FDA Decisions Near on E-Cigarettes

E-cigarette manufacturers soon will learn whether they're out of business, still in the market but facing new government controls, or back in in a big way. The companies were given a choice last year: pull their vaping products or seek Food and Drug Administration approval for them. More than 500 manufacturers have made their case to the agency, the Wall Street Journal reports, sending scientific evidence that they say shows each of their products—6.5 million in all—is safer than regular cigarettes and helps smokers quit. On the other hand, the FDA will analyze whether the products are likely to encourage young people and others to become smokers.

"We intend to use [our] authority to protect kids and optimize public health," Janet Woodcock, the agency's acting commissioner, told a congressional hearing this summer. The FDA has a deadline of Sept. 9 for deciding on the applications, but it's said it won't be able to answer every company by then. Instead, it's focusing on those with the biggest pieces of the market. The top three are Juul Labs; Reynolds American, maker of Vuse e-cigarettes; and NJOY Holdings. All said they're confident they submitted convincing cases, per the Journal. Adding to the pressure is the fact that cigarette sales stopped their decline last year, after dropping for decades, possibly because of the pandemic.

E-cigarettes haven't faced the government curbs on marketing that apply to cigarettes, and Juul has taken criticism for contributing to the increase in young customers by pushing its flavored products. The company suspended its print, digital, and TV advertising, as well as its Facebook and Instagram pages, but still faces lawsuits, per Medpage Today. Juul now sells just tobacco and menthol varieties, and has not applied to market flavored products—though competitors have—saying it's trying to win back public trust. Flavored products could be among the winners; it's possible the agency will let sales resume without limits after curbs were enacted last year. The FDA's decision on Juul products could set the tone for how it will deal with smaller companies as it attempts to bring order to what Woodcock called an "unregulated marketplace." (More e-cigarettes stories.)