FDA Releases Long-Awaited PMTA Submissions List
May 20th, 2021
Today, May 20th, 2021, FDA released the “Deemed New Tobacco Product Applications Lists” the electronic nicotine delivery systems (ENDS) industry has been waiting for since the September 9th 2020, premarket tobacco application (PMTA) deadline.
Per FDA’s definition, a new tobacco product is “any tobacco product (including those products in test markets) not commercially marketed in the United States as of February 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after February 15, 2007. New tobacco products may not be legally marketed in the U.S. without a tobacco product marketing order from the FDA”.
On August 8th, 2016, it was ruled ENDS products were to be included in these deemed tobacco product requirements and under FDA regulation. These regulations require any new tobacco product, including ENDS products that were on the market as of August 8th, 2016, to receive premarket authorization from the FDA in order to stay on the market. Applications to receive market authorization (PMTA) were due to FDA for review by September 9th, 2020. Per the FDA, brands that submitted their applications for review by the PMTA deadline may continue to market their products for up to one year while their application is under review, unless a negative action is taken by the FDA against their application.
According to FDA, the lists released today contain over 6 million total products. These lists do not specify where each application is in the PMTA process and do not reflect whether the application has received a negative action by FDA. Negative actions taken by FDA (108 total as of date of this publication) can be found easily in the consolidated list here. If a positive marketing order is issued by the FDA to any firm, it will be listed under a separate list: Positive Marketing Orders. At this time, no ENDS products have received positive marketing orders from the FDA, with the most recent premarket tobacco product marketing order being granted to Phillip Morris Products S.A. in 2020 for their non-combusted cigarette product, IQOS.
May 20th, 2021
Today, May 20th, 2021, FDA released the “Deemed New Tobacco Product Applications Lists” the electronic nicotine delivery systems (ENDS) industry has been waiting for since the September 9th 2020, premarket tobacco application (PMTA) deadline.
Per FDA’s definition, a new tobacco product is “any tobacco product (including those products in test markets) not commercially marketed in the United States as of February 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after February 15, 2007. New tobacco products may not be legally marketed in the U.S. without a tobacco product marketing order from the FDA”.
On August 8th, 2016, it was ruled ENDS products were to be included in these deemed tobacco product requirements and under FDA regulation. These regulations require any new tobacco product, including ENDS products that were on the market as of August 8th, 2016, to receive premarket authorization from the FDA in order to stay on the market. Applications to receive market authorization (PMTA) were due to FDA for review by September 9th, 2020. Per the FDA, brands that submitted their applications for review by the PMTA deadline may continue to market their products for up to one year while their application is under review, unless a negative action is taken by the FDA against their application.
According to FDA, the lists released today contain over 6 million total products. These lists do not specify where each application is in the PMTA process and do not reflect whether the application has received a negative action by FDA. Negative actions taken by FDA (108 total as of date of this publication) can be found easily in the consolidated list here. If a positive marketing order is issued by the FDA to any firm, it will be listed under a separate list: Positive Marketing Orders. At this time, no ENDS products have received positive marketing orders from the FDA, with the most recent premarket tobacco product marketing order being granted to Phillip Morris Products S.A. in 2020 for their non-combusted cigarette product, IQOS.
