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 


 
August 8, 2018 











Date: 5/9/2017

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