• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Tobacco Products

Tobacco Health Document Submission


April 2010 







This guidance document is intended to assist persons submitting to FDA certain documents identified in section 904(a)(4) of the act (referred to in this guidance as “tobacco health documents”). The guidance document explains, among other things:

  • The statutory requirement to submit tobacco health documents;
  • Definitions;
  • Who submits health documents;
  • What information is included in the submissions;
  • How to submit the information;
  • When to submit the information; and
  • FDA’s compliance policies.






Contact FDA

(9am EST-4pm EST)

For General Inquiries:

Center for Tobacco Products Food and Drug Administration

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002