In late December of last year, the Government of Canada announced a proposal to lower the allowable levels of nicotine in vaping products from 66 milligrams per millilitre to 20 mg/ml in an effort to curb youth vaping. The public consultation period would be in effect for 75 days, closing on Mar. 4, 2021.
Credit: Toptop54
The proposed reduction is a move vaping advocates say will minimize their value to adult smokers looking to transition away from cigarettes, according to the Morinville News.
However, the Canada-based Vaping Industry Trade Association (VITA) says smokers having access to sufficient nicotine levels in an alternate product is essential to the effectiveness of vaping as a harm reduction product. “A limit of 20mg/mL is simply too low for many smokers,” Allan Rewak executive director of VITA stated in a media release. “Adult smokers need access to higher nicotine vapor products at the beginning of their journey from smoking to vaping. Lowering this limit is just going to keep more smokers smoking.”
The Canadian government is following a move by Nova Scotia, who in April of this year, instituted a 20mg/mL nicotine cap as well as a flavor ban. VITA says that change in the rules saw a 25 percent increase in legal cigarette sales increase, an increase four times higher than surrounding provinces. The regulations also resulted in half of the province’s specialty vape shops closing their doors.
“Considering the disparity of harm between vaping and smoking, we don’t understand why the federal government would be using Health Canada resources during a global pandemic to explore making it harder for adult smokers to switch to a reduced risk product,” said VITA president Daniel David.
Enforcement the real problem
The Government of Canada has previously put some measures in place to address youth vaping. Those changes include public education campaigns and banning the advertising of vaping products in public spaces if the ads can be seen or heard by youth.
Thomas Kirsop, owner of Alternatives & Options, a vape store in Morinville and St. Albert said he believes the government is taking the wrong approach with the nicotine reduction to handle the rise in youth vaping.
“A 60 percent reduction in commercially available nicotine concentration will impede my ability to assist the heaviest smokers,” Kirsop said. “It is a federal offence to knowingly sell vapor products to minors or for members of the adult population to provide these products to underaged consumers. In practice, however, I find this law poorly enforced. I think enforcing the current law would yield more significant gains than destroying the efficacy of a less harmful solution.”
Health Canada says restricting flavors in vaping products, and requiring the vaping industry to provide information about their vaping products, including sales, ingredients, and research and development activities are under consideration.
In late November, the City of Missoula, Montana banned flavored vaping products and not flavored combustible tobacco products. Now, Missoula County is considering using its extraterritorial powers to extend the city’s ban on the sale of flavored vapes and their display five miles outside city limits next week.
If approved, it would be the first time Missoula County applied its extraterritorial powers in four years. The last time it did was related to the city’s smoking ordinance.
“This initially started with the health board adopting a resolution and asking both the commission and City Council to do something to stop the epidemic of youth tobacco, especially using vape products,” said Shannon Therriault, county director of environmental health. “We were seeing a giant increase in the number of kids becoming addicted to nicotine, and a lot of that traces back to flavored tobacco products.”
The city ordinance goes into effect this month.
The city ordinance bans the display of self-service tobacco products of any kind, except where children aren’t permitted. It also banned the sale of all flavored electronic tobacco products, and made it illegal to sell tobacco to anyone under the age of 18.
“The health board reviewed it and approved. Now, it’s coming to the commissioners to review and approve,” said Therriault, according to the Missoula Current. “If approved, it can be applied five miles outside the city limits. It’s great, because it takes in a large amount of the area – the urban area.”
The original city ordinance included a ban on all flavored tobacco, which had the support of health officials but was opposed by dozens of businesses and tobacco users.
Two California cities have become the only jurisdictions in the U.S. to eliminate the sale of all vaping and traditional tobacco products. On January 1st, Beverly Hills and Manhattan Beach, both in the Los Angeles area, began to enforce the strictest vaping rules in the country. The law also included a phase-out period for retailers to empty their shelves of e-cigarettes. Other cities are considering enacting similar bans.
The Beverly Hills City Council, the first to pass its ordinance, proposed the rule nearly three years ago during a meeting discussing the potential ban of flavored vaping products. Ultimately, the council settled on a total ban of all vaping and traditional tobacco products.
Credit: Haiberliu
“Somebody’s got to be first, so let it be us,” said then-Mayor, current Councilmember John Mirisch, who first proposed the concept in 2017, according to a press release. Mirisch recently joined the Board of Trustees of the advocacy group Action on Smoking & Health (ASH), which coordinates Project Sunset, an effort to phase out tobacco sales worldwide.
