The reason for the jubilation was the decision by Judge Amit P. Mehta, of the United States District Court for the District of Columbia, ruling in favor of cigarmakers in their long, expensive fight in the court case known as Cigar Association of America, et al. v. U.S. Food and Drug Administration, et al. Judge Mehta said that the FDA, the agency that oversees all tobacco products sold in the U.S., violated the American Procedure Act in its handling of Substantial Equivalence, one of the ways cigarmakers can get their products to market. His ruling provided immense relief to an industry in need of a break.
“I think it’s a giant burden and weight off our backs,” says Rocky Patel of Rocky Patel Premium Cigars. “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.”
Robert Levin of Ashton Distributors Inc., says, “It was a long and very expensive court case, but the premium cigar industry should celebrate . . . Not having to submit premarket approval and
Substantial Equivalence filings for all our products will allow our small industry to not only survive but prosper and grow.”
Selling cigars in the U.S. was once straightforward. An entrepreneur could reach out to a cigar producer, make a brand and try to sell it. Success was far from guaranteed, but it was the consumer who ultimately decided if a brand would become a star or fall into the discount bin.
But in 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act, putting the entire U.S. tobacco industry under the domain of the FDA. Cigarette regulations came first, and cigars were initially left alone, but in May 2016 the agency released strict new rules on cigars, adding numerous barriers and prohibitions that made the cigar business far more burdensome, expensive and confusing. Among these regulations was Substantial Equivalence, a way of showing the government that a new cigar size, blend or brand has similar characteristics to a grandfathered (predicate) tobacco product, or doesn’t raise any new questions of public health.
The decision by Judge Mehta means that the Substantial Equivalence approval process will be delayed until the FDA can make changes, a process that could take years. This ruling gives relief to a small industry that has been saddled with far too much government interference.
We never should have been here. The handmade cigar industry should never have come under the domain of the FDA, an organization that is busy enough maintaining the safety of our food supply and our medicines. The government has enough on its hands. We applaud Judge Mehta for getting this decision right. Now it’s time to completely free our cigarmakers so they can get on with the business of making cigars. Let the market dictate which cigar brands prosper—not our elected officials.