Tag: e-cigarettes

  • Smoore Reports Half-Year Revenue of $705.4 Million

    Smoore Reports Half-Year Revenue of $705.4 Million

    Photo:TacoTuinstra

    Smoore International Holdings reported revenue of RMB5.04 billion ($705,4 million) for the six months that ended June 30, down 1.7 percent from the comparable 2023 period. Gross profit rose 3.2 percent to RMB1.91 billion while pretax profit was up by 1.9 percent to RMB811.56 million.

    The group’s branded business grew by 71.9 percent to RMB1.12 billion in the first half of 2024, boosted by the company’s digital marketing operations, which enabled the company to respond rapidly to consumer preferences. The group’s Vaporesso brand continued to increase its market share in the open system product segment and has become the leading brand in this category.

    Smoore’s corporate client sales meanwhile, declined by 12.3 percent to RMB3.92 billion in the first six months of 2024, reflecting  different sales performances in different markets around the world.

    In the U.S., Smoore faced competition from noncompliant vaping products. However, the company said it was encouraged by clarifications of the regulatory framework and the strengthening of enforcement in that market, pointing to creation of a federal multi-agency task force to combat the illicit market, among other developments.

    Increasing regulation of the vaping market in Europe, meanwhile, has impacted demand for traditional disposable products, causing the group’s revenue from single-use vapes to decline by approximately 18.9 percent year-on-year to approximately RMB1.22 billion.

    Smoore said it has successfully launched a number of new closed system products in the international market in the first half of the year, and it is confident that this will translate into stronger orders in the second half of the year.

    In China, where the group’s corporate client oriented business centers on closed system electronic vaping products, Smoore reported sales revenue of RMB87.78 million, representing an increase of approximately 41.4 percent  as compared to the same period last year.

  • Supreme Decision

    Supreme Decision

    Credit: Sean Pavone Photo

    The U.S. vaping industry is anxiously awaiting a decision from the highest court in the land.

    By Timothy S. Donahue

    The Supreme Court of the United States (SCOTUS) is poised to address a crucial case for the vaping industry that challenges the U.S. Food and Drug Administration’s decision to block the marketing of flavored e-cigarette products. The FDA is contesting a lower court ruling that favored two vaping companies, which argue that the FDA unjustly rejected over a million premarket tobacco product applications (PMTAs) to sell flavors other than tobacco or menthol.

    Under the agency’s PMTA pathway, companies must demonstrate that the marketing of a product would be appropriate for the protection of public health (APPH). When the FDA makes decisions about vaping products, it must take into consideration the risks and benefits to the entire population, not just users of the products.

    The case, Wages and White Lion Investments v. U.S. FDA, is compelling because a major factor in predicting how SCOTUS will rule in the first vaping case to be heard by the high court, and potentially at least three others, is that in the wake of another SCOTUS ruling, courts no longer need to defer to agency interpretation of the law simply because a statute is ambiguous (see “Principle Response,” page 22).

    Gregory Conley, an experienced industry attorney and director of legislative and external affairs at the American Vapor Manufacturers Association, said that the overturning of the Chevron deference could have a profound impact on the vaping and broader nicotine industries by reducing the deference courts previously granted to regulatory agencies like the FDA.

    “Judges will now critically evaluate the FDA’s regulatory processes and interpretations of ambiguous statutes rather than assuming the agency knows best,” Conley said. “In simpler terms, for the first time since its creation, the FDA’s Center for Tobacco Products will have to follow the law as written.”

    Vape companies secured a legal victory when the 5th U.S. Circuit Court of Appeals sided with Wages and White Lion (doing business as Triton Distribution) and Vapetasia when it overturned the orders denying the marketing of the companies’ flavored products. In its decision, the 5th Circuit condemned the FDA’s imposed requisites as “unfair,” noting that the agency “unexpectedly demanded” that the companies present studies demonstrating that flavored products would contribute to smoking cessation.

    In January, the en banc panel of the 5th Circuit voted 9-5 to grant the petitions for review. The judges ruled that the FDA had been “arbitrary and capricious,” in violation of a federal law called the Administrative Procedure Act (APA), by denying the applications without considering the companies’ plans to prevent underage access and use.

    “Over several years, the [FDA] sent manufacturers of flavored e-cigarette products on a wild goose chase. First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products. Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need,” Circuit Judge Andrew S. Oldham wrote in the majority opinion. “The agency said manufacturers’ marketing plans would be ‘critical’ to the success of their applications.

    “And the agency promulgated hundreds of pages of guidance documents, hosted public meetings and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so.

    “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all 1 million flavored e-cigarette applications for failing to predict the agency’s volte-face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

    The case began when the FDA rejected 55,000 applications to market flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval. The Office of the Solicitor General asked the Supreme Court to review whether the 5th Circuit’s decision relied upon “legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders.”

    The regulatory agency’s “legal theories” in Triton are based on administrative fairness and regulatory consistency, not Chevron deference. In most vaping industry lawsuits, appeals courts have supported the FDA, and manufacturers have sought appeals. In the Triton Distribution case, however, the FDA had to petition the court to review the 5th Circuit’s decision, which was based more on APA violations. SCOTUS is scheduled to hear the case sometime during its new session, which begins in October.

    Conley explained that, while the end of Chevron signals a new openness by the Supreme Court to scrutinize federal agencies, the 5th Circuit’s opinion focused on matters of statutory interpretation, including procedural conduct and the FDA’s sudden imposition of new standards without proper notification.

    “With or without Chevron deference, we believe that the ‘switcheroo’ pulled by the FDA was arbitrary, capricious and not in line with the Administrative Procedures Act,” said Conley. “This stance aligns with the court’s broader view that agencies should not have unchecked power to interpret and enforce ambiguous statutes without clear congressional authorization.”

    Much of the lower court’s opinion is based on APA violations. The APA process for creating federal regulations has (typically) three main phases: initiating rulemaking actions, developing proposed rules and developing final rules. In practice, however, this process is often complex, requiring regulatory analysis, internal and interagency reviews, and opportunities for public comments.

    At its most basic level, the APA requires that an agency create a draft proposed rule, review/approve it, publish a notice of proposed rulemaking in the Federal Register and open a public comment period of at least 30 days. In a footnote to the Triton decision, the court characterized the FDA’s denial of all PMTAs for nontobacco-flavored e-cigarettes as a “de facto flavor ban” that circumvented the APA’s required notice-and-comment rulemaking process:

    “(5) FDA’s categorical ban has other statutory problems. For example, the TCA states that FDA must follow notice-and-comment procedures before adopting a ‘tobacco product standard.’ See 21 U.S.C. § 387g(c)–(d). And Congress specifically called a ban on tobacco flavors a ‘tobacco product standard.’

    “See id. § 387g(a)(1)(A) (referring to tobacco flavors, ‘including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke’); see also id. § 387g(a)(2) (cross-referencing notice-and-comment obligation to revise flavor standards). FDA unquestionably failed to follow § 387g’s notice-and-comment obligations before imposing its de facto ban on flavored e-cigarettes.”

