View Rule

FDA is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing for manufacturers of tobacco products. FDA needs complete and accurate establishment registration and product listing information to accomplish important statutory, regulatory, and public health objectives. Currently, only domestic manufacturers are required to register their establishments and list their tobacco products, creating significant gaps in agency information. This action, if finalized, would extend registration and listing requirements and FDA inspections to include foreign establishments and new categories of domestic establishments.