A Maryland district court ruling has ordered a 10-month deadline for Electronic Nicotine Delivery Systems (ENDS) companies to submit their Premarket Tobacco Applications (PMTAs) to the Food and Drug Administration (FDA).
Judge Paul W. Grimm’s ruling in the American Academy of Paediatrics (AAP) v FDA case has put into place a deadline of 11th May 2020 for vapor product companies to submit their applications.
The order of the ruling is as follows:
Accordingly, it is this 1th day of July 2019, hereby ORDERED that
1. The FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule (“New Products”), applications for marketing orders must be filed within 10 months of the date of this Memorandum Opinion and Order;
2. New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion;
3. New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application:
4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.
Compiling an application requires significant time and investment from companies wishing to continue trading in the US. This accelerated deadline from the previously stated date of August 2022 (or August 2021 for flavour products) means that companies must now be proactive in implementing their PMTA strategies.
Hall Analytical can fully support you through the PMTA process. Head over to our TPD2 and PMTA regulatory services page to download our simplified 4-phase approach to a PMTA submission