On March 12, FDA issued warning letters to 13 firms who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal, and therefore they cannot be sold or distributed in the U.S. The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline.
The firms receiving warning letters are VapinUSA-WI, LLC d/b/a VapinUSA, Vapor Springs, LLC, Vapor Cigs, LLC, Vegas Vapor Emporium, LLC, Vape 911, The Philosopher's Stone, LLC, The Clean Vape, Tooters Vape Shop, Cloudchasor LLC, Boardwalk Elixir, LLC, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors LLC, and Revolution Vapor LLC.
While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for these types of products.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application. FDA recently published an update on its progress on the processing and review of the applications received by Sept. 9, including a list of companies that submitted timely applications.