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U.S. Department of Health and Human Services

Tobacco Products

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Timeframe for Submission of Tobacco Health Documents

 

December 2009

 

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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

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

For General Inquiries:
AskCTP@fda.hhs.gov

Center for Tobacco Products Food and Drug Administration

9200 Corporate Boulevard

Rockville, MD 20850-3229