VTA Statement: Critiques FDA’s Denial of Suorin Device and blu PLUS+ PMTAs

Published on January 19, 2024

STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO CTP’S DECISION TO DENY MARKETING OF SUORIN AND blu PLUS+ E-CIGARETTE PRODUCTS

WASHINGTON, D.C. – January 19, 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 marketing denial orders (MDOs) for Suorin and blu PLUS+ e-cigarette premarket tobacco applications (PMTAs) is just the latest installment of FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.”

“The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH.”

”Having failed to objectively define this standard while simultaneously using it to deny marketing authorization to critical smoking-cessation and harm-reduction products is a gross overreach for any governmental institution whose mandate is to follow the science. Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined. Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”

“What is most striking is that CTP claims that its denial of Suorin’s PMTAs was because its product promoted ‘continued use and development’ of dependence. If this is the standard, then every nicotine product will fail the bizarre standards of CTP, since nicotine is addictive, which will further CTP’s implementation of a ban on less harmful forms of nicotine and further lock 30 million Americans in the grip of toxic cigarettes.”

“This action by CTP comes on the heels of an earlier MDO against another c-cigarette company and clearly reflects CTP’s steadfast commitment to deny any and all products or devices which Americans can use as a dramatically less harmful alternative to combustible cigarettes.”

“CTP also continues to falsely assert that these products are popular with younger users. FDA’s own data in fact demonstrate a rate of 70,000 out of 28 million, approximately 0.25%. At what point will CTP stop and realize the dramatically low youth rate merits real and thoughtful consideration of the value of e-cigarette products for adults looking for a less harmful alternative to combustible tobacco?”

“Today’s actions of FDA and CTP do nothing to protect public health or help Americans who smoke. VTA once again calls on CTP to reverse course on its bad faith actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough.”

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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.