person to do something by telling them it was difficult. It is time to take advantage of some corporate speak. For years now, no company worth its salt has faced problems; it has instead faced challenges. Note, the obstacle hasn’t changed, just the way of looking at it.

    The worker faced with a problem is entitled to hold her chin and shake her head. The worker faced with a challenge is set up to measure the height of the obstacle and the length of the run-up needed to clear it.

    We of the THR persuasion should not perpetuate the myth that quitting tobacco is difficult. We are not sea squirts attached to the anti-tobacco/anti-nicotine rock and being force-fed its solutions. It is not in our interests to perpetuate such myths, though it could be seen as being in the interests of those in the anti-tobacco camp. After all, if smokers came to know that it was not difficult to quit, they might do so and put those employed to be anti-tobacco out of work.

  • Licensed to Thrive

    Licensed to Thrive

    There may soon be a licensed medicinal inhaled nicotine product on the market if Qnovia finds success.

    By Timothy S. Donahue

    The story of the vaping industry tends to be dominated by two countries—the United States and the United Kingdom. In the U.S., the world’s largest vaping market, misinformation and a regulatory roller coaster continue to rattle the business of electronic nicotine-delivery systems (ENDS). Meanwhile, in the U.K., vaping products are being embraced as a harm-reduction tool to end the use of combustible cigarettes.

    Elsewhere, the gamut of vaping regulations ranges from complete bans to minimal rules. There has not been any advocacy group, research project or product development that has been able to bring global regulators under one unified ENDS umbrella.

    Many experts have said over the years that licensing ENDS as medicinal products could lend credibility to vaping products and their tobacco harm reduction potential. Approval from both the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Center for Drug Evaluation and Research (CDER), the drug approval division of the U.S. Food and Drug Administration, could provide consumers with confidence that ENDS have the potential to be an effective nicotine-replacement therapy (NRT) product.

    Although several media outlets reported that Johnson & Johnson’s Nicorette QuickMist is the first medically licensed vaping product, it isn’t a vaping product. It’s a mist sprayed into the mouth and is not inhaled. One product, however, does have the potential to make the dream of a medicinal ENDS product a reality. U.S.-based Qnovia is presently working with both the CDER and the MHRA to bring its RespiRx nicotine-containing cessation device to market.  

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG. 

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product. 

    “The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he says. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, says Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day. 

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” says Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.” 

    Brian Quigley

    Every smoker smokes differently. One smoker may have their first cigarette after their morning coffee. Another may have to light up the moment they wake up. Quigley says that Qnovia patients can use their daily doses to replace each occasion where they’re used to having their combustible cigarette. They have hand-to-mouth action. They get reinforcements to those behavioral cues that smokers have become accustomed to. 

    “With a piece of gum or a patch, if you have a patch on and you’re having your cup of coffee and you’re fighting through your cravings, it just doesn’t work. I think there’s a lot of benefits to this type of therapy to really help the patient replace their occasion when they need to smoke and then stick with that 12-week step-down program,” says Quigley.

    Choosing sides

    In the U.K., Quigley says the process to become a medicine is less challenging than in the U.S. “Whereas in the U.S., we have to go through a pretty rigorous process and really our competition is once that patient decides they want to try to quit smoking [and] we’re competing against the existing NRTs, which every smoker has tried. Consumers know that none of them are as effective as an inhalable product,” he says.

    If RespiRx decided to be a tobacco product instead of medicine in the U.S., the device may have already been on the market. The FDA’s premarket tobacco product application process is less stringent than the CDER approval process. However, drugs gain approval all the time, while the FDA has approved only 23 vaping products for market, and most of those are technologically obsolete. An NRT comes with less baggage than a tobacco product, and as far as the FDA’s Center for Tobacco Products (CTP) is concerned, vaping products are tobacco products.

    “I think the unfortunate reality facing reduced-risk products is that FDA on the CTP side—they’re in a very tough spot. The industry is kind of stuck in the middle where, yes, the FDA needs to review these applications and approve reduced-risk products, but over the long term, I think FDA will ultimately continue to constrain that industry,” says Quigley. “Ultimately, I think the long-range path of CTP will be to continue to tighten regulations on all tobacco products. That would be a very challenging environment. That space presents a lot of risk.”

