The Center for Tobacco Products (CTP) is using the eSubmitter application to collect the following information, based on the Federal Food, Drug, and Cosmetic Act (the act), as modified by the Family Smoking Prevention and Tobacco Control Act:
- Tobacco Establishment Registration and Product Listing Submissions (per Section 905 of the Tobacco Control Act)
- Listing of Ingredients in Tobacco Products (per section 904a1 of the Tobacco Control Act)
- Tobacco Health Documents (per section 904a4 of the Tobacco Control Act)
- Reporting Harmful and Potentially Harmful Constituents (per Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act)
eSubmitter may be used for efficient electronic preparation and submission of the this information. See the FDA Center for Tobacco Products eSubmitter Submission Checklist and Technical Working Instructions (PDF - 612KB) to reference while preparing your electronic submission. For more information, see www.fda.gov/tobaccoinfoindustry
For regulatory questions regarding sections 904 and 905 of the act, and the related guidance documents, email TobaccoIndustryQuestions@fda.hhs.gov.
For eSubmitter technical support, please email email@example.com or call 1-877-CTP-1373.
For Electronic Submission Gateway (ESG) support, please visit the ESG website or call 1-877-CTP-1373.
Persons with disabilities having problems accessing the PDF files may call 1-877-CTP-1373 for assistance.
Family Smoking Prevention and Tobacco Control Act (Public Law 111-31) Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Final Guidance for Industry: Listing of Ingredients in Tobacco Products Final Guidance for Industry: Tobacco Health Document Submission