Four more companies have received warning letters for violating marketing orders for the sale of e-liquids. The U.S. Food and Drug Administration (FDA) says the companies failed to submit a premarket tobacco product applications (PMTA) by the Sept. 9, 2020 deadline. The regulatory agency posted the letters to RP Vapor, DIY Vapor Supply, Electric Freedom (Crown7) and KV Liquids were received on April 23 and posted to the FDA website on April 27.
RP Vapor has over 4,600 products listed with the FDA. DIY Vapor Supply is the registered manufacturer for over 73,300 products listed with FDA. Electric Freedom has over 80 products listed with the FDA, while KV Liquids has more than 300. The FDA 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. This means that the company may or may not have submitted a PMTA for some of its registered products.
The regulatory agency has now issued warning letters to 96 companies in 2021 for violating PMTA rules. 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.
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.