FDA Issues 3 Warning Letters for PMTA Violations

The U.S. Food and Drug Administration (FDA) has issued three more warning letters for illegal e-liquids. The regulatory agency issued the letters on May 28 and June 3 and posted them to its website on the same days. Companies that received the latest round of letters have a combined 750 products registered with the FDA. The agency has now issued 123 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.

North Carolina-based Asheville Vapor received letter on May 28 (50 registered products), while Kansas-based Tiger Vapes (100) and New York-based The Vapor Shop received the letters on Thursday, June 3.

In May, the FDA issued a total of 19 warning letters to firms who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S.

While each of these 19 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively those firms have listed a combined total of more than 378,000 products with the FDA, according to an email from the agency.

Since January 2021, FDA has issued a total of 123 warning letters to firms selling or distributing more than 1,280,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline.

The FDA recently released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.

The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

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.