Vaporetti LLC, an East Providence vape shop, and Sunshine Vape LLC, which runs three stores in Providence, Warwick and South Kingstown, filed a lawsuit against the Rhode Island Department of Revenue, Division of Taxation and Department of Health last month in an attempt to block the statewide ban.
The business owners are asking the court to stop the “unconstitutional” and “unlawful” ban from taking effect on Jan. 1, 2025, media reports. Gov. Dan McKee signed the statewide ban, which was included in his $14 million budget proposal for the next fiscal year, into law over the summer.
In the lawsuit, the business owners warned that the ban would severely impact their bottom lines and force their inevitable closures. “Each [business] derives more than 70% of its annual sales revenue from flavored ENDS products,” the lawsuit explained. “The sale of flavored ENDS products is an integral part of [their businesses], and the viability of their businesses is directly related to their ability to sell these products.”
If enforced, the ban “will prove fatal to these businesses because they cannot survive the loss of nearly three quarters of their revenue.” In the lawsuit, the business owners also stressed that the ban may do more harm than good.
Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).
According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.
IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.
This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.
“The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.
Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.
FDA alignment on key points:
Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.
IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.
“Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer
Vapes are a powerful tool for adult smokers making the transition from cigarettes to reduced-risk products (RRP). The category is governed by market-specific regulation, often influencing public perception and, therefore, uptake.
Last week, following an extensive scientific review, the U.S. Food and Drug Administration authorized the marketing of four menthol-flavored e-cigarette products for Altria-owned vaping company Njoy. This is a watershed moment for the sector and one which will have a huge and significant impact on the global RRP market.
This announcement signifies the FDA’s acknowledgment that menthol vaping products have the potential to be an important and effective tool for adult smokers looking for reduced-risk alternatives. This is significant for the wider sector in a number of ways; above all, it sets a precedent for other markets, paving the way for other regulators, particularly those looking at bans, to consider flavors in the context of public health.
Across the globe, we are seeing an increasing number of markets introduce bans on flavors on a precautionary basis in a bid to mitigate youth uptake. At Plxsur, we have long advocated against the ban of flavors on vape products, arguing that it has the potential to negatively impact those making the transition from conventional cigarettes, who often are drawn to vapes for their flavor, amongst other factors such as price and convenience. There are also arguments and emerging evidence that flavor bans drive the black market sale of unregulated, dangerous products.
There will be many that, understandably, say this decision is “too little, too late,” but it is nonetheless encouraging to see the FDA, with its extensive science and evidence-based review, validating that with effective regulation and enforcement, flavored vape products are “in the interest of public health.” Those countries that have considered flavor bans should look to the U.S. and conclude that it can’t be justified from a scientific review perspective.
While this is the first authorization of a “characterizing flavor” by the FDA for vaping products, two of the major regulatory influencing bodies, the FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA), now acknowledge that there is value in non-tobacco-flavored vaping products.
This decision has the potential to impact the world. The U.S. has long influenced international markets, so it sets a benchmark that we expect other, less vape-supportive governments and regulatory bodies will follow.
Rob Burton
In Italy, tobacco-flavored vapes constitute 40% of the vape market, while menthol represents 21%.[1] This demonstrates the significance of flavored products in the market as a whole. If such flavors were to be banned, this would act as a barrier for smokers to move to reduced-risk alternatives and potentially lead vapers to return to cigarettes.
In some geographies, it is great to see that vapes are being accepted as an effective alternative to conventional cigarettes, even this week’s news from Australia announcing that vapes – which until now have only been available through prescription – will soon be available for sale within pharmacies without the need for a prescription, offering an effective pathway to end the smoking epidemic in the country.
As we anticipate the potential revision of the Tobacco Product Directive Review next year, the justification for banning flavors, from a scientific point of view, simply isn’t there. In the case of Njoy, this has been shown through closed-system pod-based devices, which offer a more cost-effective avenue for existing smokers and disposable systems while incorporating child lock systems that will restrict access to children, as is already applied by a Plxsur company, ProVape, in its SALT and KUBIK brands.
