NACS, as well as other organizations that service convenience stores, are asking the Food and Drug Administration for more transparency on its premarket tobacco product application (PMTA) process. This includes public lists of which electronic nicotine delivery systems (ENDS) are legal to market, and which have been issued marketing denial orders (MDOs).
There is “widespread confusion in the marketplace as to which products can remain on shelves and which need to be removed,” NACS said.
The trade associations had sent a similar request in September 2021.
“It has been 18 months since this request, and the agency has received millions of applications and made decisions on 99% of them to date, yet the only list publicly available is the names of the manufacturers and not the names of the products themselves,” NACS said on its website, quoting the letter sent to the FDA. “This is not an adequate list for our retail members who strive to comply with the law and need to know which products specifically are legal to market and which products are not.”
The latest letter, dated May 31 and addressed to FDA Commissioner Robert Califf and Center for Tobacco Products Director Brian King, was signed by the Energy Marketers of America (EMA); the Food Marketing Institute (FMI); the National Association of Convenience Stores (NACS); the National Grocers Association (NGA); the Natioanal Association of Truck Stop Operators (NATSO); and the Society of Independent Gasoline Marketers of America (SIGMA).
The FDA responded to the associations’ first letter in January 2022, NACS said, stating that it understands the retail groups’ request for specific names of products and that it was working to update the list with final actions taken on individual products. This required additional time as there are many products involved, though, the FDA said at the time, and the agency does not disclose confidential commercial information about products that are not yet marketed.
NACS said in its most recent letter, however, that while it can appreciate the immense task of reviewing millions of applications, there is widespread confusion and the burden of verifying products is currently placed on retailers, who the FDA has asked to verify the marketing status of ENDS and vape products with the manufacturers.
“Many of our members are small operators who do not have the resources or bandwidth to contact the manufacturers,” the retail associations said. “Moreover, manufacturers providing a list does not guarantee accuracy or give the assurance that a verified list from the agency would give. These retailers stand to face enforcement if they are out of compliance with the law and the only way to ensure they can comply is if they have a verified list from the agency.”
The FDA addressed some of these concerns in its response to a report from the Reagan-Udall Foundation. The agency said it plans to enhance the FDA’s Tobacco Product Marketing Order webpage and develop a searchable public database of all tobacco products that have an FDA marketing order.
The Northeast Wholesalers Association and the Southern Association of Wholesale Distributors have also sent similar letters to Xavier Becerra, the U.S. Department of Health and Human Services secretary, and Califf.
The organizations ask for more clarity and communication regarding the PMTA process, including a list of e-cigarettes with marketing granted orders, MDOs and that have filed timely PMTAs. Outside of the PMTA process, they asked help with enforcement throughout the supply chain and at borders to combat the growth of the illicit market for e-cigarettes.
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