WASHINGTON—More than a month has passed since the Food and Drug Administration’s (FDA) deadline for e-cigarette manufacturers to submit premarket tobacco product applications (PMTAs). In a letter to the agency, Senator Dick Durbin (D-IL) raised concerns that the agency has yet to publish a list making enforcement and compliance more difficult.
As part of FDA’s deeming rule and order from the District Court of Maryland, any e-cigarette maker on the market prior to August 8, 2016, must submit a PMTA to the agency by the Sept. 9, 2020, deadline. These products will be permitted to stay on the market for one year while the agency reviews the applications, or until the agency takes a negative action. If manufacturers did not submit PMTAs by the deadline, their products must be removed from shelves. Any products new to the market after August 8, 2016 are illegal to market.
“It has been more than one month since PMTA applications were submitted to FDA. In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA,” stated Senator Durbin.
In early September, the FDA Center for Tobacco Products Director Mitch Zeller announced that the agency does intend to publish a list of products for which it received PMTAs. However, he did not disclose when a list would be available and asked for patience as the agency worked through the process.
His announcement followed a letter that NACS sent to FDA raising concerns that without a credible list from the agency, the retail industry would not know which products were legal to sell. NACS was joined in the letter by FMI, The Food Industry Association; the National Association of Truckstop Operators; the Petroleum Marketers Association of America; and the Society of Independent Gasoline Marketers of America.
“The PMTA list will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy. Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline,” stated the retail associations.