The rule would establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This rule would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This rule provides manufacturers with flexibility in the manner in which they comply with the requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health. In April 2023, FDA held an all tribes’ call to provide an overview of the proposed rule, answer questions, and receive tribal feedback. Additionally, in May 2023, FDA held an open session meeting of the Tobacco Products Scientific Advisory Committee to enable the committee to discuss and provide recommendations on the proposed rule. FDA made background material available to members of the public and interested persons were able to present data, information, and views on issues pending before the committee.