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Category: Global Regulation

  • Industry Group Files Amicus Brief in Triton Case

    Industry Group Files Amicus Brief in Triton Case

    This week, the Coalition of Manufacturers of Smoking Alternatives (CMSA), a trade coalition that represents a diverse array of members who manufacture and distribute smoking harm reduction products, filed an amicus curiae brief before the Supreme Court of the United States supporting White Lion Investments, dba as Triton Distribution, in its case against the U.S. Food and Drug Administration.

    In its brief, CMSA argues that FDA violated the Family Smoking Prevention and Tobacco Control Act (TCA) in its wholesale rejection of applications for flavored vaping products by applying a surprise and improperly adopted standard and foregoing the required notice-and-comment process. The brief emphasizes that the U.S. Congress specifically requires the FDA to undergo a transparent rulemaking process before imposing any restriction that amounts to a “tobacco product” standard.

    “Importantly, this process tasks FDA with considering the broader public health effects of any such standard, ‘such as creating demand for and increasing the use of unregulated black-market products,’ or other harmful consequences,” the CMSA states. “In its efforts to unilaterally reject flavored vapor product applications based on a new and heightened standard, FDA unlawfully sidestepped this critical regulatory check and operated outside the bounds of its authority.”

    The CMSA states that the FDA circumvented the very procedures Congress imposed to check the arbitrary or unreasonable exercise of such delegated power, and causes real harms as the FDA “misleads and whipsaws” manufacturers seeking to provide a robust set of options for consumers seeking to quit smoking,” the CMSA wrote in its brief. Further adding that “the long delays in FDA’s review of the many PMTAs (premarket tobacco product applications) it has received, coupled with the moving goal posts imposed via the review process, creates a level of uncertainty that severely deters investment and innovation in new products with harm-reduction potential.”

    Earlier this week, 13 members of Congress, including U.S. Senator Roger Marshall and U.S. Representative Andy Harris, filed an amicus brief supporting the position of Triton Distribution and CMSA. In their brief, the members of Congress write, “There is a clear lack of authority for such a ban. Congress has specifically prohibited the FDA from banning products. Despite this, the FDA imposed a categorical prohibition.”

    Also, the Global Action to End Smoking wrote in its amicus brief to SCOTUS that the FDA strayed from a “sensible, science-based harm-reduction approach, adopting an all-or-nothing stance that exalts outright cessation and all but ignores the harm-reduction strategy that Congress mandated…. [ignoring the] overwhelming scientific evidence that e-cigarettes containing flavor additives have an important role to play in moving adult smokers down the continuum of risk.”

    SCOTUS announced Dec. 2, 2024 as the date for the U.S. Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution hearing.

  • Taxpayer Group Files Amicus Brief

    Taxpayer Group Files Amicus Brief

    Image: hafakot

    The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.

    The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.

    Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.

    The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.

    The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.

  • Supreme Court to Hear Avail, Reynolds PMTA Case

    Supreme Court to Hear Avail, Reynolds PMTA Case

    TR Archives

    The Supreme Court of the United States has agreed to consider another case involving federal approval of vapes at the request of the Biden administration on Friday.

    The case arose after the Food and Drug Administration denied R.J. Reynolds Vapor Company’s request to introduce three flavored vapes on the market. The FDA said the company failed to meet federal requirements concerning tobacco products’ marketing, but the company contends that the decision was arbitrary and capricious.

    Reynolds is based in North Carolina, and the federal appeals courts located there and in D.C. already had precedent on the books unfavorable to the manufacturer.

    Under federal law, companies can challenge the FDA denying of a marketing order for a new tobacco product in Washington, D.C., or where the company’s principal place of business is located, reports The Hill.

    The 5th U.S. Circuit Court of Appeals has been more sympathetic to the industry, making it an attractive place for companies to contest their products being denied.

    The 5th Circuit’s rule effectively enables it to host any tobacco company’s challenge, so long as its lawsuit is joined by a convenience store or other retail seller within the 5th Circuit’s borders—which span Louisiana, Mississippi and Texas.

