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.
China’s vapor market has mushroomed offline after the country banned online sales of e-cigarettes about a year ago, reports Bloomberg. Not even the coronavirus has stopped the expansion.
RELX Technology, the country’s largest player, opened more than 1,000 stores in the first half of 2020, and said in January it planned to add 10,000 outlets within the next three years. Its rival, Yooz, has also boosted the number of stores.
Shares in Smoore International Holdings, the world’s largest maker of vaping devices and components for brands, have more than quadrupled in value since the company’s July debut, making it one of Hong Kong’s best-performing initial public offerings of the year. RELX and Yooz are both clients of Smoore.
Smoore founder Chen Zhiping’s net worth has surged to $14.2 billion, according to the Bloomberg Billionaires Index.
While the coronavirus outbreak affected Smoore’s production and operations in the first quarter of the year, it still managed to post a 19 percent increase in revenue to CNY3.9 billion ($592 million) for the first six months, with more than half of its sales coming from mainland China and Hong Kong.
Smoore held one-sixth of the global market share for vaping products by revenue last year, and that pie is poised to grow further, according to Frost & Sullivan data it cited in its prospectus. The $36.7 billion global e-cigarette market will reach $111.5 billion by 2024, increasing at an annual compound rate of 25 percent, projections show.
Mounting restrictions on vapor products globally, including a ban on certain e-cigarette flavor in the world’s largest vapor market, the United States, haven’t scared off investors. Stocks linked to China’s consumer sector have been particularly popular this year as the nation has been among the first to emerge from the pandemic.
The U.S. Congress has banned all electronic nicotine delivery system (ENDS) products from being mailed by the United States Postal Service (USPS). The rule change was lumped into the Covid-19/ omnibus budget bill passed yesterday. The proposal, collectively called the Consolidated Appropriations Act, 2021, now awaits a signature from President Trump to become law. Trump is expected to sign the bill later today.
Credit: Motion Studios
The updated provision redefines the word “cigarette” under the Prevent All Cigarette Trafficking Act (PACT Act), which is part of the federal Jenkins Act, to include ENDS products.
By including ENDS products within the PACT Act, manufacturers and retailers will be banned from shipping vaping products to consumers using the USPS within the next 120 days. All orders of vaping products will be required to ship using an alternate (and considerably more expensive) service that verifies the recipient of a package is at least 21 years old.
Beginning 90 days after enactment, all online retailers also will be required to file monthly reports with native, state and local governments disclosing the identity, address and product received for all customers, as well as remit any excise taxes owed.
Many vaping industry advocates are angered by the text of the proposal because legislators used an expansive definition of what qualifies as an “electronic nicotine delivery system” that seems to include products that may not contain nicotine. The term “means any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device,” the legislation states.
Greg Conley, president of the American Vaping Association, said that despite the inclusion of the word “nicotine,” the definition used in the bill is so broad that it appears to capture vaping liquids containing CBD and standalone devices intended for vaping THC or other substances.
“The sponsors of this legislation repeatedly refused to consider common sense amendments that would have protected youth, while also not needlessly shutting down small businesses. Thanks to their intransigence, the language included in the omnibus is so sloppily drafted that it will also ban the USPS from shipping CBD liquids intended to be vaporized, as well as devices intended for use with THC or other non-nicotine substances,” said Conley. “There are still 36 million American adults smoking combustible cigarettes and over 400,000 will die from smoking-related illnesses this year alone. The American people should start questioning why their government is so intent on making it harder for adults to quit smoking.”
According to its website, UPS prohibits the shipment of all cigarettes and little cigars to consumers, regardless of destination state. Other tobacco product shipments must be made using the “UPS Delivery Confirmation Adult Signature Required service, requiring the signature of an adult 21 years of age or older upon delivery.”
Trump has the authority to use a line item veto on the provision and still pass the larger bill, though that is not expected.
Australians importing liquid nicotine for e-cigarettes will need to have a prescription from Oct. 1, reports The Sydney Morning Herald, citing the country’s medical watchdog.
The Therapeutic Goods Administration (TGA) said its decision balanced consumer demand for the product as a smoking cessation aid and the potential for nicotine e-cigarettes to lead to addiction.
“A patient’s doctor is uniquely placed to give the support required for long-lasting smoking cessation,” the agency said, adding that it had not yet approved any vapor product as a smoking-cessation aid.
In response to the TGA’s decision, the government will scrap contentious customs regulations, which included a fine of up to $200,000 for those illegally importing nicotine. The regulation was opposed by a large group of backbenchers, and due to kick in from the start of next year.
The possession of nicotine-containing e-cigarettes is illegal without a prescription in every state and territory, besides South Australia.
Health Minister Greg Hunt said it was important to note that any doctor could prescribe nicotine-based e-cigarettes.
“This is not widely understood, and it is an important matter of public information that over 30,000 GPs may currently, and in the future, prescribe nicotine-based e-cigarettes for smoking cessation,” he said.
Critics say Australia’s prescription-only policy is hampered by the reluctance of many general practitioners to prescribe liquid nicotine and by a requirement to seek a special exemption for each patient.
Four people have been arrested and 10 million baht worth of e-cigarettes and related items seized in Bangkok following an investigation into illegal online sales of the banned products.
Credit Jim Moylan
The arrests followed a raid by police from the Central Investigation Bureau (CIB) of a warehouse in Kheha Rom Klao Soi 27 in the Rat Phattana area of Saphan Sung district on Friday, according to the Bangkok Post.
