Keller and Heckman Associate Neelam Gill will present, “Remote Regulatory Assessments for Vapor Product Manufacturers in PMTA Review: What to Expect and How to Prepare,” at the Next Generation Nicotine Delivery USA 2021 event, June 9, 2021. This virtual event will bring together business leaders from the ENDS and tobacco industry together with other experts
Ahead of Final Rule, U.S. Postal Service Publishes Guidance Regarding Non-Mailability of Electronic Nicotine Delivery Systems
As we have previously reported, on December 27, 2020, Congress amended the Prevent All Cigarette Trafficking (PACT) Act to apply to e-cigarettes and all vaping products (referred to in the legislation collectively as “Electronic Nicotine Delivery Systems” or “ENDS”). Under the amended PACT Act, these products are subject to the same federal and state
FTC Orders E-Cigarette Manufacturers to Provide Advertising and Sales Information
Reposted from Keller and Heckman’s Blog, Consumer Protection Connection.
The Federal Trade Commission (FTC) has issued orders to five e-cigarette manufacturers (JUUL Labs, Inc., R.J. Reynolds Vapor Company, Fontem US, LLC, Logic Technology Development LLC, and NJOY, LLC) seeking information about the companies’ 2019 and 2020 sales, advertising, and promotions. The FTC sent similar
Congress Amends the PACT Act to Apply to All Vaping Products, Placing Huge Burden on Small Manufacturers as Third-Party Common Carriers Refuse to Ship Products
Background on the PACT Act
As part of the “Consolidated Appropriations Act, 2021,” in the most recent COVID-19 relief bill signed into law on December 27, 2020, Congress amended the Prevent All Cigarette Trafficking (“PACT”) Act to apply to e-cigarettes and all vaping products. Originally passed in 2009, the PACT Act amended the
FDA Issues Warning Letters to Vape Companies that Did Not Submit Premarket Tobacco Product Applications (PMTAs)
Reposted from Keller and Heckman’s Blog, The Daily Intake
- On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning lettersto ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids. FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal
Agenda and Speakers Announced: 2021 E-Vapor and Tobacco Law Symposium
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
E-Vapor and Tobacco Law Symposium – Registration Is Now Open
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.
FDA Releases Updated Module, “Tobacco Registration and Listing Module Next Generation (TRLM NG)” for Tobacco Product Manufacturing Establishments
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.
A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules
Reposted from Keller and Heckman’s Blog, The Daily Intake
- The Food and Drug Administration (FDA) is one of 27 agencies and offices within the U.S. Department of Health and Humans Services (HHS). FDA’s final rules have typically been signed by the FDA Commissioner, or more often a lower appointed officer within the agency. FDA’s rules
Keller and Heckman LLP Files Citizen Petition Requesting 180-day Extension of PMTA Deadline for Small Open-System Vape Companies Due to COVID-19
On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021)