The U.S. Supreme Court said Tuesday it will not review Avail Vapor’s case challenging the Food and Drug Administration’s rejection of its application to sell flavored e-cigarettes.
Avail Vapor said it followed the FDA’s guidance and recommendations when it prepared its premarket tobacco product applications (PMTAs) and provided the studies the FDA endorsed. But 10 months after the Sept. 9, 2020, submission deadline, the FDA decided to apply a new evidentiary standard for applications for non-tobacco-flavored electronic nicotine delivery system products, including Avail's bottled e-liquids, the vapor company claimed in its petition to the U.S. Supreme Court.
“FDA adopted this new evidentiary standard without notice or warning, and only disclosed it when the agency issued the first of hundreds of orders denying marketing authorization for some 99% of all timely filed applications for ENDS products,” Avail Vapor claimed. “Despite Avail’s submission of extensive scientific evidence tailored to FDA’s prior representations, FDA denied Avail’s application because it failed to include the studies that FDA now newly required and instead included extensive evidence that FDA had previously recommended and described as ‘critical’ to its evaluation, but now chose to ignore or reject.”
This is one of several cases challenging the FDA’s regulation of the vaping industry. When reached for comment, the FDA told CSP Daily News it would not comment on pending litigation.
While the FDA issued a marketing denial order (MDO) for Avail’s flavored ENDS products in September 2021, the agency in November 2021 issued a stay on the MDO, pending further review. So far, the agency has not authorized any flavored e-cigarette products through the PMTA process.
Avail Vapor first challenged the MDO in an appeals court, but when that court denied its petition in December 2022, the vapor company took its challenge to the Supreme Court in March 2023. The Supreme Court denied the petition Tuesday, according to its website.
“Given that, per FDA and CDC, 77% of adult e-cigarette users use non-tobacco flavors and 92.8% of e-cigarette users over 45 years old are former or current cigarette smokers (and in the age range most susceptible to near-term adverse health effects from smoking combustible cigarettes), we are disappointed that the Supreme Court has declined to review FDA’s failure to properly advise applicants about the agency’s specific longitudinal comparative efficacy study requirements for flavored e-cigarettes,” Eric Heyer, counsel for Avail Vapor, said Wednesday in a statement to CSP Daily News.
The FDA said it expects to complete its review of PMTA’s for covered applications, or those which filed PMTAs on time and reach 2% or more of total retail sales volume, by the end of the year. It has made determinations already on more than 99% of the nearly 26 million deemed tobacco products for which applications were submitted.