While the FDA’s authorization is specific to these four products made and sold by Njoy and does not apply to any other menthol-flavored e-cigarettes, our expectation is this will open a channel for other such products to achieve authorization by providing the necessary framework and the potential for knowledge-sharing and guidance. With the weight of data-led evidence, the category can advocate for the democratization of this framework, enabling further regulatory authorizations for products produced by responsible vaping companies in the interest of the adult smoker.
At Plxsur, we have a clear purpose – to facilitate adult smokers to make positive health decisions by transitioning away from cigarettes to reduced-risk products. Flavor is a key factor in supporting smokers moving completely to such alternatives, and we look forward to seeing a more science and data-led approach being adopted across all markets as we work to save the lives of those impacted by smoking, mitigate the risk of youth uptake, and do so sustainably and responsibly.
We view this FDA decision as a significant step forward in broadening the pathway for adult smokers, and previously lacking “off-ramp” for U.S. menthol smokers looking to make the switch, which, according to Public Health England, is 95% less harmful and, therefore, undeniably, “in the interest of public health.”[2]
Robert Burton is Group Scientific and Regulatory director for Plxsur.
A new study has found that smokers who get help picking flavored e-cigarettes and receive supportive text messages are more likely to quit smoking, reports The Guardian.
The study was led by London South Bank University (LSBU), and it explored in what settings vapes could help smokers quit. After three months, about 25 percent had quit and a further 13 percent reduced cigarette consumption by more than half.
Those who received help choosing a vape flavor and got supportive texts were 55 percent more likely to quit smoking in three months.
“Smoking kills approximately 8 million people worldwide every year, and even some of the often most effective treatments have little effect on reducing the number of smokers,” said Lynne Dawkins, professor of nicotine and tobacco studies at LSBU. “From this treatment, 24.5 percent were smoke-free after three months and a further 13 percent had reduced their cigarette consumption by more than 50 percent.
“The simplicity of tailored support through flavor advice and supportive messages could have a huge impact in helping people lead smoke-free lives.”
The research examined: tailored advice on which product, nicotine strength or flavor to buy; brief information on vaping harms relative to smoking; and text message support. Some people received all of these, others received none and some received some but not all.
The Netherlands banned flavored e-cigarettes effective Jan. 1, reports The Brussels Times. Companies have until Oct. 1 to remove the flavored products from shelves; retailers can sell their current stock until that date, but new flavors may not be marketed.
Belgium plans to tighten vaping regulation as well, according to Federal Health Minister Frank Vandenbroucke.
“E-cigarettes contain some 1,800 different products of which we are far from knowing all the health consequences,” he said. “Maybe some people will switch from regular cigarettes to e-cigarettes, but maybe by using e-cigarettes, people will just end up smoking regular cigarettes.”
A ban on flavors is not currently planned in Belgium, but a royal decree will soon be published imposing more restrictions on the sale of flavored e-cigarettes. “No more trendy names will be allowed to be given to those flavors, and lights will no longer be allowed on e-cigarettes either,” said Vandenbroucke.
There will be a six-month transition period for the industry to adapt to the new rules and another six-month period to sell current stock.
The idea that e-cigarette flavors hook kids is simple, compelling—and false.
By Clive Bates
In a fact sheet titled “Flavored E-cigarettes Hook Kids,” the U.S.-based Campaign for Tobacco-Free Kids asserts that “Flavored e-cigarettes are undermining the nation’s overall efforts to reduce youth tobacco use and putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use.” Let us call this “the activist proposition.”
The challenge with simple but false activist propositions is that refuting them can require a lengthy embrace of more complex arguments. Brandolini’s law, also known as the bullshit asymmetry principle, can be expressed: “The amount of energy needed to refute bullshit is an order of magnitude larger than to produce it.” In this article, we shall demonstrate Brandolini’s law by addressing the simple but false activist proposition about flavored e-cigarettes through a series of questions.
