FDA Issues 2 More Warning Letters for Lack of PMTAs

The U.S. Food and Drug Administration (FDA) issued warning letters to two more e-liquid manufacturers for violating the agency’s marketing rules. Nice Guys Distributing and Lucky’s Vape Lounge received the letters and posted them to the FDA website on Thursday and Friday, respectively. The regulatory agency has issued 92 warning letters for illegal e-liquids in 2021, so far.

Nice Guys was warned for its “Mr. Nice Guy’s E-Juice Etc. 2 Pussy Cat e-liquid,” according to the FDA and has more than 600 products listed with the FDA. Lucky’s Vape :Lounge was cited for selling “Lucky’s VapeWaterpop 6 e-liquid product” and has more than 16,000 products with the FDA. It is impossible to know if more than the mentioned products that received the warning letters violate the FDA’s premarket tobacco product application (PMTA) rules.

The FDA states that the companies failed to submit PMTAs by the required Sept. 9, 2020 deadline. The FDA also states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter.

In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.

Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.