pdf

FDA Delays Upcoming Deeming Compliance Deadlines by Three Months; Sign Up for our FDA Compliance Webinar on May 9, 2017

Date: May 02, 2017


Although we are still waiting for an official announcement, FDA's Stakeholder Relations Office recently indicated that the Agency will be delaying enforcement of all future Deeming Regulation compliance deadlines set for May 10, 2017 or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports. We understand that this does not apply to provisions of the Deeming Regulation where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.
 
The Stakeholder Relations Office further indicated that "this extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court".

Click here to learn more about Keller and Heckman LLP's lawsuit on behalf of the e-vapor industry currently pending before the U.S. District Court for the District of Columbia.
 
We will let you know as soon as FDA officially announces the new deadlines or issues new guidance. 
 
In the meantime, it is still not too late to sign up for Keller and Heckman's upcoming webinar on the Deeming Regulation compliance requirements. Join attorneys Azim Chowdhury and Benjamin Wolf as they provide a detailed overview of the legal requirements, and provide 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 will also discuss health document notifications and ingredient reporting for e-liquids and vapor devices using FDA's eSubmitter program and the CTP Portal.

Registration is complimentary but required. Please click here to register now.

Areas Covered in the Webinar:

  • New Deeming Regulation Compliance Deadlines
  • 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

Webinar Details: 

Date: Tuesday, May 9, 2017
Time: 1:00PM - 2:30 PM ET
Cost: Complimentary 
Registration: Click here to register.
*Login instructions and information will be sent the day before and the morning of the webinar*

Updated Compliance Deadlines Under Deeming Rule [Pending FDA Official Announcement]



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 


For more information on our tobacco and e-vapor practice, please contact Azim Chowdhury (+1 202.434.4230; chowdhury@khlaw.com) and visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor partner Azim Chowdhury on Twitter