Tobacco Health Document Submission

In the guidance document, FDA requests tobacco health document submissions from manufacturers and importers of tobacco products based on the statutory requirements and compliance dates. As indicated in the guidance, all manufacturers and importers of tobacco products are required to provide immediate and ongoing submission of health documents developed after June 22, 2009. However, FDA generally does not intend to enforce the requirement at this time with respect to all such health documents, so long as a specified set of documents, those developed between June 23, 2009, and December 31, 2009, are provided at least 90 days prior to the delivery for introduction of tobacco products into interstate commerce. Thereafter, manufacturers should preserve all health documents, including those that relate to products for further manufacturing and those developed after December 31, 2009, for future submission to FDA. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA requests information including: submitter identification, submitter point of contact, submission format and contents (as applicable), confirmation statement, document categorization (as applicable), document readability and accessibility, and document metadata. The information collected will inform FDA's regulatory processes and decision making such as, development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others.

The latest form for Tobacco Health Document Submission expires 2029-04-30 and is listed under ICR 202508-0910-003.

Tobacco Health Document Submission

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.