Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hamburger-cigarren-contor-hacico-gmbh-ug-11102015
Timestamp: 2019-07-21 01:22:25
Document Index: 13772145

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 4402']

Hamburger Cigarren Contor (HACICO) GmbH UG - 11/10/2015 | FDA
Hamburger Cigarren Contor (HACICO) GmbH UG - 11/10/2015
Hamburger Cigarren Contor (HACICO) GmbH UG Nov 10, 2015
Hamburger Cigarren Contor (HACICO) GmbH UG
Julia Molter, Managing Director
Dear Ms. Molter:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.hacico.de and determined that the cigarette and smokeless tobacco products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes and smokeless tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor. Additionally, FDA has determined that several smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your webpages regarding smokeless tobacco products fail to include any health warning label statements.
Our review of the website, http://www.hacico.de, revealed that you offer for sale or distribute the following cigarette products: Djarum Super Filter (clove), Djarum Special Filter (clove), Djarum Black Filter (clove), Djarum Cherry Filter (clove, cherry), and Djarum Menthol Filter (clove).
If, however, these cigarette products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, clove or cherry as a characterizing flavor of the tobacco products.
Additionally, our review of the website, http://ww.hacico.de, revealed that the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: Alpenprise, Braniff, Edel-Prise, Kensington, Pöschl, Rumney’s, Singleton’s, Tucky, Grimm & Triepel, Tobacco Cuts, and Oliver Twist. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
Please note your reference number, RW1500426, in your response and direct your response to the following address:
admin@privatedomaincontrol.com
Fabulous.com Pty. Ltd.