First, do flavors cause youth tobacco or nicotine use? The activist proposition builds in an assumption that flavors cause e-cigarette use. Lots of young people use flavored e-cigarettes. Therefore, it is claimed, flavored e-cigarettes must cause young people to use e-cigarettes. But how likely is that? We know from the past that a high proportion of young people can use tobacco if they choose to, mostly without flavors. According to the Monitoring the Future survey, for most of the 1990s, U.S. 12th-grade past 30-day cigarette smoking prevalence was at or above 30 percent. By 2021, teenage cigarette smoking had fallen around 4 percent, but nicotine vaping had reached 20 percent. Perhaps there is a persistent demand for nicotine or tobacco, regardless of whether it is flavored. Also, let’s look over time. In the United States, high school past 30-day vaping was 11.3 percent in 2016, rose to 27.5 percent in 2019 but fell to 14.1 percent by 2022. Yet there was very little change in the availability of flavored e-cigarettes to explain these swings. There are also countries where flavors are widely available but youth vaping is relatively low. Take the U.K., for example, which takes a positive approach to tobacco harm reduction and vaping. Thousands of flavored products are available, but according to a recent official evidence assessment, youth vaping remains below 10 percent. And the U.K. offers us a further important insight: “[D]ata showed that most young people who had never smoked were also not currently vaping (98.3 percent).” This tells us that vaping is highly concentrated in adolescents already open to tobacco use.
Second, so what does cause youth tobacco or nicotine use? Most of the evidence points to characteristics of the individual and their circumstances not tobacco product features. Tobacco use is driven by a complex mix of psychosocial factors, including genetics, parental smoking, poverty, delinquency, rebelliousness, low self-esteem, peer group, etc. A 2016 literature review identified 98 conceptually different potential predictors of smoking onset. A 2019 study looked at stated reasons for e-cigarette use and concluded there were two main drivers: “alternative to cigarettes” and the “larger social environment.” For some young people, tobacco or nicotine use may have functional benefits. It may modulate stress or anxiety, improve concentration or help control conditions such as attention deficit hyperactivity disorder(ADHD). For others, it may be just frivolous and experimental. In 2019, the U.S. Centers for Disease Control and Prevention asked young people why they vaped; the top reason was, “I was curious about them.”
Third, what would teenage vapers do if they were not vaping? Implicit in the activist proposition is the idea that removing flavors will remove the reason to vape and stop the user from vaping. At one level, there is some truth in this. If the products are bland, unpleasant or tasteless, perhaps no one will use them. But here is the problem: What if the demand for tobacco and nicotine has deeper psychosocial causes, such as those discussed above? Removing the flavored products does not make the demand go away. Would the teenage vapers just give up vaping and do more homework and piano practice instead? If the underlying demand remains, that is unlikely. Teenagers interested in nicotine might revert to cigarettes, cigars or other tobacco products. We have some evidence for this: When e-liquid flavors were banned in San Francisco in 2019, there was an increase in teenage smoking compared to other areas where flavors had not been banned. This is hardly a surprise—in one study, young adults were asked what they would do if e-cigarette flavors were banned. About one-third said they were likely to switch to cigarettes.
In 2022, Boston-based public health scientists Mike Siegel and Amanda Katchmar reviewed the body of evidence on youth smoking and vaping, concluding that it “suggests that youth e-cigarette use has instead worked to replace a culture of youth smoking.” Economic analysis also backs this idea—when prices of e-cigarettes increase, youth vaping falls, but youth smoking rises. That tells us that e-cigarettes and cigarettes function as substitutes. If regulators ban e-cigarette flavors, then they should not be surprised if more smoking is the result. For that reason, Siegel and Katchmar concluded “[W]e propose a reevaluation of current policies surrounding e-cigarette sales so that declines in e-cigarette use will not come at the cost of increasing cigarette use among youth and adults.” That is very troubling for the activist proposition—it means policies to address youth vaping cannot be evaluated without concern for their effect on youth smoking. It also means that some youth vaping may be a diversion from smoking and is beneficial. It follows that regulation discouraging vaping could easily be harmful.
