FDA Warns Sellers of Unauthorized Liquids

The U.S. Food and Drug Administration on Feb. 12 sent warning letters to 11 firms for selling unauthorized e-liquids.

The firms receiving warning letters are Jojo’s Smokeless World (Mod Shield), Sugar Vapor Co., DC Vapor, Take Off Corp., The Vapor Spot, Premium Vapor Technologies, Vaping Xtreme, Vapes Gone Wild Juice, Vapeoholic, Vaporescence (Vape King USA) and Elemental Vapor Bar.

The firms did not submit a premarket tobacco product application by the Sept. 9, 2020, deadline.

Collectively, these companies have listed a combined total of more than 150,000 products with the FDA.

Following an initial set of such warning letters announced earlier this year, the 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,” the agency wrote in a statement.

“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.”