This guidance describes FDA’s current thinking regarding the submission of health-related documents required by section 904(a)(4) of the Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 387d(a)(4)). This guidance is intended for manufacturers and importers of cigarettes, cigarette tobacco, roll your own tobacco (RYO), smokeless tobacco and those tobacco products subject to FDA’s final rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (81 FR 28974) (the deeming rule).
This guidance explains, among other things:
- The statutory requirement to submit health documents
- Who should submit health documents
- FDA’s compliance policies
- What information to include in health document submissions
- How to make health document submissions
- When to make health document submissions