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Tag: PMTA

  • 5th Circ. Backs FDA’s Block on Vape Marketing

    5th Circ. Backs FDA’s Block on Vape Marketing

    The U.S. Court of Appeals for the Fifth Circuit upheld the U.S. Food and Drug Administration’s denial of marketing applications for menthol-flavored e-cigarette products submitted by two vape manufacturers, ruling that the agency reasonably concluded the products’ potential benefits for adult smokers did not outweigh the risks of youth initiation. The decision affirms the FDA’s application of the “appropriate for the protection of public health” standard required under the Premarket Tobacco Product Application (PMTA) pathway.

    The ruling, against Triton Distribution and Vapetasia LLC, reinforces the FDA’s authority to reject flavored vaping products where applicants fail to provide sufficient evidence that the products offer a net public health benefit.

  • Zest Gets Injunction Against FDA for Pouches

    Zest Gets Injunction Against FDA for Pouches

    Zest Brands LLC announced that it secured a preliminary injunction from the U.S. District Court for the Middle District of Florida, allowing its ZEO Universe nicotine pouch products to remain on the U.S. market while the company challenges an FDA Refuse-to-File (RTF) decision related to its May 2022 Premarket Tobacco Product Applications. The injunction temporarily stays the FDA’s action as the case proceeds through the courts.

    According to the company, the court found Zest Brands is likely to succeed on claims that the FDA failed to adequately assess the impact of its 2021 PMTA regulations on small businesses, as required under the Regulatory Flexibility Act. The court also indicated that aspects of the agency’s actions may have been “arbitrary and capricious.” Zest said it remains committed to working with the FDA to complete the PMTA process and is currently in discussions with strategic and financial partners to support future growth.

  • Charlie’s Holdings Touts Progress to Shareholders

    Charlie’s Holdings Touts Progress to Shareholders

    Charlie’s Holdings, Inc. sent out a shareholder letter today (June 8), outlining its recent progress and highlighting improved financial stability, portfolio expansion, and regulatory positioning across its premium vapor products business. The company said it strengthened liquidity and operations over the past year, including the $7.5 million sale of 16 PMTA-authorized products to a major tobacco company and the expansion of its U.S. manufacturing footprint to support domestic production, reduce costs, and meet state-level compliance requirements.

    The letter also emphasized Charlie’s strategic focus on regulatory innovation and capital market advancement. The company detailed its licensing agreement with IKE Tech to commercialize an AI-powered age-gating system for disposable vapes, which it believes could unlock significant licensing revenue and potential partnerships. It also noted steps toward a potential uplisting to a national exchange, including a clean 2025 audit, elimination of prior business lines, and shareholder approval of a reverse stock split, while reaffirming its goal of growing compliant nicotine and alternative vapor product sales amid tightening enforcement against illicit products.

  • FDA Releases Environmental Review for Oral Nicotine Products

    FDA Releases Environmental Review for Oral Nicotine Products

    Today (May 21), the U.S. Food and Drug Administration published a programmatic environmental assessment covering nicotine pouches and other oral nicotine products reviewed through the premarket tobacco product application (PMTA) process. The assessment applies to products categorized as “other,” including nicotine pouches, lozenges, tablets, gums, discs, dissolvable tobacco products, and nicotine-infused products, while excluding traditional smokeless tobacco products such as snus, dip, and chewing tobacco.

    The FDA concluded that the environmental impact of these products is generally minimal, citing the absence of airborne emissions during use and relatively limited environmental contamination from product waste. According to the agency, these products reduce or eliminate secondhand and thirdhand exposure risks compared with combustible products, while the waste generated contains comparatively fewer harmful chemicals that persist or bioaccumulate in the environment.

    The agency said the assessment is intended to support transparency and may be referenced by FDA reviewers evaluating individual product applications. However, the FDA emphasized that authorization decisions will continue to be made on a case-by-case basis based on the specific scientific evidence submitted for each product.

  • BAT Stock Surges, Despite Legacy Combustibles Shrinking

    BAT Stock Surges, Despite Legacy Combustibles Shrinking

    Shares of British American Tobacco climbed 13.99% in London trading last week to £48.64 on May 15, as investors reacted to a mix of regulatory, legal, and capital signals. Market attention followed the U.S. Food and Drug Administration authorization of flavored Glas ENDS products, seen as a reference point for how flavored e-cigarettes may fare under the PMTA pathway, even though the decision did not involve BAT’s Vuse brand. Sentiment was further supported after a U.S. court dismissed a sanctions-related criminal case tied to BAT’s prior North Korea compliance matter, confirming the company had fulfilled its deferred prosecution agreement, alongside continued focus on BAT’s planned £1.3 billion 2026 share buyback and growth prospects for its newer nicotine portfolio, including VELO.

