Download Legislation Here
Court ruling of AAP V. FDA was released today regarding PMTA.
- 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 order must be filed within 10 months of the date of this memorandum Opinion and Order;
- New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion.
- 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;
- The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.
There is currently no information yet as to whether or not the FDA will file an appeal as they requested the 10 month deadline. More information to come soon along with a webinar July 18th.