Tag: regulation

  • U.S. Supreme Court Overturns Chevron

    U.S. Supreme Court Overturns Chevron

    The U.S. Supreme Court on June 28 overturned the “Chevron deference,” a doctrine that requires courts to defer to federal agencies when sorting out ambiguities in law. The 6-3 majority ruling could impact the U.S. Food and Drug Administration and its premarket tobacco product authorization process. According to critics, the Chevron deference often gives agencies leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    Chris Howard, executive vice president, external affairs & new product compliance for Swisher, welcomed the ruling, saying that for decades federal agencies have had too much power. “That ended today with the Supreme Court’s decision overturning the long-standing Chevron Doctrine,” said Howard. “The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary. It fundamentally alters how courts rule on agency statutory interpretation. As the majority states, courts will no longer be restrained by the need to provide deference.

    “Instead, ‘Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA requires.’ This transformation will likely lead to significantly less regulatory flexibility and increased judicial scrutiny. The implications of this decision will resonate across industries, including the tobacco industry, influencing regulatory practices and shaping the future of administrative law. Regulatory overreach will become the exception as opposed to the norm and enable courts to fulfill their duty to interpret the law.”

    In the years since electronic nicotine delivery systems (ENDS) became subject to FDA regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    “For far too long, unelected bureaucrats at the FDA have been making up the law to suit their own ulterior agenda and Today, the Supreme Court has thankfully put a stop to it once and for all,” said Allison Boughner, vice president of the American Vapor Manufacturers Association. “No longer will it be good enough for prohibitionists in Congress to write vague, Crayola language and then connive behind closed doors with FDA to impose arbitrary policies on the American public that could never withstand the light of day.”

    It has been nearly 40 years since the Supreme Court indicated in Chevron v. Natural Resources Defense Council that courts should defer to an agency’s reasonable interpretation of an ambiguous statute.

    The court’s ruling could have ripple effects across the federal government, where agencies frequently use highly trained experts to interpret and implement federal laws, according to SCOTUSblog. Although the doctrine as relatively noncontroversial when it was first introduced in 1984, in recent years conservatives—including some members of the Supreme Court—have called for it to be overruled.

    The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule, issued by the National Marine Fisheries Service, that requires the herring industry to bear the costs of observers on fishing boats. Applying Chevron, both the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the 1st Circuit upheld the rule, finding it to be a reasonable interpretation of federal law.

    The fishing companies came to the Supreme Court, asking the justices to weigh in on the rule itself but also to overrule Chevron. Roman Martinez, representing one group of fishing vessels, told the justices that the Chevron doctrine undermines the duty of courts to say what the law is and violates the federal law governing administrative agencies, which similarly requires courts to undertake a fresh review of legal questions.

    Under the Chevron doctrine, he observed, even if all nine Supreme Court justices agree that the fishing vessels’ interpretation of federal fishing law is better than the NMFS’s interpretation, they would still be required to defer to the agency’s interpretation as long as it was reasonable. Such a result, Martinez concluded, is “not consistent with the rule of law.”

  • Menthol Marketing Orders ‘Significant Step’

    Menthol Marketing Orders ‘Significant Step’

    By Robert Burton

    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.

    [1] The Global Vaping Market: A Plxsur Snapshot

    [2] E-cigarettes: an evidence update: A report commissioned by Public Health England

  • Vape Registry Rule Slipped Into NC Bill

    Vape Registry Rule Slipped Into NC Bill

    North Carolina State House of Representatives Chamber (Credit: J Zehnder)

    A new bill in North Carolina, if passed, would require the state to certify vaping and other next-generation tobacco products for sale.

    The Senate Judiciary Committee approved the proposal Wednesday. It was slipped into HB 900, which deals with Wake County leadership academies and their ability to maintain state designations. The House passed it without objection.

    To become law, the bill would need to pass the Senate and then the House before the end of the session. Senate leaders have said they plan to complete their work by the end of the month, local media reports.

    The chambers, both controlled by Republicans, have been unable to come to an agreement on budget modifications for the fiscal year that begins July 1.

    A North Carolina lawmaker wrongly told other lawmakers during debate that the U.S. Food and Drug Administration regulates the products, but the regulatory agency does not have the ability to check which products are being sold.

    The bill would fine retailers who sell products that aren’t on the registry for initial violations. The legislation could also suspend or revoke the establishment’s license.

    Vaping industry representatives warned lawmakers that the bill will cost people jobs and money.

    PMTA registry laws are already being enforced in AlabamaLouisiana and OklahomaWisconsin passed a registry law in December and will become effective July 1, 2025. 

    Utah also passed a registry bill that included a flavor ban that will become active on Jan. 1, 2025, and Florida has a unique registry that also begins Jan. 1, 2025.

  • Philippines: New Vape Rules in June

    Philippines: New Vape Rules in June

    Credit: Adobe Photo

    The new Vape Law in the Philippines will take effect on June 1. The new rules also apply to all next-generation tobacco products, including heat-not-burn and e-cigarettes. The Department of Trade and Industry (DTI) will require all vape products to be registered with the agency on that date, an official said on Tuesday.

    At a forum organized by the Bantay Konsumer, Kalsada, Kuryente (BK3) in Makati, DTI Undersecretary Amanda Nograles said the “importation and manufacturing of vaporized nicotine and non-nicotine products and novel tobacco products must now undergo the DTI certification process.”

    This means that products must have the Philippine Standard (PS) mark and Import Commodity Clearance (ICC) sticker first before they can be sold on the market.

    Nograles said at least 3 companies have already applied for registration, and they urge others to begin the process since the registration may take some time. She clarified that there will be a 6-month transition period to allow all firms to comply.

