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D.C. Judge Delays FDA Warnings

Jul 5, 2018 | By Andrew Nagy
D.C. Judge Delays FDA Warnings

The cigar industry received a huge victory today as a Washington D.C. judge issued an injunction postponing the looming effective date for the FDA’s onerous warning label scheme for cigar packaging and advertisements. While the order does not outright ban the new warning label requirements, which were scheduled to go into effect on August 10, it should delay their implementation for at least a year, if not longer.

The filing was the newest development in Cigar Association of America, et al. v. United States Food and Drug Administration, a lawsuit that Judge Amit P. Mehta of United States District Court for the District of Columbia has presided over ever since it was filed in 2016. In May, Judge Mehta ruled in favor of the FDA. However, in that opinion, the judge expressed his displeasure with the FDA’s warning label plan, saying that it “smacks of basic unfairness.”

Last month the cigar industry filed an appeal asking the court to stop the enforcement of the new FDA warning labels, or at the very least, delay the effective date. Today’s decision does exactly that, as Judge Mehta barred the U.S. Food and Drug Administration from enforcing its new warning label requirements until 60 days after the completion of the appeal. Sources close to the situation said that could last one year, or even several years. 

“In the end, the court believes that Plaintiffs are entitled to a full hearing before an appellate court without the specter of a warnings regime going into effect that might ultimately be found to run afoul of the First Amendment,” wrote Judge Mehta in today’s order. “Accordingly, the court enjoins Defendants from enforcing the new warnings requirements for cigars and pipe tobacco set forth in 21 C.F.R. §§ 1143.3 and 1143.5 until final disposition of Plaintiffs’ appeal.”

The premium cigar industry, unsurprisingly, was ecstatic about the news, especially with the IPCPR trade show scheduled to take place next week. 

“This is unbelievable,” Rocky Patel, owner of Rocky Patel Premium Cigars, told Cigar Aficionado. Patel has been at the forefront of the fight against FDA regulation. “It’s a great day for the handmade cigar industry. It’s going to save us millions of dollars in wasted energy and time. It’s a monkey off our backs.”

Scott Pearce, executive director of IPCPR, added: “This deadline has been bearing down on our members for some time now. And while this is a temporary reprieve, it is a welcome development and hopefully a sign that our message is resonating. IPCPR is proud to be a party to this lawsuit, and we’ll continue to work with our great legal team and staff in D.C. to bring about the optimum regulatory framework for the premium cigar industry.”

Drew Newman, general counsel of J.C. Newman Cigar Co., said that “It seems only fitting that the day after our country celebrated America’s independence, a federal court has stepped in to help preserve the right of American adults to enjoy a handcrafted cigar.”

“We are extremely pleased that Judge Mehta has delayed the implementation of the FDA’s new massive cigar warning labels indefinitely until the courts have a chance to decide their constitutionality,” added Newman.

"On behalf of each manufacturer that has joined Cigar Rights of America in this fight against onerous and unjustified warning labels on artisan and culturally significant handmade cigar packaging, we applaud the decision by Judge Mehta," said Glynn Loope, executive director of CRA. "While this brush fire is momentarily extinguished, possibly for several years, the premium cigar industry still must attack the remaining and potentially more threatening FDA bureaucratic agenda. Substantial equivalence, pre-market approval of new blends, onerous and expensive applications for reporting, barriers of entry for new companies and products—whether now or after 2020—all need to be addressed, to insure the future of the premium handmade cigar industry."

Today’s ruling affects not only handmade cigars, but all cigars.

FDA

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