Tag: Chemular

  • IKE Tech, Ispire to File Age Gating Technology PMTA

    IKE Tech, Ispire to File Age Gating Technology PMTA

    Credit: Thapana Studio

    Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).

    According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.

    IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.

    This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.

    “The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.

    Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.

    FDA alignment on key points:

    • Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
    • Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.

    IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.

    “Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer

     

  • Schmidt Joins Chemular as Senior Consultant

    Schmidt Joins Chemular as Senior Consultant

    Rachael Schmidt

    Chemular, a provider of regulatory and compliance solutions to the tobacco, nicotine, and medical device industry, announced that Rachael Trimpert Schmidt has joined the company as a senior consultant.

    “I am excited to join the Chemular team,” says Schmidt. “I’ve spent a large part of my career immersed in the tobacco industry, identifying issues and opportunities, while shaping its policies through my work with the FDA and the Center for Tobacco Products. I look forward to taking an active role with Chemular and helping its customers pave a smooth path to compliance.”

    Schmidt joins the team from her recent position with the U.S. Food and Drug Administration, where she served as assistant director of Laboratory Compliance & Coordination of the FDA’s Center for Tobacco Products (CTP). In that role, she was responsible for establishing and coordinating all FDA tobacco regulatory laboratories in support of the Family Smoking Prevention and Tobacco Control Act.

    At CTP, she was a key leader, responsible for developing and executing all tobacco product testing programs, including pre-market application reviews, post-market compliance, and adverse events, to support FDA’s tobacco regulatory mission, according to a press release. In her more than 12 years at the CTP, Schmidt engaged with both national and international partners to harmonize tobacco enforcement.

    “Schmidt brings a wealth of knowledge to our team,” says Jason Carignan, chief commercial officer for Chemular. “She’s been deeply involved with developing and implementing regulations within the tobacco industry for many years and has a sharpened ability to identify and address emerging issues. This firsthand experience will ensure that Chemular stays at the forefront of compliance initiatives, and that our customers can launch and keep their products on the market. She is going to be a valuable asset to Chemular and supporting our customers through her insights and action.”

  • Ispire Technology Adds Partners for Joint Venture

    Ispire Technology Adds Partners for Joint Venture

    Credit: Kamiphotos

    Ispire Technology has partnered with Touchpoint World Wide, parent to Berify, a platform that links physical products to the digital world, digital engagement, and brand protection, and Chemular International, a multi-disciplinary regulatory consulting firm to form a joint venture.

    The group hopes to expedite innovation in the e-cigarette technology space, including developing secure, user-friendly solutions for age verification and age-gating nicotine vapor devices.

    “The U.S. market is ripe for technological disruption that addresses age-verification, safety, and counterfeit issues,” said Berify Founder and CEO Dan Kang. “Our mission is also to create smart products that generate a new level of consumer satisfaction. We plan to achieve this by leveraging our blockchain authentication, tokenized rewards, and creating true decentralization while keeping companies in control of their products and data.”

    Leveraging Berify’s multi-patented technology, Chemular’s regulatory consulting and PMTA expertise, and Ispire’s hardware capabilities, the joint venture’s goals are to introduce an industry-standard age-verification solution for vapor devices as well as the submission of PMTA applications that incorporate new technologies across the U.S. e-cigarette market.

    “Our commitment is not only to create next-gen vapor devices but also to elevate market education. This venture includes additional partnerships that will bring together biometric identity and access control, ensure the solution is embedded into vapor devices during manufacturing, and provide safety, security, and privacy for consumers,” Kevin Burd, CEO of Chemular, added. “It is also a testament to our dedication to positively shaping the future of vape hardware innovation.”

    Some of the possible solutions include:

    • Next-generation e-cigarette hardware with a user-friendly point-of-use age-verification and geo-fencing capability that eliminates the use of hardware in certain designated areas such as schools and sensitive areas;
    • E-cigarettes with end-to-end a range of dynamic features such as authentication, direct-to-consumer engagements, and exclusive offerings all built on the foundations of blockchain technology;
    • A real-time biometric identity platform for user access controls, creating added security and reliability that deters counterfeiting.

    “By combining our collective expertise in hardware, blockchain and regulatory consulting, we aim to set a new standard for age verification, security and overall quality in the e-cigarette space,” said Ispire Technology Co-CEO Michael Wang. “Our hope is that this JV will be a large step forward in innovative device control, safety, counterfeit prevention and enhanced user experiences that increase overall market and consumer satisfaction.”

  • Chemular, IGEN Team up to Streamline Compliance

    Chemular, IGEN Team up to Streamline Compliance

    Chemular and IGEN have formed a strategic alliance to create a new Compliance as a Service (CaaS) platform focused on streamlining the burden of compliance to small-sized and medium-sized companies who need turnkey solutions for Prevent All Cigarette Trafficking (PACT) Act, excise tax reporting and registration services.

    “The time and effort required to stay compliant with federal, state and local laws is increasingly burdensome for small-[sized] to mid-sized companies in regulated categories,” said Jason Carignan, chief commercial officer of Chemular, in a statement. “Except for larger players, most companies don’t have a dedicated compliance officer who can ensure every regulatory detail is addressed so their products can stay on the market—especially in industries like ours, where the rules change rapidly. Chemular, now powered by the IGEN backbone, will be able to significantly scale its turnkey compliance service offering to a growing portfolio of tobacco manufacturers and distributors.”

    In addition to saving time, utilizing the new CaaS platform can provide regulated companies with many other benefits, according to a company press release, including: streamlined remittance and reporting for excise tax, PACT Act, state registrations, and license capture; optimized growth opportunities by allowing employees and leadership to focus on what they do best: developing products and services; avoiding penalties with scaled compliance efforts that easily adapt to new markets with potentially different laws and regulations as the company grows; and reducing risk by monitoring real-time data and evolving regulations while establishing automated procedures that can minimize errors and detect fraud.

    Failure to adhere to compliance guidelines can be costly for companies, leading to large fines and expensive sanctions, regulatory scrutiny and loss of trust in the marketplace. In some cases, noncompliant companies can have their products removed from store shelves, giving space to competitors who were able to better adjust to changing regulations.

    “Compliance can be a long-term strategic advantage, yet most emerging businesses don’t have the resources and expertise to keep up with the growing complexity in regulatory requirements,” said Ryan Padget, president of IGEN. “We’re excited to bring our technology to Chemular, whose clients are regularly faced with regulatory hurdles, like PACT and excise tax reporting. This is just the beginning for our partnership—one that we see as a win for the industry as a whole.”

    Along with this announcement, the Chemular and IGEN teams will be appearing at the tobacco industry’s largest trade show, TPE24, providing resources and education to the show’s retail attendees. Chemular will be hosting the “Fortify Your Future” educational sessions of the show from Jan. 30, 2024, to Jan. 31, 2024, and will be available to speak with attendees at their second-floor meeting room located next to the educational session.

    Companies interested in becoming compliant or streamlining their current processes can visit www.chemular.com for more information.

  • Chemular Adds Carignan as Chief Commercial Officer

    Chemular Adds Carignan as Chief Commercial Officer

    Jason Carignan

    Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.

    Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.

    “Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”

    With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.

    Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”

    Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.

    Carignan said he was excited to join the Chemular team.

    “Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”