    While a much longer and more expensive process, Quigley says the CDER standard is straightforward. It’s about safety and efficacy. It’s a balance between scientific risk and regulatory risk. When the CDER asks a question, it usually requires a study to answer. Studies can be very expensive. “I think that another potential challenge will be that we’ll generate data, and we expect the FDA will be very conservative,” he says. “They could ask us questions that require us to generate additional data that we didn’t think we had to generate. But our view is that we’re going to do this right. If they need data, we’re going to generate it for them. The biggest risk is really the time and money to get through the approval process … but I do believe that we are taking a proactive scientific approach.”

    For Qnovia, the premise that the CDER must be more directly involved with a company working on a new drug than the CTP needs to be when working with the e-cigarette industry was important. Quigley says that he also believes that having less harmful vaping products on the market available to consumers is important in the fight to end combustible tobacco use. He says having e-cigarettes available to former or current smokers who want to continue to have nicotine be part of their life is important. But for Qnovia, its client base is those smokers who are saying they want to end their addiction to nicotine.

    “CDER, for example, has timelines it must adhere to. When we give CDER information, they stick to these timelines. I think it’s a more responsive center than CTP needs to be with e-cigarette manufacturers,” explains Quigley, adding that the company likes the engagement opportunity with the CDER to advance a potential breakthrough therapy for smoking cessation. “The conversation we have with FDA on helping to provide more effective cessation tools is very different than a conversation a tobacco company would have. I do think that we have the opportunity to be viewed as an ally with FDA in their fight against smoking. We’re trying to help solve a problem that is important.”

    Mario Danek

    One of the main issues that the FDA has with vaping products is heat. E-liquid is heated, and that heating process has the potential to create harmful and potentially harmful constituents in the vapor. Quigley says that this is why he doesn’t ever see a vaping product with an atomizer that heats the liquid to vaporize being approved as an NRT product. While e-cigarettes are surely less harmful than combustible cigarettes, there are still potential constituents in the e-liquid aerosol, and the CDER would have a problem approving a vaping product with the potential to have those constituents.

    Qnovia is preparing to submit its investigational new drug application to the FDA. It also expects to begin human clinical trials this year, according to Quigley. Ultimately, Qnovia’s goal is to have its new drug application, its final drug application, submitted to the FDA in 2025.

    “The IND, basically, is where we give them all of our safety data, all of our drug manufacturing and device characterization data. And after that application is submitted, once the FDA gives us the approval, then we can begin human clinicals,” says Quigley. “And we have a phase one, phase two and phase three human clinical plan that we will have to execute.”

    A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA postmarket safety monitoring. Importantly, a major difference between the CTP and the CDER pathways to market is that drug applicants have safety standards that e-cigarette manufacturers don’t have. For example, for RespiRx, the container that holds the nicotine needs to be sterilized. It needs to be filled aseptically in an ISO 5 cleanroom environment. The vaping industry would only require an ISO 6-certified lab.

    “I think another element is our airpath safety. It’s something that FDA really cares about on the drug side. When the patient is actually inhaling on the device, not only the aerosol but even the breath path, where they’re drawing air from, has to be totally sealed off and isolated from electronics and other materials,” says Quigley “That’s not the case with standard e-cigarettes. Everything, the breath-activation function and all the electronics have to be sealed off entirely from the drug-containing reservoir and the patient’s airpath. These are more stringent safety requirements that have forced us to do extra work from a design perspective and a safety perspective.”

    Forward thinking

    Qnovia was founded in 2018 in Los Angeles by Danek as Respira Technologies. Danek invented the underlying technology. He rebranded the company as Qnovia last year. The company also moved to Richmond, Virginia, in part because that state offers a more business-friendly environment, according to Quigley, whose tobacco career included a six-year stint as CEO of Altria’s U.S. Smokeless Tobacco Co. subsidiary.

    In addition, many of the partners the company works with are on the East Coast. Qnovia contracts with a Boston manufacturer to make its device and a firm in Pennsylvania to create the medicine administered through the device.

    One controversial aspect of e-cigarettes is unlikely to be a problem for Qnovia: The role RespiRx is to play in a medical context offers an opportunity to make use of flavors. Quigley says flavors could potentially help a smoker make the transition from combustibles and stick through the therapy and ultimately quit.

