This guidance document is intended to assist persons making tobacco product ingredient submissions to FDA. 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, May 10, 2016) (the deeming rule).
The guidance document explains, among other things:
- The statutory requirement to submit a list of all ingredients in tobacco products;
- Who submits ingredient information;
- What information is included in the submissions;
- How to submit the information;
- When to submit the information; and
- FDA’s compliance policies.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.