In an email to stakeholders on May 1st FDA alerted the “deemed” tobacco products industry that FDA intends to delay enforcement of all compliance deadlines concerning newly deemed tobacco products for 3 months. Though, this did not come through the usual FDA channels, i.e updates to guidance documents and formal publication in the Federal Register, we have confirmed directly with our FDA sources that the information is credible and provides a brief reprieve for the industry.
What Products will be Affected?
This deferred enforcement applies to newly deemed tobacco products, which include:
- e-liquids
- e-cigarettes
- other electronic nicotine delivery systems (ENDS)
- cigars
- and pipe tobacco
When will these Deadlines take Place?
According to the announcement, FDA’s compliance deadlines after May 10, 2017 will affect cigar warnings label plans, registration and listing, health documents, ingredient listings, harmful and potentially harmful constituent (HPHC) reports, and premarket tobacco product applications (PMTA).
New Compliance Dates:
Although FDA has not officially announced the new compliance dates, below we have calculated new (likely) dates based upon the FDA announcement. We will have finals of these shortly and will update this notice as soon as we can.
- Cigar Warning Plans: August 10, 2017
- Registration & Listing: September 30, 2017
- Ingredient Listing: November 8, 2017
- SE exemption request: November 8, 2017
- SE report: May 8, 2018
- Cigar Warnings on Packing and Advertisements: November 8, 2018
- PMTA: November 8, 2018
- HPHC: November 8, 2019
FDAImports assists manufacturers, importers, distributors and others subject to the new tobacco deeming rules navigate this challenging regulatory landscape. From registration & listing to premarket tobacco product applications (PMTA) we can help your company adapt and meet FDA’s regulatory requirements. Contact Us today for support.