“Cigarettes have become so normalized that to some this might seem like a drastic step,” said Chris Bostic, ASH Policy Director. “But if another product emerged tomorrow that was highly addictive and killed when used as intended, of course we’d ban its sale. We’d probably charge the people who marketed it with manslaughter too.”
Total vaping and tobacco bans have been gaining traction more recently, within the public health community and more broadly. The Danish Institute for Human Rights, after concluding a human rights assessment of Philip Morris International in 2017, concluded that “there can be no doubt that the production and marketing of tobacco is irreconcilable with the human right to health. For the tobacco industry, the UNGPs [United Nations Guiding Principles on Business and Human Rights] therefore require the cessation of the production and marketing of tobacco.”
Vapor industry advocates say that banning e-cigarettes only pushes former combustible cigarettes smokers back to combustibles. They also say that vaping bans increase the size of the black market. Black market THC vaping products were the cause of a lung disease that sickened and killed numerous youth in 2019.
RLX Technology, parent to the RELX brand of vaping products, has filed with the Security Exchange Commission (SEC) in the U.S. to raise up to $100 million in an initial public offering (IPO).
Credit: RELX Technology
The $100 million request is well below the $1 billion the company said it expected to raise when it announced Citigroup as the bank of record for its planned initial public offering in the U.S., people with knowledge of the matter said.
The Shenzhen-based company, which counts Sequoia Capital among its backers, boasts a 62.6 percent market share in China for closed-system vaping products in terms of retail sales, according to a press release.
“The company has partnered with 110 authorized distributors to supply its products to over 5,000 RELX Branded Partner Stores, and over 100,000 other retail outlets nationwide, covering over 250 cities in China,” the release states.
Revenue for the company nearly doubled in the nine months ended September 30, 2020 to $324 million, with net income of $16 million.
The Beijing, China-based company was founded in 2018 and booked $400 million in sales for the 12 months ended September 30, 2020. It plans to list on the NYSE under the symbol RLX. RLX Technology filed confidentially on October 26, 2020. Citi is the sole bookrunner on the deal. No pricing terms were disclosed.
Vaping studies often contain a lot of modal verbs like can, could, may and might. For example, an updated study on e-cigarettes for smoking cessation by the Cochrane Review suggest that vaping “could” help smokers quit using deadly combustible cigarettes.
The Cochrane study looked at 50 studies that took place in the US, the UK, Italy, Australia, New Zealand, Greece, Belgium, Canada, Poland, South Korea, South Africa, Switzerland and Turkey. The review found that e-cigarettes “could” be the answer many smokers are looking for according to an article in The New Strait Times.
Among the key findings were that smokers were likely to stop smoking for at least six months by switching to a vaping device with a nicotine e-liquid as compared to nicotine replacement therapy (such as gum and patches), nicotine-free vaporizers or behavioural support.
The researchers, made up of multiple independent and internationally-renowned healthcare experts, found that vaping with a nicotine e-liquid can help 10 in 100 people to stop smoking, compared to only 6 in 100 people who have tried using nicotine-replacement therapy or vaping nicotine-free e-liquids. Only an estimated 4 in 100 who try to quit without support, or those who rely only on behavioural support, are likely to succeed.
They also did not detect any clear evidence of serious harm from vaping a nicotine e-liquid.
Jamie Hartmann-Boyce from the Cochrane Tobacco Addiction Group said there is an increase in evidence of smoking cessation through the use of e-cigarettes compared to the last review in 2016.
“The randomised evidence on smoking cessation has increased since the last version of the review and there is now evidence that electronic cigarettes with nicotine are likely to increase the chances of quitting successfully compared to nicotine gum or patches,” said Hartmann-Boyce, the lead author of the review. “While there is currently no clear evidence of any serious side effects, there is considerable uncertainty about the harms of electronic cigarettes and longer-term data are needed. Scientific consensus holds that electronic cigarettes are considerably less harmful than traditional cigarettes, but not risk-free.”
In contrast, a recent study from the University of California San Francisco (UCSF), led by Richard Wang, determined that that e-cigarettes do not lead smokers away from addiction. Wang also claims that e-cigarettes “could” increase a users risk of disease. “If the use of consumer device products is not associated with increased smoking cessation, there is no health benefit,” he said. “Also, as people who smoke add e-cigarettes to their smoking, their risk of disease could increase.”
Wang worked with fellow UCSF researcher Sudhamiyi Bhadriraju and disgraced former UCSF researcher Stanton Glantz, who has recently had multiple studies retracted for what has been labeled by fellow scientists as “explicit dishonesty.”
This latest study was based on the collection of 64 trials in which participants were examined. All of them are e-cigarette users, according to an article on Explica.com.
