Webinar: Deeming Regulation Compliance: FDA Registration and Product Listing, Health Document Submissions and Ingredient Reporting for E-Liquids and Vapor Devices

Several FDA Deeming Regulation compliance deadlines are rapidly approaching for newly deemed tobacco products, including cigars, hookah, e-liquids and vapor devices. Keller and Heckman LLP attorneys Azim Chowdhury and Benjamin Wolf provided a detailed overview of the legal requirements, and provided step-by-step instructions for completing registration and product listing for U.S. manufacturing establishments using FDA's Unified Registration and Listing Systems (FURLS). Azim and Benjamin also discussed health document notifications and ingredient reporting for e-liquids and vapor devices using FDA's eSubmitter program and the CTP Portal.

Areas Covered in the Webinar:

• Overview of Registration, Product Listing, Health Document Submission and Ingredient Reporting Requirements for Deemed Products
• Step-by-Step guide through FURLS for Registration and Product Listing
• Step-by-Step guide through eSubmitter and CTP Portal for Health Document Submissions and Ingredient Listing for E-Liquids and Devices

Upcoming Compliance Deadlines Under Deeming Rule

Requirement	Deadline for Large-Scale Companies	Deadline for Small-Scale Companies
Registration of U.S. manufacturing establishments	September 30, 2017	September 30, 2017
Submission of List of Products manufactured in U.S. establishments	September 30, 2017	September 30, 2017
Health Document Submission	February 8, 2017 [Note: This deadline has passed.]	November 8, 2017
Submission of Ingredients Listing Reports	November 8, 2017	May 8, 2018
Premarket Tobacco Product Application (PMTA) for products on market on August 8, 2016	November 8, 2018	November 8, 2018
Submission of Harmful and Potentially Harmful Constituents (HPHCs) Reports	November 8, 2019	November 8, 2019