    “I think that the lens is those flavors; it just becomes a safety question. Which is, you just have to make sure that whatever flavors you wanted to include, you’re actually generating the safety data to support new questions of safety by including those flavors. You have to check the safety box,” says Quigley. “E-cigarettes or e-vapor products are a different experience than what our smoker is used to, and flavors play or can play an important role in helping smokers switch to that reduced-risk platform.

    “There’s also a lot of data that show that flavors are an important part of helping smokers move to reduced-risk products. But now the industry has been put in a very tight, constricting box. Over time, hopefully, that will kind of correct itself, but it’s going to have to happen with data. I think that the industry understands that—regulators and public health officials look at flavors as a youth appeal issue.”

    The industry now must figure out how to ensure that it’s not creating a youth appeal issue but still creating a product that is going to be appealing to a smoker trying to switch to reduced-risk products, according to Quigley. “I think it’s going to be a long, slow road, but vapor products will continue to be a part of the reduced-risk product landscape in the U.S., but I think it’s going to be challenging,” he says.

    RespiRx is expected to hit the market as a prescription-only treatment. Qnovia is also interested in exploring how the technology can be used for asthma, pain management, vaccines and other applications. As far as using synthetic nicotine, Quigley says it is not out of the question but says he is concerned that currently, the FDA doesn’t know enough about synthetic nicotine to be able to approve a synthetic product.

    “We’re using pharma-grade nicotine. It is tobacco derived. I think with synthetic nicotine, the FDA may have lots of questions whereas they have a deep body of evidence and understanding of tobacco-derived nicotine,” says Quigley. “However, if there was data to show that synthetic nicotine is safer because it in no way can have any kind of nitrosamines, for example, it’s something we could consider in the future with strong safety data.”

  • Certified Medicine

    Certified Medicine

    Credit: Krakenimage

    More than a year after the U.K.’s MHRA updated guidance, there are still no medicinal vapes on the market.

    By Pete Lomas

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for licensing electronic nicotine-delivery systems (ENDS) as medicinal products on Oct. 29, 2021. The new guidance marked a shift in approach from the MHRA as it began actively encouraging applications and sought to support companies through the process. Over a year on, however, we have to wonder why the industry doesn’t have any medicinal vapes on the market.

    The change in direction by the MHRA was likely spurred by the U.K. government’s desire to meet its “Smoke-Free by 2030”1 target, which stipulates that less than 5 percent of the population should be smokers by the end of the decade. Using ENDS can be a good way to reduce the harmful effects of smoking, and the hope is that this new approach will change the perception of ENDS, bringing them more in line with other nicotine-replacement therapies, including gums, sprays and patches.

    Pete Lomas

    The pathway via which e-cigarette products can be certified as medicinal products is known as a marketing authorization application (MAA). Since nicotine is not a new chemical entity, the MAA can be abbreviated with respect to safety and efficacy information. Instead, the application will rely primarily on a pharmacokinetic study to compare the new product with an appropriate reference medicinal product. Given the intended route of administration, an already approved inhaled nicotine product such as the Nicorette 15 mg Inhalator has been suggested by the MHRA as a suitable comparator.

    As well as conforming to the MAA requirements, any ENDS devices will also need to be proven to be electromechanically safe. In the U.K., this will require it to be U.K. Conformity Assessed marked, following assessment by an authorized approved body.

    Encourage licensing

    In a bid to elucidate the new application process, the MHRA initially ran a webinar titled “Licensing Electronic Cigarettes as Medicines,” which was retroactively made available on YouTube.2 In short, the MHRA is committed to providing as much assistance as is needed to ensure potential applicants understand the process and feel able to make applications in a timely manner.

    But the MHRA has gone beyond simply putting on talks and answering questions—it has also widened the goalposts slightly, making applications more likely to succeed. One way this has been done is by adapting how delivered dose uniformity (DDU) is measured. As a medicinal product, vapes are classified in a similar way to conventional pressurized metered dose inhalers (pMDIs), meaning the criteria that must be met before approval is very similar.

    E-cigarettes, however, are a fundamentally different technology to pMDIs. Whereas pMDIs use a pressurized canister calibrated to deliver an exact amount of aerosol per puff, an e-cigarette is traditionally based on coil and wick technology. This difference makes the DDU per-puff of an e-cigarette much less consistent, and that is before considering self-titration (the patient taking larger or smaller puffs based on preference and habit) is even considered.  

