Tobacco Product Establishment Registration and Submission of Certain Health Information

The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

The latest form for Tobacco Product Establishment Registration and Submission of Certain Health Information expires 2022-09-30 and can be found here.

Tobacco Product Establishment Initial Registration and Listing and Product Listing

Federal Enterprise Architecture: Health - Consumer Health and Safety

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