    Attorneys from the U.S. Department of Justice told the justices that the 5th Circuit’s ruling “has far-reaching consequences for public health and threatens to undermine the TCA’s central objective of ‘ensuring that another generation of Americans does not become addicted’” to nicotine products.

    In court papers, Solicitor General Elizabeth Prelogar told SCOTUS justices that the FDA has never adopted a categorical ban on flavored e-cigarette products. “Rather, it has recognized that, because such products pose a ‘known and substantial risk to youth,’ applicants bear a particularly high burden of proving a potential for benefit to adult smokers that could justify the risk,” she wrote.

    Robert Burton, a longtime player in the U.S. vaping industry and current group scientific and regulatory director for the U.K.-based vaping company Plxsur, said that concerning the Triton case, decisions will now need to carry a significant weight of evidence on both sides.

     “Without the Chevron precedent, it may come down to a judgment based upon who knows the market and consumer best and who understands ‘best’ what is in the interest of public health, but based upon facts and data rather than a gray area deferral,” said Burton.

    Attorney Eric Heyer, who is representing Triton, expressed intense anticipation for the Supreme Court’s hearing of the case. He strongly criticized the FDA for imposing “surprise, after-the-fact … study requirements” and failing to adhere to the guidelines the agency itself had developed.

    It is unclear whether SCOTUS will hear the three other vaping-related cases, which are also before it (Magellan Technology Inc. v. Food and Drug Administration; Lotus Vaping Technologies LLC v. Food and Drug Administration; and Logic Technology Development LLC v. Food and Drug Administration). In these cases, vaping manufacturers seek a review of their losses in FDA-issued marketing denial order appeals handed down by various other circuit courts.

    Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, has urged the high court to overturn the appeals court order, emphasizing that if allowed to stand, it could significantly harm public health, particularly that of children. Vaping companies have asserted that their products can mitigate the harm caused by smoking combustible cigarettes.

    When the Triton decision was announced, Tony Abboud, executive director of the Vapor Technology Association, welcomed the decision as a “blistering indictment” of the FDA’s Center for Tobacco Products for its “intentional misleading” of the U.S. e-cigarette industry.

    “The court was so stupefied by the FDA’s bad-faith efforts to reject all flavored e-cigarette products [that] it cited Shakespeare to illustrate the full extent of the FDA’s disingenuity, particularly after the court explained that the plaintiffs in that case provided scientific evidence that e-cigarettes ‘save lives,’” Abboud said. “The court also emphasized the dramatic and abrupt ‘FDA flip-flop,’ which led to the implementation of what the court called a ‘de facto ban’ on flavored e-cigarette products in the U.S.

    “This was in addition to the voluminous jurisprudence cited by the court laying bare just how egregious the behavior of the FDA administrative state has been toward e-cigarette products and the consumers that use them. As the court stated, ‘No principle is more important when considering how the unelected administrators of the fourth branch of government treat the American people.’”

    Triton Cited as Precedent by 5th Circuit

    The U.S. Food and Drug Administration is starting to see vapor on the horizon. The regulatory agency has been handed another brutal defeat by a federal court. The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.

    The court sent the company’s marketing denial orders (MDOs) back to the FDA for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco product applications (PMTAs) or until the Supreme Court takes action.

    “Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.

    Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging, first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.

    In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month, the Supreme Court agreed to hear the agency’s appeal.

    The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now, another panel of the 5th Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.

    “From 2018 to 2020, FDA provided a ‘dizzying’ array of detailed instructions explaining the requirements for PMTAs,” the opinion states. “But ‘[n]ever in this long, winding and byzantine regulatory process of meetings, PowerPoint decks, proposed rules, comment periods, guidance documents and enforcement priorities did FDA ever say that it was contemplating an across-the-board ban on flavored products. Nor did FDA ever give fair notice that flavored product manufacturers had to submit robust scientific studies on flavored e-cigarette products.’”

    The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote. “Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials as well as those of thousands of other e-cigarette manufacturers.

    “Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying petitioners’ PMTAs based on the absence of long-term clinical studies.”

    The FDA’s failure was not simply a failure to provide notice that a particular type of study was required (long-term studies) but a failure to provide notice of the substantive standard requiring comparison between the flavored products at issue and tobacco-flavored juices, according to the USVA.

    “USVA members have now won important legal precedent in the 11th and 5th Circuits,” the USVA posted. “Note that manufacturers who didn’t file a petition in a court of appeals to challenge their MDOs can still sue in district court, and if you’re in the 5th or 11th Circuit, you have binding precedent in place that should provide a solid prospect of securing a quick ruling vacating your MDO.”

  • Principled Response

    Principled Response

    VV Archives

    The end of Chevron deference could have ripple effects across the nicotine industry.

    By Timothy S. Donahue

    U.S. courts will no longer need to “humbly respect” how government agencies interpret the law. The end of Chevron deference means unelected officials will no longer have the leeway to subjectively decide what Congress intends when it passes regulatory legislation.

    The court’s ruling in Loper Bright Enterprises v. Raimondo and the related case Relentless v. Department of Commerce will likely have far-reaching impacts on nearly every action government agencies take. For the nicotine industry, it could change how courts view the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process. It could also impact the agency’s efforts to regulate menthol and lower the levels of allowable nicotine in combustible cigarettes.

    “For far too long, unelected bureaucrats at the FDA have been making up the law to suit their ulterior agenda and … 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, in a statement. “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. [This] ruling is a stirring rebuke of FDA and, we hope, with more soon to follow in pending cases.”

    In declaring the doctrine’s demise, Chief Justice John Roberts wrote that agencies “have no special competence” in resolving statutory ambiguities—but courts do.

    “Chevron is overruled,” wrote Justice Roberts in the Loper Bright decision. “Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA [Administrative Procedure Act] requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry.

    “And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”

    Agustin E. Rodriguez, a partner with Troutman Pepper, explained that “under the doctrine of Chevron deference, courts would defer to a federal agency’s interpretation of an ambiguous statute if the agency was charged with administering the statute in question and its interpretation was reasonable. However, the end of Chevron deference may alter that traditional thinking.”

    Bryan Haynes, also a partner at Troutman Pepper, added, “The Supreme Court’s decision overruling Chevron in the Loper Bright Enterprises v. Raimondocase could affect federal courts’ overall outlook on agency interpretations, possibly making courts hesitant to defer to agencies as a general practice.”

    The decision could potentially result in alterations to the FDA’s methods of regulating vaping products. The Supreme Court of the United States (SCOTUS) has agreed to hear its first-ever vaping case, Wages and White Lion Investments v. U.S. FDA, which is compelling because deferring to Chevron has been the standard for lower courts when deciding regulatory cases brought by manufacturers of nicotine products (the end of Chevron deference isn’t likely to directly impact the White Lion case, according to its attorneys).

