Latest news with #PremarketTobaccoProductApplication
Associated Press
6 days ago
- Business
- Associated Press
IKE Tech's PMTA for First-Ever Standalone Age-Gating System at Point of Use Accepted for FDA Review Just One Month After Submission
The organization's blockchain technology is set to redefine public health safeguards and help end youth vaping for good. LOS ANGELES, June 4, 2025 /PRNewswire/ -- IKE Tech LLC ('IKE Tech'), a leading innovator at the intersection of Internet of Things (IoT), identity verification, and tokenization technology, has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its Premarket Tobacco Product Application (PMTA), just one month after submission on April 26. This marks the first time the FDA has proceeded with a PMTA for a standalone, interoperable age-gating component providing real-time age verification at the point of use for electronic nicotine delivery systems (ENDS). Potentially compatible with all ENDS devices, the IKE system integrates a Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled IKE Mobile Application, enabling secure, continuous age and identity verification. In a multi-center Human Factors Validation Study, submitted with the PMTA, 0% of underage users were able to activate a device, showcasing the reliability of IKE Tech's blockchain-based technology in safeguarding public health. Receipt of the FDA's Acceptance letter confirms that the IKE Tech PMTA meets regulatory requirements to be accepted and moves the application into the FDA's filing review phase. John Patterson, President of IKE Tech, said: 'Receiving the Acceptance Review letter from the FDA faster than most applications is a major milestone for IKE Tech and a promising step forward for public health in the ENDS category. By leveraging Bluetooth, biometrics, and blockchain, we're unlocking a new era of vaping – one that gives regulators and manufacturers the power to lock out youth and ensure adult-only access. We're proud to be leading the way with a secure, scalable solution that could become the new baseline for responsible product access in the US and beyond.' – ENDS – Notes to Editors: Human Factors Study Design and Key Results Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric activation. Key performance highlights: Devices could only be activated after successfully passing the age-gating process. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error and prevent underage access. About IKE Tech IKE Tech LLC ('IKE Tech') is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products. A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products. IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good. Media contact [email protected] View original content: SOURCE IKE Tech LLC
Yahoo
6 days ago
- Business
- Yahoo
IKE Tech's PMTA for First-Ever Standalone Age-Gating System at Point of Use Accepted for FDA Review Just One Month After Submission
The organization's blockchain technology is set to redefine public health safeguards and help end youth vaping for good. LOS ANGELES, June 4, 2025 /PRNewswire/ -- IKE Tech LLC ("IKE Tech"), a leading innovator at the intersection of Internet of Things (IoT), identity verification, and tokenization technology, has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its Premarket Tobacco Product Application (PMTA), just one month after submission on April 26. This marks the first time the FDA has proceeded with a PMTA for a standalone, interoperable age-gating component providing real-time age verification at the point of use for electronic nicotine delivery systems (ENDS). Potentially compatible with all ENDS devices, the IKE system integrates a Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled IKE Mobile Application, enabling secure, continuous age and identity verification. In a multi-center Human Factors Validation Study, submitted with the PMTA, 0% of underage users were able to activate a device, showcasing the reliability of IKE Tech's blockchain-based technology in safeguarding public health. Receipt of the FDA's Acceptance letter confirms that the IKE Tech PMTA meets regulatory requirements to be accepted and moves the application into the FDA's filing review phase. John Patterson, President of IKE Tech, said: "Receiving the Acceptance Review letter from the FDA faster than most applications is a major milestone for IKE Tech and a promising step forward for public health in the ENDS category. By leveraging Bluetooth, biometrics, and blockchain, we're unlocking a new era of vaping – one that gives regulators and manufacturers the power to lock out youth and ensure adult-only access. We're proud to be leading the way with a secure, scalable solution that could become the new baseline for responsible product access in the US and beyond." – ENDS – Notes to Editors: Human Factors Study Design and Key Results Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric activation. Key performance highlights: 100% of users (n=101) successfully completed age verification 0% of underage users were able to activate a device 100% of devices deactivated after set period of inactivity or loss of Bluetooth signal 91% rated the app "Extremely Easy" or "Very Easy" to use Errors occurred in only 1% of task attempts Devices could only be activated after successfully passing the age-gating process. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error and prevent underage access. About IKE Tech IKE Tech LLC ("IKE Tech") is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products. A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products. IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good. Media contactiketech@ View original content: SOURCE IKE Tech LLC Sign in to access your portfolio
