Latest news with #Vapetasia
New York Post
3 days ago
- Health
- New York Post
Unregulated chemical 13,000 times sweeter than sugar is used in most e-cigarettes: study
A little-known artificial sweetener that's up to 13,000 times sweeter than sugar is now used in most popular flavored e-cigarettes — even though it is not listed on labels and is only FDA-approved for food, a new study found. Neotame was detected in 57 of 73 flavored vaping products often marketed to kids and teens and had an average content nearly five times higher than in a mint candy, a study conducted by researchers from Yale School of Medicine and Duke University found. Little is known about the health effects of inhaling the potent, no-calorie alternative, which was created by NutraSweet and is also known as Newtame, and current regulations do not limit its use, according to the June 2 study published in the Journal of the American Medical Association. 3 Researchers at Yale detected the sweetener in a majority of flavored vaping products on the market. The researchers set out to prove, mainly to regulators and clinicians, how commonly the chemical, which is also up to 65 times sweeter than aspartame, is being used in newer products, they said. All popular disposable e-cigs introduced after 2021 that haven't yet received U.S. Food and Drug Administration marketing authorization — 27 devices across 11 different brands — contained neotame, according to the study. Among them were vapes from brands like Breeze Smoke, Elf Bar and Vapetasia, which offer flavors like Strawberry Apple, Killer Kustard and Blue Razz Ice. Products from three brands — Vuse and NJOY, which are FDA-approved, and JUUL, which is awaiting approval — that were introduced before 2021 do not contain it, the study found. The substance was likely chosen for its heat stability compared to other sweeteners, but its behavior when heated and vaporized in e-cigarettes is unknown, the scientists wrote in their findings. 3 Flavored e-cigarettes, often marketed to kids and teenagers, are rife with the artificial sweetener neotame. Vapetasia 'There are two specific concerns about the finding: How does it affect the potential for addiction to the product, and what are the product's adverse health effects when inhaled?' said Hanno Erythropel, the paper's lead author. 'Eating versus inhaling something is very different,' Erythropel, a Yale researcher, added. 'There are many examples in which chemicals are safe for eating but not for inhalation.' Neotame is approved by the FDA for use in food, but not in vaping products, according to the researchers. When eaten in foods like cakes, soft drinks and chewing gum, neotame can seriously damage gut health, a study published last year in the medical journal Frontiers found. 3 Neotame is an artificial sweetener similar to aspartame. luchschenF – 'The respiratory and systemic health effects of neotame and its potential decomposition products during heating in an e-cigarette are unknown,' the scientists said. Alarmingly, most of the 'funky' flavors used in e-cigarettes have not been evaluated for use in products other than food, Erythropel added. The team hopes its findings pave the wave for further studies on neotame toxicity and exposure once it is heated and inhaled, and how users rate the appeal of e-cigarettes that contain it.
Yahoo
03-04-2025
- Business
- Yahoo
The Supreme Court Blesses the FDA's Rejection of Flavored Nicotine Vapes
In a unanimous decision on Wednesday, the Supreme Court rejected an appeals court's conclusion that the Food and Drug Administration (FDA) violated the Administrative Procedure Act by "arbitrarily and capriciously" refusing to allow continued sales of flavored nicotine solutions produced by Vapetasia and Triton Distribution. The decision effectively approves the FDA's de facto ban on nicotine vaping products in flavors other than tobacco and menthol, meaning that unfair and irrational policy will continue unless it is reversed by the Trump administration. Vapetasia, which is based in Las Vegas, and Triton Distribution, which is located in the Dallas area, complained that the FDA had improperly changed the criteria for approving their products after they sought permission to keep selling them. Last year, the U.S. Court of Appeals for the 5th Circuit agreed, saying the FDA "sent manufacturers of flavored e-cigarette products on a wild goose chase" by issuing guidance on which the companies relied in preparing their applications, only to discover that the agency's advice had been nullified by subsequent "regulatory switcheroos." The FDA appealed that decision, and last July the Supreme Court agreed to take up the case. It heard oral arguments in December. "The essence of respondents' argument," Justice Samuel Alito notes in FDA v. Wages and White Lion Investments, "is that the FDA told them in guidance documents that it would do one thing and then turned around and did something different when it reviewed their applications." But with one exception that may not have made a difference, he says, the FDA did not really change its position on what it would take for these companies to stay in business. "In respondents' view," Alito notes, "the FDA initially stated that manufacturers would not need to provide specific kinds of studies like randomized controlled trials or longitudinal cohort studies but then treated such evidence as essential." Although