Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwsmokobiz-09232014
Timestamp: 2020-08-05 02:14:47
Document Index: 141837891

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

www.smoko.biz - 09/23/2014 | FDA
www.smoko.biz - 09/23/2014
www.smoko.biz September 23, 2014
www.smoko.biz
To: support@smoko.biz
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.smoko.biz, and determined that cigarette products listed there are offered for sale 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, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
You sell or distribute products that you list on your website, http://www.smoko.biz, as being light or super light by referring to them as such in product labeling or advertising and adding the qualifiers “Light,” or “Super Light” to the product names. Specifically, our review of http://www.smoko.biz revealed that you sell or distribute the following cigarette products: Donskoy Tabak (“Donskoy Tabak Lights Cigarettes”) and Marlboro Silver (“Marlboro Silver Super Light Cigarettes”).
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your website uses the descriptor “Light” or similar descriptors for the above listed products, these products are modified risk tobacco products. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally, our review of the website, http://www.smoko.biz, revealed that you offer for sale the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Esse Aura Green Apple, Esse Aura Pink Strawberry, Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Richmond Cherry, Richmond Cherry Gold, and Richmond Superslim Cherry, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
If, however, these cigarette products donot contain a characterizing flavor, they aremisbranded 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, apple, rum & cherry, strawberry, and cherry as a characterizing flavor of the tobacco products.
Please note your reference number, RW1400223, in your response and direct your response to the following address:
Iasas-Amrita, Ltd.
sales@smoko.biz
Menomen7@gmail.com
Marcaria.com, Inc.
iuraqq@gmail.com
abuse@alexhost.com
www.smoko.biz - Close Out Letter 9/15/15