    Robert Burton, an expert with more than 11 years of experience in the U.S. vaping industry and current group scientific and regulatory director for the U.K.-based vaping company Plxsur, said another general concern is that now, federal agencies may have to put more resources into the additional legal challenges that they will likely face and divert staff away from review/approval processes.

    “Agencies, such as FDA, may also have to look to improve their primary knowledge in those ‘gray areas’ to be able to demonstrate they actually have the knowledge and expertise rather than it being ‘assumed’ or deferred by judges based upon Chevron,” Burton explained. “I also can’t see anything changing soon; if anything, this will create a further backlog of court cases and delays in regulatory decisions based upon the potential for an agency to be challenged legally.”

    How it started

    The Chevron doctrine, based on the 1984 decision in Chevron v. Natural Resources Defense Council, held that courts should defer to the interpretations of “expert” federal agencies regarding ambiguous laws they are required to implement, as long as the agency interpretations are reasonable.

    In many cases, what would be considered “reasonable” was also left to government agencies to decide because nonelected bureaucrats were often considered “experts” even though they had little to no experience in the industries they were regulating.

    For 40 years, unelected officials were given latitude to decide on their own what Congress had intended when it wrote unclear laws—even if there were other sufficient interpretations that the courts could have considered. According to the New York Times, Chevron deference was applied in 70 Supreme Court decisions and 17,000 lower-court rulings during those years.

    The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule issued by the National Marine Fisheries Service (NMFS) 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 brought their case to the Supreme Court, seeking the justices’ input on both the rule in question and the overruling of the Chevron doctrine. Roman Martinez, speaking on behalf of a group of fishing vessels, informed the justices that the Chevron doctrine undermines the courts’ responsibility to interpret the law and violates the federal law that governs administrative agencies, which calls for courts to independently review 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’ 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.”

    Chris Howard, executive vice president of external affairs and new product compliance for Swisher, parent to the vaping company E-Alternative Solutions, welcomed the ruling, saying that federal agencies have had too much power for decades.

    “That ended with the Supreme Court’s decision overturning the longstanding 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.”

    Immediate uproar

    The end of Chevron deference is extremely far-reaching, with other industries, such as healthcare, likely to review previous decisions that have gone against them. Justice Elena Kagan, in her dissent, asserted that government regulators are best positioned to tackle highly technical subjects.

    “This court has long understood Chevron deference to reflect what Congress would want, and so to be rooted in a presumption of legislative intent,” Kagan wrote. “Congress knows that it does not—in fact cannot—write perfectly complete regulatory statutes. It knows that those statutes will inevitably contain ambiguities that some other actor will have to resolve and gaps that some other actor will have to fill.

    “Today, the court flips the script: It is now ‘the courts (rather than the agency)’ that will wield power when Congress has left an area of interpretive discretion. A rule of judicial humility gives way to a rule of judicial hubris. In recent years, this court has too often taken for itself decision-making authority Congress assigned to agencies. The court has substituted its own judgment on workplace health for that of the Occupational Safety and Health Administration, its own judgment on climate change for that of the Environmental Protection Agency and its own judgment on student loans for that of the Department of Education.

    “In one fell swoop, the majority today gives itself exclusive power over every open issue—no matter how expertise-driven or policy-laden—involving the meaning of regulatory law. As if it did not have enough on its plate, the majority turns itself into the country’s administrative czar. It defends that move as one (suddenly) required by the (nearly 80-year-old) Administrative Procedure Act. But the act makes no such demand. Today’s decision is not one Congress directed. It is entirely the majority’s choice. And the majority cannot destroy one doctrine of judicial humility without making a laughingstock of a second.”

    Several national healthcare groups made a joint statement expressing that Chevron deference protected the legal stability of public health programs such as Medicare and Medicaid. The groups claim that Chevron ensured that laws passed by Congress were interpreted and implemented by expert federal agencies such as the Centers for Medicare and Medicaid Services.

    “As our amicus brief noted, large health programs such as Medicaid and Medicare, as well as issues related to the Food, Drug and Cosmetic Act, are extremely complex, so it is key that decisions about how to interpret and implement relevant laws are made by experts at government agencies,” the statement reads. “Yet [this] majority opinion explicitly ends the use of this sensible doctrine.

    “As leading organizations that work on behalf of people across the country who face serious, acute and chronic illnesses and many people who lack access to quality and affordable healthcare, we will continue to work to ensure that healthcare laws are implemented in ways that benefit public health.”

    In its response to the Chevron ruling, the Public Health Law Center at the Mitchell Hamline School of Law stated that the Loper Bright ruling will “undoubtedly impact” the field of administrative law and implicate regulations that, in addition to promoting public health and safety, have served to protect consumers, workers, civil rights and the environment.

    “Legal experts differ on the degree to which Loper Bright may wreak havoc on the federal administrative state; however, the forceful dissent written by Justice Kagan in this case and its companion case, Relentless v. Department of Commerce, should not be ignored. The dissent expressed grave concern that these decisions ‘will … cause a massive shock to the legal system, cast doubt on many settled constructions of statutes and threaten the interests of many parties who have relied on them for years.’

    “In the absence of Chevron deference, the tobacco industry will doubtless feel emboldened to dispute any regulatory actions taken on its products. This includes e-cigarette manufacturers who will be eager for courts to undo FDA-issued premarket tobacco product application denial orders for many thousands of vape products.”

    The Biden administration called the Chevron decision “yet another deeply troubling decision that takes our country backward,” adding that President Biden’s legal team would work with federal agencies to do “everything we can to continue to deploy the extraordinary expertise of the federal workforce.”

    Reshma Ramachandran, a health policy expert and assistant professor at the Yale School of Medicine, said, “This term has been disastrous for public health in many ways.”

    In the vaping industry, however, Tony Abboud, executive director of the Vapor Technology Association (VTA), said that the decision clearly bolsters what the VTA has been saying for years: the FDA and, specifically, the Center for Tobacco Products overstepped their authority when they chose to implement a de facto ban on flavored e-cigarettes in their deeply flawed implementation of the PMTA process.

    “To be clear, it is [the] FDA’s responsibility under the law to create a regulation that clearly addresses the statutory standard of what is ‘appropriate for the protection of public health’ since the Tobacco Control Act is ambiguous on how that determination should be made. However, there is no question that the FDA violated the Administrative Procedure Act by implementing what the 5th Circuit Court of Appeals called ‘a de facto ban on flavored e-cigarettes’ through its shifty implementation of the PMTA regulation by imposing new requirements on products after applications were already filed, ultimately ensuring their application’s demise.

    “The Supreme Court’s decision elevates the importance of the Reagan-Udall Foundation’s findings after being convened at the request of the FDA commissioner, which specifically and clearly criticized the FDA’s Center for Tobacco Products for failing to inform companies what must be provided under the regulation to demonstrate APPH [appropriate for the protection of the public health] and, as importantly, for failing to inform the public on how FDA is applying this standard.”

