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In follow up to our recent update on FDA’s motion with the United States District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline for many e-cigarettes, cigars and other tobacco products, FDA announced today that the motion has been granted.

In the announcement FDA states that the new deadline of September 9, 2020 will better serve the public health by allowing manufacturers to prepare for, and the Agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period. Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. You may read the full announcement here.

Please contact us with any questions or if we can be of assistance in the preparation and filing of your PMTAs.

Posted in COVID-19, Tobacco.