Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cross-street-tobacco-494273-04132016
Timestamp: 2020-08-10 03:01:54
Document Index: 367308413

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

Cross Street Tobacco - 494273 - 04/13/2016 | FDA
Cross Street Tobacco - 494273 - 04/13/2016
Cross Street Tobacco MARCS-CMS 494273 — April 13, 2016
1103 Light Street
Attn: Sheldon Zayon
info@cstcigars.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.cstcigars.com and determined that the 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, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including 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 General Snus is 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 website regarding smokeless tobacco products fails to include any health warning label statements.
Our review of the website http://www.cstcigars.com revealed that the following smokeless tobacco product that you offer for sale or distribute in the United States does not include any health warning statements: General Snus. 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, requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
Because your website regarding smokeless tobacco products does not include any health warnings, your smokeless tobacco product is 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)).
Please note your reference number, RW1600470, in your response and direct your response to the following address:
Attn. Susan Zayon
1065 S. Charles St., Stall 1610
Cross Street Tobacco - Close Out Letter 3/21/17