Yahoo
20-05-2025
- Business
- Yahoo
U.S. Tobacco Market to Surpass $180 Billion by 2030, Despite Declining Cigarette Consumption and Rising Regulatory Scrutiny
Rapid Expansion of Nicotine Pouches and Smokeless Alternatives Present Lucrative Opportunities Dublin, May 20, 2025 (GLOBE NEWSWIRE) -- The "United States Tobacco Market by Region, Competition, Forecast & Opportunities, 2020-2030F" report has been added to United States Tobacco Market was valued at USD 112.82 Billion in 2024 and is projected to reach USD 180.48 Billion by 2030, rising at a CAGR of 8.15%. Despite declining cigarette consumption and rising regulatory scrutiny, the market continues to hold substantial value. Traditional cigarettes still lead in sales, but the industry is undergoing transformation, with increasing demand for smokeless tobacco, cigars, and emerging alternatives like e-cigarettes and heated tobacco products. Leading companies such as Altria Group and Reynolds American are shifting focus toward next-generation nicotine delivery systems. Product innovation, brand loyalty, and diversification are helping firms navigate a market challenged by health concerns, regulatory pressure, and high taxation. New categories such as nicotine pouches and vaping devices are gaining momentum, particularly among younger adult consumers, signaling a shift in preferences and shaping the market's future trajectory. Key Market Driver: Growth of Reduced-Risk and Alternative Tobacco ProductsThe growing popularity of reduced-risk products (RRPs) is a major force reshaping the U.S. tobacco market. These include e-cigarettes, heated tobacco systems, nicotine pouches, and other non-combustible options. As health concerns increase and public health campaigns discourage traditional cigarette smoking, consumers are actively seeking alternatives perceived as safer. Tobacco companies have responded by expanding their portfolios with brands like JUUL, Vuse, and ZYN, which appeal to adult users looking for convenient and lower-risk products. Advanced technology, a variety of flavors, and modern product designs are boosting consumer adoption. Although regulatory oversight has tightened - particularly concerning flavor bans and youth access - the category continues to grow, allowing major tobacco firms to remain competitive and maintain revenue despite declines in conventional cigarette Market Challenge: Intensifying Regulatory Pressures and Compliance CostsA key challenge for the United States tobacco industry is the increasingly stringent regulatory environment. The FDA continues to introduce comprehensive measures aimed at reducing tobacco use, especially among youth. These include regulations on flavored products, warning label mandates, restrictions on marketing, and the demanding Premarket Tobacco Product Application (PMTA) process. Compliance requires extensive investment in product research, scientific testing, and documentation, placing financial strain on companies - particularly smaller firms. The potential for additional regulatory actions, such as banning menthol cigarettes or reducing nicotine levels, creates further uncertainty. These regulatory burdens can delay innovation, increase operational costs, and result in product removals, all of which impact profitability and market Market Trend: Rapid Expansion of Nicotine Pouches and Smokeless AlternativesA prominent trend in the U.S. tobacco market is the surge in popularity of nicotine pouches and other smokeless tobacco alternatives. Brands such as ZYN, VELO, and On! are increasingly preferred by adult users seeking smoke-free, discreet nicotine consumption options. These products, which contain nicotine salts derived from tobacco but not the tobacco leaf itself, offer a modern, clean, and portable alternative to traditional formats. Their appeal is especially strong among younger consumers and those seeking to reduce smoking or avoid combustion-based products. The segment is seeing rapid year-over-year growth and gaining shelf space in retail channels. With the support of strong marketing and broad flavor assortments, nicotine pouches are expected to remain a major growth driver in the evolving tobacco Players Profiled in this United States Tobacco Market Report Altria Group, Inc. Reynolds American Inc. ITG Brands, LLC Liggett Vector Brands LLC Swedish Match USA, Inc General Cigar Co., Inc. Turning Point Brands, Inc. Dosal Tobacco Corporation J.C. Newman Cigar Company Swisher International Group Inc. Report ScopeIn this report, the United States Tobacco Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:United States Tobacco Market, by Product Type: Cigarettes Cigar Smoking Tobacco Smokeless Tobacco United States Tobacco Market, by Distribution Channel: Tobacco Shops Convenience Stores Supermarkets and Hypermarkets Online Others United States Tobacco Market, by Region: South West Midwest Northeast Key Attributes Report Attribute Details No. of Pages 70 Forecast Period 2024-2030 Estimated Market Value (USD) in 2024 $112.82 Billion Forecasted Market Value (USD) by 2030 $180.48 Billion Compound Annual Growth Rate 8.1% Regions Covered United States For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
01-05-2025
- Business
- Associated Press
