Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/httpwwwcigbasecom-06042015
Timestamp: 2020-02-19 05:40:14
Document Index: 553352257

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

http://www.cigbase.com - 06/04/2015 | FDA
http://www.cigbase.com - 06/04/2015
http://www.cigbase.com June 04, 2015
http://www.cigbase.com
To: contact@privacyprotect.org
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.cigbase.com, and determined that the cigarette 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 cigarettes, 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 cigarette products are adulterated 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 productsare adulterated 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 they purport to contain a natural or artificial characterizing flavor.
Our review of your website, http://www.cigbase.com, revealed that you sell or distribute the following cigarette products listed or described in product labeling or advertising as being “light,” or using similar descriptors:
Glamour Superslims Menthol (described as “light”)
Kiss brand cigarettes (described as “light”)
Magna Balanced Blue (described as “light”)
Pall Mall Blue (described as “Pall Mall Lights (Blue)”)
Prima Lux Gold (described as “ultra light”)
Sobranie Blue (described as “light”)
Sobranie Gold (described as “light)
In addition, our review of your website revealed the following cigarette products are offered for sale under the headings “Lights Cigarettes” and “Ultra Lights Cigarettes”:
“Lights Cigarettes”
“Ultra Lights Cigarettes”
Kent HDs Blue Super Slims 100s
Kiss Dessert (mini)
Kiss Mohito (mini)
West Black Compact
Camel Black Super Slims 100s
Magna Balanced Blue
More Balanced Blue
Richmond Cherry Gold Super Slims 100s
Richmond Klan
Bond Special Compacts
Chesterfield Classic Bronze
Kent HDs Silver Super Slims 100s
Kent Silver Neo Nr. 4
L&M Motion Blue (mini)
L&M Motion Silver (mini)
Parliament Carat Blue
Vogue Super Slims Lilas 100’s
Winston Subtle Silver
Camel White Super Slims 100s
Marlboro Gold Prime Edge 100s
More Subtle Silver
Pall Mall Azure
Richmond Masculine Super Slims 100s
Richmond Platinum Filter
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)).
The above listed products are modified risk tobacco products because the website uses the descriptor “light”or similar descriptors to describe these 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.cigbase.com, revealed that you offer for sale or distributethe following cigarette products: Aroma Rich Apple, Aroma Rich Rum Cherry, Kiss Mohito(mini), Kiss Super Slims Clubnichka 100s (strawberry), Kiss Super Slims Fresh Apple 100s, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, Richmond Cherry 4, and Richmond Cherry.
These products arepurported 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:
Cigarettes that are distributed or offered for sale 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 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.
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising 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, 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, RW1500321, in your response and direct your response to the following address:
abuse@netlynx.com
abuse@leaseweb.com