US: Litigants Suing FDA Over Deeming Rule Regroup

September will be a decisive month for the industry as litigants in a lawsuit seeking to overthrow the FDA’s so-called deeming rule regroup in light of recent policy changes and the agency's new leadership, according to a tobacco-conference panelist.

In late July, the U.S. Food and Drug Administration, under new commissioner Dr. Scott Gottlieb’s guidance, issued several directives that pushed back critical new-product application deadlines for cigar and e-cigarette manufacturers. The move possibly altered some factors involved in the case, said Daniel Trope, director of federal government affairs for the International Premium Cigar and Pipe Retailers Association (IPCPR), Washington, D.C.

Before about 350 attendees at the Smoker Friendly Conference and Tobacco Festival in the Denver area on Aug. 25, Trope said the court gave both sides time to see how the new directives issued on July 28 affected their positions. The IPCPR, along with several other associations and trade groups, still believe many of the complaints in their original 2016 lawsuit stand, including the argument that the rules amount to taxation vs. a lawful user fee, as well as how the FDA failed to conduct a required impact analysis of its final regulations.

Another speaker on the panel, Thomas Briant, executive director of NATO, Minneapolis, said the FDA does not have a strong track record in the courts. “They tend to overreach,” he said.

In addition to the legal update, Trope shared several legislative measures moving through the U.S. House of Representatives and the Senate that could allow for additional reprieve, some of which carve out premium cigars from the jurisdiction of the FDA. Some are stand-alone and others are tied to the Agricultural Appropriations Bill, which is making its way through the legislative process.