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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.

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

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; and visit Follow Keller and Heckman Tobacco and E-Vapor partner Azim Chowdhury on Twitter