NACS Presses FDA to Release Names of Denied ENDS Products

The association asks the agency to provide transparency for retailers in their PMTA decisions.

October 15, 2021

FDA Office

ALEXANDRIA, Va.—NACS, along with five other retail associations, sent a letter to the Food and Drug Administration (FDA) asking the agency to release the names of the R.J. Reynolds products for which it issued marketing denial orders (MDOs). The letter follows yesterday’s FDA approval of R.J. Reynolds’ Vuse Solo closed electronic nicotine delivery system (ENDS) device and tobacco-flavored e-liquid pods.

“Our members do not need any confidential or detailed information about the products, they simply need to know the names of the products so that they can be identified and taken off the market,” said NACS in the letter.

The FDA says that it cannot identify the products because of “potential confidential commercial information issues.”

“While the agency claims that it cannot identify the products that received MDOs, in the same release it discloses the three products that received authorization and that menthol products are still under review,” states the letter. “Asking the hundreds of thousands of tobacco retailers to verify the PMTA status of ENDS products with each manufacturer does not fulfill the agency’s responsibility to inform regulated businesses of its decisions.”

In addition to NACS, the letter was signed by 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.

On Sept. 10, NACS and these groups asked the FDA in a letter to release a list of ENDS products for which the agency has issued 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 the Sept. 10 letter to the FDA. “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.”

R.J. Reynolds also released an update and list of FAQs for its retailers yesterday regarding the FDA’s PMTA review of Vuse Solo. In its FAQs, the company shares that the FDA issued MDOs for five of its flavors, comprising 10 products, and that none of these products are currently on the market.