FDA Lawsuit Marches Forward As Agency Files Response

FDA Lawsuit Marches Forward As Agency Files Response

The cigar industry is seeking relief, but the FDA wants it denied. The U.S. Food and Drug Administration has asked the court overseeing the cigar industry’s joint lawsuit against the government agency to deny the industry’s motion for preliminary injunction as well as its motion for partial summary judgment filed last month.

The cross motion, which was filed on October 24 with the U.S. District Court for the District of Columbia, is the FDA’s response to motions that the cigar industry filed on October 4. The filings are part of the cigar industry’s ongoing lawsuit that was filed last year by the major cigar lobbying groups—The Cigar Association of America, International Premium Cigar & Pipe Retailers Association and the Cigar Rights of America—against the FDA.

In the case, called Cigar Association of America, et al. v. United States Food and Drug Administration, the cigar industry is challenging the FDA’s Final Deeming Rule, which was published in 2016 and placed strict regulations on cigar manufacturers, including costly quarterly user fees, pre-market approval for new products and more stringent packaging/warning label guidelines.

The cigar industry is asking for, among other things, the FDA to vacate costly user fees and set aside the warning requirements scheduled to go into effect on August 10, 2018. Additionally, the motions argue that the Final Deeming Rule violates the First Amendment, while also seeking injunctions restraining the FDA from implementing the health warning and other labeling requirements on cigars.

In response, the FDA argues that the cigar industry’s motions wrongly ignore the carcinogenic and toxic effects associated with cigars. The FDA’s cross motion also claims that since the cigar industry waited 17 months to ask for an injunction, this “undercuts any claim of irreparable harm, and it should not be rewarded by a favorable exercise of equitable discretion.”

The FDA also contends that new cigar packing and health warnings do not violate the First Amendment. Also, the FDA believes that the costly user fees placed on cigar manufacturers are not unfair, but are in line with the Family Smoking Prevention and Tobacco Control Act, which was the law passed in 2009 that granted the FDA regulatory authority over all tobacco products.

Previous reports online from other outlets wrongly stated that Judge Amit Mehta, who is overseeing the lawsuit, rejected the cigar industry’s motions. However, Judge Mehta has not ruled on the motions, and won’t do so until December 14, when the lawsuit trial is scheduled to begin. 

Click here to read more about the FDA and premium cigar regulation.

This article first appeared in the November 7, 2017 issue of Cigar Insider.