Fourth, how would a ban on flavors work? The logic of the activist proposition is that a ban on flavored products would remove flavored products from the market, thus removing the reason for young people to vape. But that is not how prohibitions work in practice. A prohibition does not cause the prohibited product to disappear. But in practice, a prohibition causes the perturbation of a market. It causes changes to the behavior of consumers, legal and illegal suppliers, prices and availability. Foreseeable consequences include switching to cigarettes or other tobacco products; switching to other substances; switching e-cigarettes to the permitted flavors; illicit trade in flavored liquids; home mixing and informal selling; cross-border trade or internet sales; stockpiling and workarounds such as sales of flavors for aromatherapy. Prohibitions change the supply side, and rarely for the better. There should be no mystery about this: Despite longstanding prohibition, the Monitoring the Future survey shows that U.S. 12th-grade past 30-day cannabis use has been around 20 percent and daily use around 5 percent for about the past 25 years. Some of these responses to flavor prohibition will clearly increase harm compared to vaping. Because smoking is so much more harmful, it would only take a slight uptick in smoking to offset any benefit of significantly reduced teenage vaping. But there are also hazards arising from informal manufacturing and workarounds. Illicit supply will bring adolescents into contact with criminal networks as consumers and potentially as low-level participants.
Fifth, what is really going on with youth vaping? I believe there are two broad patterns of youth vaping and two distinct behaviors at work, but these are often conflated. The first is frivolous and experimental use, where young people try new things. This has characteristics of a frothy fad: infrequent use, transient and unpredictable. The second is more determined nicotine use: frequent, intense and entrenched. But this group is more likely to be the adolescents who would otherwise be using cigarettes or other tobacco products. The first group contributes to the “youth vaping epidemic” narrative but is not really a cause for great public health concern. The second group represents the migration of nicotine use in society to far safer technologies and is likely beneficial for public health. The activist proposition, however, requires policymakers to believe there is no latent demand for nicotine use and that removing products will eliminate nicotine from society. But it is much more plausible to think of the demand for nicotine in similar terms to alcohol, caffeine, cannabis and other recreational substances. People use nicotine for a reason, and there will be a long-term demand for it. The task for policymakers and regulators is to make that acceptably safe and to resist simplistic activist propositions that are likely to do more harm than good.
In November 2022, the Campaign For Tobacco Free Kids celebrated the success of a mass activist campaign to secure Proposition 31, a ban on flavored products in California. They may have won their political battle, and their aggressive promotion of the activist proposition has again prevailed. But nowhere in its advocacy literature does this powerful coalition level with California’s voters about the underlying drivers of youth nicotine use, the linkages between smoking and vaping, and the risks of unintended consequences. They can deny this real-world complexity, but policies built on bullshit have a nasty tendency to go wrong, to do more harm than good and to call into question the credibility of their advocates.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
The nicotine business is bracing for a likely “yes” vote in the Nov. 8 ballot on California’s flavored products ban.
In 2020, California lawmakers passed a ban on all flavored nicotine products—including vapes and cigarettes—except in hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.
Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.
If voters uphold the legislation next week, California will join a number of states that have already prohibited the sale of at least some flavored nicotine products. Massachusetts banned the sale of flavored nicotine products (including menthol) in 2019; New Jersey, Rhode Island and New York have all banned flavored vaping products.
California’s proposed law is unique in that it also bars so-called “flavored enhancers,” preventing a person from buying flavored non-nicotine e-liquid and adding it to flavorless nicotine at home.
