In August 2017, after the U.S. Food and Drug Administration (FDA) granted a four-year extension of the deadline for pre-market tobacco product applications (PMTAs) for electronic nicotine-delivery systems, the vapor industry breathed a collective sigh of relief. However, panelists participating in the “Vapor: A Survivor’s Game” panel at the 2018 Tobacco Plus Expo (TPE) cautioned vapor product manufacturers, retailers and consumers not to grow complacent.
All three panelists agreed that despite the optimistic outlook of many in the industry, the challenges related to applying for the right to keep products on store shelves have been delayed, not removed. For example, nothing has yet been done to mitigate the estimated cost of the application process, which even conservative estimates put at $330,000 per SKU. Furthermore, there have been some misconceptions about what the extension means, with some in the industry misinterpreting it as an extension of the Aug. 8, 2016, predicate date by which products had to have already been on the market in order to be sold without first receiving authorization from the FDA.
“It still stands that, as of Aug. 8, 2016, no changes can be made to your product absent filing a PMTA or whatever application is appropriate, and you cannot market that product unless you receive a marketing order from the agency,” Brittani Cushman, vice president of external affairs for Turning Point Brands told the panel audience. “So it’s only those products that were on the market as of Aug. 8, 2016, that have the extra window of time to prepare and submit the appropriate application.”
In other words, there are no guarantees, noted Phil Daman, founder of Daman & Associates and former president of the Smoke-Free Alternatives Trade Association, who has been a longtime advocate for the vapor industry. “We are not grandfathered in; we simply have a gratuitous limbo period.”
In fact, new challenges are emerging to threaten the industry, panelists agreed, pointing out that the threat of FDA regulation of nicotine levels in products and of banning flavors looms. “We think that flavors are critical to providing an [attractive, less harmful] alternative for smokers,” noted Jacopo D’Alessandris, president of E-Alternative Solutions, a sister company of Swisher International, who said that while an outright ban is unlikely, regulation of ingredients could achieve the same purpose. “I think there is not enough evidence today for [the] FDA to come out with an outright ban to flavors, but what they could do is something more sneaky.”