Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/samar-tobacco-company-inc-04172015
Timestamp: 2020-07-08 12:34:30
Document Index: 747397925

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

Samar Tobacco Company, Inc. - 04/17/2015 | FDA
Samar Tobacco Company, Inc. - 04/17/2015
Samar Tobacco Company, Inc. April 17, 2015
Samar Tobacco Company, Inc.
23238 Southwest 112th Avenue
d/b/a The Smoke Shop
Attn: Gus Hasni
info@mysmokeshop.net
Dear Mr. Hasni:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.mysmokeshop.net, 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 (the 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 your Dark Fire Cured Tobacco Leaf Dark Fonto/Grabba 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 webpage regarding this smokeless tobacco product fails to include any health warning label statements.
Our review of the website, http://www.mysmokeshop.net, revealed that your webpage regarding the following smokeless tobacco product that you offer for sale in the United States does not include any health warning statements: Dark Fire Cured Tobacco Leaf Dark Fonto/Grabba. 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 labeling and/or advertisements for smokeless tobacco products bear one of the following health warning label statements:
Because your webpage regarding the smokeless tobacco product described above doesnot include any health warnings, these smokeless tobacco productsaremisbranded 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)).
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise, and in retail establishments, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please note your reference number, RW1500276, in your response and direct your response to the following address:
VIAElectronic Mail and UPS
Gus Hasni
tprank.tp@gmail.com
Samar Kasha
11958 SW 97th Street
Samar Tobacco Company, Inc. - Close Out Letter 8/21/15