An Oct. 4 poll from the Berkeley Institute of Governmental Studies found that 57 percent of respondents planned to support the flavor ban, whereas just 31 percent would vote “no,” with only 12 percent looking to be undecided.
Supporters of the ban appear to have outspent opponents by a significant margin. By mid-October, the billionaire anti-smoking and anti-vaping activist Michael Bloomberg had provided $15.3 million of the $17.3 million raised by the committee in favor of the ban, according to the San Francisco Chronicle. By contrast, the opposition had raised just over $2 million, almost entirely comprised of donations from Philip Morris USA ($1.2 million) and R.J. Reynolds ($743,000).
Critics worry that, if passed, the ban will spawn a considerable illicit market, as it appears to have done in states that have similar restrictions in place. Massachusetts’ ban on tobacco flavors, for example, appears to have encouraged smokers and vapers to obtain their products in neighboring states.
The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for several menthol-flavored vaping products marketed by Logic Technology Development. The products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. It’s the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
The move seems inline with the regulatory agency’s goal to ban menthol flavors from tobacco products. The FDA also isn’t expected to approve any flavored vaping product other than tobacco. In June, the National Institutes of Health and the FDA gave the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products. The study is still being conducted.
“Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP), in a release. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Vapor Voice the latest move by the FDA to ban menthol vaping flavors is reminiscent of the agency’s “fatal flaw” review of PMTAs that resulted in millions of denials. The term “fatal flaw” was used by the FDA for PMTA submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The dysfunction at the FDA knows no bounds. For the last year-plus, the FDA has sat back deferred decision making on menthol vaping products,” Conley said. “Lest anyone believe that FDA was hard at work coming up with ways to achieve balance, today they revealed that their big plan for menthol vaping products is to follow the exact same ‘fatal flaw’ review process that has led to dozens of lawsuits being filed against the agency.”
The agency stated that after reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”
The FDA stated that the evidence provided within Logic’s denied PMTAs did not demonstrate that menthol-flavored e-cigarettes are more effective in promoting “complete switching or significant cigarette use reduction” relative to tobacco-flavored e-cigarettes.
The announcement is concerning, especially since CTP is undergoing an external review in which many industry stakeholders have called for a comprehensive plan for PMTA reviews, according to Tony Abboud, executive director of the Vapor Technology Association. He says that the FDA’s action raises at least four major concerns.
“First, the announced rationale makes no mention of the net public health benefit prong, begging the question of whether FDA addressed that required element of the APPH test? Second, how is the public health benefitted by FDA’s approval of 123 new menthol cigarette/cigar products, given its inability to authorize a single less-harmful menthol vaping product?” Abboud asks. “Third, how can the Agency continue to rely on general (i.e., non-Logic specific) menthol youth data to impose a heightened Logic-specific cessation standard, especially given the dramatically reduced [National Youth Tobacco Survey] NYTS youth use rates and no apparent tie to Logic products?
“Fourth, is the Agency undermining its proposed menthol cigarette rule, given that FDA’s science shows that half of the predicted quitters under the proposed standard must switch to menthol vapes, none of which have been authorized?”
Logic must now decide if it will resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. However, the FDA states that for non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, “existing evidence demonstrates a known and substantial risk” with regard to youth appeal, uptake and use.
“The FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard,” said King. “In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth.”
A recently accepted manuscript of an article set for publication in Nicotine & Tobacco Researchfound that flavored vaping and other tobacco sales restrictions in California did not affect youth e-cigarette use.
The MDO letter that Logic received today is not limited to the two products named above, according to the agency. In general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
In addition to ensuring that Logic complies with this order, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the “statutorily required premarket authorization” are marketed unlawfully and their distribution or sale is subject to enforcement action.
Recently, the U.S. Department of Justice filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Retailers should contact Logic with any questions about products in their inventory.
In a 2-1 decision, a panel of the U.S. Court of Appeals for the Ninth Circuit held that the Family Smoking Prevention and Tobacco Control Act neither expressly nor impliedly preempts Los Angeles County’s ban on the sale of flavored tobacco products.