    So, if ENDS are subjected to DDU regulations on a per-puff basis, then most will fall short—what to do then? To address this, the MHRA has instead set DDU requirements that are averaged over 10 puffs, rather than one, thus making it easier for vapes to comply.

    Achieving DDU

    Despite the leeway given by the MHRA, delivering dose uniformity is still very important. For products to reach medicinal standards, they must be designed to be as consistent, puff to puff, as possible. In that respect, any applicant seeking approval will need to focus on three key points: consistent power, consistent delivery of liquid and consistent airflow—achieve all three and a device stands a good chance of complying with the new guidance.

    Modern developments in vape technology will help address the issue of DDU further. Non-heated vaping technologies based on ultrasonics, piezo-ceramic mesh and micro-nozzles are now being used to develop these products and offer greater inhalation consistency. Piezo-ceramic technology, in particular, is well suited for medicinal products as it offers the ability to fine-tune the mesh, vibration frequency or other parameters within the device, depending on the liquid formulation.

    Another key difference between ENDS and their inhaler cousins is that the performance of electronic products tends to vary at the beginning and end of the product’s lifecycle. That means priming and end-of-life doses may not deliver the same uniformity as is expected for the bulk of the product’s use. Within the new guidance, applicants will now be able to define these different doses and exclude them from the uniformity criteria, so long as appropriate justification is provided and information on these differences is communicated to the end users.

    Achieving MAA licensing

    To date, only one e-cigarette product has successfully passed through the MAA process, around a decade ago. However, smokers did not find the product sufficiently satisfying to make a permanent switch. It was withdrawn from the market only a couple of years after launch due to low smoker compliance. Technology has evolved much since then, resulting in products that are much more satisfying for smokers, allowing them to transition away from combustible cigarettes altogether.

    Typically, performing the necessary studies and data gathering for the application would be expected to take 12 months to 18 months. Once collected, the MHRA offers a 150-day accelerated assessment for “high-quality” MAAs, with an intervening “clock-off period” where further clarification and information can be provided, as required. The clock-off period should last no longer than 60 days.

    For applicants with products undergoing a U.S. FDA premarket tobacco product application (PMTA) process, or for the 23 ENDS that have already been approved3 via this route, there is opportunity to reduce the number of new studies that are required for an MAA. The MHRA has said it is happy to discuss what data may be relevant for a U.K. MAA, therefore reducing the need for additional studies in some cases.

    Even if the majority of the data from a PMTA cannot be used directly as part of the MAA, data generated for the PMTA can be used to help strengthen the Pharmaceutical Development section within Module 3 of the application. In addition, a successful product on the U.S. market will provide confidence to regulators of consumer acceptance, which can be an important consideration.

    All told, any applicant beginning data collection for an MAA should anticipate the entire process, from product finalization to market approval, taking in the region of two years. This explains why we are yet to see a product reach approval since the guidance was only updated in October 2021. As we approach the two-year mark at the back end of 2023, it seems plausible that the first medicinally licensed ENDS could come on sale in the U.K.

    Credit: Minerva Studio

    Where to find medicinal vapes

    If the license granted permits the product to be sold and supplied as a General Sales List (GSL) medicine, then the retailer does not need to be a pharmacy. Examples of common GSL medicines include ibuprofen and paracetamol, which can be purchased from retail outlets such as convenience stores and supermarkets, where they are available for self-selection, albeit with appropriate sale restrictions on purchaser age and quantity of the product.

    Most existing nicotine-replacement therapies—products like patches, gum and sprays—are listed as GSL items, and so the assumption is that ENDS would be made available in the same way. That said, approval onto the GSL doesn’t automatically exclude a product from being prescribed to patients by a healthcare professional. Applicants may still wish to secure contracts with healthcare providers to distribute their product through alternative channels, which can include being exclusively sold as a prescription treatment.

    Making a difference

    It is fair to say that the perception of vaping, both in the eyes of the public and healthcare professionals, has declined in recent years. A 2021 survey by Action on Smoking and Health4 (ASH), for example, found that nearly a third (32 percent) of smokers incorrectly believe that vaping is more or equally as harmful as smoking. Whatever the reasons are behind this—I suspect there are several—it needs to change if we are to reach the smoke-free target by 2030.

