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Tobacco Products

Timeframe for Submission of Tobacco Health Documents

December 2009

This guidance document is intended to assist persons making submissions of certain documents (referred to in this guidance as “tobacco health documents”) to FDA under Section 904(a)(4) of the Federal Food, Drug and Cosmetic Act. This document explains:

  • The statutory requirement to submit tobacco health documents; and
  • The Agency’s enforcement policy on the timeframe for submissions of tobacco health documents. 


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: 07/27/2016
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