TobaccoReporter logo

Tag: FDA

  • IKE Tech Engages FDA on AI-Powered ENDS Compliance Solutions

    IKE Tech Engages FDA on AI-Powered ENDS Compliance Solutions

    Today (April 9), IKE Tech LLC participated in a formal listening session with the FDA’s Center for Tobacco Products. The company, a joint venture between Ispire Technology Inc., Berify, and Chemular Inc., presented its point-of-use compliance technology, including its patented Human Identity Token (HIT) that prevents youth access to ENDS products, and highlighted the need for a regulatory framework recognizing software as a tobacco product.

    The session focused on enforcement challenges in the ENDS market, including underage access and the spread of illicit products. IKE Tech outlined its technology platform, which integrates biometric age-gating, blockchain-based product authentication, and an AI-powered governance backend. Executives emphasized that these point-of-use systems address compliance gaps that traditional point-of-sale measures cannot.

    IKE Tech also argued that software embedded in or governing a tobacco product should be regulated under the Tobacco Control Act, noting that current PMTA frameworks do not account for continuous updates and lifecycle management of software. The engagement follows FDA guidance identifying Device Access Restrictions as critical for public health determinations, and builds on IKE Tech’s first standalone PMTA for an interoperable, blockchain-based, point-of-use age-gating solution, which demonstrated 100% effectiveness in preventing underage device activation in human factors studies.

  • FDA Wins Default Judgment Against NC Vape Distributor

    FDA Wins Default Judgment Against NC Vape Distributor

    A federal judge granted the U.S. Food and Drug Administration a default judgment against a North Carolina vape distributor accused of importing and selling unauthorized flavored e-cigarettes from China. The ruling allows the FDA to seek a judgment permanently barring the company from importing, marketing, or distributing the products cited in the complaint after the defendant failed to respond to the lawsuit.

    Because the defendants did not appear, they are not publicly posted in the docket entries. However, in September 2025, the FDA filed a complaint against North Carolina-based distributor Dream Distro LLC and its owner, Faisal A. Alhadrami.  

  • FDA Sends ENDS Comment Period Reminder

    FDA Sends ENDS Comment Period Reminder

    Today (April 8), the U.S. Food and Drug Administration’s Center for Tobacco Products issued a reminder that the public has until 11:59 p.m. EDT on May 11 to submit comments on its draft guidance for flavored e-cigarette applications, docketed as FDA-2026-D-1817 on Regulations.gov.

    The reminder relates to draft guidance the agency released on March 11, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” which outlines how the FDA plans to weigh the youth appeal of flavored products against any added benefit they may provide to adults compared with tobacco-flavored options, including expectations for evidence on adult switching, youth initiation risk, and the potential use of device access-restriction technology.

  • ‘Made in America’ Claims Rise as Brands Navigate Crackdown

    ‘Made in America’ Claims Rise as Brands Navigate Crackdown

    A Reuters investigation reports a growing wave of vape brands promoting “Made in America” credentials as the U.S. market faces tougher enforcement against unlicensed products, particularly those linked to Chinese manufacturers. The article says at least eight new brands have emerged since October, emphasizing U.S. identity, despite lacking authorization from the U.S. Food and Drug Administration, which has approved only a limited number of vaping products for sale.

    According to the report, trademark filings show some of these brands are tied to Chinese or Hong Kong interests, suggesting the marketing shift may be aimed at avoiding scrutiny from customs officials amid heightened trade tensions and regulatory pressure under the administration of Donald Trump. Analysts cited by Reuters say the tactic could slow efforts to push consumers from the illicit to the regulated vape market.

    The story also highlights that China remains the dominant supplier of vapes to the U.S., with trade data showing exports worth over $4 billion in 2025, even as companies experiment with partial U.S. production or American-themed branding to adapt to tariffs, enforcement actions, and changing consumer perceptions.

  • 22nd Century to File New PMTA for 100mm VLN

    22nd Century to File New PMTA for 100mm VLN

    22nd Century Group, Inc. said it will submit an additional premarket tobacco product application to the U.S. Food and Drug Administration for a new 100mm version of its VLN reduced-nicotine cigarette, building on its status as “the only company with FDA authorization for a low-nicotine combustible product.” The company’s existing 84mm king-size VLN cigarettes received PMTA authorization in 2021.

    The new product, developed under its “Operation 100” initiative, is designed to offer adult smokers a familiar format while significantly lowering nicotine intake. 22nd Century said expanding into the 100mm size responds to retailer and consumer feedback and could widen access to reduced-nicotine alternatives without requiring smokers to switch to non-combustible products.

    Beyond the single submission, the company outlined plans to pursue multiple PMTAs across different combustible formats, blends, and sizes, including filtered cigars, creating a broader portfolio that can be licensed to other tobacco companies. Management said this strategy is intended to accelerate retail penetration of VLN products and to position the company as a provider of regulatory pathways for reduced-nicotine tobacco offerings.

