NACS Requests Public List of FDA-denied ENDS Products

Retailers need to know what products to pull from their shelves.

September 13, 2021

E-Cigarettes (ENDS)

ALEXANDRIA, Va.—NACS is calling on the Food and Drug Administration to release a public list of electronic nicotine delivery system (ENDS) products for which the agency has issued marketing denial orders (MDOs).

“Without this list, our retail members, who make every effort to comply with the law, do not know which products must be removed from shelves,” NACS stated in a letter to the FDA.

Four other national retail associations signed the letter, including the Energy Marketers of America; FMI, The Food Industry Association; the National Association of Truckstop Operators; and the Society of Independent Gasoline Marketers of America.

The FDA did not complete its review of premarket applications for ENDS products by the court-ordered deadline, which expired last Thursday.

“As the Agency takes action on PMTAs, it is imperative that there is continued transparency in the process and that stakeholders across the tobacco trade know all of the products that have had PMTAs rejected as well as all of the products that have had marketing orders granted,” the letter stated.

The agency said it has taken action on about 93% of applications for more than six million ENDS products that were submitted by the September 9, 2020, deadline.

“All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion,” the agency said in a statement. While all products are now illegal to sell, the FDA will continue to review pending applications and may approve the sale of additional products in the future.

The FDA said it has issued 132 MDOs for more than 946,000 flavored ENDS products because the premarket applications the companies submitted lacked scientific evidence showing that their products were less harmful than cigarettes and that they would make smokers more likely to squash the habit if they used it.

Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products, the FDA said, noting that it can’t release additional information about those companies.

Here is information on the companies that have received an MDO.