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NAQC Newsroom: Tobacco Control

FDA's Proposed Rule on the Details of its Premarket Tobacco Product Applications.

Thursday, October 24, 2019  
Posted by: Natalia Gromov
The U.S. Food and Drug Administration issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.

The proposed rule will be open for public comments for 60 days through November 25, 2019.
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