 Foundational Rules Provide Additional Information on the Minimum Requirements for Premarket Tobacco Product Applications and Substantial Equivalence Reports Reviewed by the Agency Today, the U.S. Food and Drug Administration finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA. "The finalization of these foundational rules is an important milestone in the FDA's regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA's critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act," said FDA Commissioner Stephen M. Hahn, M.D. "These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. "These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law." PMTA Final Rule A PMTA is a type of application for any new tobacco product seeking an FDA marketing order. The FDA expects all premarket applications for electronic nicotine delivery systems (ENDS) products will be submitted through the PMTA pathway. However, the FDA has also issued authorizations for... | 
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