    In contrast, BAT Bangladesh reported a 14% year-on-year drop in cigarette volumes and a 34% decline in profit for Q1 2026 amid higher taxes, inflationary pressure, and weaker consumer purchasing power, underscoring the diverging performance between BAT’s legacy combustible markets and investor expectations tied to reduced-risk product expansion.

  • FDA Makes ENDS PMTA Roundtable Materials Available

    FDA Makes ENDS PMTA Roundtable Materials Available

    Today (May 14), FDA released materials from its Feb. 10 Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products, providing the public and industry with a detailed look at discussions between agency officials and small manufacturers. Led by Dr. Matthew Farrelly and moderated by Dr. Todd Cecil, the sessions focused heavily on product characterization, manufacturing controls, pharmacological and toxicological data, and how applicants can demonstrate adult benefit through longitudinal or randomized studies. FDA said the purpose of the roundtable was to solicit feedback on how to improve the efficiency and clarity of PMTA reviews while remaining bound by statutory requirements under the Tobacco Control Act.

    Industry participants used the forum to reiterate concerns about the lack of objective scientific benchmarks guiding ENDS applications, arguing that uncertainty around testing parameters—particularly for open-system products—and the inability to update long-pending PMTAs create significant barriers for small businesses. The Vapor Technology Association, through Executive Director Tony Abboud, said members appreciated the opportunity for dialogue but left the meeting seeking clearer standards and more predictable regulatory expectations.

    Find the FDA’s resources below:

    FDA ENDS Roundtable Hub

    FDA ENDS Roundtable Video

    FDA ENDS Roundtable Transcript

  • CTP Director Touts Progress, Future in Statement

    CTP Director Touts Progress, Future in Statement

    The FDA’s Center for Tobacco Products says it has made significant progress in streamlining the review of premarket tobacco product applications (PMTAs), reducing its backlog by approximately 70% in 2025 and eliminating the queue for initial acceptance review. In a statement dated May 7 and released today (May 13), acting Director Bret Koplow said new efficiencies are allowing applications to move into review almost immediately, while accelerated filing and scientific review processes—particularly for nicotine pouches and electronic nicotine delivery systems—are helping bring compliant products to market more quickly.

    Koplow also highlighted the success of a pilot program for nicotine pouch applications, which led to authorizations for six products within three months, a record pace for the agency. The FDA plans to apply lessons from the pilot more broadly, including expedited review for product modifications and increased real-time communication with applicants, signaling a shift toward faster but still science-based regulatory decision-making in the nicotine category.

    Read the full release here.

  • FDA Files MRTP Renewal for Two 22nd Century Products

    FDA Files MRTP Renewal for Two 22nd Century Products

    Today (May 12), FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review for 22nd Century Group Inc. products VLN King and VLN Menthol King. Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

    The renewal follows MRTP orders first granted in 2021, which are set to expire in December 2026, requiring FDA reauthorization for continued marketing with reduced-risk claims. The agency has begun releasing redacted application materials for public access and has opened a docket for public comment, allowing stakeholders to submit data and feedback as part of the review process.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • 5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    5th Circuit Considering if FDA Overstepped in Vape Flavor Regs

    A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit heard oral arguments this week in a case brought by seven small vape-liquid companies challenging the FDA’s denial of marketing authorization for flavored electronic nicotine delivery systems. The companies argue the FDA rejected their applications based on a comparative efficacy requirement they say was not disclosed before the 2020 PMTA deadline, in violation of the Tobacco Control Act.

    The FDA defended the denials, saying manufacturers must prove their specific products are appropriate for the protection of public health. Government counsel argued that non-tobacco flavors add youth-use risk and that applicants failed to show added adult switching benefits over tobacco-flavored products.

    The panel questioned both sides on whether the FDA’s approach was lawful adjudication or rulemaking in practice. Courthouse News Service said, this “ruling could affect thousands of pending applications and clarify how much procedural leeway the FDA has when reviewing the flood of vape products submitted after the 2020 PMTA deadline.”