    Beyond nicotine

    The cannabis industry also will likely be impacted by the Chevron ruling. Asheville, NC-based attorney Rod Kight, a global resource and expert in cannabis law, said that the recent ruling by the SCOTUS that Chevron deference is dead is welcome news to the cannabis industry. With respect to the hemp sector, the death of Chevron means that unofficial positions taken about various cannabinoids and processes to produce hemp products by both the U.S. Drug Enforcement Agency (DEA) and the FDA on their respective websites and in letters to stakeholders do not hold any weight, at least not with the courts.

    “In practical terms, this means that judges may not defer to federal agency positions and interpretations and, instead, must weigh their positions relative to the strength of the legal positions and interpretations put forth by the hemp industry,” explains Kight. “For instance, with respect to tetrahydrocannabinolic acid (THCA), the DEA has stated in two letters during the past year that ‘cannabis-derived THCA does not meet the definition of hemp under the CSA because upon conversion for identification purposes as required by Congress, it is equivalent to delta-9 THC.’

    “As I have discussed in several blog posts and interviews, this is partially incorrect and is not exactly what ‘Congress required.’ Rather, Congress requires a post-decarboxylation test for hemp production (i.e., cultivation) but not for harvested hemp or hemp products.”

    In the past, this type of unofficial guidance may have warranted a court’s deference to the DEA, even if an opposing position by a hemp industry participant was stronger and more well articulated. However, Kight said that, in the post-Chevron world, the DEA’s position will not hold any more weight with the court than a counter-position by an opposing litigant.

    “The same thing applies to any number of other issues, from vapes to synthetic cannabinoids,” said Kight. “Hopefully, this exciting legal development will curb the appetite for DEA and FDA to take strong positions that are often unwarranted while helping the hemp industry to carve out favorable judicial rulings based on the best and most well-articulated positions.”

    Abboud said the SCOTUS’ decision in Loperexposes the FDA’s improper regulation of flavored e-cigarettes. While the vaping cases that have gone before the SCOTUS were not explicitly decided on Chevron deference, it is hard to believe that the court will not look skeptically on the FDA’s prior “regulatory shenanigans and post-hoc justifications” laid bare by the 5th Circuit Court of Appeals in the White Lion case.

    “However, unlike the complete overturning of Chevron, it is likely that the court would issue a more limited ruling in the vape cases before it. That said, the real power of Loper is that it provides a template for new litigation against the FDA that is not limited to individual application decisions,” said Abboud. “This new regulatory challenge would reveal the full story of FDA’s tortured and disingenuous implementation of the ambiguous PMTA statutory provisions to ban flavored vaping products and possibly, as a result, spell the demise of the PMTA regulation.

    “VTA is once again calling for the FDA to immediately suspend any further denials based on its existing process and instead create a clear and streamlined tobacco product standard that will allow independent companies of all sizes to get less harmful nicotine alternatives on the market as it is required to do under the law.”

  • RLX Revenue Jumps 66 Percent to $86.3 Million

    RLX Revenue Jumps 66 Percent to $86.3 Million

    Photo: RLX Technology

    RLX Technology reported net revenues of RMB627.2 million ($86.3 million) in the second quarter of 2024, up 66 percent from the comparable 2023 quarter. U.S. GAAP net income was RMB134.9 million, down from RMB204.7 million in the same period of 2023. Non-GAAP soared to RMB213.1 million from RMB86.2 million. Gross profit was RMB157.9 million, compared with RMB98.5 million in the comparable 2023 period.

    “We delivered a strong second quarter performance as revenue continued to increase sequentially, driven by our international business expansion,” said RLX Chairperson and CEO Ying (Kate) Wang in a statement.  

    “Our deep exploration of overseas markets and regulations has provided us with valuable insights into the global e-vapor landscape, enabling us to create effective, targeted regional strategies. This year, global regulations are rapidly evolving, with more regulators recognizing e-vapor products as harm-reduction tools for adult smokers. Leveraging our broad expertise in regulatory compliance, we are well-prepared to navigate these changes and ensure a seamless transition for our users and partners.”

    Chief Financial Officer Chao Lu said the considerable year-on-year increase in net revenues reflected the company’s ability to capture growth opportunities in international markets. “While our gross margin declined slightly due to an unfavorable shift in our revenue mix, disciplined cost management bolstered our non-GAAP operating profit margins,” he said.

    “Looking ahead, we are confident of driving continued improvement in both our top and bottom lines, fueled by ongoing revenue growth from international markets and our relentless focus on operational efficiency. As always, our priority is to deliver sustainable and profitable returns to our shareholders.”

  • Industrial Sabotage

    Industrial Sabotage

    Credit: Stock Photo Pro

    The Mary Miller Amendment will kill the hemp industry, including its industrial sector.

    By Rod Kight, Jonathan Miller and Chris Fontes

    When the Mary Miller Amendment (MMA) passed the U.S. House Agriculture Committee, I wrote an article about how it is specifically designed to kill the hemp cannabinoid industry. Unfortunately, and even though this industry generated $28 billion in revenue last year, there are groups that want it dead, including a small cartel of marijuana corporate conglomerates who seek to destroy the hemp industry so they can control the entire cannabis supply chain to the exclusion of small hemp businesses.

    In addition to deploying millions of dollars into lobbying efforts to shut down the hemp industry, these conglomerates have launched a massive disinformation campaign about hemp products and child safety that is largely bereft of substantive factual support.

    But that’s not all. In addition to killing the hemp cannabinoid industry, the MMA will also kill the industrial hemp industry. Aside from the marijuana cartel, there are others who do not care about the hemp cannabinoid industry but who do care about industrial hemp. These groups are fine with the MMA because, to their understanding, it does not impact “industrial” hemp. This view is not only incorrect, but it is a direct result of the disinformation campaign referenced above. To be clear, the MMA will kill all hemp, including “industrial hemp.” This is because the MMA does the following:

    • It changes the definition of “hemp” so that total THC must not exceed 0.3 percent. Some people have argued that the MMA merely codifies current U.S. Department of Agriculture (USDA) policy in measuring THC in the field. That’s not true because the MMA goes well beyond measuring THC in the field to making a sweeping change to the current definition of “hemp” in the Farm Bill. Contrary to popular belief, THCa, the nonpsychoactive precursor to THC, is not mentioned in the Farm Bill’s definition of hemp. Importantly, it is not part of the legal “metric” for determining whether cannabis material is lawful “hemp.” In fact, the opposite is true. The current definition of hemp specifically includes its “acids.” (THCa is one of many acids the plant produces. The “a” in THCA stands for “acid.”) The only statutory reference to THCa in the Farm Bill is via an inference.

    The Farm Bill directs the USDA to use a “post-decarboxylation” method to test hemp in the field. This means that a hemp crop cannot be harvested unless it passes a total THC test, which accounts for the THCa concentration. In other words, even though THCa is never mentioned in the Farm Bill, it is implied by virtue of the required post-decarboxylation test that must take place before a hemp crop can be harvested. Once this test is passed, the hemp crop may be harvested. Thereafter, the concentration of THCa is irrelevant and, under the Farm Bill, the sole metric to distinguish between lawful hemp and unlawful marijuana is the concentration of delta-9 THC, not THCa. This is a critical point since most harvested hemp crops would fail if the THCa concentration was included as the compliance metric in defining harvested hemp, something that the MMA would require. Notably, grain crops require late flowering and will have no legal pathway if the MMA becomes law and “total THC,” rather than delta-9 THC, becomes the new legal compliance standard.

