CRA Submits Docket Comment To FDA On Substantial Equivalence

As the comment period came to a close, on behalf of a coalition that includes 108 premium cigar companies, Cigar Rights of America (CRA) filed public comments, making the case that a one-size-fits-all approach to regulation of premium cigars, does not work.

The sixty-one page document with almost a dozen attachments makes the case that premium cigars should be exempt from federal regulation, given the clear evidence from credible third-party studies that premium cigars do not adversely threaten public health, and have no statistically significant impact on mortality or youth access.

CRA Board chairman Robert Levin stated, “This was a team effort that unifies our industry arguments into yet another filing with the FDA. By soliciting industry input on the question of Substantial Equivalence, this comment period presented an opportunity for us to reiterate many of our standing positions and arguments – that premium handmade cigars do not present a threat to the public health; that as an all natural product, there are natural agricultural variances that make regulations such as testing inappropriate for premium handmade cigars; and that the agency approach to this regulation will economically cripple what is a very small percentage of the overall tobacco market.

Rocky Patel added, “We are saying it again, the premium cigar industry doesn’t deserve the treatment it has been subjected to, and that there are jobs being threatened in the United States and Latin America due to these rules, while doing little in the name of public health. This filing articulates a position that works to protect all segments of the premium handmade cigar industry.

Carlito Fuente noted, “We are each family-owned companies, that simply want to carry out our craft that has been passed down from generation to generation, with dedicated artisans that have a profound passion for producing some of the greatest cigars in the world. Such a mission does not threaten public health, and we are not producing a product that comes off an assembly line by the billions. Each and every cigar is a work of art, and because of that, it shouldn’t be subjected to these onerous regulations.

CRA Executive Director Glynn Loope stated, “With the endorsement of the comment from the CRA board on behalf of our sponsoring manufacturers and consumer membership, coupled with a sincere word of appreciation to the Boutique Cigar Association of America, and the new Coalition of American Cigar Rollers, this was a unique opportunity to serve as the voice for over 100 premium cigar producers, of all sizes, spanning the nation and Latin America. We also appreciate the letter of endorsement for the filing that was provided by the Premium Cigar Association.

Loope continued, “We are approaching the one year mark, next week, for the filing of the last public comment, purely on the question of premium cigars. We fully intend to take this comment, combined with last year’s filing, to proclaim to the Trump Administration and allies in Congress that this is a clear case of bureaucratic overreach, that goes beyond congressional intent, that threatens jobs, investment, security interests, all while having no affect on the protection of the public health. This filing makes the case, again.