On Wednesday, August 19th, Judge Amit P. Mehta of the District Court for the District of Columbia rendered his decision in the lawsuit brought by the premium cigar industry challenging aspects of the Deeming Rule and its application to premium cigars and certain other tobacco products.
In announcing the decision, the court granted summary judgment for the premium cigar industry on one count by finding that FDA violated the Administrative Procedure Act in its promulgation of the final deeming regulation.
Below is a summary of the decision and impact points moving forward:
Court Findings & Decision:
- While FDA solicited comments on different options for exempting or regulating premium cigars in the proposed deeming regulation, the Agency did not adequately address in the final deeming regulation industry comments on a potential streamlined approach to compliance with premarket review requirements under the substantial equivalence (“SE”) pathway for this category of products;
- By inviting and receiving comments, FDA had an obligation to meaningfully address relevant, substantial comments and FDA’s response mischaracterized the comments as requesting only an exemption from compliance with the premarket review requirements, which did not meet requirements for “reasoned decision-making”;
- 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 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 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 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.
***Note: This definition does not include flavored cigars, mass produced or machine made cigars, or an economic quantifier/price point in defining a premium cigar.***
- Provides immediate relief to manufacturers and importers of premium cigars, who, under the AAPcase’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 FDA’s current compliance policy;
- Suspends enforcement of the premarket authorization requirements for all “premium cigars,”
- Requires 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 Food & Drug Administration for further consideration. Premium cigar industry stakeholders and Congressional allies will need to continue to educate and advocate before the Administration and FDA.