    • It excludes viable seeds from the definition of “hemp” when they come from a plant with total THC that exceeds 0.3 percent, even though cannabis seeds contain almost no THC, and the U.S. Drug Enforcement Administration itself considers them to be lawful. Notably, all grains, including hemp seeds, are “viable” before they are rendered nonviable.
    Credit: 24K Productions

    As discussed above, the MMA’s requirement that all post-harvest material pass a post-decarboxylation test would deem all hemp seeds from such plants to be Schedule 1 controlled substances. Given that as much as 88 percent of harvested hemp plants fail a total THC test and are illegal marijuana under the MMA, the grain market will collapse if the MMA is enacted into law. I should note that this specific provision has nothing to do with health, safety or anything else along those lines. Rather, it is solely about consolidating power in the hands of a few corporate marijuana conglomerates who perceive all competition, even from hobbyist home growers, as a threat to their bottom lines.  

    • It excludes “quantifiable amounts” of THC, including THCa, from the definition of “hemp.” Hemp is cannabis. It is not some other species of plant. One of the most notable and fundamental characteristics of the cannabis plant is that it expresses THC. By eliminating all THC, the MMA would render all hemp, including industrial hemp, a Schedule 1 controlled substance since ALL hemp plants express THC in quantifiable amounts.

    The founder of one of the top cannabis laboratories in the country informed me that his lab can detect THC at levels down to picograms per milliliter (0.0001). This roughly equates to a drop of THC in an Olympic-sized pool. Moreover, even if an industrial hemp plant could be grown with no quantifiable amounts of THC, the fiber market is not currently viable enough on its own to support an industry. It does not produce sufficient revenue to support testing labs, regulators’ budgets or the bottom lines of most businesses. Given time, this will change, but only if the entire hemp industry is allowed to survive and thrive.

    Rod Kight

    The MMA pulls the rug out from underneath the multibillion-dollar hemp industry that Congress created in 2018. This includes the grain and fiber sectors. Even though the MMA is promoted as an effort to close the so-called hemp loophole, what it will really do is kill the entire legal hemp industry while giving away billions of dollars to the illegal marijuana industry. If Congress truly believed that hemp products constitute a public health crisis, then it would have enacted legislation requiring the U.S. Food and Drug Administration or another federal agency to oversee it many years ago. The fact that it hasn’t done this belies the shrill cries of concern of the marijuana cartel’s disinformation campaign that mask its true intent to destroy its hemp competitor.

    Moreover, there are better ways to address safety than by killing the hemp industry, including by promulgating regulations that prohibit access by minors, mandating quality control in production and standardizing labeling so adults can make educated decisions about what products they choose to purchase. These three regulatory zones, what I call the “Three Pillars,” have been addressed in hemp industry-sponsored bills in state legislatures throughout the country, many of which have been defeated due to intense lobbying against them by the marijuana industry.

    Finally, for proponents of “industrial” uses for hemp who also think that it is OK to give the illegal corporate marijuana cartel a giveaway while destroying thousands of legal small businesses, be aware that MMA will kill the entire hemp industry, including the industrial sector that they purport to support. 

    Rod Kight is an attorney who represents businesses in the hemp industry.Jonathan Miller is general counsel to the U.S. Hemp Roundtable. Chris Fontes is president of the U.S. Hemp Authority.

  • A Cold Chill

    A Cold Chill

    Credit: Yusif

    While FDA menthol market authorizations are rightly seen as a victory, they may be pyrrhic.

    By Rich Hill

    The flavored electronic nicotine-delivery systems (ENDS) road has been a bumpy ride. Going back to pre-deeming days, flavored ENDS were ubiquitous, as were unquantified, anecdotal reports of their cigarette-smoking cessation efficacy. Following the accelerated premarket tobacco product application (PMTA) submission timeline, as everyone knows, the Center for Tobacco Products’ (CTP) decisions decimated flavored ENDS. Likewise, even the most sophisticated companies were receiving marketing denial orders (MDOs) for menthol ENDS. Throughout this bloodbath, the CTP oft repeated that flavored products need to demonstrate a cessation benefit to adult smokers weighed against the risk of youth initiation. Until recently, this had not played out.

    Njoy’s marketing granted orders (MGOs) for menthol Ace and Daily products was a watershed moment demonstrating that an ENDS product with a flavor other than tobacco could be granted marketing authorization status. However, the authorization does leave some questions unanswered.

    CTP’s Menthol Positioning

    In 2022, the CTP staked out its position on menthol in the cigarette context with the product standard prohibiting menthol in cigarettes. The center asserted that menthol reduces irritation and harshness of smoking, increases appeal and makes cigarettes easier to use—especially for youth, increases nicotine’s sensory effects in the brain and makes it more difficult to quit smoking. While the first points on irritation and harshness are unique to cigarettes, the CTP’s other points arguably apply to menthol and nicotine more generally—a dour omen for ENDS and other products.Given this position, particularly on youth initiation, it came as little surprise that several menthol ENDS products received MDOs over the past several years.

    An About Face?

    The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?

    Beyond Njoy’s successful showing of product characterization, toxicology and abuse liability data, according to the Njoy Ace Technical Project Lead Review (TPLR), behavioral studies and marketing restrictions appear to have made the difference. Alongside other behavioral studies, Njoy simply did what the CTP required and conducted a longitudinal study comparing cigarette smoking cessation efficacy between tobacco and menthol ENDS products. Per the TPLR, “[t]he applicant’s findings and additional analyses conducted by statistics demonstrate a statistically significant added benefit of using menthol-flavored Njoy Ace compared to classic tobacco flavor … in achieving past-30-day [combustible cigarette] smoking cessation ….” Among other data in the TPLR, Table 3 reports that in the Intention to Treat Analysis, initial flavor at baseline analysis resulted in 26.6 percent past-30-day abstention rates for menthol versus 19.3 percent for tobacco at 6 months. When analyzed by flavor at time of switching, past-30-day cessation rates of 27.1 percent for menthol versus 19.3 percent for tobacco at 6 months were reported.

    Along with the adult cessation data, Njoy agreed to a long list of marketing restrictions—beyond what is observed in other applications. The restrictions included limitations on advertising means including no radio, television, outdoor, print, search engine advertising, social media promotions, product placements, engagements or activations or influencers, sponsors, etc., among others. Talent portrayals would be limited to models over 45 years of age. Njoy identified a range of sales restrictions as well.

    Ultimately, after assessing the youth data and risks, the TPLR executive summary states, “[t]he PMTAs contain sufficient evidence to show that the new products have the potential to benefit adults who smoke combustible cigarettes and who switch completely or significantly reduce their combustible cigarettes  use …. The applicant also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization. The Office of Health Communication and Education has determined that these restrictions may help further limit youth exposure to the new product, the products’ labeling, advertising, marketing, and/or promotion, and the potential for youth initiation.”