Vapetasia and Triton "express frustration about the lack of clear prior notice regarding the type of scientific evidence that was essential for approval of an application," he says, "we cannot agree with their argument that the FDA went back on any commitments made in the guidance it provided before ruling on respondents' applications." It is not hard to see how Vapetasia and Triton got the impression that no specific type of study was necessary. "In most situations," an FDA official said at a public meeting in October 2018, "it is likely that at least some analytical testing specific to the product would be conducted" to support an application. In addition to "randomized clinical trials," he mentioned "alternatives" such as literature reviews and "pharmacokinetic," "pharmacodynamic," "biomarker," "topography," or "focus group" studies. As Alito notes, "the official never stated that any particular type of study was necessary." To the contrary, "the FDA acknowledged that it was open to evidence besides 'new nonclinical or clinical studies.'" It also said "it would consider evidence 'bridging' new tobacco products to already marketed products whose safety was backed by 'existing clinical, nonclinical, or product information.'" But as Alito and the other justices see it, "none of this amounted to anything like a hard-and-fast commitment as to the minimum evidence the agency would require for marketing authorization." A June 2019 guidance document "was similarly noncommittal," Alito says. The FDA "recognized that the 'relatively new entrance' of e-cigarettes 'on the U.S. market' meant that 'limited data may exist from scientific studies and analyses.'" In light of that problem, the FDA said, it would consider other "valid scientific evidence," although it warned that "nonclinical studies alone are generally not sufficient." If applicants cited "data from the published literature or government-sponsored databases," the FDA said, they should make sure that evidence was "adequately bridged to your product" based on "a scientific rationale." Manufacturers could draw on "published literature reviews," although those are "considered a less robust form of support." Applicants could "conduc[t] independent analyses of published studies," but it was important to include "critical study details" to make that information "useful in FDA's review." The gist of the FDA's message, Alito says, was that "it was not essential for manufacturers to submit evidence based on 'well-controlled investigations,' such as randomized controlled trials or longitudinal cohort studies." But "if they did not do so, they would have to provide rigorous scientific evidence that the sale of their particular products would be appropriate for the protection of the public health"—the nebulous standard established by the 2009 law that authorized the FDA to regulate tobacco products. Since Vapetasia and Triton "did not submit randomized controlled trials or longitudinal cohort studies," Alito says, "the fate of their applications turned on whether they submitted 'other evidence' that met the FDA's standard of scientific rigor and relevance to their product. The FDA rejected respondents' applications because it concluded that its 'other evidence' test was not met, and the explanation in its denial orders echoed statements made at various points in its earlier guidance." That gloss is hard to reconcile with an internal FDA memo written in July 2021—10 months after the application deadline. In that memo, Alito concedes, the FDA took "a far less capacious view of the scientific evidence it would consider," saying "it would consider it a 'fatal flaw' if an application lacked scientific evidence about a product based on either a randomized controlled trial or a longitudinal cohort study." But the FDA insists it did not apply that rule when it rejected the applications from Vapetasia and Triton. The Supreme Court is obliged to accept that claim, Alito says, because the FDA is "entitled to a presumption of regularity" that can be overcome only by a "strong showing of bad faith or improper behavior." Vapetasia and Triton also complained that the FDA "initially gave applicants broad discretion to select appropriate comparators for their products" but later insisted they demonstrate that their e-liquids were more effective at achieving smoking cessation than tobacco-flavored alternatives. Because the FDA worried that fruit, candy, and dessert flavors appeal to teenagers, it was not enough to show that former smokers overwhelmingly prefer those flavors, that vaping products help smokers quit, and that switching to vaping dramatically reduces the health risks of their nicotine habits. Alito concedes that "the FDA did not provide this precise instruction in its predecisional guidance." But he thinks applicants should have anticipated that the FDA "might consider whether an application for a flavored product included a comparison with other products in the flavored category," especially in light of the agency's concerns about underage vaping. Those concerns, Vapetasia and Triton noted, had always been focused on cartridge-based vapes, which accounted for the vast majority of underage consumption, as opposed to the refillable "open" systems for which their liquids are designed. The latter, which are sold in vape shops that exclude minors, have never been very popular among teenagers. According