FDA Publishes List of Legal ENDS Products for US Sales

News This Week PMTA
May 20, 2021
22 minutes read

Credit: Hase Hoch

The list has arrived. The U.S. Food and Drug Administration (FDA) published its list of electronic nicotine-delivery system (ENDS) products that can be legally marketed in the U.S. Due to the sheer volume of the list, Vapor Voice has not yet been able to break down the full contents of the list. However, if each of the 15 files the agency published contains 430,000 cells that’s over 6 million individual products.

The publication of the list likely signals the start of enforcement crack-downs. The FDA has already issued 111 warning letters to vapor companies in 2021.

One item that stands out immediately is that one company, JD Nova Group, parent to Vapolocity and De-Ja Juice among others, has filed the majority (an estimated 4 million) of the PMTA submissions.

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.

“Please note that FDA has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list does not include entries of products from companies that did not provide information on current marketing status of their products to FDA so that the Agency could determine whether the existence of the application could be disclosed,” the FDA states. “It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement.”

The FDA had stated in September of 2020 that it would publish a list of vapor companies that had submitted PMTA’s by the Sept. 9, 2020 deadline. The news came just one week after several retail groups submitted a letter to the agency asking for a published list of applicants. Nearly eight months later the list has been published on the FDA’s website.

Companies that submitted their application by the Sept. 9, 2020, deadline can keep their products on the market for one year pending FDA review.

If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.

The list consists of 361 companies that filed PMTAs. The company’s on the list are as follows: