By Nathalie Voit
The Food and Drug Administration (FDA) ordered JUUL to stop the sale of its flavored e-cigarettes in the U.S., according to a news release posted by the agency on June 23.
The ruling affects all of JUUL’s products on the U.S. market, including the company’s JUUL vaping device and four types of tobacco- and menthol-flavored pods.
The federal agency said it reached the order after the FDA reviewed scientific data on the toxicological composition of JUUL’s products and determined that the products did not meet the agency’s public health protection standards. In particular, the FDA said that JUUL put forth “insufficient and conflicting data” about potentially harmful chemicals that could leach from its proprietary e-liquid pods on its Premarket Tobacco Product Application (PMTA). A PMTA is a report applicants for new tobacco products must submit to the FDA to obtain commercial marketing approval.
The ruling is part of a two-year-long investigation by the FDA into the safety of JUUL’s devices. The e-cigarette maker has been the subject of intense scrutiny since 2018 when federal regulators announced a review of JUUL’s questionable marketing practices. In April that year, the FDA declared an aggressive crackdown on the illegal sale of e-cigarettes to minors.
“The nicotine in these products can rewire an adolescent’s brain, leading to years of addiction,” former FDA Commissioner Scott Gottlieb wrote in a statement in 2018. Although e-cigarettes “may offer a potentially lower-risk alternative for individual adult smokers,” any potential benefits of e-cigarettes are offset “if those products entice youth to start using tobacco and nicotine,” Gottlieb said.
The action is part of a wider range of efforts by the Biden-Harris administration to limit the sale and consumption of smoking and vaping products to the public.
On June 21, the FDA proposed new rules to reduce the addictiveness of cigarettes and other tobacco products. The proposed regulations would establish a maximum legal level of nicotine in cigarettes. In April, the agency proposed a prohibition on menthol as a predominant flavor in cigarettes.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in the statement.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products, and many have played a disproportionate role in the rise in youth vaping,” Califf said.