    Questions Remain from the Njoy Decision

    The MGO, however, raises two interesting questions. First, how much adult benefit is enough to overcome youth uptake? And second, what impact do marketing restrictions have on marketing authorization decisions?

    The Math on Youth Use vs. Adult Cessation – How Much Differential is Enough?

    The TPLR reports youth Njoy use data from both applicant data and national surveys and concludes that “[w]hile ENDS with nontobacco flavors and high nicotine delivery may help adults who smoke switch from CC to ENDS, these same characteristics may facilitate initiation and continued nicotine use by youth.” The cost-benefit analysis is troubling because CTP provides no real quantitative measure comparing youth use rates to adult cessation rates. Rather than a numerical comparison, the analysis seems to rely upon the totality of the evidence. As the TPLR states, “the totality of evidence provided by the applicant suggests that the menthol-flavored [product] … is associated with significantly higher smoking cessation rates than tobacco-flavored Njoy Ace products, and epidemiology concluded that the new products are highly beneficial to adults who smoke CC.” The close of the TPLR user population synthesis states that menthol-flavored new products pose a risk to youth but went on to assert that the data “demonstrate added benefit of using menthol-flavored compared to classic tobacco-flavored … Njoy Ace in achieving past-30-day smoking cessation—a showing required to outweigh the risks associated with flavored ENDS among youth.”

    For some time, many in industry have wondered how much cessation difference between tobacco and flavored ENDS would be enough to outweigh risk to youth. While the balancing test is not numerically quantified, this marketing decision does provide some level by which to assess menthol products.

    Are Marketing Plans Back on the Table?

    In the White Lion Investments dba Triton Distribution v. FDA5th Circuit Court of Appeals decision from January 2024, the majority opinion found that the FDA ignored marketing plans in the Triton PMTAs: “[w]orse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

    Njoy’s marketing plan, however, seems to have an effect on the outcome. Reviewers remarked that the Njoy plan was “robust and is expected to limit youth exposure” to marketing materials. Interestingly, the TPLR states that the marketing plan was “not considered in the APPH assessment,” but then goes on to refer to the plan positively, stating, “the applicant’s approach to marketing may help further limit youth exposure to the new products.”In Njoy’s case, the marketing plans may not have moved the APPH needle but were considered as a net positive in youth prevention.

    Are marketing plans important to your application? Beyond being a required part of the PMTA submission, it appears that in this case, the restrictions at least supplemented the adult benefit data to good effect.

    Will Menthol MGOs Have an Impact in This Market?

    While the menthol market authorizations are rightly seen as a victory, such a victory may be a pyrrhic one.

    The presence and consumer acceptance of flavored disposable ENDS products looms over this seminal marketing authorization. The fact is that many menthol-flavored ENDS products with pending PMTAs remain on the market. Even in the face of the availability of menthol ENDS, flavored disposable ENDS sales have skyrocketed.

    The Centers for Disease Control and Prevention published a Morbidity and Mortality Weekly Report (MMWR) in 2023 assessing e-cigarette unit sales across the various categories of products and flavors using scan data from brick-and-mortar retailers only. The MMWR reported that “the percentage of disposable e-cigarette sales more than doubled, from 24.7 percent in January 2020 to 51.8 percent in December 2022.” The predominant disposable flavors reported were “flavors other than tobacco, menthol or mint” (71.4 percent in 2020 and 79.6 percent in 2022). At the same time, menthol ENDS sales overall did not significantly change, while tobacco and mint flavors declined. With half of the market occupied by flavors that consumers clearly want, the growth space for a couple of menthol products seems limited.

    VV Archives

    While the FDA continues to publicize enforcement efforts, the flavored disposable ENDS trend will not abate anytime soon. Given that flavored disposables are crushing the category, it seems unlikely that the MGOs for Njoy’s menthol products will play a significant role in shifting market share in the near term.

    Where Does This Leave Us?

    Foremost, good on Njoy for cracking the code—most observers have been very skeptical that an ENDS product with any flavor would ever be granted marketing authorization. Ultimately, Njoy demonstrated what the industry knows to be true from ENDS consumers—flavors, including menthol, are a net positive for adults who smoke to transition away from higher-risk combustible cigarettes. However, questions remain about how the risk-benefit test will be applied—how that math actually works and who, other than the largest companies, can afford to produce such evidence.

    Rich Hill is senior director and new product compliance counsel at E-Alternative Solutions.

  • Power Moves

    Power Moves

    Credit: Bodu9

    Many in positions of authority ignore alcohol problems and exaggerate vaping issues.

    By George Gay

    The U.K. Vaping Industry Association (UKVIA) has welcomed, with a few reservations, the publication of a report by the Royal College of Physicians (RCP) that broadly supports vaping as an effective, less risky alternative to tobacco smoking.

    This is not surprising because much of what the RCP has to say is in line with what the UKVIA has been saying for some time. Still, it is good to have such a well-respected medical organization on your side, especially given the heft of its 267-page report, “E-cigarettes and harm reduction: An evidence review,” which was published on April 18.

    George Gay
    George Gay

    The report looks at several themes, including how e-cigarettes can be used to support more people to make quit attempts while discouraging young people and never-smokers from taking up e-cigarette use; trends in tobacco and vaping use; the effectiveness of e-cigarettes to treat tobacco addiction; the differences in health effects of vaping in people who smoke, vape or do neither; the role of the tobacco industry in the rising use of e-cigarettes; and the ethical dilemmas presented by e-cigarettes.

    In responding to the report on April 22, the UKVIA firstly warned the government “not to consider banning flavors as [to do so] would be going against the advice of one of the most eminent and respected medical bodies in the U.K.” I am not sure this is completely true because the report seems to leave enough wiggle room for the government to ban at least some flavors without flouting the RCP advice.

    My reading is that the RCP believes that to exploit fully the potential of vaping as a means of encouraging smokers to quit their habit it is necessary in part to allow consumers access to a “range” of flavors. But I think it is calling for more research to try to identify those flavors that are the most efficacious from the point of view of encouraging smokers to quit but also those, if any, that are off-the-scale attractive to the underage.

    This is one of the strengths of the report, I believe. For too long, it has been all too easy for commentators to say there is, in respect of vaping flavors, a need to balance the interests of smokers wanting to quit their habit who are attracted to certain flavors and those of the underage who should be discouraged from vaping by restricting the flavors available. Often, the flavors concerned are the same ones, and the commentators never put forward credible ways of finding this balance, which leaves policymakers and, therefore, policies in a state of limbo.

    The RCP, while, to some extent, dancing to the same tune about the need for balance, has at least come forward with some better steps, and it will be interesting to see if the government takes up the RCP’s advice or if it blunders on in the normal way. My concern is that with a problematic national election coming up this year or, at the latest, January next year, I cannot see it learning any new steps. More likely, it will continue to put its feet down like ready money.