IKE Tech Files First-Ever PMTA for Standalone Interoperable Blockchain-based Age-Gating System at Point of Use - Marking a New Chapter in Youth Vaping Prevention
LOS ANGELES, May 1, 2025 /PRNewswire/ -- IKE Tech LLC('IKE Tech'), a leading innovator in the intersection of Internet of Things (IoT), identity verification (IDV) and tokenization technology, announced today that it has filed a component Premarket Tobacco Product Application (PMTA) and Tobacco Product Master File (TPMF) with the US Food and Drug Administration (FDA) for its blockchain-based Bluetooth Low Energy (BLE) System-on-a-Chip with the smartphone-enabled identity and age-verification IKE Mobile Application. This marks the first ever complete PMTA submission for a standalone, scalable age-gating component that provides real-time continuous age verification at the point-of-use for electronic nicotine delivery systems (ENDS). The IKE System is designed for universal integration across all ENDS devices, utilizing unique blockchain-based tokenization technology to further ensure user privacy and security. According to a multi-center Human Factors Validation Study submitted as part of the PMTA, the IKE system proved to be 100% effective in preventing device activation for anyone under the age of 21. The company has formally requested expedited review of its application, emphasizing the system's potential to enhance public health. 'This is a major milestone for IKE Tech and the ENDS category', commented John Patterson, President of IKE Tech. 'We're not just building technology. We're paving a new regulatory framework that gives the FDA and manufacturers powerful tools to safeguard public health and ensure adult-only access to vaping products. With proven, scalable age-gating technology built into ENDS devices, the sector now has a real opportunity to eliminate underage vaping for good'. One chip, every device: unlocking new era of vaping IKE Tech adopted a rigorous software development lifecycle, following consultation with the FDA. The IKE platform offers a seamless identity and age verification experience via a single, user-friendly mobile app available on iOS and Android. By leveraging blockchain technology, it securely validates user's identity and age through integrated identity verification (IDV) partners, anchoring credentials to a tokenization system without storing sensitive data on user's device, nor on IKE's system, to ensure complete user privacy and security. Unlike existing solutions that allow permanent access after a single verification, IKE's system requires continuous verification to maintain device access. Human Factors Validation study showed 91% of users (aged 18 – 67) rated the app as 'Extremely Easy' or 'Very Easy' to use - with a user error rate of less than 0.8% - proving its appeal to the wider market. 'This is a pivotal moment from a regulatory perspective,' said Kevin Burd, CEO of Chemular. By embedding robust age verification at the point of use, the IKE technology enables manufacturers and regulators to confidently allow access to a broader range of products for verified adults. This approach opens the doors for responsible flavor pathways, empowering adult consumers with more choice, while maintaining the highest levels of youth protection.' Building Smarter and Better ENDS IKE Tech is dedicated to building a better, more secure future for all. To meet the evolving needs of manufacturers, the company is planning to continue integrating advanced features like counterfeit protection, geofencing, targeted messaging, and real-time data access to its systems. These innovations are designed to address underage vaping and combat the illicit market, ensuring that only products that FDA has determined are Appropriate for the Protection of Public Health (APPH) are available to adult users. To learn more about IKE Tech, visit Notes to Editors: Human Factors Study Design and Key Results Conducted with 102 participants (51% male, 49% female, aged 18–67 across race/ethnic demographics), the study simulated real-world use of the IKE system. Participants downloaded the app, verified their age, paired with a test device and interacted with BLE-based access controls including biometric reactivation. Key performance highlights: Devices could only be reactivated with biometric authentication. Demographic data (age, race/ethnicity, gender) was accurately verified in all cases. The results confirm the IKE System's ability to reduce user error, prevent underage access, and provide a user-friendly experience for adults. About IKE Tech IKE Tech LLC ('IKE Tech') is pioneering real-time age and identity verification at the point of use, helping to safeguard access to age-restricted products. A leading innovator at the intersection of Internet of Things (IoT), identity verification (IDV), and tokenization technology, IKE Tech has developed an industry-first, scalable age-gating component that provides continuous, real-time verification for electronic nicotine delivery systems (ENDS) and other restricted consumer products. IKE Tech's interoperable Bluetooth Low Energy (BLE) System-on-a-Chip, powered by a user-friendly mobile app available on iOS and Android, integrates seamlessly into ENDS devices, giving manufacturers and regulators a flexible, future-proofed solution to combat underage vaping and illicit markets. By setting the new standard for responsible, adult-only access, IKE Tech is helping eliminate youth vaping for good. View original content: SOURCE IKE Tech LLC
