Suppliers’ Advice to Retailers on PMTA

CHICAGO — What is the most important thing for tobacco category managers in convenience stores to know about the premarket tobacco application (PMTA) process?

CSP asked tobacco and e-cigarette manufacturers. Here’s what they said:  

George Parman, director of communications for Altria, Richmond, Va.: “We are directly communicating with our trade partners so they have clarity on the [Food and Drug Administration's] requirements for deemed tobacco products. We are giving our assurance that Helix Innovations and JMC will submit the appropriate product applications by the deadline to comply with the FDA’s requirement for deemed tobacco products. We also want to make sure they understand that Philip Morris USA and U.S. Smokeless Tobacco Co. products are not impacted by the impending PMTA deadline.”

Jessica Fratarcangelo, marketing director at Cheyenne International Inc., Grover N.C.: “Tobacco category managers have to remain diligent in monitoring the viability and reliability of manufacturers and brands, just like they have in the past; however, c-store tobacco category managers must confirm that they’re working with manufacturers who are compliant with FDA regulations. Having an open line of communication with distributors and manufacturers, while also having a distinct understanding of the PMTA process, will ensure that products on the shelf are properly managed while the PMTA review phase in underway.”

Chris Howard, vice president, general counsel and chief compliance officer at E-Alternative Solutions, Jacksonville, Fla.: “Ask their clients if FDA has accepted and filed their PMTAs. They need both to show that the products are in substantive review. This means that the application has met all key FDA statutory requirements.”

Gerry Roerty, vice president legal and general counsel for the U.S. division at Swedish Match, Richmond, Va.: “The PMTA process is very data intensive and therefore likely will involve a back and forth process where the FDA will seek, and the manufacturer will be suppling additional information throughout the scientific review process. So long as the PMTA is timely filed by a manufacturer, retailers can feel confident in their ability to sell a product that is subject to an accepted PMTA application throughout the PMTA review process.”

Natasha Webster, senior director of brand and innovation communications at Reynolds American Inc. Services, Winston-Salem, N.C.: “Successful PMTA submission(s) will transform the market by creating a clear understanding of the range of authorized, new category alternatives that are available to adult nicotine consumers (ANCs). We expect our retail and trade partners will benefit from streamlined supply chains and supplier relationships, while at the same time being able to ensure they are offering consumers a wide array of enjoyable product options from a number of brands. This should enable ANCs to feel a renewed confidence in the products they buy at reputable retailers as they know they have been through the PMTA authorization process.”