Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tobaccovipcom-08212015
Timestamp: 2019-09-19 10:46:32
Document Index: 235047756

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

tobaccovip.com - 08/21/2015 | FDA
tobaccovip.com - 08/21/2015
tobaccovip.com August 21, 2015
To: support@tobaccovip.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.tobaccovip.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)).
Our review of the website, http://www.tobaccovip.com, revealed that you sell or distribute the following cigarette products which arelisted or described as being “lights,” “ultra light,”or using similar descriptors, for example: Chesterfield Classic Blue (described as “lights”), Chesterfield Classic Bronze (described as “ultra light”), Kiss Super Slims Cigarettes (described as “light” and “very light”), and L&M Blue Label (described as “light”).
In addition, you sell or distribute cigarette products that are described as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance. Specifically, the website includes products with the following claims: Blood Blue, Blood Gold, and Blood Red are described “to reduce the health risks associated with smoking” and as having “very effective mono-acetate filters, with advanced smoke-preventing capacities”; Cigaronne Classic Slims Silver and Richmond Cherry Gold are described as having a “low content of nicotine”; Rothmans Blue and Rothmans Silver are described as having “less nicotine”; Gauloises Blondes Cream, described as “quantity of nicotine . . . less”; Kent HD Infinia 1 and Kent Nanotek Infinia are described as having a “small amount of nicotine”; Marlboro cigarettes are described as being available with “low nicotine.”
The above listed products are modified risk tobacco products because the website uses the descriptors “lights,” ”ultra light,” or similar descriptors to describe these products or describes them as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance. 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.tobaccovip.com, revealed that you offer for sale or distribute the following cigarette products:Armada Blue (honey, vanilla), Armada Red (honey, vanilla), Kiss Super Slims Fresh Apple, Rich Apple, Rich Rum & Cherry, Richmond Cherry, and Richmond Cherry Gold. These products 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 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 their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, honey, vanilla, apple, rum & cherry, 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, RW1500343, in your response and direct your response to the following address:
AnonymousSpeech LLC
Offshore Racks, S.A.
abuse@offshoreracks.com
tobaccovip.com - Close Out Letter 1/16/16