to the 2024 National Youth Tobacco Survey, 6 percent of middle and high school students were "current" e-cigarette users, meaning they reported vaping during the previous month. Among those current users, just 7 percent said they used "tanks or mod systems." In an April 2020 guidance document, Alito notes, the FDA "said it would 'prioritize enforcement of flavored, cartridge-based' e-cigarette products 'other than tobacco- and menthol-flavored products.'" It explained that "youth overwhelmingly prefer cartridge-based" vaping products, which are "easy to conceal, can be used discreetly, may have a high nicotine content, and are manufactured on a large scale." And it said its enforcement actions "should have minimal impact on small manufacturers (e.g., vape shops) that primarily sell non-cartridge-based" products. From such statements, Vapetasia and Triton surmised that the FDA did not view their products as significant contributors to underage vaping. They were therefore surprised by the hard line it took against their nontobacco flavors. Alito concedes that "the FDA's central concern" was cartridge-based vapes. But he says "nothing in the 2020 guidance suggested the FDA would decline to take enforcement action against other products that might be appealing to the young." Although "the 2020 guidance may have led respondents to believe that the FDA was more likely to authorize their open-system products than other manufacturers' cartridge-based products," he says, "such a belief about how an agency is likely to exercise its enforcement discretion is not a 'serious reliance interes[t].'" Finally, Vapetasia and Triton complained that the FDA changed its mind about the importance of "marketing plans" aimed at minimizing underage use. "After telling manufacturers that their marketing plans were 'critical' to their applications," the 5th Circuit noted, "the FDA candidly admitted that it did not read a single word of the one million plans." The FDA said it decided to ignore those plans "for the sake of efficiency." The 5th Circuit saw that reversal as a clear change in the FDA's position, and the FDA does not contest that conclusion. But this particular "switcheroo," it argues, was "harmless." Although the 5th Circuit disagreed, Alito says the appeals court did not apply the correct test in assessing that issue, so it should try again. Although the 5th Circuit's decision allowed Vapetasia and Triton to stay in business, it was never clear how long that reprieve would last. The appeals court remanded "the matters" to the FDA, which could still reject the applications after reviewing them again. Congress gave the FDA wide discretion to block the sale of nicotine products based on a collectivist calculus that invites value judgments and entails highly uncertain predictions. And even though adolescent vaping has been declining for years, the FDA under the Biden administration saw it as a threat so grave that it overrode the interests of adult consumers and the businesses that serve them. That could change. During his 2024 campaign, President Donald Trump bragged that he "saved flavored vaping" during his first term and promised that he would "save vaping again." The post The Supreme Court Blesses the FDA's Rejection of Flavored Nicotine Vapes appeared first on
Yahoo
02-04-2025
- Health
- Yahoo
Supreme Court upholds FDA decision banning flavored vapes
The Supreme Court ruled unanimously Wednesday that the FDA properly refused to approve flavored vape products by two e-cigarette companies because regulators determined they were too great a risk to public health. The ruling overturned a decision by the 5th Circuit Court of Appeals that found that the FDA unfairly changed its standards while assessing products made by Triton Distribution and Vapetasia. The FDA's denial orders were 'sufficiently consistent with its predecisional guidance,' Justice Samuel Alito wrote for the court. 'Affected parties may have come away with the impression that the agency would apply a less demanding standard of proof than is evident in the denial orders the FDA ultimately issued, but in the end, we cannot say that the FDA improperly changed its position with respect to scientific evidence, comparative efficacy, or device type.' The e-liquid flavor products marketed by Triton and Vapetasia include dessert, candy and fruit flavors such as 'Killer Kustard Blueberry,' 'Rainbow Road' and 'Pineapple Express.' They were among millions of other flavored e-cigarette products that the FDA barred in 2021 due to their attractiveness to young people and addictive nature, the court said. E-cigarettes hit the market in 2007 and soon became ubiquitous. Use surged after 2010, reaching 11.2 million American adults by 2016, according to a study cited by the court. A 2009 law called the Tobacco Control Act gave the FDA broad powers to restrict the sale and marketing of new tobacco products that would negatively impact public health, especially in terms of the potential for addiction. Justice Sonia Sotomayor wrote separately to clarify that she did not agree with the majority that the FDA had been unwilling to clearly state what companies needed to prove to get their products approved. The agency instead gave manufacturers 'some flexibility as to the forms of evidence,' while sticking to its duty to ensure products were ultimately safe for the general public, Sotomayor said.
