FDA WARNING_LETTER - CigarWebService

The FDA's Center for Tobacco Products reviewed several websites (cigarwebshop.net, cigarwebshop.com, heerenvanruysdael.com, rookwaren.com, tabakwebshop.com) affiliated with Cigar Web Service, determining they offer tobacco products to U.S. customers in violation of the FD&C Act. The agency found two primary violations. First, Brookfield cigarette tobacco is adulterated under 21 U.S.C. § 387b(8) because it is promoted as a modified risk tobacco product, using the descriptor "mild," without an FDA order in effect as required by 21 U.S.C. § 387k(a). Second, Pink Elephant Vanilla Flavor cigarettes are either adulterated under 21 U.S.C. § 387b(5) for containing a prohibited characterizing flavor (vanilla), or misbranded under 21 U.S.C. § 387c(a)(1) if they lack the flavor but are falsely labeled. The letter mandates immediate correction of these violations and submission of a written response within 15 working days detailing corrective actions, including dates of discontinued violative activities. Failure to comply could lead to severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.