FDA Releases PMTA List

Includes more than 6 million tobacco products submitted by Sept. 9 deadline
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) posted a list of deemed new tobacco products for which premarket tobacco product applications (PMTAs) were submitted by the Sept. 9 deadline. The list includes more than 6 million products.

Convenience-store retailers have long-awaited this list, which will help them ensure they are selling legal tobacco products, particularly electronic nicotine delivery systems (ENDS). Anyone can download the lists of submitted products, which are broken up into sections and organized alphabetically by company name, from the FDA’s website.

Most products on the list are ENDS products. In August 2016, the FDA was granted authority over all “deemed” tobacco products, including e-cigarettes, cigars, hookah tobacco and nicotine gels. New tobacco products, or ones that were commercially marketed in the United States as of Feb. 15, 2007 (grandfathered products), were then required to submit a premarket application to the FDA by Sept. 9 to receive a marketing order. 

The FDA noted the lists are not comprehensive, and retailers should still discuss with their suppliers the status of any tobacco product’s application or any product’s marketing authorization. For example, grandfathered products do not appear on the list and tobacco products on the lists may be the subject of a warning letter.

There is a one-year period for the FDA to determine what products might remain on the market pending FDA review. If a negative action is taken on an application before Sept. 9, 2021, the product must be removed for the market or risk FDA enforcement. If a positive action is issued, the product will be listed on the positive marketing orders page and can continue to be sold according to the terms specified in the order letter.

In February, the FDA posted a list of deemed new tobacco products with timely applications submitted through the substantial equivalence (SE) and exemption from substantial equivalence (EX REQ) pathways, two of the ways to receive a marketing order. The PMTA list took longer to upload because of the large number of applications and size of the applications, among other factors, the agency said.

The FDA will regularly be updating lists and its metrics and reporting webpage for all pathways as positive or negative actions are issued on the products. 

The FDA’s Center for Tobacco Products will hold a virtual meeting from 1 to 3:30 p.m. ET on June 11 with CTP Office of Science Director Matt Holman to improve public understanding of the policies and processes for tobacco product application review. Click here to register.

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