Tobacco Products

Tobacco Health Document Submission

December 2016

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
  • Definitions
  • 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

Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002


Courier Deliveries

Page Last Updated: 12/02/2016
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