On March 18, 2022, a divided panel of the U.S. Court of Appeals for the Ninth Circuit held that Los Angeles County’s flavored tobacco ban is not preempted by the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (June 22, 2009) (the “TCA”). Judge Lawrence VanDyke wrote the majority opinion, which was by joined by Judge Karen E. Schreier of the U.S. District Court for the District of South Dakota sitting by designation on the Ninth Circuit. Judge Ryan D. Nelson dissented. The case is R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 20-55930 (9th Cir. Mar. 18, 2022).
As previously reported (here and here), the litigation focuses on a Los Angeles County ordinance making it unlawful for tobacco retailers/licensees to sell flavored tobacco products or components, parts, or accessories intended imparting a characterizing flavor to a tobacco product or nicotine delivery device. Enforcement of the ban was to begin May 1, 2020, and a few days later the plaintiffs initiated litigation in the U.S. District Court for the Central District of California. The plaintiffs contended that the County’s flavored tobacco ban is expressly preempted under the TCA, 21 U.S.C. § 387p(a), or impliedly preempted as an obstacle to the fulfilment of Congress’ purposes and objectives in enacting the TCA. At the trial level, Judge Dale S. Fischer of the U.S. District Court for the Central District of California held that the County’s flavor ban is not preempted. She denied the plaintiffs’ requests for a preliminary injunction and for summary judgment and dismissed the case for failure to state a claim.
The plaintiffs appealed to the Ninth Circuit. The Washington Legal Foundation filed an amicus brief in support of the plaintiffs. The State of California filed an amicus brief in support of Los Angeles County, as did a number of public health, medical, and local government organizations.
Judge VanDyke’s Majority Opinion
Judge Lawrence VanDyke
Judges VanDyke and Schreier affirmed Judge Fischer’s holdings, agreeing that the County’s flavored tobacco ban is not preempted.
On the issue of express preemption, the majority addressed 21 U.S.C. § 387p(a), including its “preservation clause” (subsection (1)), “preemption clause” (subsection (2)(A)), and “savings clause” (subsection (2)(B)).
In the majority’s view, [T]he TCA’s text sandwiches limited production and marketing categories of preemption between clauses broadly preserving and saving local authority, including any “requirements relating to the sale” of tobacco products. This unique “preservation sandwich” enveloping the TCA’s preemption clause reveals a careful balance of power between federal authority and state, local, and tribal authority, whereby Congress has allowed the federal government to set the standards regarding how a product would be manufactured and marketed, but has left states, localities, and tribal entities the ability to restrict or opt out of that market altogether.
As to the preemption clause, the majority held the County’s flavor ban is not a preempted “requirement which is different from, or in addition to, any requirement under the provisions of [the Food, Drug, & Cosmetic Act’s ‘Tobacco Products’ Subchapter] relating to tobacco product standards.” Seeid. § 387p(a)(2)(A). The majority read that clause’s reference to preempted “tobacco product standards” as “pertaining to the production or marketing stages up until the actual point of sale.” Thus, the majority concluded “that the phrase ‘tobacco product standards’ in the TCA’s preemption clause does not encompass the County’s sales ban.”
Ninth Circuit Court of Appeals
The majority continued, opining that even if the County’s flavor ban were covered by the preemption clause, it would still survive preemption as a permissible “requirement[] relating to the sale . . . of[] tobacco products [to] individuals of any age” under the savings clause. Seeid. § 387p(a)(2)(B). The majority opined that “[a] ban on the sale of flavored products is, simply put, a requirement that tobacco retailers or licensees throughout the County not sell flavored tobacco products.” As to the “of any age” language in the savings clause, the majority considered this to “suggest[] that state and local governments are not limited to enacting only age-based rules, but rather can enact regulations for people ‘of any age’—in other words, for everyone.
