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U.S. Department of Health and Human Services

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

Building 71, Room G335

Silver Spring, MD 20993-0002