The fate of Juul e-cigarettes has been hanging in the balance for the last few years as the US Food and Drug Administration reviews the company’s products to determine if they are safe to inhale.
Two years after issuing marketing denial orders (MDOs) to Juul in June 2022, the FDA announced Thursday that the applications are getting a second chance thanks to a new legal precedent.
The FDA had put the initial ban on hold in July 2022, and in the time since has been reviewing “certain scientific issues,” as well as conducting “additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science and clinical pharmacology.”
Now the ban has been rescinded. “This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant,” the FDA said in a June 6 statement. “Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied.”
FDA regulations limit how much information can be publicly disclosed about pending applications.
Read more: Juul vape: What is it, why are teens addicted, and is it safe?
Juul manufactures e-cigarettes and e-liquid pods that heat and then vaporize nicotine salts. The user inhales vapor instead of smoke.
For years, the FDA has challenged the company’s tactics, including making products that appeal to teenagers and promoting vaping as being safer than smoking cigarettes. There have also been concerns about potentially harmful chemicals contained in Juul’s e-liquid pods. One such chemical is benzoic acid, a food additive and preservative that can be both environmental and health hazards in large amounts. At the time of the ban, the FDA didn’t have enough toxicological evidence that the product marketing met the legal public health standard.
Read more: FDA calls out Juul for promoting vaping as safer than cigarettes
