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FDA Codifies Premium Cigar Definition; Finalizes SE for Flavored Cigars & Other Tobacco Products – halfwheel

FDA Codifies Premium Cigar Definition; Finalizes SE for Flavored Cigars & Other Tobacco Products
Yesterday, the U.S. Food & Drug Administration (FDA) announced finalized rules for premarket product approval through substantial equivalence (SE) or the premarket tobacco product applications (PMTA) pathways; only none of those rules will apply to “premium cigars,” at least not yet.
All tobacco companies were required to submit applications to FDA by Sept. 9, 2020 in order to keep their current products except for “premium cigars” on the market. Those companies are allowed to keep their current products on the market while FDA reviews the applications.
For cigars that were marketed prior to Feb. 15, 2007, the process is quite easy. Those products are grandfathered and primarily just needed to provide evidence that they were being sold prior to that date. ....

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