The fate of Juul e-cigarettes has been up in the air for the past few years as the U.S. Food and Drug Administration reviews the company’s products to determine whether they are safe to inhale.
Two years after issuing a marketing denial order (MDO) to Juul in June 2022, the FDA announced Thursday that the applications will get a second chance due to new legal precedent.
The FDA put the initial ban on hold in July 2022 and has since been reviewing “certain scientific issues” and conducting “additional substantive review of applications in multiple disciplines including toxicology, engineering, sociology, and more.” Pharmacology.
The ban has now been lifted. “This action was taken in part as a result of new case law and FDA’s review of information provided by the applicant,” the FDA said in a June 6 statement. “Withdrawal of an MDO is not an authorization or denial, nor does it indicate that the application whether it may be authorized or denied.”
FDA regulations limit the amount of information that can be publicly disclosed about a pending application.
read more: Juul vape: What is it, why are teens addicted, and is it safe?
Juul makes e-cigarettes and e-liquid cartridges that heat and then vaporize nicotine salts. The user inhales vapor rather than smoke.
For years, the FDA has questioned the company’s tactics, including producing products that appeal to teenagers and promoting e-cigarettes as safer than smoking cigarettes. There are also concerns that Juul’s e-liquid cartridges contain potentially harmful chemicals. One such chemical is benzoic acid, a food additive and preservative that can cause environmental and health hazards when used in large amounts. At the time of the ban, the FDA did not have sufficient toxicological evidence to demonstrate that marketing of the product met statutory public health standards.
read more: FDA calls on Juul to promote e-cigarettes as safer than cigarettes
