Judge Amit P. Mehta of the U.S. District Court for the District of Columbia has ruled that the U.S. Food and Drug Administration cannot move forward with the enforcement of premarket rule requirements until he comes up with a streamlined process for premium cigars. This means the September 9th, 2020 date has been thrown out the window.
While it seems like a win in some respects, Judge Mehta still upheld much of what the FDA has in the Deeming Rule as lawful. While the FDA will have to go back to the drawing board if it wants to implement and enforce, Substantial Equivalence, it still is a delay to what has been considered the most costly part of FDA regulation to date.
In the ruling Judge Metha said, “In issuing the Final Deeming Rule, the FDA arbitrarily failed to address commenters’ requests for a streamlined substantial equivalence process for premium cigars undergoing premarket review. Accordingly, the court remands the Final Deeming Rule for the limited purpose of considering that issue anew and enjoins enforcement of the premarket review requirements against premium cigars during that time. In all other respects, however, Defendants’ actions were lawful, reasonable, and adequately explained.”
Under the Deeming Rule, products released after February 15, 2007 could only stay on the market if they apply for premarket approval or demonstrate that the product is “substantially equivalent” to a product allowed to be on the market. Any products released before the February 15th date are grandfathered and called “predicate products.”
The Court relayed upon a definition of premium cigar utilized by the FDA in an August 5, 2020 filing – namely that a premium cigar: (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.”
Specific points in terms of the Judge’s decision include:
- The FDA’s refusal to adjust the 2007 grandfather date for cigars and pipe tobacco products was not arbitrary or capricious;
- Plaintiffs (Cigar Industry) have not shown that the 2016 Effective Date was premised on legal error
- The FDA’s imminent enforcement of the substantial equivalence process against cigars and pipe tobacco without finalizing implementing rules does not render the Final Deeming Rule arbitrary, capricious, or contrary to law;
- The FDA’s cost-benefit analysis was reasonable and reasonably explained to the extent it is reviewable
- The FDA arbitrarily failed to address commenters’ suggestions that the FDA create a streamlined substantial equivalence process for premium cigars
- The court therefore remands the Final Deeming Rule to the FDA to consider developing a streamlined substantial equivalence process for premium cigars. The court further enjoins the FDA from enforcing the premarket review requirements against premium cigars, as those products are defined in the August 2020 Notice, until the agency has completed its review
The cigar industry is nonetheless claiming victory on today’s ruling.
“We are very grateful for the tremendous support of U.S. Senator Marco Rubio and Congresswoman Kathy Castor for their bipartisan leadership and tireless advocacy on behalf of Florida’s historic premium cigar industry,” said commented Drew Newman of J.C. Newman Cigar Company in a press release from his company. “We also appreciate the leadership of the Cigar Association of America, Premium Cigar Association, and Cigar Rights of America for litigating this case.”
“My family has been rolling premium cigars in the United States for four generations and 125 years,” added Newman. “Our one goal is to continue our family tradition for another century. The regulatory relief provided by today’s decision will help us to achieve this goal.”
“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,” says Scott Pearce PCA Executive Director
“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, and the failure of the FDA to not only respond, but 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,” added Glynn Loope CRA Executive Director.