FDA: Two Key Rules for Premarket Tobacco Product Applications

Categories: fda, News, Top Tobacco NewsBy Published On: January 25th, 2021191 words

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 ays 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.”

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