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In a release on its website, the FDA explained that these two finalized foundational rules for the premarket review of new tobacco products, provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.

FDA Commissioner Stephen M. Hahn, M.D., explained that these two requirements will enable for greater transparency. “The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. [...]