“In observational studies you are asking people about the use of the devices they bought themselves. But they did it without specific guidance to quit smoking,” says Wang. “In a randomized trial, you test a product, treating it as a therapy or drug to quit.”
Wang then goes on to say there “may” be a cessation effect. “When certain electronic devices are treated as medicines, there may actually be a smoking cessation effect,” explains Wang. “But it has to be balanced against the risks of using cigarettes.”
Vaping can have a negative effect on memory, thinking skills and the ability to focus, particularly for young people, according to a recent study by researchers at the University of Rochester (New York) Medical Center.
“Our studies add to growing evidence that vaping should not be considered a safe alternative to tobacco smoking,” said Head researcher Dongmei Li.
The study is based on data analyzed from the over 886,000 participants involved in the Behavioral Risk Factor Surveillance System Survey and the more than 18,000 responses from the National Youth Tobacco Survey.
The researchers concluded that those who vaped or smoked cigarettes were more likely to struggle with cognitive function than those who had never smoked in any capacity. Also, the researchers noted that age played a large role in the participants’ cognitive abilities as they found that when participants were younger than 14 when they started vaping or smoking, they were even more likely to have cognitive struggles as adults.
“With the recent rise in teen vaping, this is very concerning and suggests that we need to intervene even earlier. Prevention programs that start in middle or high school might actually be too late,” Li added.
Nicotine is addictive. Most people who have smoked 60 cigarettes are going to be daily smokers. According to Jonathan Foulds, professor of public health sciences and psychiatry and co-director of Penn State Center for Research on Tobacco and Health, the average middle-aged smoker has made about 20 serious attempts to quit.
Jonathan Foulds, Penn State Cancer Institute
After deciding to try to quit, the average smoker has a 95 percent chance of still smoking a year later. Even with counselling and using a U.S. Food and Drug Administration (FDA)-approved cessation medicine, there is still an 80 percent chance they will be smoking again in a year.
Speaking during the Global Tobacco & Nicotine Forum (GTNF), Foulds said that people smoke for the psychological effects of nicotine, but they suffer the health effects created by inhaling combustible tobacco. To lessen the harms of nicotine consumption, regulators should focus on ways to get cigarette smokers to switch to less-risky forms of nicotine intake.
“If it were not for the nicotine in tobacco smoke, people would be little more inclined to smoke than they are to blow bubbles,” he said. “Blowing bubbles is fun, but no one wants to do it 20 times a day for the rest of their life. It’s the nicotine that’s key to [people smoking].”
Despite the addictiveness of nicotine, cigarette consumption in the United States has been falling consistently over the past 20 years. Cigarette consumption has fallen more than 50 percent since 1997. That is equal to approximately 200 billion fewer cigarettes being sold per year since 1997, and there are now many more people in the U.S. Foulds said there is also evidence that the decline has been accelerating over the past few years [alongside the growing popularity of vapor products].
Meanwhile, youth smoking rates have declined dramatically. In the 1970s, an average of 30 percent of high school seniors smoked cigarettes. In 1995, that number dropped to 25 percent. Today, less than 2 percent of high school seniors smoke cigarettes.
“The massive cigarette sales that the industry has been used to—clearly, that is coming to an end. I mean, the end is in sight from the cigarette industry,” Foulds told the GTNF audience. “What I’m trying to get across here to many of you—who are from the industry—is that we may be coming to a tipping point where it would be much better, rather than to just fight [regulators], it may actually be a wiser strategy to accept that this is happening sooner or later in terms of cigarettes and get ahead of it and embrace it.”
For cigarette manufacturers to survive, Foulds said they must promote less-risky forms of nicotine intake. Lower nicotine cigarettes are one example of how manufacturers can help push people to other products, such as e-cigarettes. He was unconcerned about consumers compensating for lower amounts of nicotine by smoking more cigarettes. “There’s now a bunch of studies—almost a dozen studies and they’re fairly consistent—showing that compensatory smoking really isn’t a thing that happens with these kinds of cigarettes,” he said. “The smokers learn pretty quickly that they can puff as much as they like, and they’re not going to get any satisfying amount of nicotine out of them.”
Another concern is that if only lower nicotine cigarettes are available, this would push smokers to the black market for higher nicotine cigarettes. Foulds says several studies have shown that that is not true. Smokers would be more likely to move to products such as e-cigarettes and heat-not-burn systems to get the nicotine they crave.
E-cigarettes are not without health risks, according to Foulds. “They are likely to be far less harmful than combustible tobacco cigarettes,” he clarified. “E-cigarettes contain fewer numbers and lower levels of toxicant substances than conventional cigarettes. There’s been more and more evidence that e-cigarettes deliver far, far lower levels of harmful toxicants than cigarettes. It’s become very, very consistent … e-cigarettes can help people quit.”
