Some of the largest premium cigar manufacturers have come together to file a comment with the U.S. Food and Drug Administration on the subject of Substantial Equivalence (SE) applications. These manufacturers are challenging this piece of the FDA Deeming Rule which would require manufacturers to submit an extensive application and subject their products to costly testing in order to keep their non-predicate premium cigar products on the market.
The joint comment was filed by premium cigar manufacturers Davidoff of Geneva USA, Drew Estate, General Cigar Company, Tabacalera USA, Perdomo Cigars and C.L.E. Cigar Company. The comment not only addresses the problems presented by complying with the Substantial Equivalence (SE) application process but it also calls for a full exemption of premium cigars from FDA regulation.

“Our joint comment filed today shows FDA’s Proposed SE Rules to be an overly broad and unjustifiably costly set of regulations that are so lacking in scientific substantiation as to be nothing more than an illegal economic ban on handmade premium cigars that will cripple the manufacturers and retailers in this important industry,” comments Dylan Austin, President of Davidoff of Geneva USA.

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