NATSO joined national retail associations Oct. 14 in urging the Food and Drug Administration (FDA) to publish a list of ENDS products for which it has issued marketing denial orders (MDOs). The letter was sent in response to FDA’s Oct. 12 announcement that the Agency has authorized the marketing of three electronic nicotine delivery system (ENDS) products. FDA has not released a detailed list of MDOs it has issued and without a publicly available list, retailers – including fuel marketers with convenience stores – do not know which products are illegal for them to sell.
FDA issued marketing granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods. These three products are the first ENDS products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway. The authorization orders mean that the RJR Vapor Company can legally market and sell the three approved products in the U.S. To receive FDA approval under the PMTA pathway, ENDS product manufacturers must demonstrate to the Agency that the marketing of their product presents a net benefit to public health.
Along with the approvals, the FDA issued 10 MDOs for flavored ENDS products submitted under the Vuse Solo brand by RJR. The FDA, citing “potential confidential commercial information issues” refused to publicly disclose the specific flavored products that received MDOs. Nevertheless, the FDA says that the products must be removed from the market, or retailers will risk enforcement action. The agency added that retailers “should contact RJR with any questions about products in their inventory.” SIGMA continues to urge FDA to provide retailers with a publicly available list of PMTAs for ENDS products that are approved, denied, and under review.
Additional signatories included SIGMA, the Energy Marketers of America, FMI, The Food Industry Association, the National Association of Convenience Stores.
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