    Reynolds instead filed its challenge in the 5th Circuit alongside Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association. The federal government attempted to move venues, but the 5th Circuit said the additional challengers meant the case was properly brought.

    No matter which way the justices rule, they are not expected to address the merits of the FDA’s denial. The Supreme Court only took up the question of whether the 5th Circuit was a proper venue.

    “There is no circuit conflict over the meaning of this venue provision. And other vehicle problems abound,” the company wrote in court filings urging the justices to turn away the appeal. 

  • Regulations Decimate Philippine Vape Sector

    Regulations Decimate Philippine Vape Sector

    Image: freshidea

    Onerous government regulations have forced about one-fifth of Philippine vaping companies out of business, according to Philippine E-Cigarette Industry Association President Joey Dulay. Importers, he added, have found it easier to comply than their domestic counterparts.

    “But we are pushing them to try and comply,” Dulay was quoted as saying by Business World.

    Under the Vaporized Nicotine and Non-Nicotine Products Regulation Act, manufacturers or importers must register their products and secure licenses to operate.

    They are also required to adhere to packaging standards and pay duties and taxes.

    Manufacturers, distributors and importers were given an 18-month transition period to comply with the regulations laid down in the vape law.

    Dulay noted that many vape brands and manufacturers have yet to secure their Philippine standard quality and/or safety mark and import commodity clearance sticker.

    By the end of August, the Bureau of Customs had confiscated PHP6.5 billion ($115.21 million) worth of illegal vape products, mostly from China.

    The government is estimated to miss around PHP5 billion yearly from illicit vape products.

  • At the Crossroads, Again

    At the Crossroads, Again

    Photo: jorisvo

    There are still more unknowns than knowns about the shape of future European regulation for novel nicotine products.

    By Barnaby Page

    Europe’s relationship with novel nicotine products has always been a mixed one. On the one hand, the more extreme forms of hysteria about youth vaping or supposed health risks have been relatively absent from the European scene; the U.K. in particular has been regarded as perhaps the most pro-vaping major economy in the world. And regulation—in most countries, heavily shaped by the European Union’s Tobacco Products Directive (TPD)—is in some respects light-touch.

    Most notably, rather than following the U.S. model, which in theory requires marketing authorization by the Food and Drug Administration before products can be sold, the EU has eschewed the premarket approval approach and simply asks for products and businesses to be compliant with the TPD’s requirements.

    But if Europe (which for the rest of this article mostly means the EU and its member states) has been looser in its regulatory approach than the U.S. in some ways, many of the requirements that it does make are quite onerous: the 20 mg per milliliter limit on nicotine strength, for example. It is also well known that the TPD as originally conceived was going to be far more restrictive and was only scaled back after pressure.

    And there have been distinct signs lately of Europe becoming more cautious. Most flavors were banned EU-wide in heated-tobacco products; several countries have enacted, or will enact, disposable e-cigarette bans; the Netherlands, usually famed for its tolerance, is an example of a country that has started showing a lot of skepticism toward novel nicotine products; even in the U.K.—no longer an EU member—government support for tobacco harm reduction seems to be ebbing away a little, though it certainly hasn’t turned into outright opposition yet.

    Set against this background, there is concern that the next version of the TPD may make major changes to the EU’s regulatory framework for novel tobacco products, reflecting conservative positions.

    So far, nothing is known for sure about the actual content of the next TPD or about any updates to the lesser-known Tobacco Advertising Directive and Tobacco Excise Directive—though a European Commission spokesperson did confirm to Tamarind Intelligence, late last year, that vaping would be a focus of the TPD. The commission’s job with the TPD is essentially to formulate the legislation, which representatives from all the EU member states, in the European Parliament and the Council of the European Union, then vote on.

    However, looking at what is already happening across Europe gives some indicators of what’s possible—action against disposable vapes in France and Belgium, for example, or against flavored products in Finland and Hungary. Though it’s true that EU policy certainly does not derive directly from localized policy in member states, there are trends visible that are bound to be reflected in Brussels. It’s also worth noting that the much-anticipated swing to the populist right in the most recent European elections failed to fully materialize, which may well mean that the EU will continue to favor tight, precise regulation and not care too much whether it is seen as “business-friendly.”