“Because the County banned the sale of flavored tobacco products to all individuals ‘of any age,’ the savings clause squarely applies.”
Holding that the County’s flavor ban also survived the claim of implied preemption, the majority said that the ban is not “‘an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’ expressed in the TCA” as “the TCA does not mandate that certain flavors must remain available for sale, and expressly preserves local authority to enact sales regulations more stringent than the TCA.” (Citation omitted.)
Judge Nelson’s Dissenting Opinion
Judge Ryan D. Nelson
Dissenting, Judge Nelson opined that he would have found Los Angeles County’s flavored tobacco ban expressly preempted.
According to Judge Nelson, the focus of the County’s ban on the point of sale does not remove it from the preemption clause’s coverage as a “requirement which is different from, or in addition to, any requirement under the provisions of [the Food, Drug, & Cosmetic Act’s ‘Tobacco Products’ Subchapter] relating to tobacco product standards.” Seeid. § 387p(a)(2)(A). Judge Nelson referenced two preemption decisions of the Supreme Court addressing other statutory schemes, where the Court reversed the Ninth Circuit’s distinction of a State or local sales limitation from a preempted product standard. SeeNat’l Meat Ass’n v. Harris, 565 U.S. 452 (2012); Engine Mfrs. Ass’n v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246 (2004). He also considered the majority’s reasoning to rely too heavily on the TCA’s preservation clause, which expressly states that it applies “[e]xcept as provided in” the preemption clause. See21 U.S.C. § 387p(a)(1). The savings clause did not save the County’s flavored tobacco ban from preemption, as Judge Nelson read that clause only to “save[] for states the authority to enact age requirements.”
Judge Nelson concluded,
The majority reads these three clauses as a “preservation sandwich served up by the TCA.” Majority at 25. But in holding that Los Angeles’s ban is not preempted, the majority has actually folded itself into a pretzel. The majority argues that the preemption clause is “hardly useless,” because the federal government is still the only one that can technically set standards. Majority at 30–31. But under the majority’s reading, states and municipalities can ban anything made with standards that they don’t like, and thus can “opt out of [the federal standards]” entirely. Id. This is the very reasoning that the Supreme Court says “make[s] a mockery” of a preemption clause. Nat’l Meat, 565 U.S. at 464. By construing the TCA’s preemption clause to allow sales bans that defeat its entire purpose, the majority does just that.
(Alterations in original.)
References in the Eighth Circuit
Business concept about U.S. Eighth Circuit with sign on the piece of paper.
The Ninth Circuit’s majority and dissenting opinions have since been referenced by the parties to an appeal pending before the U.S. Court of Appeals for the Eighth Circuit. R.J. Reynolds Tobacco Co., et al. v. City of Edina, et al., No. 20-2852 (8th Cir.), on appeal fromNo. 0:20-cv-01402 (D. Minn. Aug. 31, 2020) (granting the City’s motion to dismiss and denying the plaintiffs’ motion for preliminary injunction). That case involves similar TCA preemption claims regarding the City of Edina, Minnesota’s prohibition on the sale of flavored tobacco products. It was argued before Judges Steven M. Colloton, Roger L. Wollman, and Jonathan A. Kobes on May 12, 2021.
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It remains to be seen whether the plaintiffs will seek further review of the Ninth Circuit’s decision en banc or before the Supreme Court.
For the time being, the Ninth Circuit’s decision is significant not only for Los Angeles County but also other jurisdictions within the Ninth Circuit that have enacted (or may enact) similar flavored tobacco bans. For illustration of the decision’s significance within the Circuit, as of the filing of California’s amicus brief on May 14, 2021, “at least 71 localities” in the State “ha[d] prohibited the sale of all flavored tobacco products,” and the State Legislature had passed similar legislation subject to a referendum to be held in November 2022. The majority’s holding and essential reasoning in Los Angeles County will be binding upon lower federal courts within the Circuit – and panels of the Ninth Circuit – addressing materially-similar TCA-preemption cases.*
It will also be interesting to see how the Eighth Circuit resolves the City of Edina case, including whether (and to what extent) that court considers Judge VanDyke’s majority opinion – or Judge Nelson’s dissenting opinion – more persuasive.
