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GUIDANCE DOCUMENT

Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products Draft Guidance for Industry September 2011

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2011-D-0480
Issued by:
Guidance Issuing Office
Center for Tobacco Products

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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0480.

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