Davidoff- General Cigar
July 17, 2019 Submitted via www.regulations.gov Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA–2016-N-3818; Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Proposed Rule Dear Sir or Madam: Davidoff of Geneva USA, Inc. (“Davidoff USA”), General Cigar Company (“General”), Nick’s Cigar Company d/b/a Tabacalera Perdomo (“Perdomo”), SWI-DE, LLC d/b/a Drew Estate (“Drew Estate”), Tabacalera Unidas, Inc. d/b/a C.L.E. Cigar Company (“CLE Cigars”) and Tabacalera USA Inc. (“TUSA”) (collectively “Premium Cigar Manufacturers”) are the six of the largest premium cigar companies in the United States and sell most of the iconic and acclaimed brands of premium cigars on the market today. I. Background on the Premium Cigar Manufacturers Davidoff USA is the exclusive U.S. importer and distributor of the portfolio of premium cigar products of the Swiss company, Oettinger Davidoff AG (“ODAG”) based in Basel, Switzerland. Davidoff USA is based in Pinellas Park, Florida and is a wholly-owned subsidiary of ODAG. Davidoff USA’s acclaimed premium cigar brands include Davidoff, AVO, Baccarat, Camacho, Cusano, The Griffin’s, La Fontana, Legendario, National Brands, Winston Churchill, Zino and Zino Platinum. General Cigar Co. is one of the world’s foremost manufacturers and marketers of premium cigars. The company was started in 1907 by German immigrants and is now a subsidiary of Division of Dockets Management FDA-2016-N-3818 July 17, 2019 Page 2 of 40 Scandinavian Tobacco Group.
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