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Category: PMTA

  • FDA Hosting PMTA Roundtable for Small ENDS Manufacturers

    FDA Hosting PMTA Roundtable for Small ENDS Manufacturers

    The U.S. Food and Drug Administration issued a Federal Register notice announcing a roundtable discussion with small tobacco product manufacturers on February 10, 2026, from 9 a.m. to 5 p.m. ET. The meeting will focus on gathering feedback on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) and is open for public viewing.

    Participation in the roundtable is limited to 30 representatives from manufacturers with fewer than 350 employees who have previously submitted an ENDS PMTA, including applications that are still pending with the FDA. The discussion will give small manufacturers an opportunity to share their experiences and perspectives on the PMTA process, including challenges related to product characterization, manufacturing controls, pharmacological studies, adult benefit research, and toxicological assessments.

    Manufacturers interested in participating as panelists must send an email to register by January 27, 2026, with selections made on a rolling basis and limited to one representative per company. Non-panelists and members of the public will be able to watch the roundtable virtually via information posted on the FDA’s Center for Tobacco Products website. The meeting will be recorded and captioned.

  • 5th Circ. Grills FDA on PMTA Rules

    5th Circ. Grills FDA on PMTA Rules

    A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.

    During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.

    The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.

  • Don’t Gamble Your PMTA: Bet on Your Quality System

    Don’t Gamble Your PMTA: Bet on Your Quality System

    By: Gabriel Muñiz

    The recent leadership changes and staffing reductions at the FDA’s Center for Tobacco Products (CTP) have created a moment of uncertainty, but also opportunity, for the tobacco and nicotine industry. With shifting priorities and new leadership on the horizon, some manufacturers see a chance to reset the regulatory conversation. While some companies are using this moment to tighten up operations and reinforce compliance in order to have a better chance at a favorable premarket tobacco product application (PMTA) outcome, others are taking a gamble, scaling back on quality systems and asking themselves, “Do we really have to keep doing all of this?”

    The question often centers around the expectations outlined in 21 CFR Part 1114 and the commitments companies made in their PMTAs. In a push to save costs, some manufacturers are reportedly reducing quality oversight, cutting corners in documentation, and stepping away from key controls they originally described in their PMTAs. The rationale? If enforcement is slowing down, maybe the FDA won’t notice or maybe it won’t matter.

    That’s a risky assumption.

    A PMTA is more than a regulatory formality. It’s a company’s game plan. A commitment to how the product will be manufactured, tested, controlled, and distributed. If your application included a robust quality management system (QMS), specific product testing protocols, or detailed supplier qualification processes, you’re expected to follow through. Along with the science, those commitments were the basis on which the FDA evaluated whether your product was “appropriate for the protection of public health.”

    Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has the authority to withdraw or suspend a marketing granted order (MGO) if it determines that a tobacco product is no longer “appropriate for the protection of public health,” the standard upon which PMTAs are evaluated and approved. If an inspection or oversight activity reveals that a company has significantly deviated from the manufacturing methods, testing protocols, or quality systems described in its PMTA, the FDA may conclude that the product no longer meets the criteria for market authorization. While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear. An MGO is conditional—it depends on a company continuing to manufacture its product as promised. Deviating from that blueprint introduces real regulatory risk.

    While some in the industry viewed the Fifth Circuit’s ruling in Bidi Vapor v. FDA as a signal that the tide was turning in manufacturers’ favor, the outcome in FDA v. Wages and White Lion Investments LLC made it clear: Companies are still expected to meet regulatory requirements and support their products with quality data and compliance. The courts may question FDA procedures, but they won’t eliminate the work required to maintain market authorization.

    Even in a more industry-friendly political environment, the responsibility to protect public health isn’t going away. The current administration may support regulatory efficiency and streamlined processes, but not at the expense of consumer safety. Companies that ignore or scale back their quality systems risk finding themselves unprepared when FDA inspections or compliance reviews resume in full force.

