The FDA offered a delay in PMTA applications for premium e-cigarettes. but many other products still must seek approval from the FDA to continue to be sold and marketed in the U.S. These products include vapor, alternative nicotine products, e-liquid, electronic nicotine devices (ENDS) and e-cigarettes. With more than 400 million deemed products known by the FDA and a large number of applications expected to be submitted, the FDA is unsure of how long it will take to review all the submitted products by the year deadline it has to complete the process. Any deemed e-cigarettes introduced after Feb. 15, 2020 is required submit a PMTA or a Substantial Equivalence (SE) application to keep their products on the market.
The FDA will publish a list of deemed e-cigarettes that were on the market by or before Aug. 8, 2016 as well as a list of new tobacco products that are subject to the Sept. 9, 2020 deadline for PMTA applications. The exact date that these lists will be available for public viewing is unknown and the FDA is advising retailers refer to the press releases issued by various manufacturers announcing the submission of PMTA or SE applications. Trade organizations like the National Association of Tobacco Outlets (NATO) also encouraged tobacco retailers to reach out directly to manufacturers and inquire about the submission of SE and PMTA applications.
The FDA is expected to take action and enforcement against those manufacturers that do not file an SE or PMTA application with the FDA by the Sept. 9, 2020 deadline. No extensions have been granted, thus any product that lacks a SE or PMTA application after Sept. 9, 2020 will be considered illegal and will be viewed as “misbranded and adulterated” by the FDA.