The U.S. Food and Drug Administration on Thursday withdrew its marketing ban on electronic cigarettes from Juul Labs two years after it moved to take the products off the market.
The decision to rescind the marketing denial orders was informed by “new case law, as well as the FDA’s review of information provided by” Juul, officials said.
Agency officials noted that the decision will not allow Juul to market its e-cigarette products yet.
“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 said in a statement. “Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA.”
The decision came after the FDA banned the sale of Juul e-cigarettes nationwide in 2022, saying that there was not enough evidence to show that the products “met the public health standard required by law.” Juul’s products were allowed to stay on store shelves as the company appealed the decision.
In a statement released Thursday, Juul said it was looking 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,” company officials said.
Juul has long been blamed for a spike in teen vaping.
In 2022, the company agreed to pay $438.5 million to settle an investigation into its marketing to teenagers. As part of the settlement, Juul agreed to restrict marketing its products to people under 35 years old, among other conditions.
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