An analysis of PMTA applications: what they reveal about the US market

In May 2021, the US Food and Drug Administration (FDA) published the long-awaited list of deemed new tobacco products which are the subject of premarket tobacco product applications (PMTAs). This list will be regularly updated by the FDA as it updates its “positive or negative” actions on the products which have been submitted.

ECigIntelligence has carried out some analysis of this list in order to understand how the US market may change in a post-PMTA regulated market.

The list contains over 6m products submitted by 372 companies. Of those products, 99.9% are stand-alone e-liquid products – and of those, 80% of the submissions were from a single company.

It appears some applicants have developed an automated method to submit products to the FDA portal, which has allowed multiple e-liquid formats and flavours, with minor differences (for example, in size, nicotine strength etc) to be submitted separately. As such, analysis of the e-liquid products does not provide much insight into the future of the e-liquid market in the US, as it would seem unlikely that a large proportion of these submissions will achieve marketing approval.

In this analysis, we look at all the PMTA-submitted products which are not bottled e-liquid products (consisting of hardware, hardware components, or other nicotine- containing products).