* Notably, there is a pending Ninth Circuit appeal involving claims that the TCA preempts San Diego County’s flavored tobacco ban, R.J. Reynolds Tobacco Co., et al. v. San Diego Cnty., et al., No. 21-55348 (9th Cir.), on appeal fromNo. 3:20-cv-01290 (S.D. Cal. Mar. 29, 2021) (granting the County’s motion to dismiss and denying the plaintiffs’ motion for preliminary injunction); however, that case has been administratively closed since May 28, 2021, and it is set to remain administratively closed until May 24, 2022
China’s State Tobacco Monopoly Administration (STMA) regulations for e-cigarettes are strict. The country will begin enforcing the license management for e-cigarette production, wholesale and retail entities starting from May 1, according to a translated version of updated regulations. They apply to all hardware and e-liquid products, including all components and ingredients. The announcement follows preliminary draft rules authorities issued in December 2021.
“The administrative department in charge of tobacco monopoly of the State Council takes charge of national supervision and management of electronic cigarettes, and is responsible for the formulation and organization of implementing electronic cigarette industry policies,” the regulations state. “The administrative department in charge of tobacco monopoly of the State Council shall organize professional institutions for technical review of electronic cigarette products based on inspection and testing reports and other application materials.”
Rules for products being produced for export could be market changing, and crushing for destination countries. China states that all products produced for export must comply with the regulations and laws in the destination country. If a country does not regulate e-cigarettes, China’s rules for vaping products would apply to those exports, including bans on flavors and synthetic nicotine.
“Electronic cigarette products not sold in China and only used for export shall comply with the laws, regulations and standards of the destination country or region,” the rules state. “If the destination country or region does not have relevant laws, regulations and standards, they shall comply with China’s relevant laws, regulations and standards.”
One industry expert with knowledge of China’s vapor industry said that China may choose to not enforce its export rules, however. “China doesn’t want to crush vaping exports,” he said. “They could choose to hold back enforcing the export provisions.”
The most critical changes locally in China’s rules is the country will now ban all non-tobacco flavors. China will also not allow for the sale of open systems, only closed pod systems will gain marketing approval. The importation of any vaping related products, such as pre-mixed e-liquids, must also be approved by Chinese authorities, according to the regulations.
Any company that produces e-cigarettes in China must now get a license. If a company wants to expand its production or product portfolio, the company must garner approval from the STMA. All nicotine must be tobacco derived and purchased from approved sellers in China, the regulations state. Chinese regulators will also establish a unified e-cigarette traceability system to strengthen the whole-process management of vaping products.
“Electronic cigarette wholesale enterprises shall not provide electronic cigarette products to units or individuals that are not qualified to engage in electronic cigarette retail businesses,” the regulation states.
The rules also state that “enterprises or individuals that have obtained the tobacco monopoly retail license … shall purchase electronic cigarette products from local … wholesale enterprises, and shall not exclusively operate the electronic cigarette products sold on the market.” One industry expert explained to Vapor Voice that the statement means all retail outlets must sell multiple brands and not just a single brand. Traditionally, stores such as RELX, the largest vaping retailer in China, only sold its own brands.
Additionally, authorities will establish a “unified national electronic cigarette transaction management platform” that e-cigarette industry businesses that have obtained tobacco monopoly licenses must conduct all transactions through. It is unclear if China will also begin cracking down on manufacturers of counterfeit products for export, however, the rules do encourage the reporting of these and other illegal manufacturers.
“Rewards will be given to units and individuals who have made meritorious deeds in reporting cases of illegal production and sales of electronic cigarette products, e-atomization material products and electronic cigarette nicotine,” the rules state.
