Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416215.htm
Timestamp: 2019-02-18 08:38:07
Document Index: 152493869

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

www.abroadcigarettes.com 9/16/14
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.abroadcigarettes.com, 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 describe on your website, http://www.abroadcigarettes.com, as being “Light” or “Ultra Light” by referring to them as such in product labeling or advertising or adding the qualifier “light” or “ultra light” to the product names. Specifically, our review of your website revealed that you sell or distribute cigarette products listed under the heading “LIGHTS CIGARETTES,” including, but not limited to: “Bond Special Selection,” “Camel Black Super Slims 100s,” “Chesterfield Classic Blue,” “Davidoff Gold,” “Dunhill Fine Cut Dark Blue,” “Kent Blue Futura Nr. 8,” “Kiss Dessert (mini),” “Lucky Strike Original Silver,” “Marlboro Gold,” “Parliament Aqua Blue,” “Richmond Cherry Super Slims 100s,” “Richmond Klan,” “Sobranie Blue,” “West Compact Black,” “Winston Blue,” “Magna Balanced Blue,” “More Balanced Blue,” “Pall Mall Blue,” and “Viceroy Blue.” You also offer for sale Pall Mall Blue described as “Pall Mall Lights (Blue)” cigarettes.
You also sell or distribute the following cigarette products listed under the heading “ULTRA LIGHTS CIGARETTES,” including, but not limited to: “Bond Fine Selection,” “Camel Black Mini,” “Davidoff Blue,” “Dunhill Fine Cut Azure,” “Kent HDs Silver Super Slims 100s,” “L&M Motion Blue (mini),” “Marlboro Gold Prime Edge 100s,” “Parliament Silver Blue,” “Richmond Cherry 4,” “Sobranie Gold,” “Vogue Super Slims Lilas 100’s,” “West Fusion White,” “Winston Silver,” “More Subtle Silver,” “Pall Mall Azure,” and “Viceroy Silver.”
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,” “ultra 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 your website, http://www.abroadcigarettes.com,revealed that you offer for sale the following cigarette products: “Aroma Rich Apple,” “Aroma Rich Rum Cherry,” “Kiss Mohito(mini)” (sic), “Kiss Super Slims Clubnichka 100s” (strawberry), “Kiss Super Slims Fresh Apple 100s,” “Richmond Cherry,” “Richmond Cherry Gold Super Slim 100s,” “Richmond Cherry Super Slims 100s,” and“Richmond Cherry 4,” 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:
As of September 22, 2009, cigarettes, cigarette tobacco, and roll-your-own tobacco marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette productsdo 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, apple, rum cherry, mojito, strawberry, or cherry as a characterizing flavor of the tobacco products.
Please note your reference number, RW1400216, in your response and direct your response to the following address:
abuse@leaseweb.us
ripe@ocom.com
www.abroadcigarettes.com - Close Out Letter 9/15/15