FDA’s Extension of Future Tobacco Product Compliance Deadlines
On August 4, 2017, the FDA issued a guidance extending the deadline dates for certain tobacco products in relation to the May 2016 “Deeming Rule.” Under this rule, the FDA made effective the requirement to obtain its pre-market authorization in advance of selling several products which fall into the FDA’s definition of a “tobacco product.”
Known as a “marketing order,” this pre-market authorization requires the filing of 1 of 3 types of applications with the FDA for any product that had not been on the US market prior to February 2007 – which would include all e-liquid and e-cigarette products, among other types of electronic nicotine devices ("ENDS").
The FDA’s extension only applies to the compliance deadline for submitting the application relating to the premarket review for those tobacco products which were already on the market as of Aug. 8, 2016 that were either combustible or non-combustible and required the submission of a:
- Pre-Market Tobacco Application
- Substantial Equivalence Exemption Request, or
- Substantial Equivalence Report
The deadline for submitting the application or request to the FDA is now either August 8, 2021, where the product at issue is a newly regulated combustible tobacco product, or August 8, 2022 where it is a non-combustible one, such as an e-cigarette or e-cigar.
Another significant change is that whereas there had been 2 compliance dates – 1 for the submission of the application and 1 for the issuance of a marketing order – under the new compliance policy, once timely submitted there will be a continued compliance period pending review of those applications, as opposed to merely a 12 month period of continued compliance following the date of submission or where an application is withdrawn.
Aside from these, there are no other extended dates, either of those requirements which have already passed or those scheduled for a future date, which had already been extended in the FDA’s May 2017 guidance. For the time being, we can await the issuance of additional regulations and final guidances to be issued by the FDA to further enable the industry in preparing its applications for a marketing order.
pre-market tobacco application
US Food and Drug Administration