Today, the FDA rescinded its June 2022 Marketing Denial Orders (MDOs) for the JUUL System and placed our applications back into scientific review.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.
These products (the JUUL device and Virginia Tobacco and Menthol JUULpods in 5.0% and 3.0% nicotine concentration) will remain on the market during this review.
For additional information, see the FDA’s press release issued this morning.
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