FDA Receives More Than 15,000 PMTAs

Tobacco makers submitted most applications in August for fiscal year 2020
Stack of papers
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) received more than 15,000 premarket tobacco product applications (PMTAs) in fiscal year 2020, according to data provided on the agency’s website.  

The FDA received the bulk of those applications in August and September, showing many tobacco and electronic nicotine delivery systems (ENDS) companies cut it close to the Sept. 9 deadline when applications were due. In August 2020, the FDA received 10,184 applications and in September 2020 it received 4,567.

Most applicants await the FDA’s decision on whether they can legally market the products for which they submitted PMTAs.

Of the 15,020 applications turned in during fiscal year 2020, which ran from October 2019 to September 2020, 377 PMTAs closed during that period, the FDA said. Closed applications are ones the FDA issued an order letter or refuse-to-accept letter for or applications withdrawn by the applicant.

Remaining in question for convenience-store retailers is what companies submitted PMTAs.

The FDA said it will make public a list of the deemed new tobacco products that were subject to the Sept. 9 PMTA deadline, but it may take some time. First the FDA must ensure the publishing of any information complies with federal disclosure laws and regulations.

The FDA was granted authority over e-cigarettes, cigars and hookah products when the Deeming Rule took effect on Aug. 8, 2016. Deemed tobacco products became subject to the requirements of the Tobacco Control Act that already applied to cigarettes and smokeless tobacco products. This included the requirement that a new tobacco product receive premarket authorization from the FDA prior to marketing, according to the agency, which can be done through a PMTA.

The FDA issued a compliance policy to provide manufacturers of deemed products that met the definition of a new tobacco product and were on the market as of Aug. 8, 2016, time to submit their applications for authorization by Sept. 9.

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