    The hope is that by licensing ENDS as medicinal products, it will provide credibility that these products are not just safe but have genuine harm reduction potential. MHRA approval will provide customers with confidence that they are making a healthy choice when switching from smoking to vaping.

    A barrier to the success of this reclassification of vapes as medicinal products may be smokers’ perceptions of themselves. Many don’t want to be seen as “patients” per se, and so they might resist being bundled into such a group. Medicines, however, are as much about the prevention of disease as for its treatment, and given that these products will hopefully be available as GSL medicines, resistance to their purchase should be minimal. Most people don’t feel like a “patient” when purchasing ibuprofen after all.

    The impacts of the change in guidance will only become apparent once we start seeing products approved via this route. For now, there are still over 6 million people5 in the U.K. who smoke cigarettes; e-cigarettes, which have been through the rigorous medicinal licensing process, could be a safe, effective and trusted part of the solution moving forward.

    Pete Lomas is a managing consultant at Broughton Group (www.broughton-group.com), a consulting and lab services company.

    1 www.gov.uk/government/publications/the-khan-review-making-smoking-obsolete/making-smoking-obsolete-summary

     2 www.youtube.com/watch?v=OnK4u_pO2RM

    3 www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders

    4 https://ash.org.uk/uploads/Use-of-e-cigarettes-vapes-among-adults-in-Great-Britain-2021.pdf                                   

    5 www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthandlifeexpectancies/bulletins/adultsmokinghabitsingreatbritain/2021#:~:text=In%202021%2C%20the%20proportion%20of,14.0%25%20of%20the%20population

  • Head in the Clouds

    Head in the Clouds

    Credit: James Thew

    A vaping industry veteran uses some time-tested adages to reflect on his 11 years in the space.

    By Chris Howard

    In the new year, as I reflect on my past 11 years of experiences in the vapor space, I think it is better late than never to share some thoughts on where we have been and where we should be headed. Because we are never too old to learn, I thought I would strike while the iron is hot (hopefully you can see the theme here). 

    From 2018 to 2021, the industry suffered incalculable upheaval and uncertainty as we went through a shortened premarket tobacco product application (PMTA) period and a seemingly never-ending series of marketing denial orders (MDOs). While 2022 wasn’t necessarily any better for industry, it sure got a lot worse for the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP).

    To recap, we saw multiple challenges to MDOs that shed some inconvenient light on the CTP review processes. We also witnessed significant delays in the CTP’s ability to meet the Maryland Court-imposed deadlines. Congress regularly attacked the CTP (and the greater FDA) for perceived shortcomings. And, finally, we saw the results of the Reagan-Udall Foundation review that, even with the soft touch given to the CTP, did not paint a flattering picture of the workings of our regulator. In all, it was a rough year for a new center director and the staff.

    With the above in mind, a few time-tested adages can aptly describe my reflection on the vapor industry—which I offer here for your consideration:

    Make a Long Story Short. After nearly seven years since the finalization of the Deeming Rule, the CTP and industry have collectively learned that some of the standards/requirements making up the PMTA process could be streamlined to say the least. By way of example, does the CTP really need for each company to spend thousands of dollars on the same literature review? Are behavioral surveys to show youth aren’t attracted to tobacco-flavored products necessary at this point?

    Are there other commonalities across numerous applications that could now be updated or otherwise removed from consideration given consistent findings? As suggested by the Reagan-Udall Foundation, the CTP should consider providing more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.

    You Get Out What You Put In. Applicants who skimped and filed weak applications without regard to the requirements set forth by the CTP have nearly universally learned a valuable lesson. The PMTA process is expensive, and extremely rigorous science is required to show that your products are appropriate for the protection of public health (APPH). While many sought shortcuts and/or complain that the CTP’s guidance is unclear and/or vague, several companies have demonstrated that vapor products can indeed meet the FDA’s high standards.

    Which companies are these? These are the companies who expended significant time and resources to develop robust applications covering each scientific discipline and other requirements set forth in the June 2019 “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry” and in the November 2021 Final Rule regarding “Premarket Tobacco Applications and Recordkeeping Requirements.”