    One reason the RCP can put forward a more credible idea for preventing underage use is that it seems to be aware that the flavors-and-the-underage issue is something of a red herring. It is aware that many underage people take to vaping because they can. As the UKVIA has been saying for a long time and as the RCP acknowledges, the government has slashed the funding for the main agency charged with policing the retailing of such products.

    At this point, I should declare that I have not read the RCP report, only the 13-page executive summary, which, as far as I can tell, includes all 54 recommendations of the full report. And there are limits. This brings me to one of my concerns. A 267-page report is impressive, but it is not going to get through to the average smoker, and smokers need to be addressed directly if they are going to be encouraged to quit.

    Credit: Pavel Kant

    The report will be addressed to other “experts” in the field and perhaps the government, which might or might not follow through on the recommendations, some of which are excellent. But there is no point in having, for instance, a recommendation that smokers be provided with accurate reduced-risk messages if that recommendation sits in a huge report on a shelf gathering dust.

    And it must be said that while there have been two previous RCP reports going back 17 years, the intellectual dial of vaping seems not to have been advanced very far. The first report was the 2007 252-page “Harm reduction in nicotine addiction: Helping people who can’t quit” while the second was the 2016 206-page “Nicotine without smoke: Tobacco harm reduction.” In total, with the latest report, that’s 625 pages.

    No doubt much of those 625 pages comprises repetition. Still, nevertheless, one wonders how come, with so much intellectual firepower aimed at the subject, U.K. vaping policies are still sometimes a muddle. After all, the RCP reports are just three of what must be a pile of reports that could usefully be used to support Lord Nelson should his current column, like much of the U.K.’s infrastructure, fall into disrepair.

    What smokers see by and large are not these reports but the sensational media pieces such as those aimed at stirring up a moral panic about vaping among the young. And unfortunately, such negativity is not confined to the imaginings of journalists. In a 700-word opinion piece in The Guardian newspaper on April 16, the chief medical officer of England, Chris Whitty, had two things to say about vaping.

    “In addition, the [tobacco and vapes] bill will substantially reduce the ability of vape companies to market to children, an utterly unacceptable practice.” And “It [the tobacco industry] tries to pass off new tobacco products as ‘safe,’ as it did with ‘low tar cigarettes’ and cigarette filters—but no tobacco products are safe.”

    Now I have a lot of time for Whitty, who I believe is a man of integrity, but I think he should reflect on the second of these statements. How does he think this statement will be interpreted by smokers, who are more likely to read it than the 267-page RCP report?

    To my way of thinking, many smokers will conclude that on the “evidence” he offers there is no point in switching from tobacco cigarettes to vapes or even nicotine pouches. Is that the message he wants to convey?

    He seemingly conflates tobacco products with nicotine products and says that no tobacco product is “safe,” which is true, but then no product is safe, especially alcohol, as I am sure he will be aware.

    As a heading in The Guardian had it on April 23, “Record level of alcohol deaths revealed after heavy drinking in pandemic.” “Years of inaction on alcohol harm has led to this, and the heartbreaking thing is these deaths were totally avoidable,” Richard Piper, the chief executive of Alcohol Change U.K., was quoted as saying in The Guardian article. “Our government has the responsibility and the power to put preventative measures in place, including proper regulation of alcohol marketing, clear alcohol labeling and a minimum price for a unit of alcohol.”

    But the government does not take such action because hypocrisy rules. The first of the major findings described in a press note announcing an April 25 report by the World Health Organization, “A focus on adolescent substance use in Europe, Central Asia and Canada,” stated, “Alcohol is the most frequently consumed [illicit] substance among adolescents, with 57 percent of 15-year-olds having tried alcohol at least once and nearly four in 10 (37 percent) indicating they’ve consumed alcohol in the past 30 days.”

    Credit: Viktor

    The press note goes on to say, “Roughly one in 10 (9 percent) adolescents across all age groups have experienced significant drunkenness—being drunk at least twice—in their lifetime, a rate that alarmingly climbs from 5 percent at age 13 to 20 percent by age 15, showcasing an escalating trend in alcohol abuse among youth.

    “Furthermore, recent patterns reveal that the incidence of drunkenness within the past 30 days also increases with age, jumping from 5 percent among 13-year-olds to an alarming 15 percent among 15-year-olds, highlighting an urgent need for targeted intervention strategies to curb this growing issue of underage drinking.”

    And just in case it is pointed out that the WHO report covers a wide geographical area that might not correctly represent the situation in the U.K., the report says, in part, that with respect to “lifetime” use of alcohol, the “United Kingdom (England) reported the highest prevalence for 11-year-olds (35 percent for boys and 34 percent for girls) and 13-year-olds (50 percent for boys and 57 percent girls).”

    With respect to current alcohol use, the report says that “At age 13, it ranged from under 1 percent of boys and girls in Tajikistan to 32 percent of boys in Bulgaria and girls in [the] United Kingdom (England).”

    But nothing will happen in the U.K., at least nothing that will be aimed at curbing alcohol use because most people are not interested in the health of young people to the extent that they would inconvenience themselves to help them. You will not find health advocates saying that a balance needs to be sought between allowing adults to get off their heads on alcohol and protecting young people from the harms caused by alcohol to developing brains.

    Moreover, in the U.K. in recent years, young people have been uncaringly plunged into poverty, hospitalized with malnutrition and forced to attend collapsing schools in areas with appalling levels of pollution. Hypocrisy rules.

    The government, which has been promoting alcohol through its taxation policies, is not alone. The Guardian, which is totally po-faced when it comes to smoking and vaping, also promotes drinking. On May 4, shortly after it had covered the WHO report, it carried a story taking up two-thirds of a page titled, “Sparkling form: Pet nat goes from hipster bars to M&S [a major, up-market food and beverage retailer].”

    I shall quote only the final sentence of the story, which was accompanied by a large picture of young people drinking and laughing, “The funky labels and crown caps have made Pet nat a hit with younger drinkers, and, according to Beames [a wine manager], opening a bottle of Pet nat is less formal, more fun.”

    What is meant by “fun” here, I wonder? Drinking alcohol can lead to mental and physical incapacities, fights, car crashes, pedestrian deaths, domestic abuse, crime in general, you name it—none of which can be laid at the feet of vaping.

    And it is clear the WHO is not interested in going after alcohol; it is on the trail of eliminating vaping. If you read its report, after the key findings and the introduction, you will see that the first of three quotes made hugely visible against brightly colored backgrounds has nothing to do with alcohol, even though alcohol is identified in the report as the main problem; it is about vapes: “I think the biggest health concern facing young people today is vapes. I think that they should either make vapes less accessible, take the nice flavors out of them or ban them (Girl, Ireland).”

    You will look through the report in vain for a highlighted quote on alcohol, but there is another on vapes and one on “addiction illnesses.”

    Why, I wonder, are so many people in authority seemingly willing to ignore the problems caused by alcohol while making up problems in respect of vaping? I am fast concluding that most of them have drunk too much and lost too many brain cells in the process.

