Deadlines Under FDA's Final Deeming Rule Delayed

WASHINGTON, D.C. — Some deadlines under the Food and Drug Administration's (FDA) deeming rule are being pushed back as lawsuits challenging the regulations continue to wind their way through the court.

The 90-day delay also comes as the agency awaits new leadership. President Donald Trump's nominee for FDA commissioner, Scott Gottlieb, has not been confirmed though confirmation is expected soon.

In July, the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipes Retailers Association (IPCPR) asked the U.S. District Court in the District of Columbia for a declaratory injunction "vacate, set aside and enjoin the enforcement of the final rule." The groups argued the rule violates numerous federal statutes as well as the federal rulemaking process, as CSNews Online previously reported.

In relation to the litigation, according to a release by CRA, the U.S. Department of Justice informed the court that new leadership at the U.S. Department of Health and Human Services would like additional time to more fully consider the issues raised in the rule.  

United States District Court for the District of Columbia Judge Amit P. Mehta issued an order granting a 90-day extension on May 1.

The agency's extension request was its second in the past two months. When the FDA requested the first extension, the three cigar trade groups requested that any additional extension to the court case should result in an equal delay to any future deadlines as part of the deeming regulations, Halfwheel reported.

"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," said CRA Executive Director Glynn Loope. "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."

The extension applies to deadlines set in the deeming rule but keeps the final rule — and its regulations — in effect. The final rule took effect on Aug. 8. 

The deeming rule extends the FDA's regulatory authority to electronic cigarettes, cigars, hookah tobacco and pipe tobacco. The deadlines affected by the delay includes a May 10 deadline for cigar manufacturers to submit a health warning plan to FDA. The warnings will be required to appear on cigar packages and advertisements. 

In addition, the deadline for submission of product listings, previously June 30, 2017, will now be Sept. 30, 2017. The three-month extension applies to all future scheduled deadlines whether they fall in 2017, 2018, or later, according to CRA.

"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," said IPCPR CEO Mark Pursell.

The FDA is expected to publish a notice memorializing the extension of the compliance deadlines under the deeming rule in the coming days.