In a Joint Status Report filed in federal court on December 13, Plaintiffs Cigar Association of America, Cigar Rights of America, and International Premium Cigar and Pipe Retailers Association requested the extension of the Food and Drug Administration’s harmful and potentially harmful constituent (HPHC) reporting deadline. The Plaintiffs have already obtained a delay of the cigar and pipe tobacco warning labeling requirements until after the resolution of the lawsuit. Now, Plaintiffs seek an extension of the approaching November 8, 2019 deadline for HPHC reporting for cigar and pipe tobacco products.

Although FDA has stated that it intends to issue guidance on HPHC reporting and a rule providing a methodology for HPHC testing, nothing has been issued so far. In fact, FDA has not even proposed an estimated timeline for completion of these steps. In the recent court filing, Plaintiffs contend that even if the relevant guidance and rule were issued on December 13, there would still not be sufficient time to implement and carry out product testing. Further complicating matters is the public docket opened on March 21, 2018, in which FDA is soliciting comments on the appropriate regulatory status of premium cigars. In this docket, FDA requested comments that were not submitted in response to the proposed deeming rule, or that may have become available since then, that could further inform FDA’s thinking about the regulation of premium cigars. The window for submitting comments closed on June 25, 2018, and the Agency is reviewing these comments. It can typically take FDA six months to a year to review public comments, and in some cases longer, depending on the number and nature of comments received. It may be difficult for FDA to issue guidance on HPHC testing for premium cigars without first finalizing its overall regulatory approach for premium cigars.

If the extension of the November 2019 deadline is not granted by FDA, Plaintiffs state that they will need to bring claims challenging the HPHC testing and reporting requirement in January 2019, and can do so by seeking to amend the complaint, or filing a separate complaint. It will be interesting to see what FDA decides to do, as the industry anxiously awaits to get a better understanding of its requirements and potential costs of HPHC testing and reporting.