--- title: What Do Recent FDA Authorizations Mean for Your ENDS Strategy? description: Explore what recent Glas and JUUL2 FDA authorizations may mean for ENDS PMTA strategy, youth risk controls, switching studies, and product testing. --- [![Labstat\_Logo\_wDescriptor\_Final\_RGB\_Color-1](https://info.labstat.com/hs-fs/hubfs/Labstat_Logo_wDescriptor_Final_RGB_Color-1.png?width=1920&height=502&name=Labstat_Logo_wDescriptor_Final_RGB_Color-1.png "Labstat_Logo_wDescriptor_Final_RGB_Color-1")](https://labstat.com/) ### Roundtable Discussion Tuesday, November 3 | 11 AM ET **Is Your Business Ready to Enter the ENDS Market?** 2026 has brought two significant developments for the U.S. ENDS market. In May, FDA authorized four Glas products, its first marketing authorizations for flavored ENDS products. In August, FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods. Together, these decisions offer fresh insight into how FDA is evaluating youth risk, adult switching benefits, product design, and scientific evidence in ENDS PMTAs. ### You Have Questions. We Have Answers. What can these decisions teach companies considering their own ENDS products? Join experts in regulatory strategy, toxicology, analytical science, product characterization, and manufacturing for a discussion of the Glas and JUUL2 authorizations. We’ll examine the evidence FDA considered, what these decisions may signal for future PMTAs, and how companies can begin building a scientifically sound regulatory strategy long before an application reaches FDA. Whether you are evaluating an ENDS concept or already planning a PMTA, the goal is to help you better understand where to focus your resources, studies, and regulatory planning. ### What We'll Discuss: - What the Glas and JUUL2 marketing orders **may reveal** about FDA’s current Appropriate for Public Health (APPH) expectations for ENDS products. - How age verification, access restrictions, and pod authentication can **help address** youth-use concerns. - How FDA **evaluates** adult switching benefits and evidence comparing ENDS use with continued cigarette smoking. - The **role of pharmacokinetic (PK) studies** in supporting ENDS PMTAs, including key considerations for study design and their relevance to abuse liability assessments. - Whether the Glas authorizations signal a **shift in how FDA weighs flavored ENDS benefits** against youth risk. - Why product characterization, toxicology, HPHC assessment, manufacturing controls, and stability **remain critical** to PMTA review. - How smaller and mid-size companies can **better sequence** product development, testing, studies, and regulatory planning. ### Join the Roundtable ### Roundtable Discussion Tuesday, November 3 | 11 AM ET **Is Your Business Ready to Enter the ENDS Market?** 2026 has brought two significant developments for the U.S. ENDS market. In May, FDA authorized four Glas products, its first marketing authorizations for flavored ENDS products. In August, FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods. Together, these decisions offer fresh insight into how FDA is evaluating youth risk, adult switching benefits, product design, and scientific evidence in ENDS PMTAs. ### You Have Questions. We Have Answers. What can these decisions teach companies considering their own ENDS products? Join experts in regulatory strategy, toxicology, analytical science, product characterization, and manufacturing for a discussion of the Glas and JUUL2 authorizations. We’ll examine the evidence FDA considered, what these decisions may signal for future PMTAs, and how companies can begin building a scientifically sound regulatory strategy long before an application reaches FDA. Whether you are evaluating an ENDS concept or already planning a PMTA, the goal is to help you better understand where to focus your resources, studies, and regulatory planning. ### What We'll Discuss: - What the Glas and JUUL2 marketing orders **may reveal** about FDA’s current Appropriate for Public Health (APPH) expectations for ENDS products. - How age verification, access restrictions, and pod authentication can **help address** youth-use concerns. - How FDA **evaluates** adult switching benefits and evidence comparing ENDS use with continued cigarette smoking. - The **role of pharmacokinetic (PK) studies** in supporting ENDS PMTAs, including key considerations for study design and their relevance to abuse liability assessments. - Whether the Glas authorizations signal a **shift in how FDA weighs flavored ENDS benefits** against youth risk. - Why product characterization, toxicology, HPHC assessment, manufacturing controls, and stability **remain critical** to PMTA