03 May FDA Compliance Deadlines Extended
Since July 15, 2016, Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers Association (IPCPR) have been pursuing litigation in federal court against the United States Food and Drug Administration (FDA), challenging the FDA’s May 10, 2016 Rule deeming cigars and pipe tobacco to be tobacco products subject to FDA regulation.
In the context of the litigation, the FDA has announced an extension of upcoming compliance deadlines under the deeming rule. Specifically, on May 1, 2017, the United States Department of Justice (DOJ) advised the United States District Court for the District of Columbia that the FDA will extend and defer enforcement of all future compliance deadlines under the Rule for 3 months, and that it plans to issue guidance to that effect. The DOJ informed the court that new leadership at the United States Department of Health and Human Services (HHS) wish additional time to more fully consider the issues raised in the Rule. For example, the deadline for submission of product listings, previously June 30, 2017, will now be September 30, 2017. The three month extension applies to all future scheduled deadlines whether they fall in 2017, 2018, or later.
A notice is expected to be published in the coming days further memorializing FDA’s extension of compliance deadlines under the Rule.
IPCPR Chief Executive Officer Mark Pursell stated, “This is certainly good news for our retail and manufacturing community, given the nature of the rules the industry is facing, and the uncertainty they create. This gives everyone, the industry and the administration alike, time to revisit the regulation, to determine the best path forward.”
The associations will collaborate on conveying additional information to the industry as it becomes available.