    First, disposable bans: There have been debates or even legislation in most major European countries over banning disposables, partly because of youth usage but also because of environmental impacts. Even if not all of these come to pass, the fact that an outright prohibition on disposable vapes is so widely seen as a reasonable, proportionate regulatory response—not an unrealistic or extremist one—must make an EU-wide ban a possibility.

    Second, flavors: There is a precedent for some kind of vape flavor ban in the existing EU ban on flavors in heated tobacco, and a number of EU health ministers have given such a measure their support. This would be a greater blow to the industry than a disposables ban, though a crucial question would be exactly what is outlawed and what is permitted.

    The most draconian position would be a reduction of the market to tobacco and perhaps menthol/mint flavors. There could, however, be a middle ground with some other flavors allowed that still removed the more outre and (supposedly) youth-tempting ones from the market; there have also been suggestions that a ban on extreme flavor descriptions, rather than the actual flavors, could achieve the same end. So there are quite a lot of options on the table when it comes to regulation of flavors, and this is perhaps the area to watch most closely.

    Other major areas likely to come under consideration include taxation, and an extension of the existing EU ban on snus (from which only Sweden is exempt) to tobacco-free nicotine pouches.

    An equally big question, however, is when any of this will happen. The process of revising the TPD has been underway for more than two years now, suffering several delays and changes in its schedule.

    For example, the European Commission’s Directorate-General for Health and Food Safety (DG Sante) had originally promised to finalize its evaluation report on tobacco policy last year, but when the commission published its work program for 2024, it made no mention of revising tobacco policy. Therefore, it seems unlikely that there will be major announcements on the TPD or other Europe-wide tobacco regulation in 2024.

    When it eventually does happen, it will be the culmination of a process that started more than two years ago, when the commission launched a call for evidence, which ran from May 2022 to June 2022. This was then followed by a public consultation from February 2023 to May 2023. Eventually, the results of these consultations should be taken into account by the commission when it drafts a directive to be discussed by the Parliament, but so far … nothing.

    So it’s been a long period of near silence even though many expected action—and debate—much sooner. The delays may be partly down to divergence in member states’ positions on tobacco control—it’s going to be hard to come up with Europe-wide policies that at least partially satisfy enough member states and enough competing principles.

    Although the European Commission will be the one to propose the new policies, it is the legislators in the Parliament (and the Council of the European Union, the other “house” of the European legislature) who ultimately vote for or against it. So, while the commission may well be likely to maintain a conservative or even quasi-prohibitionist stance, it’s very possible that Members of Parliament (MEPs) may disagree. Some MEPs who spoke with ECigIntelligence said that they were prepared to fight conservative approaches to novel nicotine products that may be counterproductive for harm reduction, and the influx of new MEPs after this year’s election adds a further level of uncertainty.

    Moreover, positions on novel nicotine products cannot easily be predicted from political affiliation. Generally, the more right-wing a party is, the more easygoing toward novel nicotine products it tends to be (and this would in theory make the broadly rightward trend in politics a positive one for harm reduction’s proponents), but this is far from consistent and there are many exceptions (as indeed there are to that rightward trend).

    For example, arguments prioritizing consumer education and freedom of choice over strict policies, historically usually attributed to right-wing parties, are often also shared by left-wing parties. The national origin of a politician may be just as significant as their nominal position on the left-right spectrum—a left-winger from a country with very strict regulation of tobacco products is often likely, we find, to be more sympathetic to that kind of legal regime than a left-winger from a country with a much lighter touch.

    So there are plenty of unknowns, and of course the unusual position of the U.K.—the biggest market for novel nicotine products in Europe—is another one. When the last TPD appeared, the U.K. was still a member of the EU, and so it adopted the TPD’s measures into its own domestic legislation (as all EU member states must do with European directives). But it has since left the union, via Brexit. The current British government certainly seems to have a hardline attitude on disposables, but there are also indications that it remains supportive of harm reduction, so how aligned the U.K. will remain with the rest of the EU in the future is very much an open question. One distinct possibility is that even if Britain starts to tighten regulation on some aspects of novel nicotine products, it remains more liberal than an EU that gets even tougher.

