In 2016 the Food & Drug Administration “deemed” electronic cigarettes, vaping pens, and other electronic Nicotine delivery systems (“ENDS”) to be “tobacco products” under the Family Smoking Prevention and Tobacco Control Act. As a consequence, all ENDS manufacturers were required to submit premarket tobacco applications (PMTAs) in order to continue selling their wares. Under the Tobacco Act, the FDA is only to approve a PMTA if it concludes approval is “appropriate for the protection of public health,” taking into account “the risks and benefits to the population as a whole.” Without a PMTA, a deemed tobacco product cannot be sold.
PMTAs are supposed to be submitted before a new tobacco product is sold, but this was impossible since the FDA’s rule applied to products already on the market. Accordingly, the FDA announced that ENDS manufacturers would have two years to prepare and submit the lengthy and detailed materials necessary for their applications before they would face the prospect of FDA enforcement. The FDA soon realized that the material and information necessary for PMTAs would be substantial, particularly because a separate PMTA is required for each product, defined quite capaciously (i.e. each package size, each flavor, each nicotine level, each delivery system, etc.). So the FDA tried to extend the enforcement deadline until 2022, but anti-smoking groups sued, and they settled on a 2020 deadline.
The FDA ultimately received applications for over 4.8 million ENDS products from 230 companies. Needless to say, this is a bit more than the agency anticipated, and it has been working to process the applications, denying most of them. Because a PMTA denial is a death sentence, some disappointed ENDS producers have filed suit, challenging the denials and seeking judicial orders blocking FDA enforcement in the meantime.
Yesterday, the U.S. Court of Appeals for the Fifth Circuit ruled on one company’s application for a stay pending resolution of its petition challenging the FDA’s denial of its PMTAs. The court’s opinion in Wages and White Lion Investments LLC v. USFDA (WWLI) is a blistering indictment of the agency’s decision-making and evaluation …