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Two FDA foundational rules finalized

06 Oct 2021. Two final rules for the premarket review of new tobacco products have been issued by the US Food and Drug Administration (FDA), according to a press release by the agency.

The final foundational rules provide additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports. These two pathways to seek the FDAs marketing authorization for a new tobacco product are the most commonly used ones. The fact that the rules have now been finalized will ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act, reads the press release.

"These final rules are important components of the FDA's comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions," said Acting FDA Commissioner Janet Woodcock, M.D.

"Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. "These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country."