If regulators allow high-nicotine, reduced-harm products, like e-cigarettes, to remain in the market, Foulds says that it is highly likely that many current smokers will reduce their smoking, quit or switch to reduced toxic-exposure products, resulting in a substantial improvement in overall public health. “It is time for major cigarette manufacturers to support nicotine reduction in combustibles as perhaps their best chance of still being in business in 2030,” he said.
The U.S. Food and Drug Administration’s (FDA) dreaded deadline for its premarket tobacco product application (PMTA) has come and gone after multiple delays. With all that’s happened this year, it may have gone unnoticed for many. Rest assured that the process of submitting a PMTA has been long and tedious for manufacturers and vendors alike, and they have been working hard to ensure that reduced-risk products remain available for as long as possible.
Many companies have been working tirelessly to submit their applications, but the process is fairly opaque and uncertain. The filing of the PMTA does not ensure FDA acceptance, and each product must be filed separately. Currently, it is largely unknown which specific products have been submitted for FDA approval.
What is known, however, is which companies intend to submit or have already submitted a PMTA and how far along they are in the process. Keep in mind that being further along in the approval process is not necessarily an indicator of success. No vapor company at the time of this writing has received FDA approval for any product, and the length of time each submission will remain within the approval process is unknown. With so many unknowns, it can be difficult to predict which products will be legal to carry, if any. By looking at which companies are taking part in the PMTA process along with their histories, one can make reasonable assumptions as to which direction the vapor industry will begin to sway.
First, the bad news. Given that each PMTA is only valid for one “distinct new tobacco product,” and that even the smallest difference in the design of a product could warrant an entirely new SKU, it’s only reasonable to assume that there will be massive consolidation of vapor products. Products that are too similar will need to reconcile, either by being discontinued or redesigned. Even identical products with different colors, flavors, resistances or nicotine strengths could be considered separate SKUs, with each requiring its own PMTA, which has proven to be prohibitively expensive.
The massively varied choices that vapers have in products is undoubtedly going to shrink, but by what degree? A mod is considered one SKU, and an atomizer or tank is considered another. If the mod requires separate batteries, those are also considered an SKU, which requires FDA approval. Said batteries require a charger; that’s another SKU. If the mod and the atomizer come as a kit, that would yield yet another SKU. If the atomizer has three coil options of different resistances, that could require three separate PMTA applications. Clearly, this can spiral out of control quickly, so it’s expected that companies will need to streamline their product offerings.
Two parallel philosophies have been playing out over the past several years. One is to throw everything at the wall and see what sticks. Several companies have been releasing an overwhelming number of products in quick succession to try to get a better feel for what works and what does not. PMTAs are expensive, and many companies have adopted the “measure twice, cut once,” mentality. The past 10 years or so have allowed the industry to innovate, unimpeded by government regulation. This innovation naturally plateaued to a point where vapers have enjoyed a few years of refinement.
The technology seen today is not much different from the technology introduced three years ago. The difference is that today’s products have gone through a process of refinement due to the growing population of vapers providing feedback with both their voices and their wallets. It’s been a completely free market up until this point, and while manufacturers have been steadily improving their products, now is the time to lock in the best of the best and commit to the long term by submitting PMTA applications.
The other philosophy is to streamline the product offering, and this can be seen with the popularity of proprietary systems. For example, 510 devices have pretty much stagnated in popularity while pod systems have seen a boom. If a 510 device is compatible with a thousand 510 atomizers, and vice versa, that’s an impossible number of PMTAs, and without an example of a product that has undergone the process, it would be a huge gamble to try to sell the FDA on a device that is compatible with products outside the applicant’s ecosystem.
The prospect of a device such as a 510-compatible atomizer, which is ripe for facilitating the rise of black market mods, could invalidate the PMTA process on that prospect alone. Not only would the applicant be taking a larger risk by submitting a PMTA for a 510 device, but he would also be complicit in the assumed knowledge that he won’t see a return on that PMTA investment if the end user chooses to go outside said applicant’s ecosystem for complementary products. In short, manufacturer X isn’t going to shell out hundreds of thousands of dollars to submit a PMTA for a 510 mod if vaper Y is just going to turn around and buy an atomizer off the black market.
The most likely scenario is that each company is going to submit PMTAs for a line of products that keep the customer within their ecosystem. Whether that’s one type of product or several remains to be seen, but it only makes sense for any company to want to see the highest return on investment possible. Additionally, this is only the first round of PMTAs, and no product has made it successfully through the process.
