TobaccoReporter logo

Tag: PMTA

  • Ispire Says FDA Guidance Opens $50B Door

    Ispire Says FDA Guidance Opens $50B Door

    Ispire Technology Inc. says it is positioning itself to capture a multi-billion-dollar opportunity in the U.S. vaping market following the FDA’s newly issued draft guidance on flavored ENDS Premarket Tobacco Product Applications. The guidance, which formally recognized device-level age verification — or Device Access Restrictions (DAR) — as a key factor in determining whether a product meets the “appropriate for the protection of public health” standard, creates a lawful pathway for flavored products that have largely been sold illicitly.

    Ispire said its 40%-owned joint venture, IKE Tech LLC, is uniquely positioned to provide the age-gating and product authentication infrastructure required for compliance, leveraging its blockchain-secured, biometric, and Bluetooth-enabled technology platform that has been validated to prevent underage access while supporting adult consumer use.

    Ispire said the recognition of DAR technologies by the FDA opens a total addressable market estimated at $50 billion, largely comprised of illicit and unauthorized flavored ENDS products. IKE Tech’s SaaS-based compliance model, which Ispire estimates can generate $5 million to $20 million in annual recurring revenue per manufacturer customer, positions the company to capture significant enterprise value even with a limited number of clients. Beyond age verification, the platform also addresses counterfeiting and illicit trade, providing traceability and authentication across the supply chain.

  • FDA Outlines Risk-Based Approach to ENDS Flavors

    FDA Outlines Risk-Based Approach to ENDS Flavors

    Yesterday (March 9), the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining how it will evaluate flavored electronic nicotine delivery systems (ENDS) under the Premarket Tobacco Product Application (PMTA) process. The document clarifies the agency’s current thinking on determining whether such products are “appropriate for the protection of the public health” (APPH), the legal standard under the Federal Food, Drug, and Cosmetic Act. Although non-binding, the guidance emphasizes that applicants must demonstrate a net public health benefit, meaning any potential benefits to adult smokers, such as helping them switch from or reduce combustible cigarette use, must outweigh the risks to non-users, particularly youth.

    The guidance adopts a “risk-proportionate” approach based on the level of youth appeal associated with different flavors. According to the FDA, high-risk flavors such as fruit, candy, dessert, and other sweet varieties face a particularly high evidentiary burden. They must demonstrate significant added benefits for adult smokers compared with tobacco-flavored products. Lower-risk flavors, including menthol, mint, and some novel flavors such as spices, may require a smaller demonstrated adult benefit to meet the APPH standard. Applicants are encouraged to provide scientifically valid evidence, including sensory perception studies, consumer response assessments, and population-level data, to evaluate both youth appeal and potential adult benefits.

    The agency also addressed mitigation strategies designed to reduce youth access, including device access restrictions such as fingerprint authentication or geofencing. While these technologies may form part of a broader youth-prevention strategy, the FDA said they are generally insufficient on their own to offset the risks associated with highly youth-appealing flavors. The guidance reinforces the agency’s product-specific, evidence-based review process, with the most scrutiny applied to flavored products that present the greatest risk of youth initiation.

  • Atlas IoT Gets USPTO Grant for Age-Restricted Vape Technology

    Atlas IoT Gets USPTO Grant for Age-Restricted Vape Technology

    Atlas IoT announced that it secured a patent grant from the United States Patent and Trademark Office for an age-restricted device and system designed for electronic nicotine delivery systems, positioning the technology as a potential pathway to strengthen regulatory compliance and support broader adult-focused flavor approvals. The company’s standalone system uses AI-powered age verification to confirm users are 21 or older without requiring app downloads or storing personal data, followed by a one-time thumbprint enrollment that serves as the device’s unlocking mechanism. A secondary bioimpedance sensor embedded in the mouthpiece is designed to prevent use by minors, creating a dual-verification process intended to block unauthorized access.

    Atlas IoT said it has requested a Q-Submission meeting with the U.S. Food and Drug Administration to discuss a Component Premarket Tobacco Product Application covering the device’s core technology, with plans to partner with e-liquid manufacturers that would file their own PMTAs for compliant flavored pods. The company also emphasized domestic manufacturing and FDA-registered filling operations for its replaceable pods, contrasting its compliance-focused model with the illicit disposable vape market. Atlas IoT said that, if authorized, its platform could establish a new standard for age-restricted ENDS products in the regulated U.S. market.

  • K&H Announces Agenda for Industry Law Symposium

    K&H Announces Agenda for Industry Law Symposium

    Keller and Heckman LLP announced the agenda for its 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, scheduled for May 4–5, 2026, in Las Vegas, Nevada, ahead of the CHAMPS Trade Show. The two-day seminar will feature the firm’s attorneys alongside industry and scientific guest speakers, offering in-depth insights into legal, regulatory and scientific developments affecting tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers. Organizers also reminded prospective attendees that the super early-bird registration rate expires February 20.

  • Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Pharma Inc. filed a lawsuit against the U.S. Food and Drug Administration in federal court in Washington, D.C., alleging the agency unlawfully imposed costly premarket tobacco application (PMTA) requirements on its nicotine oral pouches. In a complaint filed Feb. 17, the company argues the FDA violated the Regulatory Flexibility Act and Administrative Procedure Act by subjecting pouches to the same regulatory framework as combustible tobacco without properly assessing the impact on small businesses. Enorama contends that although the FDA previously suggested publicly available data could support applications, it now requires product-specific scientific studies, dramatically increasing costs.

    According to the filing, the FDA estimated bundled application costs between $181,686 and $2 million, but Enorama claims actual expenses range from $3 million to more than $15 million — forcing some manufacturers to exit the market. The company also alleges unequal treatment, asserting that larger competitors such as Philip Morris International and Altria Group have been allowed to market similar nicotine pouch products despite pending applications, while Enorama received a refusal-to-file letter. Attorney Eric N. Heyer of Thompson Hine LLP said the company plans to seek a preliminary injunction to halt the FDA’s action.

  • VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    The Vapor Technology Association said it welcomed the chance to participate in a recent roundtable hosted by the U.S. Food and Drug Administration focused on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS), calling the meeting an opportunity for small businesses to engage directly with regulators. In a statement, VTA Executive Director Tony Abboud said industry representatives advocated for a more transparent, standards-based regulatory framework that would allow companies to invest in vapor technology and navigate product reviews with clearer scientific expectations.

    Abboud said VTA was encouraged by comments from FDA Commissioner Marty Makary acknowledging the need for predictability in regulatory standards but expressed frustration that some agency officials supported maintaining flexible or undefined scientific benchmarks.

    “Small businesses made it completely clear that they wanted and needed transparent and objective scientific standards governing how vape products should be made and how they should perform,” Abboud said. “Unfortunately, we were disappointed by so many FDA representatives throughout the meeting who either argued for continued scientific ambiguity or completely rejected standards. Their comments signaled a lack of alignment among FDA leadership on providing clear and predictable scientific standards or guidance for our industry – or even benchmarks that would ensure product and consumer safety. We received no guarantee of additional clarity on the broken and opaque PMTA rule and process, which has been used to prevent access to the products that Americans who smoke want and need to quit smoking deadly cigarettes.” 

    The association argued that clearer regulatory guidance would align with broader free-market principles supported by Donald Trump’s policy agenda.

  • Manufacturers Tell FDA They Need Benchmarks, Communication

    Manufacturers Tell FDA They Need Benchmarks, Communication

    During yesterday’s (Feb. 10) afternoon session of the U.S. Food and Drug Administration’s “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products,” Dr. Lynn Hull, acting senior science advisor in the Office of Science at FDA’s Center for Tobacco Products (CTP), moderated the Pharmacological Panel along with the FDA’s supervisory pharmacologist in CTP’s Division of Individual Health Science, Dr. Carolina Ramôa.

    Manufacturers warned that conducting studies has been prohibitively expensive and unpredictable without clear performance benchmarks. They also urged the FDA to allow greater use of modeling and data-bridging approaches, though regulators signaled that such alternatives would face strict validation requirements and may not replace product-specific clinical testing.

    “How can we simplify and have more communication and lean more toward product characteristics to model and understand abuse liability?” Dr. Willie McKinney, founder and CEO of Mckinney Regulatory Sciences asked. “How do we have more meetings regardless of where our application is in the process to understand what you are currently thinking?”

    The agency maintained that measuring nicotine delivery and addiction potential is essential when determining whether products meet public health standards, highlighting clinical pharmacokinetic (PK) data as the most reliable evidence.

    “I absolutely understand where you’re coming from,” said Dr. Ramôa, “where you want to make it as efficient as possible, but understand where I’m coming from, where I have a duty to the American public to make sure I make the correct decision that does not impact them negatively.”

  • FDA PMTA Roundtable Being Held

    FDA PMTA Roundtable Being Held

    Today (February 10), the U.S. Food and Drug Administration is hosting its much-anticipated “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products.”  Center for Tobacco Products (CTP) director Dr. Matthew Farrelly offered his opening remarks, which led into the “product characterization” panel moderated by deputy director Dr.  Todd Cecil.

    Dr.  Matthew Walters, Dr. Karen Coyne, Dr. Lynn Hull, and Dr. Carolina Ramôa rounded out the early sessions for FDA. Industry representatives said that unclear product characterization standards are limiting the long-term viability for smaller ENDS manufacturers, argued that the absence of objective, measurable benchmarks create uncertainty around PMTA compliance, and raised questions about defining testing ranges for open-system products and the ability to update long-pending PMTAs. FDA said it wants to create a dialogue with manufacturers, but statutory requirements constrain its regulatory flexibility.

    The afternoon panels were led by Cecil, Dr. Benjamin Apelberg, Dr. Mollie Miller, Dr. Amy Gross, Dr. Mary Irwin, and Dr.  Hans Rosenfeldt, and were still being held at the writing of this article. Tobacco Reporter will update the proceedings as the information becomes available.

  • FDA to Host Discussion on PMTAs Feb. 10

    FDA to Host Discussion on PMTAs Feb. 10

    FDA issued a reminder today regarding the Federal Register notice (FRN) roundtable discussion it is hosting tomorrow (February 10) for small tobacco product manufacturers (fewer than 350 employees). The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products and will be held from 9 a.m.–5 p.m. ET.

    The topics to be discussed will include certain components of ENDS PMTAs, such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).

    FDA has also established a docket for public comment on this roundtable discussion. All electronic comments must be submitted on or before March 12. The regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 12.

  • IKE Tech Invited to FDA Roundtable on PMTA Submissions

    IKE Tech Invited to FDA Roundtable on PMTA Submissions

    IKE Tech LLC has been invited by the U.S. Food and Drug Administration to participate in an invitation-only roundtable discussion with small electronic nicotine delivery system (ENDS) manufacturers focused on Premarket Tobacco Product Application (PMTA) submissions. The news was announced by Ispire Technology, a founding partner of IKE Tech.

    The February 10 forum, limited to 30 companies nationwide, is designed to gather direct industry feedback on the PMTA process, with IKE Tech selected to participate in the Manufacturing Controls panel examining operational challenges and compliance practices. The company is developing a blockchain-enabled, Bluetooth-based age-gating system intended to verify legal-age access at the point of use, which has been submitted as a component PMTA for an interoperable age-verification technology. The FDA session is expected to inform future regulatory guidance and potential refinements to the PMTA review framework.