OAN’s James Meyers
1:16 PM – Thursday, June 6, 2024
The Food and Drug Administration (FDA) rescinded its marketing ban on Juul labs Inc. on Thursday, which now opens the door to a possible reauthorization of its products.
The announcement comes two years after the federal health agency ordered the company’s e-cigarettes and vaping products to be taken off the market.
The FDA had initially blocked Juul’s application to sell its vaping device and tobacco, as well as menthol flavored pods in June 2022, after completing an almost two-year review of the manufacturer’s application. The FDA found that the company’s 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.”
Juul has claimed for several years that it can be used as a tool to stop smoking cigarettes.
The FDA subsequently paused the blocking just weeks later in July 2022 to conduct an additional review.
“In parallel, in the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA said in a statement.
Additionally, the agency said that rescinding the marketing denial orders was not the same as a new decision whether to formally authorize sales of the e-cigarettes. Juul’s applications have been returned to “pending status,” according to the agency.
Meanwhile, the FDA has issued over 300 marketing denial orders for new tobacco products since 2021. A handful have since been rescinded by the agency or blocked by federal court rulings.
“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,” Juul said in a statement.
According to Juul, their products will continue to be on the market during the FDA’s renewed review of the application.
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