Since then, as rightly stated by The National Review, the agency “has set up roadblock after roadblock for companies attempting to get vaping products approved.” First it set up the very complicated, lengthy and expensive Pre Market Tobacco Application (PMTA) process and then it started “inexplicably shifting its criteria for approval and moving its goalposts, suggesting an abuse of administrative procedures.”
Such patterns have attracted multiple complaints and lawsuits, and in many cases, US courts have ruled against the agency. “The FDA admits that it ‘has yet to grant’ a single application to market non-tobacco-flavored e-cigarettes. This means it has denied over 355,000 such applications, which amount to 99% of all timely-filed (applications),” the Fifth Circuit ruling read in a recent reading.
The court also highlighted the agency’s erratic patterns. “[The FDA] has created a de facto rule banning all non-tobacco-flavoured e-cigarettes without following APA notice and comment requirements,” said the Fifth Circuit, referring to the Administrative Procedure Act.
The FDA seems to change requirements randomly
The panel also referred to the fact that the FDA has been changing its requirements and stance without warning. “The FDA inexplicably switched its position on menthol-flavored e-cigarettes in at least two crucial ways,” they read. “The FDA’s prior representations were that RJRV need not submit long-term studies showing that its menthol-flavored e-cigarette was more likely than a tobacco-flavored e-cigarette to cause smokers to quit. Yet the lack of that evidence became the very basis on which the FDA denied RJRV’s application.”
In this case, discussing R.J. Reynolds Vapor Company’s (RJRV) submissions, the Fifth Circuit said that the FDA had specific requirements, which the company fullfilled. “RJRV’s proposed marketing plan accounted specifically for these and many more measures.”
However, wrote Judge Edith Jones on behalf of the panel, the FDA then randomly deemed them insufficient. “..when rejecting RJRV’s evidence in the Denial Order, the FDA brushed over its prior statements about the low popularity of menthol-flavored e-cigarettes among youth and substantial benefits for cigarette smokers who make the switch. . . . This sudden turnabout further reinforces that the Order is likely arbitrary, capricious, or otherwise unlawful.”
