In a release on its website, the FDA explained that these two finalized foundational rules for the premarket review of new tobacco products, provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.

FDA Commissioner Stephen M. Hahn, M.D., explained that these two requirements will enable for greater transparency. “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.”

The new rules provide additional information on the minimum standard requirements for the content, format and review of PMTAs and SE reports.
Director of the FDA’s Center for Tobacco Products, Mitch Zeller, J.D., said that these rules will help enforce current regulations. “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,” concluded Zeller.

Warnings issued to businesses who have not submitted PMTAs

In another recent release, the FDA announced that it had just issued its first set of warning letters to firms who have not yet submitted their PMTAs and are therefore selling authorized products. The agency explained that for companies that submitted applications by the set deadline, the FDA generally continues to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.

Last September the agency disclosed that the process will be made public, and the agency will be publishing a list of all the products subject to the deadline which have filed applications. The announcement was made by Mitch Zeller, director of the FDA’s Center for Tobacco Products, via a blog post, by which time the agency had already received applications for approximately 2,000 e-cigarettes and other newly regulated tobacco products. Zeller had pointed out that there are over 400 million eligible items that would need to apply in order to stay on the market.

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