Submit Tobacco Product Applications for Deemed Tobacco Products

Resources for Applicants Required to Submit by September 9, 2020

This page provides a compilation of information and resources that may be helpful to those preparing and submitting tobacco product applications for deemed products that were on the market as of August 8, 2016, in accordance with the September 9, 2020 submission due date (extended from May 12, 2020).

When Do I Need to Submit an Application for a Tobacco Product?

All new (i.e. non-grandfathered) tobacco products are required to obtain premarket authorization. If you are marketing a deemed tobacco product that is new and that was on the market as of August 8, 2016, you will need to submit a marketing application by September 9, 2020 as required by the Court, and as set forth in CTP’s compliance policy. If you want to market a new tobacco product that was not on the market as of August 8, 2016, you will need to submit a marketing application and receive authorization before marketing the product.

Products on the market as of February 15, 2007 are considered grandfathered tobacco products. A grandfathered product is not a new tobacco product and does not require an application. Learn about your product’s potential grandfather eligibility and submit a voluntary grandfather determination request.

A new tobacco product is:

• Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
• Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

Read full article here.

U.S. Food & Drug Administration – June 18, 2020.