FDA finalizes two key rules for companies seeking to market new tobacco products

FDA issued on Tuesday two final foundational rules for the premarket review of new tobacco products. The rules include additional information on the minimum requirements for the content, format, and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. “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, MD. The new final rules are effective 30 days after publication in the Federal Register.