Fall 2020 PCA Magazine

PREMIUMCIGARS.ORG AUTUMN 2020 | PCA The Magazine 11 News + Notes cont. N E W S + N O T E S only an exemption from compliance with the premarket review requirements, which did not meet requirements for “reasoned decision- making.” – The FDA incorrectly implied that it lacks authority to adjust requirements for compliance with the premarket review requirements under the SE. – Returns the final deeming regulation to the FDA “for the limited purpose of considering whether a streamlined substantial equivalence process is appropriate for premium cigars.” – Blocked FDA enforcement of premarket review until agency review is complete and ordered the FDA to retain discretion to specify the amount of time premium cigar manufacturers will have to file substantial equivalence reports after the agency completes its review. For purposes of this remedy, the court adopted the definition of “premium cigar” recently proposed by the FDA to the District Court for the District of Maryland in the American Academy of Pediatrics (“AAP”) case: 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. This definition does not include flavored cigars, mass-produced or machine-made cigars, or an economic quantifier/ price point in defining a premium cigar. Impacts: – Provides immediate relief to manufacturers and importers of premium cigars, who, under the AAP case’s modified remedy order, would have needed to file SE reports for those of their products that (i) qualify as “new tobacco products,” (ii) were on the U.S. market on 8/8/2016, and (iii) lack otherwise-required marketing authorizations in order to continue marketing those products after 9/9/2020 under the FDA’s current compliance policy – Suspends enforcement of the premarket authorization requirements for all “premium cigars”; – Requires the FDA to engage in additional rulemaking should it wish to enforce the premarket review requirements of the FFDCA. Next Steps: This issue will be returned to the FDA for further consideration. Premium cigar industry stakeholders and congressional allies will need to continue to educate and advocate before the administration and FDA. Premium Cigar Industry Town Hall On Tuesday, Sept. 29, the Premium Cigar Association, along with Cigar Rights of America, hosted a virtual town hall discussing the important legislative, legal and regulatory victories and challenges facing the industry. The session featured PCA executive leadership John Anderson, Greg Zimmerman and Scott Regina, along with manufacturers Jorge Padron, Carlito Fuente, Dr. Gaby Kafie and Rocky Patel. Attorney Michael Edney provided a legal update and PCA’s Head of Government Relations discussed federal and state strategy. Thousands of retailers, manufacturers and consumers attended the session.