WASHINGTON — E-cigarette company Juul could eventually be allowed to resume selling its products in the U.S.
Back in June 2022, the U.S. Food and Drug Administration (FDA) banned Juul from selling products in the states after the company claimed its e-cigarettes could help people stop smoking traditional cigarettes.
"The FDA had determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law," the FDA wrote.
The FDA then paused the block in July 2022 to conduct more scientific review.
The agency says since then, it has conducted an additional review of Juul and conducted additional substantive review of the applications "in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology."
As a result of "review of information provided by the applicant," as well as new case law stemming from court decisions involving marketing denial orders (MDOs) for e-cigarette products, the FDA is now lifting the marketing ban on Juul products.
However, the agency noted that the ban reversal doesn't mean Juul products will end up back on U.S. shelves.
"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," the FDA wrote. "Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA."
Once accepted and filed by the FDA, applications under review either receive marketing granted orders or MDOs.
The FDA said its continued review doesn't change the fact that all e-cigarette products, including JUUL's, are required by law to have FDA authorization to be legally marketed.
Juul Labs released a statement Thursday in response to the FDA's decision. It reads in part:
"Today, the FDA rescinded its June 2022 Marketing Denial Orders (MDOs) for the JUUL System and placed our applications back into scientific review. We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.
We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health."
E-cigarette use among U.S. youths
Juul says its pods contain nicotine strengths of 5% or 3% and are designed for adult smokers over the age of 21.
But that hasn't stopped younger people from using them. The 2023 National Youth Tobacco Survey found Juul was the fourth-most popular e-cigarette brand used by adolescents. That was, however, down from the most popular in the 2020 survey.
According to the Centers for Disease Control and Prevention (CDC), more than 2 million American middle and high school students used e-cigarettes last year, with nearly nine in 10 students saying they used flavored e-cigarettes. E-cigarette use among high school students declined from 14.1% to 10% from 2022 to 2023, but e-cigarettes remained the most commonly used tobacco product among youths.