    “We will allow them to sell all the existing inventory. On January 5, 2025, we will do market clearing. There should be no vape products without a PS license and ICC [sticker],” Nograles said, adding that the agency will continue to monitor shops to ensure that no minors will be allowed to buy vape products. They will also check if the vape has marijuana oil.

  • PMTA Filed for Njoy ACE 2.0 With Age Check

    PMTA Filed for Njoy ACE 2.0 With Age Check

    Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.

    The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.

    “Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Njoy President and CEO Shannon Leistra in a statement. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”

    The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.

    Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.

    “Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of regulatory affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

    The Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods.

    Njoy believes its latest applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.

  • White House Asked to Reclassify Marijuana

    White House Asked to Reclassify Marijuana

    Vapor Voice Archives

    The U.S. Drug Enforcement Administration plans to reclassify marijuana as a less dangerous drug, which could have far-reaching implications for American drug policy.

    The proposed measure, which is yet to be reviewed by the White House Office of Management and Budget, aims to acknowledge the medical benefits of using cannabis and recognize the fact that it is less prone to abuse in comparison to some of the most dangerous drugs in the country and reclassify cannabis as a Schedule III drug.

    However, it does not seek to legalize marijuana for recreational purposes.

    Five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review confirmed the agency’s move to the AP on Tuesday. The move clears the last significant regulatory hurdle before the agency’s biggest policy change in more than 50 years can take effect.

    According to the DEA, the following are examples of Schedule I drugs: 

    • Heroin 
    • Lysergic acid diethylamide (LSD) 
    • Cannabis 
    • Methamphetamine 
    • Methaqualone (Quaalude) 
    • Peyote 

    According to the National Institute for Health, California became the first State to make it illegal to possess cannabis. In the 1930s, the then U.S. Federal Bureau of Narcotics warned of the increasing abuse of cannabis, and by 1937, 23 States had criminalized possession.

    By 1970, the Controlled Substances Act passed, and the Federal government categorized marijuana as a Schedule I substance.

    The planned DEA rule change followed an August 2023 recommendation from the Department of Health and Human Services (HHS) that DEA reschedule marijuana from Schedule I to Schedule III. Any change to the status of marijuana via the DEA rulemaking process would not take effect immediately.

  • FDA Warns 14 Sellers of Illegal Flavored Vapes

    FDA Warns 14 Sellers of Illegal Flavored Vapes

    The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.

    The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.

    The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act.

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.

    The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

  • Florida Passes First Disposables Registry

    Florida Passes First Disposables Registry

    Credit: Ajax9

    Florida’s governor, Ron DeSantis, has signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children.

    The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.

    Unlike other state registry lists, Florida is the first state in the nation to include a carve-out for refillable pod systems and open-system vaping products, as well as bottled e-liquids.

    Florida Smoke Free Association president and vape shop owner Nick Orlando was the driving force behind getting the open system exemption.

    In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval, according to media reports.

    The law now directs the state’s Department of Legal Affairs to develop and maintain a directory listing all single-use nicotine vapes it deems attractive to minors. The department must make the list publicly available on Jan. 1, 2025, and regularly update it.

    Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.

    Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors that ship products into Florida.

    Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.

  • Civil Money Penalties for 22 Elfbar Sellers

    Civil Money Penalties for 22 Elfbar Sellers

    Credit: Jeff McCollough

    The U.S. Food and Drug Administration today announced the issuance of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers and two online retailers for selling unauthorized e-cigarettes, including Elf Bar, a popular youth-appealing brand.

    The regulatory agency previously issued warning letters to these retailers for selling unauthorized tobacco products. However, according to an FDA release, follow-up inspections revealed that the retailers had failed to correct the violations.

    Accordingly, the agency is now seeking a CMP of approximately $20,000 from each retailer.

    The approximately $20,000 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including in Sept., Nov., Dec. and Feb.

    The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.

  • Brazil Agency Upholds Vaping Sales Ban

    Brazil Agency Upholds Vaping Sales Ban

    Image: VlaDee/pavlofox

    The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of e-cigarettes and other vaping products, reports Brazil Reports.

    Manufacturing, selling, importing and advertising vapes has been banned in the country since 2009, but e-cigarettes remain widely available in small shops and online stores across Brazil.

    According the Brazilian Institute of Geography and Statistics, 16.8 percent of students aged 13 to 17 said they had tried vaping at least once in their lives. An estimate 4 million Brazilians vape, according to Covitel, which carries out health-related surveys.

    Anvisa’s vote follows a public consultation on the measure. Anvisa justified its position based on the rise in underage vaping in countries that permit e-cigarettes, the addictive properties of nicotine and the lack of long-term studies on the effects of vaping on health, along with the potential impact of allowing vaping on Brazil’s overall tobacco control policies, which have been praised internationally.

    In July 2019, Brazil became the second country to fully implement all measures set out by the World Health Organization  with the aim of reducing tobacco consumption and protecting people from chronic non-communicable diseases.

    In voting to uphold the ban, Anvisa President Antônio Barra Torres cited a December 2023 World Health Organization publication recommending government prohibited electronic cigarettes based on current evidence.  

    The Brazilian Tobacco Industry Association, ABIFUMO, said that banning vapes is “ignoring the learnings of more than 80 countries that have already authorized their sale with clear rules for control, restriction of points of sale and taxation of manufacturers.”

    Philip Morris Brasil said that “maintaining the ban on vapes is out of step with the uncontrolled growth of the illicit market, proven to be accessible to around 4 million Brazilians who use a product daily without any control of quality.”

    Meanwhile, the Senate is debating a bill that would authorize the production, import, export and consumption of e-cigarettes in Brazil. The proposal is still in its early stages and does not have a date for voting.