Answer: A grandfather request asks FDA to "establish" that your cigar was commercially marketed in the United States as of a certain date, currently February 15, 2007. The request must be for a specific product ("product" here meaning the SKU level). The request must describe the cigar and attach evidence that it was commercially marketed in the United States as of February 15, 2007. FDA has listed the types of evidence it will accept in its September 2014 Guidance Document "Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007." The best evidence will include invoices, bills of lading, purchase orders or receipts dated February 15, 2007. FDA has, however, stated that it will accept evidence dated a reasonable period of time before and after February 15, 2007, if the submitting entity does not have documents from the exact date.
There are several reasons to consider submitting grandfather requests to FDA. First, once a cigar is established as grandfathered, it will not need to go through the pre-market approval process. Second, for all Substantial Equivalence ("SE") reports, a company will have to prove that the cigar being used as the predicate for the new tobacco product that is the subject of the SE report is in fact a predicate product. Having that cigar already established as grandfathered eliminates an issue to be covered in the SE report. Third, FDA has published a publicly accessible, searchable database of all standalone grandfather determinations. This means that if a grandfather request is submitted as a standalone request to FDA, and is approved, that cigar will appear in the searchable public database, giving assurance to manufacturers and retailers that the cigar can remain on the market. Note, however, that if a cigar is established as a predicate only as part of an SE Report, and not in a standalone submission, the cigar will not appear in the FDA database. CAA had long requested that FDA create and post such a database and it was first posted earlier this year.