    Barnaby Page has been covering the tobacco harm reduction business as a journalist for more than 10 years as editorial director at Tamarind Intelligence, a pioneering data intelligence and strategic insight provider offering global market and regulatory data analysis for businesses operating in fast-growing industries. Tamarind currently covers the vapor sector with ECigIntelligence, other tobacco and nicotine alternatives with TobaccoIntelligence, and cannabis with CannIntelligence. This article also incorporates research from other Tamarind staffers.
  • Brazil Mulls Legalizing the Vaping Business

    Brazil Mulls Legalizing the Vaping Business

    Image: Patricia Fragoso

    Brazilian lawmakers are considering a proposal to legalize the vaping business, reports JP.

    E-cigarettes are currently prohibited in Brazil, but they are widely available throughout the nation. To restore order to the market, Senator Soraya Thronicke has proposed legislation that would regulate the production, commercialization, importation and use of vaping devices, as well as establish rules for control, inspection and advertising.

    Among other measures, the proposed legislation would require vaping companies to register their products with the health regulatory agency, the federal revenue service and other agencies. It also prescribes fines ranging from BRL20,000 ($3,678) to BRL10 million for those who sell vapes to buyers under 18 years of age.

    Proponents see regulation as a way to combat the illegal market and protect the population, especially youth. According to the Brazilian Institute of Geography and Statistics, 22.7 percent of Brazilian teenagers have experimented with electronic cigarettes.

    Lauro Anhezini Jr, a board member of the Brazilian tobacco industry association Abifumo, believes the ban is ineffective because it enables suppliers to skirt quality standards. “What we have in Brazil today are illegal products, without any type of oversight, and they pose a risk to consumers’ health, especially teenagers,” he was quoted as saying.

    Anhezini cited the example of the United States, where strict regulations have reduced youth consumption. “In the United States, after the creation of clear rules, the use of electronic cigarettes by teenagers dropped from 27.5 percent in 2018 to 5.9 percent in 2024. This demonstrates how regulation can bring a safer and more controlled scenario for consumers,” he said.

    According to Anhezini, regulation would allow for greater control over product quality, reducing health risks and especially protecting young Brazilians who have easy access to illegal products.

    The discussion also involves economic considerations. The federal revenue service estimates that controlled legalization of e-cigarettes could generate up to BRL700 million in annual revenue.

    However, the federal highway police warns that legalization will not necessarily reduce smuggling, citing the rampant illicit trade in the regulated combustible cigarette market.

    The bill is currently in the Senate’s Economic Affairs Committee and expected to return to the agenda in November.

  • New Zealand Urged to Rethink Disposables Ban

    New Zealand Urged to Rethink Disposables Ban

    Photo: Evgeniy Vershinin

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is urging New Zealand to reconsider its proposed vaping regulations, which include a ban on closed systems, tighter limits on displays in retail shops and new flavor restrictions.

    “This amendment will make it more difficult for adults who smoke to access vaping products, potentially pushing them back to smoking,” said CAPHRA Executive Coordinator Nancy Loucas. “It’s a step backward in our journey toward a smoke-free New Zealand.”

    The CAPHRA submission highlights several concerns. According to the advocacy group, the ban disproportionately affects older adults and those with dexterity issues who rely on simpler closed systems. The proposed display restrictions, says CAPHRA, may deter smokers from switching to less harmful alternatives. Meanwhile, the focus on further display restrictions in retail shops ignores the real issue of social supply to youth, according to the organization, while flavor restrictions could hinder successful smoking cessation efforts.

    “Consumers have the right to make informed choices about their health. This amendment proposes to restrict consumer autonomy and may hinder harm reduction efforts,” said Loucas. 

    “Even the Ministry of Health suggested that the regulations, as they are, are fit for purpose, and the ASH Year 10 survey has shown that youth vaping has declined from the peak a couple of years ago.

    “CAPHRA calls for a more balanced approach, focusing on education and transparent risk communication. By highlighting the facts about vaping, who it is for and what it is, we can combat misinformation and support public health,” said Loucas.

