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GUIDANCE DOCUMENT

Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products Draft Guidance for Industry September 2011

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products

Issued by:
Guidance Issuing Office
Center for Tobacco Products

September 2011

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. 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)