It’s unlikely that any applicant has already submitted more than a few products for approval. Even with FDA guidance, the industry is figuratively a canary in a coal mine. Until there is a solid example of a product successfully navigating the PMTA process, companies are likely to be conservative in how many products are submitted for approval. Those that do will likely be product types that have proven to be the most profitable and simple.
Pod systems are the most likely products to have already been submitted, along with e-liquids. They’re the most popular products in today’s market and are the easiest to consolidate. There are many pod systems out there, perhaps too many, but for good reason. They appeal to the widest market and ensure that consumers remain within the ecosystem as they keep coming back for replacement coils and pods.
Pod systems are also the most resistant pieces of hardware when it comes to a black market, therefore mitigating any risk for a PMTA rejection based on that premise. Many companies have released multiple pod systems over the years and by now have a good idea of which designs are the best. In terms of hardware, expect to see a pod system as the first “FDA-approved” vapor product.
As for specific companies to keep an eye out for, look at the largest companies. Smok, Innokin, Vaporesso, Juul—these manufacturers have been preparing for the PMTA deadline for years and have already submitted applications. In fact, almost all the big names in the vapor industry have submitted applications, including Uwell, HorizonTech, Sigelei, Suorin and others. Currently no PMTA has been approved, but none have been rejected either. These companies have the most resources, motivation and resolve to see this process through to the end.
E-liquid, however, is a completely different animal. It takes much more to create vapor hardware than it does to create e-liquid, and that means that smaller companies have also been submitting PMTAs for e-liquid. Unfortunately, much more consolidation will likely also be occurring. Remember, if only one flavor is available in four nicotine strengths and three bottle sizes, that’s potentially 12 PMTAs for “one” e-liquid. So even though more e-liquid companies are submitting PMTAs than hardware manufacturers, each e-liquid manufacturer will likely have to consolidate much more than a hardware manufacturer. This is also heavily reliant on how the FDA receives the PMTA. Many e-liquid manufacturers have submitted one PMTA for multiple flavors, but the success of this method remains to be seen, and the FDA’s own language is ambiguous:
“A manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when [the] FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA …. [The] FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product.
So will each different nicotine strength of each bottle size require a separate PMTA, or can they be combined? It’s unclear, but some manufacturers such as AMV Holdings are confident that multiple SKUs can be covered by a single PMTA successfully. In a Sept. 9 press release, AMV writes, “AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs.”
However, even if multiple SKUs can be approved by the FDA under a single PMTA, consolidation will still occur, and only the most popular flavors, strengths and sizes will be submitted, at least initially. Given the popularity of pod systems, many manufacturers will likely submit a PMTA for e-liquids that use nicotine salts for a high concentration of the stimulant. Non-nicotine e-liquid is also likely to be among the first wave of submissions as well as one that is medium-strength. The reason being is that if a vaper prefers a nicotine strength of 3 mg, then unofficially the user can mix a higher strength with the non-nicotine e-liquid to achieve the desired strength.
Several well-known e-liquid companies have submitted applications, including Humble Juice Co., Suicide Bunny, Charlie’s Chalk Dust and Beard Vape Co. While the more popular flavors may or may not have been submitted, there are several things that can be expected. First, tobacco and menthol flavors will likely be among the first flavors to receive approval, followed by basic fruit flavors.
Like with nicotine strengths, flavors can be mixed by the end user, and by keeping it simple, mixing becomes much easier. Strawberry mixed with banana is much easier than apple-peach-mango mixed with blueberry mint. Depending on how the FDA treats bottle sizes, those may be consolidated to one size as well. Thirty milliliters is far and away the most popular size bottle for e-liquid, so expect that to become the standard.
As the top level of the vapor industry consolidates its products, so too must the ground level. Doing so in a similar way to manufacturers is the most pragmatic approach. If and when products begin receiving FDA approval, look for three “levels” of products—beginner, intermediate and advanced—with minimal variation for each.
At first, all three levels may be pod systems with varying degrees of advanced features, such as variable wattage, temperature control, etc. Beginner devices like disposables and pod systems, such as the Caliburn G from Uwell (see “Building on Success,” page xx), should take priority because even if they are mostly targeted at new and beginning vapers, advanced users can find value in those products as well.
Intermediate-level products can begin to include features such as variable wattage and a larger battery capacity or e-liquid capacity. These are generally features that are requested by beginners who have had time to use a lower level product and find themselves wanting for more. Perhaps it’s more vapor or just not needing to charge the battery quite as much. Each customer base can vary, but those moving to intermediate devices want “more but better.”