    Now is the time for manufacturers to take stock of their internal systems and ensure alignment with their PMTAs. This includes verifying that quality controls, personnel training, document management, complaint handling, and supplier oversight are functioning as described. A comprehensive, well-maintained QMS doesn’t just satisfy regulatory requirements; it builds trust and stability, especially in a time of change.

    This transition at CTP represents a golden opportunity, but only if companies take the right approach. Cutting corners today to save money may end up costing you far more if it puts your MGO at risk. Regulatory clarity, product stability, and long-term market access depend on more than a favorable headline—they depend on daily operational integrity.

    The FDA may be shifting, but its core mandate remains. This is the moment for responsible manufacturers to lead by example, double down on quality, and show that this industry can thrive without sacrificing quality or consumer trust. For those willing to roll the dice, just remember, being the first company to lose an MGO over PMTA noncompliance isn’t the kind of milestone you want your brand remembered for.

    Gabriel Muñiz, an independent consultant with EAS Consulting Group, is a regulatory compliance expert with extensive experience in the tobacco industry. Muñiz’s tenure at the FDA, particularly as a director within the Office of Regulatory Affairs (ORA), involved leading compliance and enforcement activities for the agency’s tobacco program. His work in building the tobacco operations program and shaping tobacco regulatory policy was instrumental in the development of key compliance strategies and regulatory frameworks, including the proposed tobacco product manufacturing practices. After his FDA career, Muñiz further honed his skills at Juul Labs, where he played a key role in developing premarket tobacco product applications and ensuring alignment with evolving federal regulations. His deep expertise in tobacco regulation will be invaluable to EAS’ clients seeking strategic compliance advice and navigating tobacco-related regulatory challenges.

    About EAS Consulting Group

    EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by the FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers expert regulatory solutions our customers can feel confident in—so the world can trust in what it consumes. Our network of over 200 independent consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.

  • FDA Issues Final Guidance on Testing Methods

    FDA Issues Final Guidance on Testing Methods

    The FDA has published final guidance for the tobacco industry on the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides recommendations for tobacco manufacturers on how to generate validation and verification data for analytical methods supporting regulatory submissions, including Substantial Equivalence (SE) reports, Premarket Tobacco Product Applications (PMTA), and Modified Risk Tobacco Product Applications (MRTPA). It also applies to testing and reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

    The updated guidance finalizes the draft issued in December 2021, incorporating comments received from stakeholders. Key changes include updates reflecting recent statutory revisions, such as the inclusion of synthetic nicotine under the definition of tobacco products, and clarifications on alternative validation procedures. The guidance also supports the use of national and international standard test methods and provides detailed recommendations on laboratory accreditation, statistical methods, and analytical test method validation, helping the industry produce more reliable and consistent data for regulatory purposes.

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of the CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • Industry Group Files Amicus Brief in Triton Case

    Industry Group Files Amicus Brief in Triton Case

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

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

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

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

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

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

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

  • Supreme Court to Hear Avail, Reynolds PMTA Case

    Supreme Court to Hear Avail, Reynolds PMTA Case

    TR Archives

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

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

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

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

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

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

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

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

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

  • Fifth Circuit Vacates Denials Citing ‘Triton’

    Fifth Circuit Vacates Denials Citing ‘Triton’

    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.”

  • Top Court to Hear Triton PMTA Denial Order Suit

    Top Court to Hear Triton PMTA Denial Order Suit

    supreme court of USThe 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.

  • Durbin Decries Menthol Vape Order

    Durbin Decries Menthol Vape Order

    Senator Dick Durbin
    Credit: Dick Durbin

    When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Senator Dick Durbin was disappointed. He said the agency should have done better. The move marks the first nontobacco-flavored e-cigarette products to be authorized by the FDA.

    “Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”

    Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a committee hearing titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use and the role that flavors—such as menthol—play in youth use of tobacco products and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.

    Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s hearing, said he applauds the FDA’s decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.

    “The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern—the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.

    “Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”