Tobacco

NACS Asks FDA to Name R.J. Reynolds Denied Products

Agency says it cannot publicly disclose flavored products due to potential confidentiality issues
NACS

ALEXANDRIA, Va. — NACS and other retail associations are again pushing for the U.S. Food and Drug Administration (FDA) to be more transparent with its marketing denial orders (MDO).

The organization, which represents convenience stores, asked the FDA’s Acting Commissioner of Food and Drugs Janet Woodcock and Center for Tobacco Products Director Mitch Zeller in an Oct. 14 letter to release the names of R.J. Reynolds Vapor Co.’s products that received MDOs.

The letter follows the approval of the company’s Vuse Solo electronic nicotine delivery system (ENDS) device and associated tobacco-flavored e-liquid pods, which were submitted under the premarket tobacco product application (PMTA) process. The FDA also issued 10 MDOs for flavored ENDS products submitted under the Vuse Solo brand by RJR, but due to potential confidential commercial information issues, the FDA would not publicly disclose the specific flavored products. RJR did not immediately respond to CSP’s request for comment.

The FDA is working to update the public list of products with information about some products that have received MDOs, an FDA spokesperson told CSP on Friday. Given the large number of products involved, sharing this information requires additional time and resources. Please note that due to potential [confidential commercial information] issues, the FDA is not including on that list all products receiving an MDO. Retailers should contact manufacturers with any questions about products in their inventory.”

NACS said its members do not need any confidential or detailed information about the products—but they need to know the names of the denied products so they can identified and taken off the market.

“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. There is no guarantee that manufacturers will provide such information in a timely, complete, or accurate manner,” the National Association of Convenience Stores (NACS) said in the letter, also signed by the Energy Marketers of America (EMA, formerly the Petroleum Marketers Association of America or PMAA); the Food Marketing Institute (FMI), the National Association of Truckstop Operators (NATSO) and the Society of Independent Gasoline Marketers of America (SIGMA).

The group also sent a letter to the FDA in September asking it to release a public list of ENDS products for which the agency has issued MDOs. The FDA has issued more than 300 MDOs for products submitted through the PMTA pathway.  

While the FDA lists companies that received MDOs or marketing granted orders, as well as other status updates, on its website, its publicly provided list of MDOs only includes the name of the company that received the letter and not the specific products that were denied.

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