Tag: Triton Distribution

SCOTUS to Hear Triton Vaping Case Next Week

Credit: Renas Child
In one week, the U.S. Supreme Court will hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.
The live audio of the hearing can be found here.
The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.
The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.
Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.
The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.
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.
In January, 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.
November 25, 2024
Taxpayer Group Files Amicus Brief in Triton Case

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The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.
The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.
Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.
The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.
The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.
October 17, 2024
Supreme Court Urged to Overturn Triton Ruling

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Ten U.S. public health medical and community organizations have filed an amicus brief supporting the Food and Drug Administration in asking the U.S. Supreme Court to overturn a recent Fifth Circuit Court of Appeals decision forcing the FDA to reconsider several marketing denying orders (MDOs) issued vaping companies.
In their brief, the groups explain why they believe that allowing the decision in Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution to stand would undermine the FDA’s ability to protect young people from the health harms of flavored e-cigarettes.
In September 2020, the FDA denied Triton’s applications for approval of a variety of flavored e-liquids for use in e-cigarettes. Triton appealed to the Fifth Circuit, which struck down the FDA’s marketing denial orders. In July, the Supreme Court agreed to hear the FDA’s appeal of that decision.
According to amici, “E-cigarettes pose unique health risks for youth, as adolescent brains are more susceptible to nicotine’s effects due to ongoing neural development” and “[t]he tobacco industry has long known that flavors are important to its ability to successfully market its products to young people.”
The groups argue that, contrary to the vaping companies’ protestations, the FDA’s decision to issue MDOs in this case was not arbitrary or capricious, because the applicants did not present evidence that their products would benefit the public health
The brief cites notes that over 2.1 million U.S. youth, including 10 percent of high schoolers, reported current e-cigarette use in 2023, and nearly 30 percent of high school users reported daily use.
The brief was submitted by the American Academy of Family Physicians, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the American Medical Association, the American Thoracic Society, the Campaign for Tobacco-Free Kids, the Louisiana State Medical Society, Parents Against Vaping E-cigarettes and the Truth Initiative.
September 4, 2024
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.”
August 19, 2024
Fifth Circuit Cites Triton to Vacate 5 Denial Orders

Fifth Circuit Court of Appeals
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 U.S. Food and Drug Administration for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco 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 Fifth 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.
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.”
August 2, 2024
SCOTUS to Hear Vaping PMTA Suit FDA v. Triton
The U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.
The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.
The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.
Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.
The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.
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.
In January, 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.
July 2, 2024
Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

Image: BCFC
Two e-liquid companies will be able to resubmit their marketing applications to the U.S. Food and Drug Administration following a court ruling, reports Bloomberg Law.
On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
In a dissenting opinion, Judge Catharina Haynes stated that the agency “properly fulfilled its statutory mandate by considering the relevant portions of Petitioners’ PMTAs and coming to a reasonable conclusion that marketing Petitioners’ products is not appropriate for public health.”
Oldham stated that the 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 one 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 one million plans.”
In an X post, Michael Siegel, a professor at Boston University School of Public Health, stated that the ruling “exposed” the FDA’s wrongful rejection of applications for flavored vapes, ultimately resulting in a “win for public health.”
Eric Heyer, a lawyer for e-liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make “a significant course correction by communicating with specificity” what companies must do to get approval.
“No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people,” Oldham wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. “And FDA’s regulatory switcheroos in this case bear no resemblance to square corners.”
It is expected that the FDA will seek a review of the decision by the Supreme Court of the United States, however, the justice department hasn’t made an official announcement.
January 3, 2024
VTA Files Amicus Brief in Triton PMTA Lawsuit

Credit: William A. Morgan
The 5th Circuit Court of Appeals granted the Vapor Technology Association’s (VTA) unopposed motion to file an amicus brief in support of Petitioners’ Petition for a Rehearing En Banc in the case Wages & White Lion Investments, a/k/a/ Triton Distribution v. FDA.
Recently, a panel of 5th Circuit judges denied Triton Distribution’s appeal of the U.S. Food and Drug Administration’s marketing denial order for its flavored e-liquid products in a 2-1 decision. Thereafter, Triton filed a petition for en banc review, asking the entire 5th Circuit to reconsider the ruling.
The VTA’s amicus brief supports Triton’s request by explaining that it involves issues of “exceptional importance” necessitating review by the entire 5th Circuit Court of Appeals.
The VTA’s amicus brief highlights three key points: economist John Dunham and Associates’ evaluation of the adverse economic impact that the ruling would have if it led to the removal of all flavored open system vaping products from the states comprising the 5th Circuit (Louisiana, Mississippi and Texas); the leading tobacco control scientists who have warned that removing flavors will deter adult smokers from quitting and have recommended limiting the sale of flavored vaping products to adult-only stores; and the results of the VTA’s analysis of the FDA’s compliance data between Jan. 1, 2020, and June 30, 2022, which reveal that the rate of illegal youth sales of cigarettes and cigars are twice the rate of vaping products.
September 12, 2022
Court Denies Triton, Vapetasia Review of FDA Orders