Politico
02-04-2025
- Health
- Politico
Supreme Court upholds FDA decision banning flavored vapes
The Supreme Court ruled unanimously Wednesday that the FDA properly refused to approve flavored vape products by two e-cigarette companies because regulators determined they were too great a risk to public health. The ruling overturned a decision by the 5th Circuit Court of Appeals that found that the FDA unfairly changed its standards while assessing products made by Triton Distribution and Vapetasia. The FDA's denial orders were 'sufficiently consistent with its predecisional guidance,' Justice Samuel Alito wrote for the court. 'Affected parties may have come away with the impression that the agency would apply a less demanding standard of proof than is evident in the denial orders the FDA ultimately issued, but in the end, we cannot say that the FDA improperly changed its position with respect to scientific evidence, comparative efficacy, or device type.' The e-liquid flavor products marketed by Triton and Vapetasia include dessert, candy and fruit flavors such as 'Killer Kustard Blueberry,' 'Rainbow Road' and 'Pineapple Express.' They were among millions of other flavored e-cigarette products that the FDA barred in 2021 due to their attractiveness to young people and addictive nature, the court said. E-cigarettes hit the market in 2007 and soon became ubiquitous. Use surged after 2010, reaching 11.2 million American adults by 2016, according to a study cited by the court. A 2009 law called the Tobacco Control Act gave the FDA broad powers to restrict the sale and marketing of new tobacco products that would negatively impact public health, especially in terms of the potential for addiction. Justice Sonia Sotomayor wrote separately to clarify that she did not agree with the majority that the FDA had been unwilling to clearly state what companies needed to prove to get their products approved. The agency instead gave manufacturers 'some flexibility as to the forms of evidence,' while sticking to its duty to ensure products were ultimately safe for the general public, Sotomayor said.
Reuters
02-04-2025
- Business
- Reuters
US Supreme Court tosses ruling faulting FDA for denying flavored vape products
WASHINGTON, April 2 (Reuters) - The U.S. Supreme Court threw out on Wednesday a judicial decision that found the U.S. Food and Drug Administration acted unlawfully in refusing to let two e-cigarette companies sell flavored vape products that regulators consider a health risk to youths. The justices in a unanimous ruling threw out a lower court's ruling that the FDA had failed to follow proper legal procedures under a federal law called the Administrative Procedure Act when it rejected the applications by the companies, Triton Distribution and Vapetasia, to sell these nicotine-containing products. An FDA rule that took effect in 2016 under Democratic President Barack Obama deemed e-cigarettes to be tobacco products that, like traditional cigarettes, are subject to agency review under a 2009 federal law called the Tobacco Control Act. The law requires manufacturers of e-cigarette products to apply for authorization to sell nicotine vaping devices and e-liquids. Triton Distribution and Vapetasia filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade and crème brulee, and names including "Jimmy The Juice Man Peachy Strawberry" and "Suicide Bunny Mother's Milk and Cookies" - offerings that critics have said were designed to appeal to minors. The FDA denied the Triton and Vapetasia applications as well as hundreds of others by various companies involving more than a million flavored vape products. During arguments in the case, a Justice Department lawyer arguing for the FDA said the companies knew throughout the application process that the agency was concerned about the fact that flavors are attractive to youth and about the addictive nature of nicotine, a chemical dangerous to developing brains. In order to win regulatory approval, e-cigarette companies must demonstrate that a product would be "appropriate for the protection of the public health." That means that any health benefits - such as helping traditional cigarette smokers transition to generally less-harmful vaping - must outweigh the risks of bringing the new product to market. The e-cigarette companies argued that the FDA improperly assessed their applications under a regulatory standard that differed from published guidance they had relied upon. The FDA found that in 2020 nearly one in five high school students and almost one in 20 middle school students used e-cigarettes, making e-cigarettes "the most widely used tobacco product among youth by far." The agency over the years has approved only 34 flavored e-cigarette varieties, all tobacco or menthol flavored. It maintains that it has not categorically banned flavored e-cigarette products. But companies seeking its approval to sell these products face an especially tough health benefits-versus-risk legal test as a result of the FDA's finding that flavored e-cigarettes pose a "known and substantial risk" to youth. Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA's denial of their applications. The full slate of 5th Circuit judges ruled 10-6 that the FDA had been arbitrary and capricious, in violation of a federal law called the Administrative Procedure Act, by denying the applications without considering plans by the companies to prevent underage access and use. Seven other federal appellate courts had sided with the FDA in similar cases. The Supreme Court on Nov. 25 also declined to hear an appeal by RJ Reynolds and other tobacco companies of a lower court's ruling upholding graphic health warnings required by the FDA on cigarette packs. The Supreme Court, with a 6-3 conservative majority, has reined in the authority of federal agencies in a series of cases in recent years. In another high-profile case involving the FDA, the Supreme Court in June decided on procedural grounds to reject a bid by anti-abortion groups and doctors to restrict access to the abortion pill mifepristone.
