Manufacturers of e-cigarettes currently on the market were required to submit a premarket tobacco product application (PMTA) to the Food and Drug Administration (FDA) by September 9 in order for their products to be legally sold in the U.S. Manufacturers who met the deadline can keep selling those products for up to one year while the agency reviews the lengthy applications. If e-cigarette makers didn’t submit applications, their products must be removed from retailers’ shelves immediately. The rub is that retailers could face FDA enforcement if they continue to sell e-cigarettes for which a PMTA hasn’t been submitted. But how is a retailer to know which manufacturers filed PMTAs and which didn’t?
To avoid this confusion and potential enforcement, NACS asked FDA to publish a list of the ENDS products for which the agency has received PMTAs. NACS organized a letter to the agency signed by other retail associations. The retail associations’ main point was that retailers look to the agency to know which products are legal to sell so that they can ensure they are operating in compliance with the law. Without a list from the agency, there would be no credible way for retailers to truly know which products can stay on the market.
In early September, the agency announced that it would publish a list but gave the caveat that it would not be publicly available immediately.
“We request your patience as we work through the appropriate processes to ensure the posted information is accurate and compliant with federal laws,” FDA Center for Tobacco Products (CTP) Director Mitch Zeller said in a statement. “In the interim, we encourage retailers and other interested parties to refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.”
NACS responded, asking the agency to exercise its enforcement discretion in the interim since a retailer cannot credibly confirm that manufacturers have submitted PMTAs without a published FDA list. The agency has not responded to that letter as of press time.
Until a list is made public, NACS believes a best practice for retailers is to ask the manufacturers for an email in writing confirming that they submitted a PMTA for their products.