The officers seized 50,000 bottles of refill liquid for e-cigarettes, 10,000 refill pods, 1,500 e-cigarettes and 80 boxes of related products worth a total of at least 10 million baht ($335,814), CIB commissioner Police Lt. Gen. Torsak Sukwimol said during a briefing on Saturday.
One woman and three men were arrested. All were charged with colluding in the sale of banned products in violation of the Consumer Protection Act.
Torsak said the CIB had received complaints that e-cigarettes and refill products of various brands were being sold via Facebook. Administrators of the page claimed that their products were made from dried fruits and posed no harm to users.
CIB investigators found that the Facebook page had been active for three years. Female presenters or “pretties” were hired to promote the products, which drew many purchase orders, said Torsak.
The investigators then sought a warrant from the Criminal Court to search the warehouse that led to the seizure of the products, which were imported from China.
Authorities said they would also call the product presenters in for questioning.
The government passed a law banning the sale of e-cigarettes in 2014. Authorities have said import and use is banned for health reasons and because electronic cigarettes lure young people into becoming smokers.
Three recent studies demonstrate the potential for improved health effects that can come from the use of e-cigarettes, when such vaping products are used on a permanent basis and the use of all tobacco products is halted.
Credit: TTI
The arguments used to promote the use of electronic cigarettes (e-cigarettes) and other vaping products is with a reduction in the risk of cardiovascular disease or cancer, and as a strategy to decrease the addiction to conventional cigarettes.
Other smoking related diseases include risk of lung disease, including lung cancer and emphysema. The research areas that support this have been provided by trade site Vapor Solo. In relation to the research, a review commissioned by Public Health England concluded that e-cigarettes were 95 percent less harmful than tobacco.
The first set of research is from the University of Dundee, U.K., drawing on an extensive clinical trial into the cardiovascular effect
CARDIOVASCULAR HEALTH The second area of research relates to a trial that found that patients (114 in total) who switched from smoking to vaping experience a 1.5 percentage point improvement with their blood vessel function, as demonstrated across a four week period. This improvement was as measured against conventional cigarette users. Heart health was assessed using a Fibromuscular Dysplasia (FMD) test, to assess how far a blood vessel opens.
Further studies from the research team are underway to measure the effects over a longer time period across which the broader effects of cardiovascular health can be assessed, including the risk of heart attacks. The results are supported by a second study from the Vanderbilt University Medical Center, U.S.
This research strand showed that heavy cigarette smokers with at least a 20 pack-year smoking history can reduce their risk of cardiovascular disease by 39 percent within five years if they switch to e-cigarettes or quit altogether. In a follow-up letter to The Lancet, the researchers “estimate that e-cigarettes are 95% less harmful to users than smoking. Or, as we prefer, smoking is estimated to be twenty times more harmful to users than vaping e-cigarettes.”
CANCER DEVELOPMENT A similar investigation, this time into the risk of developing cancers, was conducted between the U.S. Centers for Disease Control and Prevention (CDC), the Roswell Park Cancer Institute, U.S., and the University College London., U.K. This study was slightly larger, taking in 181 smokers in order to assess the long-term effects of vaping.
The smoker group included users of electronic cigarettes and conventional tobacco products. To determine the health variance, those involved in the study volunteered to provide saliva, breath, and urine samples. Qualitative questionnaires were also completed.
The data indicated that levels of carcinogens (including tobacco specific nitrosamines, which are one of the most important carcinogens in tobacco formed from nicotine) taken from former smokers who had switched to e-cigarettes were significantly lower compared with regular users of smoking tobacco products.
People who used both types of products, so-termed ‘combination smokers’ did not experience any significant health improvements. The third study was published in the peer-reviewed journal: Annals of Internal Medicine, titled “Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study.”
On Wednesday, the Riigikogu, the unicameral parliament of Estonia, passed an amendment that exempts e-liquids from its excise duty until the end of 2022. By suspending the collection of excise duty, entrepreneurs will be given the opportunity to reduce the price of e-liquid and thus create an incentive for users to purchase products from Estonian sales outlets, not from border trade or the black market, according to Estonian officials.
Credit: Crew2139
The amendments will take effect on April 1, 2021. According to the amendments, excise duty on e-cigarette liquids will be suspended until the end of 2022. Also, the Alcohol, Tobacco, Fuel and Electricity Excise Duty Act will not apply to e-cigarette liquids during that time. During the period when e-liquids are not subject to excise duty, e-cigarette tax stamps do not give rise to an obligation to pay excise duty.
Tarmo Kruusimäe, chairman of the Riigikogu’s smoke-free Estonia support group, said the amendment will help better the health of the Estonian people.
“From June 1, 2018, an extremely high excise duty on e-cigarette liquids came into force in Estonia, as a result of which the black market and cross-border trade flourished. By suspending the collection of excise duties for two years, we are giving traders the opportunity to lower the prices of e-liquid products,” Kruusimäe said, according to an article in the err.ee.
The break in excise duty payment provides an opportunity to change the habits of consumers by redirecting them back to legal, laboratory-tested products, according to Kruusimäe. He also said that Estonia’s tobacco policy so far has been only based on scolding, without the realization that it is not easy for people to overcome an addiction.
“Estonia ranks third in Europe in tobacco deaths. Proven and less harmful alternative tobacco products are helping people quit cigarettes. By offering alternatives, we help maintain the health of the Estonian people,” he said.
Altogether 53 MPs on Wednesday voted in favor of the bill of amendment to the Alcohol, Tobacco, Fuel and Electricity Excise Duty Act initiated by Isamaa, the Estonian Conservative People’s Party (EKRE) and the Center Party.
