FDA Defers Deeming Rule Deadlines for Three Months
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.”
Cigar Rights of America Executive Director Glynn Loope added, “This extension speaks to the questions raised in the suit, and the recognized need by the new administration to review the nature and impact of the proposed regulations. It also speaks to the virtue of our multi-front strategy to mitigate the threat of these regulations. It spans both ends of Pennsylvania Avenue, and a courthouse in between.”
Cigar Association of America’s President, Craig Williamson additionally stated, “We have worked collectively on behalf of the entire industry to challenge FDA’s new regulation, raising important questions along the way. The deferred deadlines are an important step to give all parties time to review these regulations and determine a better path forward. We are pleased by this development and will continue to work with our industry partners in the months ahead.”
The associations will collaborate on conveying additional information to the industry as it becomes available.