Advanced products are much the same but with generally higher power capabilities, e-liquid capacities, etc. The advanced user will generally know what they are looking for. In the current state of the industry, advanced devices generally include rebuildable atomizers as well, but these are likely not going to be a priority outside of niche markets. There’s a good chance that the first products brought through the PMTA process will be on the simple side, and rebuildables could require a separate PMTA for each type of wire and wick in order to be usable.
The mods most commonly used with rebuildables also tend to have removable batteries, of which there are multiple brands that could, again, each require a PMTA submission. There are quite a few “moving parts,” so to speak, when it comes to advanced vapor devices, and until the industry has a more complete knowledge of how to submit a successful PMTA, the more complicated vapor products will likely be left by the wayside.
The most important thing going forward is to simplify, reduce redundant products and provide a clear advancement pathway for new users. There is massive value in being a one-stop shop for new customers to discover vaping and keep coming back as they progress at their own pace. This may prove much easier throughout the PMTA process as a store owner may very well to be able to pick one manufacturer and stick to it since currently, many products are already similar between companies. Consolidation may also serve to clarify and simplify the development of a product line within a store, making it easier for stores and customers alike.
The PMTA process is grueling and stressful for the entire industry. Although choices may soon become very limited, rest assured that the most reputable names in the business will continue to make their products available. Consolidation is inevitable, but one way or another the burden of choice is about to become much lighter, for better or for worse.
Buried in the enormous spending/COVID-19 relief package that Congress approved this week is a bill that imposes new restrictions on the distribution of all vaping equipment, parts, and supplies, including a ban on mailing them. The provision illustrates not only how utterly irrelevant legislation can be slipped into unread, must-pass bills but also how Congress warps reality through legal fictions and uses save-the-children rhetoric to justify restricting adults’ choices, writes Jason Sullum in an opinion piece for Reason, a libertarian think tank.
Jacob Sullum / Credit: Reason
Title VI of the 2021 Consolidated Appropriations Act, which appears on page 5,136 of the 5,593-page bill, is called the Preventing Online Sales of E-Cigarettes to Children Act. The bill was introduced last April by Sen. Dianne Feinstein (D–Calif.), joined by seven original cosponsors: six Democrats plus Sen. John Cornyn (R–Texas). It includes two changes aimed at complicating and obstructing online sales of vapes and e-liquid.
Feinstein’s bill amends the Jenkins Act of 1949, which requires that vendors who sell cigarettes to customers in other states register with the tax administrators in those states and notify them of all such sales so they can collect the taxes that the buyers are officially obligated to pay. In 2002, the General Accounting Office (now the Government Accountability Office) found that online cigarette sellers routinely flouted the Jenkins Act and that the federal government had done virtually nothing to enforce it. Nine years later, Congress amended the law, beefing up its reporting requirements and extending it to cover roll-your-own tobacco.
The Feinstein bill further expands the Jenkins Act, redefining cigarette to include “electronic nicotine delivery systems,” which are not cigarettes. It also counterintuitively defines electronic nicotine delivery system to include products that do not deliver nicotine: “any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device” (emphasis added). That category includes e-cigarettes, e-hookahs, e-cigars, electronic pipes, vape pens, and refillable vaporizers, plus “any component, liquid, part, or accessory” used with those devices, whether shipped together with them or sold separately.
In other words, every product related to vaping, whether of nicotine, THC, CBD, lavender, or anything else, will now be subject to the Jenkins Act’s burdensome requirements. According to Feinstein, a bottle of e-liquid is a cigarette; so is a bottle of herbal essential oil if you plan to vape it. A coil or pod cartridge for a nicotine vaporizer is now also a cigarette; so is a vaporizer designed for THC or CBD oil.
Feinstein’s bill also requires the U.S. Postal Service to “clarify” that the ban on mailing cigarettes covers all of those products, which are not actually cigarettes and may not even have anything to do with nicotine. The new ban, disingenuously presented as a clarification of the existing ban, will take effect within 120 days of the law’s passage.
These reality-defying redefinitions ostensibly are aimed at preventing the sale of e-cigarettes to anyone younger than 21, the minimum age set by federal law. “Buying e-cigarettes online is one of the easiest ways for children and teens to get their hands on these harmful products,” Feinstein said when she introduced the bill. But the new burdens and restrictions go far beyond what is necessary to enforce the minimum purchase age. Requiring robust age verification for orders or an adult signature for deliveries, for example, would prevent sales to consumers younger than 21 without the expensive disruptions this law will cause.