    Don’t Hold Your Breath. It’s hard to believe it now, but there was a time when both applicants and the CTP shared an optimism that reviews of applications could be accomplished in accordance with the prescribed timeline. This “certainty” provided an objective framework enabling industry to develop various business plans for all deemed products in the pipeline.

    Unfortunately, the ultimate glut of applications proved to be an insurmountable burden for the FDA—resulting in nearly all timelines falling by the wayside. For anyone with pending PMTAs and for those manufacturers contemplating filing new PMTAs, don’t expect to obtain results quickly. Hopefully, the CTP will adopt some of the recommendations contained in the Reagan-Udall Foundation report to increase its overall efficiency and enable the industry to plan more effectively.

    When Life Gives You Lemons, Make Lemonade. For innovators in the vapor space, initially life was very good. They had a great product that was considered profitable and a key to moving harm reduction forward. Unfortunately, things didn’t go exactly as expected, and life gave everyone in the vapor space lemons—and a huge basket of lemons at that. We had youth vaping; e-cigarette or vaping product use-associated lung injury (EVALI); near constant, questionable scientific studies demonizing electronic nicotine-delivery systems (ENDS); state and federal legislation to tax, limit and ban; a regulatory agency that swept the market nearly clean of flavored products—the list goes on.

    It’s quite easy to despair, but now is the time to make lemonade. As an industry, we need to innovate within the narrow confines provided. We need to continue to ensure that the FDA makes its decisions based on science while we develop improved nonflavored options and better marketing schemes to prevent youth exposure. Smokers deserve our efforts to offer satisfying, reduced-harm products—I’m confident this innovative and adaptable industry can do just that.

    It’s Not Over Until It’s Over. Over the past 11 years, I have seen so many industry advocates walk away from the vapor category due to a variety of circumstances. Unfortunately, with each powerful voice that leaves, the ultimate goal of ensuring that vapor products are an important part of an FDA-sponsored harm reduction platform becomes even more difficult to reach. In my opinion, the story isn’t over. Several vapor products have received market granted orders, and I expect that we will see more in the near future.

    Moreover, additional studies continue to show the obvious health benefits of vapor products as compared to combustible cigarettes and that they are a valuable tool for adult smokers seeking to quit. Maybe owning a vape store and selling thousands of flavors isn’t on the horizon, but helping smokers seeking alternatives can still be a meaningful priority. I encourage past and current members of the vapor community to revisit their priorities with a new focus on educating the public—even if the journey hasn’t been as fulfilling as you hoped it might be.

    Two Wrongs Don’t Make a Right. In case anyone missed it, several young people decided to experiment with vapor products a few years ago. Fortunately, that trend is unquestionably subsiding thanks to the introduction of T21 and the gradual decrease in the “fad” of vaping. It certainly isn’t right to (and no responsible manufacturer should) sell ENDS products to or in a manner attractive to kids. Unfortunately, the handling of the regulation of ENDS and, more particularly, flavored ENDS by both public health commentators and regulators is also wrong.

    In 2016–2017, ENDS were the next best thing. They held the promise and potential to restructure the tobacco use market in the United States from combustible cigarette death and disease to an inhalable nicotine product that reduces risk and disease burden. The “second wrong” in response to Juul, EVALI, the abandonment of harm reduction and an avalanche of inaccurate reporting, propaganda and sensationalism resulted in the gutting of the flavored ENDS space (most of which did not have a youth vaping issue) in the form of refuse-to-file letters and MDOs based on a seemingly arbitrary solution.

    These two wrongs, when coupled, don’t make a right—what these two wrongs make is a missed public health opportunity. Unlike the United Kingdom, which has embraced ENDS and driven down smoking rates, the U.S. has moved in the opposite direction—vilifying, banning and restricting. In this case, the two wrongs will result in increased smoking and increased disease.

    The Perfect is the Enemy of the Good. As the PMTA review picture gains incremental clarity, we often see policy of pursuit of perfection (e.g., ill-defined demands for long-term cessation trials for flavored products). Whether this pursuit is expedient to remove disfavored products or flavors from the market or we are seeing the level of evidence required to gain a market order rise to a standard only found in the drug center is for you to consider.

