Juul filed its appeal, asking the court to stop what it called an "extraordinary and unlawful action" that essentially would put it out of business. Late last week, the FDA denied Juul’s application to sell its tobacco- and menthol-flavored e-cigarettes in the U.S., effectively removing those products from the U.S. market.
The company and the government have tangled in the past over charges that Juul aimed some of its vaping products, which contain nicotine, at underage consumers. In particular, the FDA has cracked down on fruit-flavored vaping products popular with young people.
But the FDA’s action banning Juul products from the market was not officially connected with past issues. Rather, the agency said it hinged on product safety.
‘Lack of evidence’
“After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health,” the FDA said in a statement.
The FDA continued, "In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed."
In filing its appeal, Juul said it submitted enough data and other information to address all of the safety questions the agency raised. In addition to the toxicity questions, Juul and other e-cigarette makers are required to show that their products help adult smokers quit while not attracting young users.
In their emergency appeal, Juul’s lawyers argued that it gave the FDA plenty of evidence in support of its case, including a 125,000-page document that contained several studies looking at vaping’s health risks.
Juul claimed that the FDA cannot argue that there was a "critical and urgent public interest" in removing its products from the market so urgently when the agency allowed them to be sold in the two years since that document was submitted.
A target?
Juul’s popularity with young people perhaps raised its profile with regulators. In addition to once offering fruit-flavored cartridges for its devices, the design of the devices themselves became an issue. Critics charged the sleek design and an appearance resembling a computer flash drive is especially appealing to young people.
While the issue of underage use was not officially part of the FDA’s order, it has not completely disappeared. Late last month, researchers at the University of California San Diego issued a study finding that underage vaping had dramatically increased between 2017 and 2019.
The study found more than 1 million teens between the ages of 14 and 17 years old became daily tobacco users during that time. By 2019, the study said more than three-quarters of those young smokers were vaping on a daily basis.