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
Document Control Center

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

Courier Deliveries

Page Last Updated: 07/22/2016
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