Fifth Circuit Court of Appeals
Two e-liquid manufacturers may be forced to pull their products from store shelves after they lost their bid to force the U.S. Food and Drug Administration to allow them to market their vaping products.
The U.S. Court of Appeals for the Fifth Circuit denied Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s requests Monday for review of the agency’s marketing denial orders (MDOs) in a 2-1 decision.
The manufacturers didn’t show that the FDA acted arbitrarily or capriciously when it rejected their premarket tobacco product applications (PMTAs), the Fifth Circuit said.
“In a mockery of ‘reasoned’ administrative decision-making,” Judge Edith Jones, a former chief judge of the Fifth Circuit who has served since the Reagan administration, wrote in her dissent. “FDA (1) changed the rules for private entities in the middle of their marketing application process, (2) failed to notify the public of the changes in time for compliance, and then (3) rubber-stamped the denial of their marketing applications because of the hitherto unknown requirements.”
If the ruling holds, Triton and Vapetasia will not be able to sell their reduced-risk electronic nicotine-delivery system (ENDS) products.
The companies had applied to market products with flavors like sour grape, pink lemonade, crème brulee and milk and cookies and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
Dozens of other smaller vape companies also have accused the regulatory agency of operating unfairly, and will likely be disheartened by this ruling, reports Alex Norcia for Filter.
Todd Wages, a partner at Triton Distribution, told Filter he was “very disappointed” in the court. “We’re exploring our next steps. I will not stop fighting until I can’t any longer, until every door is closed,” he said.
The FDA rejected applications to market 55,000 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.
A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.
Eric Heyer, the lawyer representing Triton Distribution, told Filter that the company “intends to file a petition for rehearing en banc by the entirety of the Fifth Circuit.”
Most circuit court appeals are decided by a three-judge panel, however special circumstances could motivate the court to allow a majority of the active judges to vote to rehear the case “en banc.”
Moving forward, Triton had asked the court in briefs to allow the company to “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy” if the panel ruled against Triton. The court denied that request.
July 19, 2022
Triton Unleashes its Opening Argument in FDA Lawsuit
In a highly anticipated case for the vapor industry, Triton Distribution made its opening arguments Monday in its battle with the U.S. Food and Drug Administration over how the regulatory agency conducted it premarket tobacco product application (PMTA) reviews. Triton’s lawyer urged a three-judge panel of the 5th U.S. Circuit Court of Appeals in Houston to conclude the FDA could not force manufacturers to provide studies that the agency had previously stated would not be required.
“The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies,” said Triton’s attorney Eric Heyer, a partner at Thompson Hine.
Credit: Sergign
In August, the FDA rejected applications to market 55,000 flavored e-cigarettes, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval, according to Reuters. The new requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to keep selling e-cigarettes until another panel could hear its appeal.
In recently released internal FDA correspondence, the agency’s scientific staff conducted “fatal flaw” reviews that only looked for the presence of the newly required long-term studies, and if those studies were not present the agency issued a marketing denial order (MDO). During oral arguments, Heyer said the FDA’s new requirement was “arbitrary and capricious, a position conservative U.S. Circuit Judge Edith Jones appeared to agree with.
“It seems to me that’s the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences,” she said, alluding to COVID-19 vaccines.
Heyer argued that the process the FDA established set Triton up for failure because the new requirements were only conveyed after the deadline for when PMTAs needed to be submitted (Sept.9, 2020) had passed. It was only then that the FDA indicated that applicants would likely need randomized controlled trials (RCTs) and longitudinal cohort studies to demonstrate “comparative efficacy.”
The other two judges questioned Triton’s case. U.S. Circuit Judge Gregg Costa asked whether Triton’s products, such as one called Jimmy the Juiceman Strawberry Astronaut, were really targeted to adults. “That’s supposed to be appealing to a 40-year-old?” he asked.
U.S. Circuit Judge Catharina Haynes questioned why companies like Triton did not have enough time to develop such support for their products’ health benefits for adults given the years they have had to prepare for FDA regulation. The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act. Manufacturers were ultimately given until 2020 to seek approval to market them.
If the court disagrees with Triton’s argument, Heyer has requested that the judges “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy,” according to legal documents.
There is no timeline for a decision in the Triton lawsuit. Judges are expected to take at a minimum weeks, if not months, to make a decision.
February 1, 2022