U.S. FDA Sends 11 Warning Letters for Illegal Products

The U.S. FDA issued warning letters today to 11 firms who manufacture and sell unauthorized e-liquids for premarket tobacco product application (PMTA) violations. The regulatory agency advised the manufacturers that selling products which lack PMTA authorization is illegal, and therefore cannot be sold or distributed in the U.S. The firms did not submit PMTA by the Sept. 9, 2020 deadline.

The firms receiving warning letters are Jojo’s Smokeless World Inc. d/b/a Mod Shield; Sugar Vapor Company; DC Vapor, Inc.; Take Off Corp; The Vapor Spot, LLC; Premium Vapor Technologies LLC; Vaping Xtreme, LLC; Vapes Gone Wild Juice, LLC; Vapeoholic LLC; Vaporescence LLC d/b/a Vape King USA; and Elemental Vapor Bar, LLC.

While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 150,000 products with the FDA, according to a to the FDA’s website.

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. The FDA sent 10 warning letters in mid-January.

“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,” the agency wrote. “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.”