Keller and Heckman is pleased to announce the agenda for our 5th Annual E-Vapor and Tobacco Law Symposium. This year’s virtual program will feature new, timely topics specifically designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies. Topics that will be discussed include: FDA’s new guidance and proposed rulemakings Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) Report strategies for small businesses Completing environmental assessments…

Registration is now open for Keller and Heckman’s 5th annual E-Vapor and Tobacco Law Symposium! This comprehensive three-day seminar will address legal, scientific, and public health issues relevant to the e-vapor and tobacco industries as we move forward in a post-PMTA world. This year’s program will be taking place virtually February 9 – 11, 2021. The virtual platform we have chosen will closely replicate the interaction and dynamics that are experienced at our in-person event, including…

The U.S. Food and Drug Administration (FDA) recently released an updated module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” to its FDA Unified Registration and Listing (FURLS) Tobacco Registration and Listing Module (TRLM) (FURLS TRLM). TRLM NG was developed to better assist industry stakeholders submitting information and to improve system usability. Section 905(b) of the Family Smoking Prevention and Tobacco Control Act requires the owners and operators of domestic establishments that…

On April 22, 2020, the U.S. District Court for the District of Maryland modified its July 12, 2019 Remedies Order (the “Remedies Order”) in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.) to extend the May 12, 2020 premarket application deadline to September 9, 2020 for all deemed tobacco products (e.g., e-cigarettes, cigars, hookah, etc.) on the market as of August 8, 2016. Although the vapor[i] and cigar…

Since the Farm Bill of 2018 changed the definition and regulatory status of hemp from an agricultural perspective, confusion and misinformation has been rife on the U.S. Food and Drug Administration (FDA) regulatory status of hemp and its products—including cannabidiol (CBD), a non-psychoactive cannabinoid.  Despite there not being a clear basis for concluding that CBD has an appropriate FDA regulatory status for use in food, CBD has gained mass popularity, and it is not uncommon…