Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/www555cigarettescom-05062015
Timestamp: 2019-10-14 19:27:28
Document Index: 389444807

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

www.555.cigarettes.com - 05/06/2015 | FDA
www.555.cigarettes.com - 05/06/2015
www.555.cigarettes.com May 06, 2015
www.555.cigarettes.com
To: ACD02321BC1F42BFB77A686FBE8CBA70.PROTECT@WHOISGUARD.COM
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.555cigarettes.com, and determined that 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 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 of your 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 webpage regarding smokeless tobacco products fails to include any health warning label statements.
Our review of your website, http://www.555cigarettes.com, revealed that your webpage regarding the following smokeless tobacco products that you offer for sale or distribute in the United States does not include any health warning statements: Copenhagen Fine Cut Regular, Copenhagen Pouches, and Marlboro Snus Peppermint. 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:
Because the webpage regarding smokeless tobacco products does not include any health warnings, your smokeless tobacco products aremisbranded 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, RW1500293, in your response and direct your response to the following address:
support@whoisguard.com