A federal judge has given cigar and e-cigarette manufacturers 10-months to apply for approval from the U.S. Food and Drug Administration (FDA) to keep their products on the market. This decision stems from a lawsuit filed on March 27, 2018 by the American Heart Association and five other groups and individual pediatricians.
It’s a decision that’s had both industries hoping for a different outcome. On July 12, 2019, U.S. District Judge Paul W. Grimm set a deadline of May 2020 for cigar and e-cigarette manufacturers to submit their Substantial Equivalence (SE) applications. This is earlier than expected and tosses out a previous ruling that had extended the deadline for Substantial Equivalence applications that was set for August 2021. Several public health groups and advocates filed the lawsuit against the FDA, claiming that the extension of the Substantial Equivalence applications was a risk to public health, keeping e-cigarettes and other covered tobacco products on the market longer but without the FDA’s review and approval.
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