    Finally, I think it is a shame that the RCP, in a report that, while somewhat repetitious, provides much food for thought, finds it necessary to attack the tobacco industry for being “self-serving,” an accusation that can be leveled at every industry, business, individual and organization—even, heaven forfend, the RCP and me.

    The 13-page executive report references “research” 20 times and 10 times to say that more of it is needed. And yes, I think each piece of research should be covered by a story in Vapor Voice written by me.

  • Thailand: Home Vaping Violates Child Protection Laws

    Thailand: Home Vaping Violates Child Protection Laws

    VV Archives

    Exposure to secondhand vapor from vaping at home could be considered a violation of Thailand’s child protection laws, according to child health and rights experts who are calling for more awareness of the dangers of vaping around children, reports The Pattaya Mail.

    Under national laws, vaping around children could be considered “domestic violence,” according to Thai authorities. They are calling for stricter enforcement.

    The Royal College of Pediatricians of Thailand wants stronger government measures to restrict the import and sale of e-cigarettes and increase educational campaigns about the risks of nicotine.

  • Flonq Ultra Provides the Ultimate Outlook

    Flonq Ultra Provides the Ultimate Outlook

    The Flonq Ultra stands on its own as a high-quality disposable vaping system.

    By Mike Huml

    It would be easy to say that the Flonq Ultra is simply a variation of the Flonq Max Pro and call it a day. After all, they share many of the same features—e-liquid and battery capacity, a screen, USB type-C charging, and so forth. However, that wouldn’t be at all fair to a device that by all rights stands on its own and in every case above the rest. As a disposable device, the Ultra combines simplicity and quality in a concise package that any vaper can appreciate.

    The Flonq Ultra features a modest, yet adequate, 650 mAh battery, which is charged via a USB type-C port located on the bottom of the device. It holds 18 mL of e-liquid, which should last for about 20,000 puffs before running dry. Airflow comes from two pinholes next to the charging port, which provides an extremely smooth, quiet and nonturbulent draw.

    The Ultra is slightly less bulky than the Max Pro, being a bit flatter and symmetrical. As such, the only two ways to set the device down are either on the face where the screen is located or on the opposite side. Despite that, leaking and spitback are never a problem.

    The screen and button are located on the front face of the Ultra, and the screen displays the remaining battery life and e-liquid as labeled rotary icons. As each segment fades away, it naturally indicates the level of battery or liquid depletion. The screen also shows a rocket ship icon that’s white in normal mode and red while in burst mode.

    Burst mode increases the power output and allows for quicker drags more akin to an analog cigarette while normal mode caters to the standard mouth-to-lung vaping style of taking slower, longer drags. As such, burst mode won’t necessarily deplete the battery or liquid reservoir faster than normal mode unless long drags are taken.

    The back face of the device, opposite the screen, has a small latch for a lanyard. For those willing to forego any semblance of fashion, the Ultra can be hung around the neck or wrist to make it easily accessible and less likely to be dropped or lost.

    While the screen and mouthpiece are made of glossy, hard plastic, the majority of the device is a matte, rubberized texture. Normally, this would lend itself to dirt accumulation, but unlike many other devices that combine colored hard and rubberized plastic, which accentuates the contrast in dirtiness, most wear and tear will be unnoticeable given the uniformity of the materials used. This also arguably makes the device less slippery and more comfortable to hold.

    Flonq offers 25 flavors in nicotine strengths of 5 percent, 2 percent and 0 percent—no nicotine. That’s a great variety, especially considering that many vapers are looking to taper down their nicotine consumption, and a surprising number of disposable devices simply don’t offer that option and are only available at high concentrations.

    The flavors available are varied, and anybody can find something to love. Vanilla, tobacco, menthol, fruits, beverages—nearly every flavor profile is represented in some way, including flavorless in the “Clear” variety. Each flavor is crisp and distinct, even when the liquid reservoir starts to run low.

    Many of the fruit flavors also include a touch of menthol, making them very refreshing, especially on warmer days. Every flavor tastes very natural and bold, with no break-in period or weird flavors to speak of. The color of each Ultra corresponds to the flavor selection, so Lemon Mint will always be a lime green color. There are far too many combinations to have each color available for each flavor, but it’s nice that the variety of flavors is represented as an aesthetically pleasing color spectrum.

    The Flonq Ultra clearly succeeds as the large, flagship offering. It holds a monstrous amount of liquid that can last heavy users several days at minimum and average users a week or more. The battery capacity is large enough to last at least a day, but passthrough functionality allows the Ultra to be used while charging to mitigate any downtime. Even so, a full charge only takes about 30 minutes.

    Along with the Max Pro, the Flonq Ultra is undoubtedly one of the best disposable vapes on the market. All the extra features only serve to enhance convenience and simplicity rather than add complication, which should be a main focus for any disposable device. After all, the purpose of disposables is to not have to deal with much in the way of maintenance—refills, coil swaps, battery changes and so forth.

    The screen is attractive and easy to decipher, providing essential information after every drag. Aesthetically, the Ultra steers away from the toy-like vibe and more toward the medical device look, save for the bright colors. Nothing about it comes across as gaudy or cheap. The shape is a bit more suited to smaller hands compared to the Max Pro due to the symmetry and being a bit thinner, but that shouldn’t be an issue for the majority of vapers.

    There’s not much more to be said about the Flonq Ultra. Overall, it’s fantastic. It’s simple, convenient and provides an excellent vape experience. It can be used right out of the box, the screen is useful and intuitive, and boost mode provides a little extra oomph that allows for slightly different vaping styles.

    When put next to the Flonq Max Pro, look and feel are the biggest differentiating factors. There are minor nuanced differences, such as the Ultra having a lanyard hook or airflow being slightly more open with the Ultra, but they are very similar. The Flonq Ultra stands on its own as a top-tier disposable and surely should not be overlooked.

  • FDA Wants Tracking Numbers of Imported Vapes

    FDA Wants Tracking Numbers of Imported Vapes

    Credit: Eduardo Barraza

    The U.S. Food and Drug Administration and the Department of the Treasury have announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of electronic nicotine delivery system (ENDS) products into the electronic imports system operated by U.S. Customs and Border Protection.

    The new requirement will help streamline the process of reviewing the admissibility of ENDS products into the United States, according to the FDA’s website.

    After an applicant submits a marketing application for a new tobacco product, FDA assigns a unique identifier called an STN. Under the proposed rule, if finalized, any ENDS product, including e-cigarettes, for which the STN is not submitted may be denied entry into the U.S.

    An FDA-issued STN is one data element that is important to FDA’s admissibility review and determination, which also includes review of other information about the product as well as possible sampling and examination of the product, according to the agency.

    “Beginning tomorrow, the docket for the proposed rule, titled ‘Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products,’ will be open for public comment through October 15, 2024.

    Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.”Beginning tomorrow, the docket for the proposed rule … will be open for public comment through October 15, 2024.

    Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.