FDA Finalizes Two Key Rules for Premarket Tobacco Product Applications

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FDA Finalizes Two Key Rules for Premarket Tobacco Product Applications

On the final full day of the Trump Administration, the U.S. Food and Drug Administration (FDA) finalized two foundational rules for the premarket review of new tobacco products. These rules relate to the format and review of premarket tobacco product applications (PTMAs) and substantial equivalence (SE) reports. Both rules are set to go into effect 30 days after they have been published in the Federal Register.

In a press release, the following statements were made by key figures involved in U.S. tobacco regulation on what it has billed as a “historic public health milestone” impacting tobacco products in the U.S.:

Stephen M. Hahn, M.D., FDA Commissioner: “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.”

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products: “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. 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.”

The PMTA (premarket tobacco applications) final rule addresses the information that the FDA will need to carry out a sufficient evaluation of new tobacco products being marketed and sold in the U.S. PMTAs will be required for electronic nicotine delivery systems (ENDS), combustible cigarettes, non-combusted cigarettes and smokeless tobacco products. During the PMTA process, the FDA will review details and information provided by manufacturers of these products and their potential impact on the public’s health. The final rule formalizes the FDA’s procedures surrounding the review of PMTAs and the postmarked reporting requirements for applicants that receive granted marketing orders. The final rule also will require manufacturers to keep records that will show that its tobacco products and legally be marketed, including documents that show that a particular product doesn’t require FDA review or approval as well as those that show that a product has received the FDA’s premarket authorization.