This guidance document is intended to assist owners and operators of domestic tobacco product establishments with the registration and product listing submissions required by section 905 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance document explains, among other things:
- The statutory requirement to make establishment registration and product listing submissions;
- The definitions of terms used in the statute and this guidance;
- Who should make establishment registration and product listing submissions;
- What information to include in the submissions;
- How to submit the information;
- When to submit the information; and
- FDA’s compliance policies.