Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/httpwwwdirtcheapbuttscom-09252014
Timestamp: 2020-07-05 12:05:22
Document Index: 612250875

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

http://www.dirtcheapbutts.com - 09/25/2014 | FDA
http://www.dirtcheapbutts.com - 09/25/2014
http://www.dirtcheapbutts.com September 25, 2014
http://www.dirtcheapbutts.com
To: support@dirtcheapbutts.com
The Center for Tobacco Products of http://www.dirtcheapbutts.com, and determined that your 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 (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 cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).the U.S. Food and Drug Administration (FDA) recently reviewed the website
FDA has determined that several of your cigarette products areadulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that several of your cigarette productsareadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or 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)) because theypurport to contain a natural or artificial characterizing flavor. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You sell or distribute products that you describe on the website, http://www.dirtcheapbutts.com, as being light, super light, extra light, ultra light, and mild by referring to them as such in product labeling or advertising and adding the qualifiers “Lights,” “Extra Lights,” “Ultra Lights,” “Super Lights,” or “mild.” Specifically, our review of the website revealed that you sell or distribute the following cigarette products: “Pall Mall Lights (Blue)”; “Pall Mall Ultra Lights (Amber)”; “Parliament Extra Lights (Silver Blue)”; “Parliament Lights (Aqua Blue)”; “Marlboro Lights (Gold)”; “Marlboro Accent (Ultra Lights)”; “Marlboro Ultra Lights (Silver)”; “Bond Lights (Special Selection)”; “Camel Lights (Blue)”; “Camel Super Lights (Silver)”; “Davidoff Slim Lights (Gold)100’s”; “Kent Premium Lights Nr. 8 (Futura)”; “Kent Super Lights Nr. 4 (Neo)”; “L&M Lights (Blue)”; “L&M Super Lights (Silver Label)”; “Lucky Strike Lights (Blue)”; “Lucky Strike” brand cigarettes (described as “mild”); “Pall Mall Super Slims Blue (Lights) 100’s”; “Pall Mall Blue (Lights)”; “Winston Lights (Balanced Blue)”; “Winston Super Lights (Subtle Silver)”; and “Winston One” (described as “ultra light).” You also describe products you offer for sale on your website as products that present a lower risk of tobacco-related disease or as being less harmful than one or more other commercially marketed products. Specifically, you offer for sale Epique cigarettes described as being “a healthier cigarette choice.”
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)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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 the website uses the descriptors “Lights,” “Extra Lights,” “Ultra Lights,” “Super Lights,” “mild,” or other similar descriptors for the above listed products or represents that a product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed 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.dirtcheapbutts.com, revealed that you offer for sale the following cigarette products: “Aroma Rich Apple,” “Aroma Rich Rum & Cherry,” “Kiss Super Slims Fresh Apple 100’s,” “Kiss Mohito(mini)” (sic), “Kiss Super Slims Clubnichka 100’s” (strawberry), “Richmond Cherry 4,” “Richmond Cherry Gold Super Slims 100s,” “Richmond Cherry Super Slims 100s,” “Richmond Cherry,” and “Sobranie Slims Mints 100’s,” 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 cigarette products areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette products do not 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 their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, mojito, strawberry, cherry, or mint as a characterizing flavor of the tobacco products.
It is your responsibility to ensure that your tobacco products and all related promotional 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 sell or advertise, 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, RW1400206, in your response and direct your response to the following address:
dirtcheapbutts.com@iprivacyltd.com