ALEXANDRIA, Va. — The U.S. Food and Drug Administration (FDA) released more than 160 denials for tobacco products submitted under the premarket tobacco product application (PMTA) process—but convenience-store retailers want more information.
NACS is asking the FDA to release a public list of electronic nicotine delivery system (ENDS) products for which the agency has issued marketing denial orders (MDOs).
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.
“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 letter, which was also 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.
Products subject to the Sept. 9, 2020, deadline that have been reviewed and authorized by the FDA will continue to be posted on the agency’s website, an FDA spokesperson said to CSP.
“All new tobacco products without premarket authorization are marketed unlawfully and subject to enforcement at FDA’s discretion, consistent with the priorities outlined by FDA,” the agency said. “Retailers can contact their suppliers for clarity on the current status of any particular tobacco product’s application or any product’s marketing authorization, including whether specific products are subject to a marketing denial order. FDA intends to follow its usual enforcement practices and will send warning letters before taking enforcement action.”
While the FDA had a year to review PMTAs submitted by the deadline, it said on Sept. 9, 2021, that it needed more time to review applications and acted on about 93% of timely applications so far.
“As the [FDA] 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,” NACS said.
Founded in 1961 as the National Association of Convenience Stores, Alexandria, Va.-based NACS is a global trade association for the convenience and fuel retailing industry, which has more than 150,000 stores nationwide and serves 165 million customers daily. NACS has more than 1,500 retailer and 1,500 supplier members from more than 50 countries.
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