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U.S. Department of Health and Human Services

Tobacco Products

Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products

 

November 2011

 

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This guidance document is intended to assist persons submitting warning plans for cigarettes, as required by section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), and warning plans for smokeless tobacco products, as required by Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act). This guidance document discusses, among other things:

  • The statutory requirements to submit warning plans
  • Definitions
  • Who submits a warning plan
  • The scope of a warning plan
  • When to submit a warning plan
  • What information should be submitted in a warning plan
  • Where to submit a warning plan
  • What approval of a warning plan means

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means something is suggested or recommended, but not required. 


  

 

 

 

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

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002