review. - How smaller and mid-size companies can **better sequence** product development, testing, studies, and regulatory planning. ### Join the Roundtable ## Meet Our Panelists [![Pete\_Gibbons\_200x250](https://info.labstat.com/hs-fs/hubfs/Pete_Gibbons_200x250.png?width=200&height=250&name=Pete_Gibbons_200x250.png "Pete_Gibbons_200x250")](https://www.linkedin.com/in/pete-gibbons-b34a707a/) ### Pete Gibbons, Ph.D. #### *Director of Business Development, Labstat* Pete Gibbons leads business development for Labstat International’s Reduced-Risk Products (RRP) sector, where he focuses on expanding advanced analytical testing services for nicotine products. With a background as Head of Reduced-Risk Product Analysis at Element Life Sciences EMEAA, Peter brings deep expertise in analytical science, product evaluation, and market development. He works closely with manufacturers and regulators to support science-driven, defensible approaches to nicotine product safety and performance. [![Beth\_Oliva\_200x250](https://info.labstat.com/hs-fs/hubfs/Beth_Oliva_200x250.png?width=200&height=250&name=Beth_Oliva_200x250.png "Beth_Oliva_200x250")](https://www.linkedin.com/in/beth-oliva-b057667/) ### Beth G. Oliva #### *Partner, Fox Rothschild* Beth Oliva is a Partner at [Fox Rothschild LLP](https://www.foxrothschild.com/), who has advised tobacco and nicotine clients for nearly 20 years. Her practice focuses on advising nicotine and tobacco product manufacturers on FDA compliance, premarket review, and post-marketing requirements. She works closely with clients from product development through PMTA submission, drawing on deep experience before FDA and state agencies, as well as extensive collaboration with scientific and medical experts to support defensible regulatory  strategies. She serves on the Board of Directors of the Food and Drug Law Institute (FDLI) and the Nicotine Resource Consortium (NRC). [![Bryan\_Burd\_200x250](https://info.labstat.com/hs-fs/hubfs/Bryan_Burd_200x250.png?width=200&height=250&name=Bryan_Burd_200x250.png "Bryan_Burd_200x250")](https://www.linkedin.com/in/bryan-burd-542a18221/) ### Bryan Burd #### *General Manager, Chemular Inc.* Bryan Burd is the CEO of [Chemular Inc](https://chemular.com/)., bringing over 20 years of experience in business operations, product development, manufacturing, and regulatory compliance. With extensive expertise in international tobacco and nicotine regulations, Bryan has played a key role in navigating FDA requirements and Premarket Tobacco Product Applications (PMTAs). He works closely with companies across the industry to address regulatory challenges and support compliance in the evolving tobacco and nicotine landscape. [![Malcolm\_Saxton\_200x250](https://info.labstat.com/hubfs/Malcolm_Saxton_200x250.png "Malcolm_Saxton_200x250")](https://www.linkedin.com/in/malcolm-saxton-a2550512/) ### Malcolm Saxton, #### *Sr. Director of Scientific Strategy, Labstat* Malcolm Saxton is Senior Director of Scientific Strategy at Labstat International, with more than 25 years of experience in analytical and product characterization science. His expertise includes mass spectrometry, method development, non-targeted analysis, emissions testing, and the characterization of ENDS and other reduced-risk nicotine products. He helps clients develop robust analytical strategies and defensible data packages to support product development and regulatory submissions. [![Bonnie\_Coffa\_200x250](https://info.labstat.com/hubfs/Bonnie_Coffa_200x250.png "Bonnie_Coffa_200x250")](https://www.linkedin.com/in/bonniecoffa/) ### Bonnie Coffa, Ph.D., DABT #### *Scientific Director of Toxicology, Labstat & ToxPharm LLC* Bonnie Coffa is a board-certified toxicologist with more than a decade of experience supporting nicotine and cannabis products across regulatory science, *in vitro* toxicology, and risk assessment. She works with manufacturers on toxicological evaluations, literature reviews, and FDA regulatory applications, delivering clear, science-based insights to support defensible product submissions. ## About Certified Group [Certified Group](https://www.certifiedgroup.com/?utm_source=CL&utm_medium=referral&utm_campaign=FDA%20import) partners with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, [Certified Group](https://www.certifiedgroup.com/) includes [Food Safety Net Services (FSNS)](https://fsns.com/), FSNS Certification & Audit, [Certified Laboratories](https://certified-laboratories.com/), [EAS Consulting Group](https://easconsultinggroup.com/), and [Labstat International Inc.](https://labstat.com/) Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. Copyright © 2026 Labstat. All Rights Reserved.