Huge Win against FDA: Mishandled Pre-Market Review Process

 

 

 

Yesterday, Cigar Rights of America (CRA) issued a press release emphatically titled: “Court Blocks FDA Product Approval Requirements for Premium Cigars.” For cigar makers, retailers and the cigar community, the news was deafening. The welcome news comes after DC Circuit Judge Amit Mehta poked holes in the FDA’s Final Deeming Rule regarding regulating premium cigars. Regarding the Judge’s decision, CRA points out ,”[The FDA] completely mishandled the important question of how premium cigars should proceed through the premarket review process.”

 

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Judge Amit P. Mehta

 

 

Further, the decision also highlighted Mehta’s conclusion that the FDA’s failure to use “reasoned decision-making”, with respect to premium cigars, violated federal law. Judge Mehta further stipulated FDA’s response to the premium cigar industry’s request “for a more tailored regulatory review process” was “arbitrary” based on its [FDA], “incorrect and conclusory assertion that its hands were tied.”

 

 

CRA eloquently pointed out what this means for the premium cigar industry, stating in their release, “Accordingly, the FDA enjoined application of the premarket review requirements until the agency goes back and addressed the important questions regarding premium cigars ignored in the Final Deeming Rule.  Premium cigar manufacturers will not have to file for premarket approval by [sic] September 9th, 2020.”  CRA also highlighted the court’s use of the definition of a “premium cigar”, supported by both CRA and the Premium Cigar Association (PCA), and even used by the FDA itself in an earlier August 5, 2020 ruling.

 

Current definition of a premium cigar (note there is no price threshold): 

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.”

 

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Glynne Loope, CRA Exec. Dir.

 

CRA’s Executive Director, Glynne Loope, embraced the welcome news opining, “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.”

 

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Scott Pearce, PCA Exec. Dir.

 

PCA’s Scott Pearce also celebrated the ruling offering, “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.”

 

This judgement completes a hat trick of judicial decisions against the FDA this year that include 2 previous court rulings against the agency’s push for large, garish warning labels on premium cigars. The decision yesterday is truly a big win for the cigar industry and I think it is fair to say it has pushed the door open for a full frontal assault on the FDA’s questionable arguments surrounding regulating premium cigars. Formidable lobbying groups like CRA and PCA have managed this stand against what is considered bloated and misdirected regulation extremely successfully. Many are celebrating this much-needed relief, especially cigar makers and retailers. – In Fumo Pax!

 

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