    However, the net effect is an increasingly complex (and expensive) set of criteria to satisfy the APPH standard. The public health standard, however, should not be a pursuit of perfection—it should be a pursuit of decreasing cigarette smoking mortality and morbidity. While there may be risks associated with some of the reduced-harm products, those risks are dramatically fewer than those posed by cigarettes. Accepting reasonable evidence to support reduction of harm to enact lifesaving and life-extending regulatory policy just makes good sense.

    Don’t Miss the Forest for the Trees. Throughout the public health community, harm reduction principles are embraced and promoted to reduce the harms related with drugs, sex and other potentially harmful activities. For some reason, though, with rare exception, nicotine and combustible cigarette smokers don’t seem to merit a harm reduction strategy.

    In the face of 460,000 smoker deaths each year, prudent regulatory policy would embrace products down the spectrum of risks—not ban them. European regulators have seen the forest—they promote reduced-harm products while discouraging combustible cigarette smoking. In the U.S., unfortunately, we ran into the first sapling off the trail and haven’t really progressed from there. 

    While the past 11 years have provided many ups and downs in the vapor space (a lot of downs), I’m hopeful that we can turn a corner in 2023 and beyond. In the past, it seemed like it was the vapor industry versus the world. Today, however, it is possible that we are at the dawn of a new era of tobacco regulation.

    My hope is that when I look back on the next 11 years, the CTP has learned from the missteps of the past. I hope the center uses the valuable insights it has been provided, like the findings in the Reagan-Udall Foundation report, to reorient the center on not just prohibiting products but rather crafting policy and standards that assist combustible cigarette smokers in moving away from those harmful products. I hope to look back on tobacco control policy that doesn’t just involve saying “no” to every option but rather embraces harm reduction and doesn’t leave smokers behind. Maybe we can have our cake and eat it too.

    Chris Howard is executive vice president of new product compliance and external affairs for Swisher and former senior vice president, general counsel and chief compliance officer for E-Alternative Solutions.

  • Behind Schedule

    Behind Schedule

    Credit: Burdun

    Two branches of federal government have the power to change marijuana’s Schedule I status.

    By Willie McKinney and Emily Burns

    The primary obstacle for the U.S. cannabis industry is that possession and use is still illegal according to federal law. And there could be severe penalties if you’re convicted under those federal laws. This is because the removal of state criminal penalties (decriminalization) doesn’t “undo” or “negate” federal laws criminalizing such conduct, even though they both can coexist due to something called the anti-commandeering doctrine. In short, cannabis users in legalized states still face the reality that their conduct remains federally illegal and punishable by federal authorities under the federal Controlled Substances Act (CSA).

    The current Schedule I status of marijuana means that it’s strictly prohibited for sale or use under federal authority. Yet, over the last several decades, most states and territories have deviated from across-the-board prohibition of cannabis and now have laws and policies allowing for some cultivation, distribution and possession of cannabis. It is difficult to predict when cannabis will be federally legal. It’s even harder to predict how cannabis will be regulated and the impact.

    The CSA classifies drugs and their chemical analogs in five schedules—Schedules I–V:

    • Schedule I means a drug has a high potential for abuse, with no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug under medical supervision.
    • Schedule II drugs have a high potential for abuse but have an accepted medical use, though abuse of the drug may lead to chemical or physical dependence.
    • Schedule III drugs have a lower potential for abuse and are currently accepted for medical use in the United States, and abuse of the drug may lead to lower physical dependence but high psychological dependence.
    • Schedule IV drugs have a low potential for abuse, a low risk of dependence compared to Schedule III and have a currently accepted medical use.
    • Schedule V drugs have a low potential for abuse and a currently accepted medical use.

    Who controls marijuana’s status?

    The legislative and executive branches of the federal government have the ability to change marijuana’s Schedule I status. The executive branch can take action to change marijuana’s status; however, it is bound by the CSA to consider factors such as a substance’s risk of abuse and medical utility prior to altering its scheduling.

    Under the CSA, the Drug Enforcement Administration (DEA), Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration make a decision to reschedule or de-schedule a drug based on the relative abuse potential of the drug. The HHS’ recommendations are binding on the DEA as to scientific and medical matters. The HHS must consider the eight following factors in making its recommendation:

    • the drug’s actual or relative potential for abuse;
    • the drug’s scientific evidence of its pharmacologic effect, if known;
    • the state of current scientific knowledge regarding the drug;
    • the drug’s history and current pattern of abuse;
    • the drug’s scope, duration and significance of abuse;
    • the risk, if any, to public health; and
    • the drug’s psychic or physiological dependence liability.