“While there is no shortage of talk in Congress about the importance of small businesses and social distancing, the decision to shove this ban in the middle of a pandemic relief package reveals how hollow that rhetoric is,” says Gregory Conley, president of the American Vaping Association, an advocacy group that supports vaping as a harm-reducing alternative to smoking. “Many Americans at risk of COVID-19 complications have been staying home and ordering their supplies online, but Congress just decided they should either pay much more for shipping or go to a retail store that may not stock the product they use to stay off deadly cigarettes.”
Conley notes that shipping vaping products to minors is already illegal, and “the Food and Drug Administration has repeatedly enforced this law against bad actors in the industry.” While law-abiding vendors for years have been using the postal service’s ID-at-delivery option to comply with the age limit, “this will no longer be permitted.”
In short, a bill presented as a commonsensical effort to enforce the minimum purchase age is actually an assault on the vaping industry and its adult customers. “If the increase in shipping costs wasn’t enough, the bill also imposes huge paperwork burdens on small retailers, and backs it up with threats of imprisonment for even innocent mistakes,” Conley notes. “This is not a law designed to regulate the mail-order sale of vaping products to adults; it’s an attempt to eliminate it.”
Thanks to Feinstein’s sweeping and arbitrary definition of electronic nicotine delivery systems, the impact extends far beyond nicotine vaping. On its face, the law requires companies that sell cannabis vaping devices to comply with the Jenkins Act. It also prohibits them from mailing their products to customers. Although that is already arguably prohibited by federal law, the issue hinges on whether vaping equipment sold without any reference to cannabis nevertheless qualifies as “drug paraphernalia.” As written, the Feinstein bill also imposes these burdens on federally legal products such as CBD oil and herbal extracts used for aromatherapy.
“This could have a significant effect on cannabis vaping products, even if the intent is clearly to curb nicotine products,” Aaron Smith, CEO of the National Cannabis Industry Association, told Marijuana Moment. “We’re making sure that Congress and the incoming administration understand that it would be a misguided waste of resources to apply this to the already heavily regulated cannabis industry. In the long run, it’s important that cannabis is descheduled so it can be appropriately regulated at the federal level, clearing up ambiguities like this.”
What might the new U.S. President’s administration have in store for the vapor industry?
By Patricia Kovacevic
At the time of writing, the results of the U.S. elections are still contested by the presidential incumbent, a Republican, via various vote recount requests and litigation; however, it is a virtual certainty that the U.S. will have a new president, representing the Democratic Party, as of Jan. 20, 2021.
The heads of departments, including the head of the Department of Health and Human Services (HHS), are appointed by the president, subject to confirmation by the Senate, and typically change with the administration. In turn, the Food and Drug Administration (FDA), which is the agency within the HHS with primary jurisdiction over tobacco products (including electronic nicotine-delivery systems, or ENDS) as well as drugs, foods and other products, will be led in the new administration by a new commissioner.
Given the Covid-19 crisis, the new president will be under immense pressure to appoint a new FDA commissioner immediately. Interestingly and somewhat surprisingly, a former FDA commissioner, David Kessler, was recently named co-chair of the new administration’s Covid-19 task force, although Kessler resigned his commissioner role in November 1996 amid controversy for overbilling his travel expenses during his tenure.
Also during Kessler’s tenure, the FDA attempted to regulate tobacco products as “delivery devices for the drug nicotine” to bring tobacco products under FDA jurisdiction. Tobacco companies challenged the rules all the way to the Supreme Court and won (FDA v. Brown and Williamson Tobacco Corp.). The Supreme Court ruled that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA’s [Food, Drug and Cosmetic Act] overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA’s assertion of jurisdiction is impermissible.”
Kessler’s wish to see tobacco regulated by the FDA was eventually granted by Congress in June 2009 through the bipartisan passage of the Family Smoking Prevention and Tobacco Control Act. While some speculate that Kessler may be on the short list for HHS commissioner, it is likely that the administration will bring forward new faces. Still, Kessler’s life-long anti-tobacco stance and past working relationship with the current head of the Center for Tobacco Products might give an indication of the increased scrutiny of the tobacco sector in the years to come.
Patricia Kovacevic
The ENDS industry status quo, from a legislation point of view, while far from ideal, is by now familiar to the ENDS industry. The recent premarket tobacco product application (PMTA) filing deadline has come and gone, and, as expected, we have not seen a flurry of warning letters post-September 2020 ordering certain vapor manufacturers to stop selling their products because they did not submit a PMTA.
The FDA is, however, expected to start enforcing this legislation sooner or later. For any dramatic change to occur, the governing legislation, the Food, Drug and Cosmetic Act, would have to be amended, which is not likely to be top of the list for the upcoming Congress given the priorities the new administration announced during the election campaign. Still, the House of Representatives, one of the chambers of the U.S. legislature, remains dominated by the Democrats, the same party whose representatives initiated several tobacco-related bills and called for confrontational hearings on vapor products. The most recent one, in February 2020, was relatively tame compared with the tone of the July 2019 Juul hearing and even with the June 2014 Senate hearing.
