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Tag: FDA

  • Nicokick and Northerner Increase Commitment to Responsible Retailing

    Nicokick and Northerner said they are strengthening their commitment to responsible and compliant retailing for adult consumers aged 21 and over, citing clearer regulatory direction from the U.S. Food and Drug Administration. The companies said their focus is on consumer safety, preventing youth access, and maintaining transparency as regulatory oversight of the category increases. Both retailers enforce a nationwide minimum purchase age of 21 and require age and identity verification through third-party provider Veratad, with orders denied or canceled if verification cannot be completed. Nicokick and Northerner said they also limit sales to states where online nicotine pouch sales are permitted and comply with state-specific requirements, including flavor rules. Products sold on their platforms must show evidence of FDA submissions and undergo third-party quality testing.

    “With enforcement ramping up and scrutiny intensifying, responsible retailing isn’t just a nice-to-have; it’s the backbone of credibility, consumer protection, and the viability of the category’s future,” said Laura Leigh Oyler, vice president for regulatory affairs with Haypp Group (parent company of Nicokick and Northerner). “Our ambition is for Nicokick and Northerner to continue standing as paragons of responsibility in the online nicotine retail space.”

    Additional safeguards include sourcing products directly from manufacturers, applying order and SKU limits, using fraud-detection systems, and restricting marketing and promotions to adult audiences. The companies said educational resources and product information are provided to support informed use, positioning responsible retailing as central to the long-term viability of the nicotine pouch category.

  • 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.

  • Pennsylvania Vape Registry Bill Draws Opposition From Both Sides

    Pennsylvania Vape Registry Bill Draws Opposition From Both Sides

    Vaping industry representatives and anti-smoking advocates are both opposing legislation moving through Pennsylvania’s General Assembly that would establish a statewide list of sanctioned nicotine vape products, according to the Altoona Mirror. The state Senate has passed an amended version of House Bill 1425, which would require vape products to appear on a state-managed directory—based on FDA authorization—to be legally sold, and the bill now returns to the House for a concurrence vote.

    Supporters say the measure would help prosecutors crack down on illicit vape sales, but critics argue it would disproportionately benefit large tobacco companies whose products dominate the FDA registry, while forcing hundreds of independent vape shops out of business. Industry groups warn thousands of jobs could be affected, while public health advocates contend the bill could legitimize flavored products that appeal to youth. Under the proposal, manufacturers would face registration fees, and retailers selling non-listed products could be fined, with enforcement beginning after a phased implementation period.

  • Philippines Requires Licenses for Vape Products With Health Claims

    Philippines Requires Licenses for Vape Products With Health Claims

    The Philippines’ Food and Drug Administration (FDA) mandated that all establishments selling vaporized nicotine and non-nicotine products (VNNPs) and novel tobacco products (NTPs) with medicinal or therapeutic claims must secure a License to Operate. Under Advisory 2025-1487, manufacturers, importers, distributors, wholesalers, and retailers are required to apply for licenses as pharmaceutical establishments.

    The FDA also said such products must be registered as pharmaceutical products through the Center for Drug Regulation and Research. The agency urged stakeholders to comply, citing the need to ensure the safety, efficacy, and quality of vape and novel tobacco products making health-related claims.

  • FDA Authorizes Six on! PLUS Nicotine Pouch Products

    FDA Authorizes Six on! PLUS Nicotine Pouch Products

    The U.S. FDA authorized the marketing of six nicotine pouch products from Helix Innovations LLC under the on! PLUS brand through the premarket tobacco product application (PMTA) pathway.

    These authorizations mark the first decisions from a pilot program launched in September to streamline the review process for nicotine pouch applications while maintaining the agency’s rigorous scientific standards. Authorized products include mint, tobacco, and wintergreen flavors in 6 mg and 9 mg nicotine strengths. The FDA noted that these products contain lower levels of harmful constituents compared with other smokeless tobacco products and do not contain measurable levels of several carcinogens linked to oral cancer.

    “While today’s actions permit these specific nicotine pouch products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,’” FDA said in a statement.  

    All packaging will feature certified child-resistant cans.

  • Report: FDA, DEA Lack Ability to Enforce Hemp Ban

    Report: FDA, DEA Lack Ability to Enforce Hemp Ban

    Last week the Congressional Research Service (CRS)—the nonpartisan investigative office that advises U.S. lawmakers—issued a report warning that both the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) do not have the resources (i.e. funding, staff, and infrastructure) necessary to enforce the new policy set to take effect in 2026 that would ban “intoxicating hemp products.” The measure, added to last month’s federal spending deal, redefines hemp to prohibit products containing more than 0.4 mg of total THC per package, effectively banning popular hemp-derived cannabinoids such as delta-8 THC, HHC, and high-THCA products.

    “It remains unclear if and how federal law enforcement will enforce the new prohibitions,” the CRS was quoted on December 3. “Both FDA and DEA may lack the resources to broadly enforce the laws prohibiting intoxicating hemp products on the market.”

