This week on August 31st, 2016, the U.S. Food and Drug Administration (FDA) published draft guidance that documents the procedures cigar manufacturers need to follow to submit warning plans. As a part of this process, the FDA is accepting comments on the procedures. The comment period will run 30 days closing on September 29th, 2016.
The implementation of warning labels on cigar packaging and advertisements is one of the components of the regulations put into effect by the FDA. The requirement for Warning Labels goes into effect two years after the issuing of the regulations (May 10, 2018). In order to comply with these regulations, cigar manufacturers are required to submit a Cigar Warning plan twelve months in advance.
The draft guidance provides a template for companies to submit the details of the Warning Plan.
For additional details the Warning Label regulations, see our article on “Understanding the FDA Warning Label Requirement for Premium Cigars“