Prepare regulatory documents to submit online:
Download the eSubmitter software to package regulatory documents into an electronic submission in order to submit online to the Center for Tobacco Products (CTP), including:
- Listing of Ingredients in Tobacco Products (Sections 904(a)(1) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
- Tobacco Health Documents (Sections 904(a)(4) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
- Reporting Harmful and Potentially Harmful Constituents (Sections 904(a)(3) and 904(c) of the Federal Food, Drug, and Cosmetic Act (FD&CA))
- Product Applications (e.g. PMTA, Exemption from SE, SE)
Upload your eSubmitter package through the CTP Portal.
- See CTP’s eSubmitter Submission Checklist and Technical Working Instructions for help preparing your electronic submission. Persons with disabilities having problems accessing the PDF may call 1-877-CTP-1373 for assistance.
- Watch video tutorials using eSubmitter.
- For regulatory questions, email TobaccoIndustryQuestions@fda.hhs.gov.
- For eSubmitter technical support, email firstname.lastname@example.org or call 1-877-CTP-1373.
- For the CTP Portal support, email CTPeSub@fda.hhs.gov.
Note: eSubmitter submission templates are updated monthly. Using updated templates for your submission helps ensure the latest fields and structure of each submission can be received and processed by the FDA. When you create a new submission, eSubmitter will provide the newer template. If you want to create a submission from a prior submission, you can use the “Save As” option and eSubmitter will load the newer template. However, if eSubmitter updates are blocked by your IT infrastructure, then eSubmitter cannot load the newer template. If eSubmitter updates are being blocked, check the FDA eSubmitter application history on the eSubmitter webpage to locate important CTP template updates so that you can perform manual reinstalls as needed.