Senate races in Georgia will require runoff elections on Jan. 5, 2021. If Democrats gain both Senate seats in Georgia in January, there would be a 50-50 tie in the Senate, and the vice president would have the tie-breaking vote in case the Senate is deadlocked on a piece of legislation. When the House, Senate and White House are controlled by the same party, the chances of the current administration to pass laws in support of its agenda are greatly increased, though divisions exist within each party, and surprises always happen. Furthermore, 34 out of the 100 Senate seats are up for regular election in two years as well as all 435 House seats; these will be a trying two years for Americans in an economic crisis, and the public sentiment can swing in the other direction. Thus, the new president may have only two years, if even that long, to pass a flurry of laws, and there may be more urgent matters than revisiting the Tobacco Control Act, which, for better or for worse, has worked so far.
The FDA already has broad powers to expand requirements and restrictions involving ENDS products, including the authority to impose product standards through notice-and-comment rulemaking. Ingredient caps and bans are among the standards the FDA has the authority to promulgate via regulation.
The latest unified agenda of regulatory and deregulatory actions
As of spring 2020, active regulatory actions include four potential future regulatory actions by the FDA, rolled over from previous agendas, with no clear deadline for publication of a proposed rule:
Requirements for Tobacco Product Manufacturing Practice (colloquially referred to as “Good Manufacturing Practices”)
Tobacco Product Standard for Characterizing Flavors in Cigars (follow-up to the 2018 Advance Notice of Proposed Rulemaking); this is unlikely to move into the final rule stage on account of recent courtroom successes by the cigar industry.
Modified-risk tobacco product applications; this future proposed rule would establish content and format requirements to ensure that modified-risk tobacco product applications contain sufficient information for the FDA to determine whether it should permit the marketing of a modified-risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified-risk tobacco product application review and require applicants receiving authorization to market a modified-risk tobacco product to establish and maintain records, conduct post-market surveillance and studies, and submit annual reports to the FDA.
Premarket tobacco product applications and recordkeeping requirements, a 2019 proposed rule, which would have as a next step at some point in the future, likely in 2020, a final rule.
Notably, ingredient bans and nicotine caps are not on the regulatory agenda. A first step toward an ingredient ban would likely be an Advance Notice of Proposed Rulemaking (ANPRM), although the FDA can in theory skip this step and move directly to a proposed rule, open a docket for comment, collect comments and consider whether it has sufficient information to finalize the rule. Given the complexity of the issue and the current research focusing on flavor ingredients in ENDS, if the FDA determines that an exploration of a flavor ban is desirable, the FDA will probably go through the ANPRM step.
One would have to wonder, though, why engage in rulemaking when the FDA already reviews all relevant information about every ENDS product on the U.S. market, present and future, through the PMTA process—thus allowing the agency to make a case-by-case determination—and the FDA will no doubt pay considerable attention to certain flavored products. In the author’s personal opinion, the PMTA process is the FDA’s preferred avenue to make decisions on individual products rather than issuing rules on product categories, which can also be challenged—and the current Supreme Court might entertain challenges to the FDA’s behavior if it came to it down the road.
Meanwhile, the majority of states by number still lean conservative, which likely means fewer developments in taxation, some scrutiny of ENDS but not necessary priority placed on shrinking the lawful ENDS market as there is no immediately quantifiable health benefit from doing so, and many potential harms. Of note are the California litigation and the potential referendum in California to overturn SB 793 (the flavor ban legislation). By the time this you read this article, we should know whether the bill opponents succeeded at collecting the necessary signatures to place the referendum on the November 2022 California elections ballot and suspend the application of the California flavor ban until then and pending the referendum’s outcome.
The question we must also ask, given the political, public health and economic crisis context is whether ENDS are a threat to anyone and why any administration would, at this juncture, prioritize overregulating a harm reduction asset over the important, systemic changes Americans expect from the administration and drastically mitigating the Covid impact. The industry is likely to consolidate and survive.
A global legal and compliance nicotine industry expert, Patricia I. Kovacevic has experience that includes general counsel and chief compliance officer roles at Nicopure Labs as well as leading senior legal and regulatory positions at Philip Morris International and Lorillard. Kovacevic served on the board of directors of the Vapor Technology Association and on the advisory board of the Global Tobacco & Nicotine Forum. She is the founder of RegulationStrategy, a global legal and compliance FDA-regulated industry consultancy.