  • Korea Urged to Regulate Vapes as Tobacco

    Korea Urged to Regulate Vapes as Tobacco

    Photo: Teo

    Health advocates are calling on South Korea to regulate e-cigarettes as tobacco products, reports the Maeil Business Newspaper.

    The current law does not classify vapes as cigarettes, which means they are exempt from many of the regulations that apply to tobacco products. For example, vaping companies do not have to print graphic health warnings on their products or charge their customers tobacco consumption tax.

    Article 2 of the Tobacco Business Act defines “cigarettes” as products suitable for smoking, sucking, inhaling, chewing or smelling.

    The calls for expanding the legal definition follow concern about the growth of unmanned e-cigarette stores in Seoul, which are said to have inadequate age-verification procedures.

    A survey by the Seoul metropolitan government revealed that the number of unmanned e-cigarette stores has quadrupled since April.

    According to data from the Korea Centers for Disease Control and Prevention, three out of 10 youth smokers started smoking e-cigarettes from 2019 to 2023. Six out of 10 teenagers who started with e-cigarettes are currently smoking regular cigarettes, the center said.

    Bills to regulate e-cigarettes were tabled in the 20th and 21st National Assembly but failed to cross the plenary session threshold in each instance.

  • Frustration Voiced at FDA Hearing

    Frustration Voiced at FDA Hearing

    Photo courtesy of Plus PR

    U.S. lawmakers and advocacy groups expressed concern about the Food and Drug Administration’s regulation of smoke-free products during a Sept. 10 House of Representatives’ Energy and Commerce Subcommittee hearing.

    Health Subcommittee Chair Brett Guthrie criticized FDA delays and what he viewed as a lack of transparency. “Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an ‘appropriate [for the] protection of public health’ still have no clear guidance and are waiting for hundreds of days for outreach on their applications,” he said.

    “More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences.”

    Full Committee Chair Cathy McMorris Rodgers highlighted the massive backlog of product applications at the FDA’s Center for Tobacco Products (CTP). “Out of the over 26 million applications for electronic nicotine-delivery systems, or ENDS products, the center has authorized fewer than 50 products,” he said.

    “However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is in keeping up with demand.”

    Representative Richard Hudson blamed the CTP for the increase in illegal products on the U.S. market from abroad. “Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or [to] even hear a word from FDA about their application,” he said.

    “The illicit market has been enabled by the Center for Tobacco Products’ lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.”

    In a separate statement, Philip Morris said the hearing put a bright bipartisan spotlight on the fact that the agency is neglecting millions of adult smokers by failing to authorize scientifically substantiated, smoke-free nicotine products that are better alternatives to combustible cigarettes.

    “More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress,” said PMI Director for Regulatory Communications Matthew Sheaff.

    “FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and more importantly provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes.”

    The Taxpayers Protection Alliance (TPA) criticized the FDA’s authorization process and noted the low rate of youth e-cigarette use. “The PMTA costs to manufacturers are astronomical while the regulatory requirements are obscure at best,” Lindsey Stroud wrote on the TPA’s website.

    “To date, the FDA has only authorized 56 products under the PMTA pathway. Given the current low rate of youth e-cigarette use and the high number of adults using novel tobacco products, there is a pressing need for the FDA to adapt its authorization strategies to better serve adults seeking to quit smoking through these alternatives. Lawmakers are urged to advocate for this necessary shift in FDA policy.”

    Americans For Tax Reform (ATR) called on the FDA to educate the public about the continuum of risk for nicotine products. “The agency’s failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75 percent of Americans inaccurately believe vaping is equal to or worse than smoking,” Tim Andrews wrote on ATR’s website.

    “The fact that the agency’s leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA’s tobacco control plan, is a downright scandal.”

  • Mixed Feelings at PMTA Anniversary

    Mixed Feelings at PMTA Anniversary

    Photo: stokkete

    Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).

    Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.

    However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.

    At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.

    According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices for as alternatives to cigarettes, compared with 1,270 combustible products.

    Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.

    “Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.

    “In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”