Update: 19 More FDA Warning Letters; Total Now 122 This Year

May 17, 2021

Since our last update on March 12, the FDA has issued 35 additional warning letters to small vape manufacturers and distributors that have not submitted Premarket Tobacco Applications (PMTAs) for some or all of the products they sell.

The agency has so farissued 103 warnings to small vape manufacturers this year (some are separate facilities owned by the same company). Each cited company registered products with the FDA, but did not submit a PMTA by the Sept. 9, 2020 deadline. Companies were required to stop selling products that weren't submitted on time for FDA review.

According to the FDA, the companies that have received warning letters sell or distribute more than 904,000 “unauthorized ENDS”—almost all of which are bottled e-liquid products.

The first round of FDA warning letters issued this year went out on Jan. 15—just two days after a letter from 12 U.S. Senators urged the agency to eliminate flavored and high-nicotine vaping products through the PMTA process. With as many as several hundred small e-liquid manufacturers still in operation without having submitted PMTAs, the FDA has plenty of additional targets to appease harm reduction opponents in Congress.

Forcing small manufacturers to exit the legal market may earn the FDA brownie points with some members of Congress and anti-vaping organizations like the Campaign for Tobacco-Free Kids, but it is unlikely to eliminate all of the cited products. With no real market for e-liquid labs, and online sales restricted by the inclusion of vaping products in the PACT Act, some small manufacturers will probably change their names and continue to produce e-liquid products off the regulatory grid.

The 35 manufacturing facilities that received warning letters between March 16 and May 11 are: