VTA Statement: Critiques FDA’s Denial of SMOK Device PMTAs

Published on January 16, 2024

STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO CTP’S DECISION TO DENY MARKETING OF SMOK E-CIGARETTE PRODUCTS

WASHINGTON, D.C. – January 16, 2024 – The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association (VTA):

“Today’s decision by the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) to issue 22 marketing denial orders (MDOs) for SMOK e-cigarette premarket tobacco applications further reinforces FDA’s steadfast commitment to its de-facto ban on e-cigarettes in the U.S.”

“For the first time, CTP has denied marketing authorization for purely technological devices that, per CTP’s own announcement, contain no tobacco, no nicotine, no e-liquid, and no flavorings. Still, CTP concluded that the American people couldn’t be trusted with these products because they “have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco flavored e-liquids.” In other words, CTP will deny Americans any device which allows them to consume nicotine in a manner that is scientifically proven to be dramatically less harmful than combustible cigarettes.”

“Today’s announcement reveals a rapid acceleration of CTP’s efforts remove any and all vaping devices from the market. Predictably claiming its decision was based on science, in actuality it had little to do with the data. CTP blithely asserted that SMOK products are popular with youth e-cigarette users. However, the 2023 National Youth Tobacco Survey (NYTS) data relied on by CTP, revealed the opposite. Not only did the data show another massive decline in youth use of any e-cigarettes (down 60% since 2019 and at a decade low), the data cited actually showed that less than one-tenth of one percent (230,000) of American youth even tried one of the SMOK products CTP just banned. Based on this objectively minute risk, CTP is barring millions of responsible adults from using these popular and technologically innovative products.”

“Like virtually all e-cigarettes, SMOK devices are a critical tool for American smokers looking for a less harmful alternative to smoking deadly cigarettes. CTP’s decision today is a rejection of technological innovation and is the most serious indication yet that it will not stop until all vaping products are eliminated in the U.S.”

“With CTP’s announcement, the VTA is once again renewing its call for CTP to reverse course, actually follow the science, and restore scientific primacy and integrity to its regulatory process.”

# # #

About VTA: The Vapor Technology Association is the leading industry trade association in the United States whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.