    Is the drug is an immediate precursor of a controlled substance?

    Over the years, several entities have submitted petitions to the DEA to reschedule marijuana. In August 2016, after a five-year evaluation process done in conjunction with the FDA, the DEA rejected two petitions—one submitted by two state governors and the other submitted by a New Mexico health provider—to move marijuana to a less restrictive schedule under the CSA.

    Consistent with past practice, the rejections were based on a conclusion by both the FDA and the DEA that marijuana continues to meet the criteria for inclusion on Schedule I—namely, that it has a high potential for abuse, has no currently accepted medical use and lacks an acceptable level of safety for use under medical supervision. Some drugs, like Marinol and Epidiolex, are excluded from Schedule I because they have obtained FDA authorization via the drug approval process.

    The federal government could choose to maintain the federal prohibition on marijuana. Given the current political environment, however, this scenario seems unlikely.

    Reschedule, new schedule or de-schedule?

    President Biden recently signed the “Medical Marijuana and Cannabidiol Research Expansion Act,”1 which will ease federal government research restrictions on marijuana and encourage research institutions to produce marijuana strains for research purposes. The bill also calls upon the attorney general to consider the issue of rescheduling (or de-scheduling) marijuana by engaging with officials from the Department of Health and Human Services, which houses the FDA. Once the attorney general finds sufficient evidence that a change in scheduling is warranted, he then initiates the first stages of a standard rulemaking process.

    There are at least three obvious approaches that the federal government could take to address marijuana classification conflict: creating a new schedule, rescheduling under a less restrictive schedule or de-scheduling altogether.

    Creating a new schedule, similar to the recent announcement made by the FDA addressing a new regulatory pathway for CBD outside of the traditional FDA pathways, could be a possibility; however, it is unlikely.

    If marijuana remains a controlled substance under the CSA, under any schedule, it would still maintain the existing conflict between the federal government and states that have legalized recreational marijuana. However, moving marijuana to a less restrictive schedule could help mitigate conflicts between federal law and state medical marijuana laws. If Congress chooses to remove marijuana from the CSA entirely, it could seek to regulate and tax commercial marijuana activities.

    De-scheduling cannabis appears to be the most effective option for the federal government to eliminate the existing conflict between federal and state law as it would allow cannabis to remain on the market as a medical and recreational product. Additionally, changing social attitudes toward marijuana will likely support de-scheduling. 

    Jennifer Guild, vice president of regulatory and quality at Abstrax Technologies, is hopeful that as states learn more from legalization programs across the country, they will “start to reward the responsible suppliers that are taking the initiative to self-regulate and develop their own toxicological programs to address the gap in knowledge that exists regarding the inhalation safety of various flavor ingredients.”

    However, a move to de-schedule cannabis would create new controversies. As Guild points out, testing standards created for flavors and other chemicals may prove impractically stringent, depending on the state. “There are over 678 unique chemical contaminants regulated in cannabis products among 30 state regulations (not including outside of the USA) … and flavors are not typically derived from cannabis nor do they contain any cannabinoids or other cannabis-derived extracts. Therefore, it is not feasible or appropriate for non-cannabis-derived flavors to be routinely tested for these 678 potential contaminants.”

    Regardless, Guild encourages manufacturers to “establish and implement a written quality plan to control potential safety risks [of] the products they manufacture. This risk assessment includes an evaluation of the potential chemical, biological and physical hazards that could be introduced to a party at each stage in the manufacturing operations.”

    Legalized marijuana operates in uncharted territory. There is no track record on the impact of these new laws. While outcomes might be positive, there is simply not enough information available to confidently project national success. For this reason, the federal government should work with states to learn from best practices and then develop a comprehensive program to address marijuana classification. 

    Willie McKinney is CEO at McKinney Regulatory Scientific Advisors.
    Emily Burns is senior regulatory strategy manager at McKinney Regulatory Scientific Advisors.

    1 www.congress.gov/bill/117th-congress/house-bill/8454