  • FDA Allows Fontem to Continue Selling Pouches Amid Court Battle

    FDA Allows Fontem to Continue Selling Pouches Amid Court Battle

    The U.S. Food and Drug Administration confirmed it will not block production or sales of Fontem US’s Zone nicotine pouches while a lawsuit over the product’s pending premarket tobacco product application proceeds, Law 360 reported. Fontem argued that the agency unlawfully delayed reviewing its application, leaving the product in regulatory limbo.

    The FDA said it will not take enforcement action during the litigation, allowing the pouches to remain on the market. Fontem recently voluntarily dismissed its suit in Texas and plans to refile in Washington, D.C. The case underscores ongoing tension between regulators and manufacturers over PMTA backlogs and the treatment of newer oral nicotine products, which differ from traditional cigarettes and vapes.

    According to Law 360, industry observers believe the court battle could set a precedent for how the FDA handles delayed applications and exercises enforcement discretion in the growing nicotine pouch sector.

  • Filing Shows FDA Rescinded 229 CTP RIF Notices

    Filing Shows FDA Rescinded 229 CTP RIF Notices

    A court filing in the U.S. District Court for the District of Rhode Island shows that the U.S. Food and Drug Administration Center for Tobacco Products has fully reversed a wave of 2025 reduction-in-force (RIF) notices affecting 229 employees. In a declaration filed March 27, FDA official Melanie M. Keller detailed how the notices, issued March 31, April 1, and May 2, 2025, were rescinded in stages beginning May 1 and continuing through September 12, 2025, across multiple CTP offices, including health communication and education, compliance and enforcement, management, regulations, and public health education.

    The declaration states that on February 3, 2026, all remaining RIF notices were rescinded except for eight employees who had already moved to other CTP divisions. The final rescissions covered staff responsible for public complaints, small business assistance, IT business process support, industry outreach, and management of contracts and grants. The filing also notes that two Office of Science leaders placed on administrative leave after proposed reassignments returned to their roles by November 6, 2025, and that none of the affected employees remains on administrative leave.

    The filing is part of State of New York vs Robert F. Kennedy, Jr., lawsuit.

  • FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries

    FDA’s Pouch Fast-Track Scheme Stalling Over Youth Worries

    A fast-track review program at the U.S. Food and Drug Administration aimed at accelerating authorizations for nicotine pouch products has stalled, as agency scientists weigh concerns about youth uptake and risks to non-users against potential harm-reduction benefits for smokers, according to sources cited by Reuters. Reuters said applications tied to pouch brands from Philip Morris International (Zyn) and British American Tobacco (Velo) remain under review despite expectations that decisions would be made by the end of 2025 under the pilot scheme. The FDA has already authorized six products under Altria Group’s on! brand, but reviewers are said to be taking a more cautious stance on other applications where evidence of net public-health benefit is viewed as less clear-cut.

    While FDA data shows pouch use among middle- and high-school students remains relatively low, it has been rising, prompting heightened scrutiny. Tobacco companies argue the pilot program is critical for restoring legal market competition amid a surge of unregulated products, while public-health advocates warn that rapid authorizations could fuel new addiction trends. The FDA said decisions continue to be guided by science and statutory standards rather than external pressure.

  • Nicokick Urges Clarity on Smoke-Free Information

    Nicokick Urges Clarity on Smoke-Free Information

    Nicokick.com, owned by Haypp Group, called on policymakers and health professionals to provide clearer, evidence-based information distinguishing the risks of combustible cigarettes from non-combusted nicotine products. The appeal follows a report by the Foundation for American Innovation highlighting high tobacco and nicotine use among U.S. servicemembers and recommending that institutions recognize differences between product types when addressing health and readiness. Nicokick cited the U.S. Food and Drug Administration’s recognition of a “continuum of risk” across tobacco products and said improved adult-focused communication could help consumers and healthcare professionals better understand these distinctions while reinforcing that smoke-free products are intended only for existing adult users.

  • Pouch Maker to Refile FDA Lawsuit in D.C.

    Pouch Maker to Refile FDA Lawsuit in D.C.

    Fontem US, the maker of Zone nicotine pouches, has dropped its lawsuit against the U.S. Food and Drug Administration after a Texas federal court transferred the case to South Carolina, saying it plans to refile in Washington, D.C. The company had alleged the FDA was unfairly delaying review of its premarket tobacco product application, which is required to market new nicotine products in the U.S.

    U.S. District Judge Mark T. Pittman in Texas said Fontem had little connection to the state and its congested Northern District, and sent the case to South Carolina, where Fontem is based. By voluntarily dismissing the case, the company is seeking a more favorable venue in D.C. federal court, where many regulatory disputes involving federal agencies are typically heard. Zone is manufactured by TJP Labs in Canada, and marketed by ITG Brands, a subsidiary of Imperial Brands.