Tobacco Products

Submission of Warning Plans for Cigars

December 2016

This guidance document is intended to assist persons submitting warning plans for cigars, as required by Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143). This guidance document discusses, among other things:

  • The regulatory 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

Update

Per a recent legal filing, the FDA is extending certain compliance dates related to the final deeming rule for three months. Among the dates extended is the requirement to submit cigar rotational warning plans by May 10, 2017. The new deadline for this requirement is Aug. 10, 2017.

 

Page Last Updated: 05/09/2017
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