When the FDA first asserted the authority to regulate e-cigarettes in 2016, many people assumed the agency would quickly get rid of vapes with flavors like cotton candy, gummy bears and Froot Loops that appeal to kids.
Meanwhile, today's vapes have become"bigger, badder, and cheaper" than older models, said Robin Koval, CEO of the Truth Initiative, a tobacco control advocacy group. The enormous amount of nicotine in e-cigarettes -- up 76% over five years -- can addict kids in a matter of days, Koval said. The e-cigarette industry maintains that higher nicotine concentrations can help adults who smoke heavily switch from combustible cigarettes to vaping products, which are relatively less harmful to them. The FDA has approved high-nicotine, tobacco-flavored e-cigarettes for that purpose, said April Meyers, CEO of the Smoke-Free Alternatives Trade Association.
Most U.S. teen vapers begin puffing within an hour of waking up, according to a survey of e-cigarette users ages 16 to 19 presented at the Society for Research on Nicotine and Tobacco in March. The agency has struggled to stop e-cigarette makers who continue selling vapes despite the FDA's rejection of the products, as well as manufacturers who never bothered to apply for authorization, and counterfeiters hoping to earn as much money as possible before being shut down.
The FDA said it would not complete reviewing applications by the end of June, as it previously forecast, but would need until the end of the year. The FDA ordered Juul to remove its products from the market in June 2022, for example, but was immediately hit with a lawsuit. The U.S. Court of Appeals for the D.C. Circuit sided with Juul and issued a temporary stay on the FDA's order. Within weeks, the FDA announced it would hold off on enforcing its order because of"scientific issues unique to the Juul application that warrant additional review.