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district cout rules in cigar industry favor


August 24th, 2020

FDA’s Premarket Review Process for Premium Cigars Was “Completely Mishandled”

WASHINGTON, D.C. – On August 19, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia ruled to block the U.S. Food and Drug Administration (FDA) from requiring that premium cigar brands be submitted to the agency for review. The judgement against the FDA’s Deeming Rule is a significant victory for the cigar industry in the case of Cigar Association of America et al. v. United States Food and Drug Administration et al.

The Court found that the FDA completely mishandled the important question of how premium cigars should proceed through the premarket, Substantial Equivalence approval review process, adding that the FDA was also in violation of the American Procedure Act by failing to engage in “reasoned decision-making” with regard to premium cigars.

Judge Mehta has reproached the FDA in previous hearings for its handling of the case. His ruling said the FDA’s “incorrect and conclusory assertion that its hands were tied” in response to the premium cigar industry’s requests for a more tailored regulatory review process “was arbitrary.”

The FDA must now go back and address the questions regarding premium cigars that were ignored in the Final Deeming Rule. Mehta’s ruling means that premium cigar manufacturers will not have to file their pre-market approvals by the September 9, 2020 deadline. However, cigar smokers should be aware that the ruling is only a temporary delay, but a win for manufacturers and consumers alike, since it could take years for the FDA to come up with a new angle.

“I think it’s a giant burden and weight off our backs,” said Rocky Patel. “This has been a well-thought out and hard-fought battle for saving the premium cigar industry and finally we can focus on what we do best.”

For now, the Premium Cigar Association and Cigar Rights of America are willing to agree on the following definition of a premium cigar as utilized by the FDA in a recent August 5, 2020 filing:

[A premium cigar is] “a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.”

The definition does not include a price minimum, flavors, or cigars that are machine manufactured, but it will take a lot of pressure off manufacturers since Substantial Equivalence was the most expensive and labor-intensive procedure for product approval.

In his reaction to Judge Mehta’s ruling, PCA executive director, Scott Pearce, said, “This is another monumental victory for the premium cigar industry. We congratulate our legal team, led by Mike Edney of Steptoe & Johnson, on an important victory that protects the livelihood of PCA members across the country. This comes on the heels of legal victories striking down warning labels for premium cigars. Both our retail members and associate members provided important strategy and guidance in our legal, legislative, and regulatory appeals to define premium cigars and showcase their distinctiveness from the courts to Capitol Hill.”

CRA executive director, Glynn Loope, added: “Judge Mehta’s opinion is a testament to the virtue of the public comments filed over the years with the FDA by our industry alliance, consumer messaging and the Administration pressure and Congressional advocacy brought out by our collective lobbying efforts. FDA failed to not only respond to these comments, but also to recognize the suggestions made to address the fairness of the proposed regulations. The efforts of the advocacy strategies initiated by CRA and PCA served as the foundation for this decision, proving that you always have to carry your message to both ends of Pennsylvania Avenue, and the courthouse that sits in the middle.”

The other good news for cigar smokers is there will be little, if any, change in the cigars they buy at their local and online cigar retailers. The ruling may also see even more new releases entering the market that were being held back. So, if you got ’em, smoke ’em.