    Industry participants cautioned that an unfunded ban could drive unregulated and illicit sales. Dino Awadisian, founder of Mamba Brand, said the lack of a regulatory framework risks expanding the black market and called for structured federal oversight instead.

    “A law with no funding is not enforcement—it’s theater,” Awadisian said. “This will not protect the public. It will only reward unsafe, unregulated, and untraceable products.”

    The report also flagged potential new restrictions on hemp and cannabis seeds, which could be regulated based on genetic potential rather than THC content, exposing seed distributors to legal risk. Industry advocates are urging lawmakers to replace prohibition with nationally funded licensing, testing, age restrictions, and packaging standards.

  • FDA Launches Web-Based PMTA Forms

    FDA Launches Web-Based PMTA Forms

    Today (December 3), FDA launched web versions of four forms in CTP Portal Next Generation (CTP Portal NextGen) for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. FDA transitioned from CTP Portal to CTP Portal NextGen—a “new, improved web portal” for submitting tobacco product applications electronically—in early 2025. The web forms allow applicants to create, validate, and submit PMTA and SE Report submissions directly through CTP Portal NextGen.

    The web-based forms include Forms FDA 4057, 4057a, 3965, and 3965a. Industry stakeholders with active CTP Portal accounts had the option to test and provide feedback on the new web functionality of the forms during online development. Creating these web-based forms is part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process.

    According to the FDA, the new portal includes step-by-step instructions on completing the forms; a more user-friendly interface that helps guide applicants through the submission process; the ability for multiple users to work on a submission at the same time and easily save drafts; and real-time, automatic validation, ensuring all required fields are completed before submission.

    PDF versions of FDA’s PMTA and SE Report forms will remain available for applicants who choose not to use the web-based versions. These PDFs can still be downloaded and submitted electronically through CTP’s Document Control Center or uploaded via eSubmitter. FDA has also released updated PDF versions of Forms 4057, 4057a, 3965, and 3965a, correcting minor technical issues since their original posting in June 2025. Beginning Jan. 2, 2026, applicants using PDF forms must use these updated versions. Failure to use the current forms — or to complete them correctly — will generally result in FDA refusing to accept the application.

  • 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.

  • FDA Deploys Agentic AI to Assist Regulatory Reviews

    FDA Deploys Agentic AI to Assist Regulatory Reviews

    The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities to all agency employees, a move expected to streamline complex, multi-step regulatory tasks — including pre-market reviews, post-market surveillance, inspections, and compliance activities that would be of interest to those in the tobacco and nicotine industries.

    The new systems allow staff to build multi-model AI workflows capable of planning, reasoning, and executing tasks under human oversight. The tools are optional and operate within a secure GovCloud environment, with no training on industry-submitted data.

    In an email to StatNews, an FDA spokesperson called the tool “exploratory” and said that the AI agents do not make regulatory decisions. “All outputs from AI are reviewed and validated” by FDA staff “before being incorporated into any official regulatory action, ensuring that the AI remains a support tool rather than a decision maker,” he wrote.

    The deployment follows the success of Elsa, an internal LLM tool launched in May and now used by more than 70% of FDA personnel. The agency is also launching a two-month Agentic AI Challenge, with selected projects to be showcased in January 2026.

    FDA Commissioner Marty Makary said the upgrades mark a major step in modernizing regulatory operations, while Chief AI Officer Jeremy Walsh highlighted the potential to accelerate and validate safety assessments across all FDA-regulated sectors — including tobacco.

  • USA Vape Lab Sues FDA Over PMTA Delay

    USA Vape Lab Sues FDA Over PMTA Delay

    USA Vape Lab, maker of the Naked100 line of bottled e-liquids, filed suit against the Food and Drug Administration, alleging it unlawfully delayed action on its premarket tobacco applications for more than five years. The suit was filed November 21 in the U.S. District Court for the District of Columbia.

    In the complaint, the Huntington Beach, Calif.–based company says it submitted extensive PMTAs for its flavored and tobacco e-liquid products ahead of the September 9, 2020 deadline. Despite a Tobacco Control Act provision requiring FDA to issue decisions within 180 days, the agency has yet to act, the suit states. USA Vape Lab is asking the court to order FDA to issue final determinations.

    The company also argues FDA must consider what it describes as robust population-level evidence included in its submissions. According to the filing, a randomized controlled trial showed nearly one-third of participants achieved six-month cigarette abstinence when using Naked100 e-liquids—quit rates the company claims are two to three times higher than those reported for FDA-approved nicotine replacement therapies. USA Vape Lab further alleges that flavors such as Really Berry and Strawberry Pom demonstrate net public-health benefits that outweigh potential youth risks and exceed those of comparable tobacco flavors.

    “We felt that we had no choice but to initiate this lawsuit,” founder Huy Nguyen said in a statement, criticizing the agency for years-long delays while threatening enforcement actions against products lacking marketing orders.

    USA Vape Lab manufactures a range of popular e-liquids, including American Patriots, Crisp Menthol, and Lava Flow.