Cigar Industry Applauds Victory as Judge Delays FDA WarningsJuly 11th, 2018
As the Cigar Association of America, et al. v. United States Food and Drug Administration lawsuit presses on, last week the presiding Judge in the case, Amit P. Mehta, of United States District Court for the District of Columbia, issued an injunction that has postponed the August 10 starting date for the FDA’s cigar packaging and advertising warning label requirements. Although it marks a victory for cigar manufacturers, it could be a short-lived one, since the order only delays the warning label requirements enforcement for at least one year. Moreover, the decision to delay applies not only to premium handmade cigars, but to all cigars.
In a recent decision regarding the label requirements, Judge Mehta, who has been presiding over the case since it’s filing in 2016, ruled in favor of the FDA, but in announcing his decision, Mehta said that the FDA’s warning label plan, “smacks of basic unfairness.”
Judge Mehta’s decision to delay the warning label requirements came in response to an appeal filed last month by the cigar industry, which asked the court to either stop, or at least delay enforcement of the requirements. More specifically, the decision precludes the FDA from enforcing the label requirement until 60 days after the appeal has been completed. Additionally, it’s quite possible the delay could go well beyond one year.
“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 the 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 decision was received with praise by the cigar manufacturers, including Rocky Patel who said that it would “save the industry millions of dollars in wasted energy and time.”
IPCPR Executive Director, Scott Pearce, echoed the reaction by pointing out while the reprieve is only temporary it was “a welcome development” and a sign that the industry’s “message is resonating,” His hope is that the premium cigar industry will eventually receive the “optimum regulatory framework” for which their legal team has been fighting.
General Counsel of J.C. Newman Cigar Co., Drew Newman, also expressed his pleasure with Judge Mehta’s decision in the hope that the indefinite delay would give the courts time to “decide the constitutionality” of the warning requirements.
In a July 9 statement issued by Glynn Loope, Executive Director of Cigar Rights of America (CRA), Mr. Loope wrote: “On behalf of each manufacturer that has joined Cigar Rights of America in this fight against onerous and unjustified warning labels on handmade cigar packaging, we applaud the decision by U.S. Federal Judge Amit Mehta. [The Judge] further noted in that opinion that “this court cannot let pass without comment what it “deems” to be a grossly unfair exercise of agency authority.” In his opinion, he clearly noted that this action was to provide an injunction in order to protect the First Amendment rights of the industry.
“This is only one piece of the puzzle. 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 and reporting requirements, 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. If the FDA truly believes in their own statements on “the continuum of risk” then this current Advance Notice of Proposed Rule Making is an opportunity for a fresh start to fairly recognizing that premium handmade cigars do not deserve the level of treatment and scrutiny they have been subjected to thus far.
“We will continue with this message of regulatory relief to the Trump Administration, Congress, and the judicial branch. We encourage all patrons of premium handmade cigars to use the CRA petitions to congress to request exemption from FDA oversight of premium handmade cigars, and to submit comments requesting relief to the FDA, through the current premium cigar public comment period, before the July 25 deadline.”