Ispire Technology Inc. (NASDAQ: ISPR) recently disclosed in an 8-K filing that it successfully held an in-person pre-PMTA (Pre-Market Tobacco Product Application) submission meeting with the U.S. Food and Drug Administration (FDA) on November 18, 2024. The company, a leader in vaping technology and precision dosing, along with IKE Tech LLC, consisting of Ispire Technology Inc., Touch Point Worldwide d/b/a Berify, and Chemular Inc., presented their Age Verification technology during this crucial regulatory event.
The Age Verification technology aims to facilitate adult access to electronic nicotine delivery systems (ENDS) while restricting underage access at point-of-use, thereby reducing youth access and broadening the adult market for reduced-risk vapor products. This significant achievement signifies a milestone in the endeavor to offer an innovative, secure universal solution geared towards curbing youth access to ENDS products and enlarging the market for adults opting for flavored PMTA-authorized items.
Highlighting the alignment with the FDA on key points, IKE Tech disclosed their intent to submit a PMTA for a component, rather than a finished tobacco product, to be marketed to consumers. The FDA has indicated its willingness to accept such a component PMTA provided all statutory requirements are met, with possible consideration for a request to grant priority review status given the system’s novel point-of-use technology. Upon authorization, the component PMTA would enable ENDS manufacturers to incorporate the IKE Tech system into their finalized tobacco product PMTAs, offering a plug-and-play age-gating solution that may facilitate the approval of various flavored ENDS products.
Looking ahead, IKE Tech anticipates concluding the prerequisite studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component, by Q1 2025. Michael Wang, Co-CEO of Ispire, expressed the company’s dedication to harm reduction through innovation and collaborative compliance with regulators. He emphasized how their technology is poised to bolster adult consumer choice while markedly diminishing youth access, underlining their commitment to adhering to regulatory directives and establishing new benchmarks for safer vaping products.
IKE Tech LLC focuses on revolutionizing Identity and Age Verification (IAV) technology solutions in a joint venture involving leading technology and research entities, while Ispire Technology Inc. is actively engaged in the research, development, design, commercialization, and distribution of branded e-cigarettes and cannabis vaping products.
This press release may contain forward-looking statements within the safe harbor provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934, underscoring the company’s strategies, prospects, and financial outlook. Investors and stakeholders are urged to review the full text of the press release, detailing the company’s objectives, risks, and uncertainties related to their business operations and market strategies.
This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Ispire Technology’s 8K filing here.
Ispire Technology Company Profile
Ispire Technology Inc researches, develops, designs, commercializes, sales, markets, and distributes e-cigarettes and cannabis vaping products worldwide. The company was founded in 2019 and is based in Los Angeles, California. Ispire Technology Inc operates as a subsidiary of Pride Worldwide Investment Limited.
Further Reading
- Five stocks we like better than Ispire Technology
- Canadian Penny Stocks: Can They Make You Rich?
- Is Monolithic Power Systems a Screaming Buy After Near 40% Drop?
- What Are Dividend Contenders? Investing in Dividend Contenders
- Applied Materials Market Capitulates: Now is the Time to Buy
- Buy P&G Now, Before It Sets A New All-Time High
- 3 Ultra-High Dividend Yield Stocks for the New Year
