FDA Warning Letters: Anatolli Larionov 5/16/11


Department of Health and Human Services	Public Health Service Food and Drug Administration
	Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229

MAY 16 2011

VIA Electronic Mail

To: support@cigdot.com;

support@fast-cigarettes.com;

support@tobaccochest.com;

support@cigbuynow.com;

support@cigbuynow.net

WARNING LETTER

The Food and Drug Administration (FDA) recently reviewed the websites http://www.cigdot.com, http://www.fast-cigarettes.com, http://www.tobaccochest.com, http://www.cigbuynow.com, and http://www.cigbuynow.net, and determined that the cigarette products listed there are offered for sale to U.S. customers. These websites appear to be connected through an integrated purchasing process. 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, 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 you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your Marlboro Fresh Mint, Marlboro Crisp Mint, and Sobranie Mints cigarettes are 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

You describe products that you offer for sale on your website as being light, super light, ultra light, or extra light by referring to them as such in product advertising and adding the qualifier “Lights,” “Super Lights,” “Ultra Lights,” or “Extra Lights” to the product names. Specifically, our review of the websites revealed that you offer for sale products listed as “Bond Special Selection (Lights),” “Camel Subtle Flavor (Lights),” “Camel Refined Flavor (Super Lights),” “Classic Lights (Blue),” “Classic Super Lights (Silver),” “Davidoff Gold (Lights),” “Davidoff Slims Light 100s,” “Esse Superslims Blue 100s (Lights),” “Lucky Strike Original Silver (Lights),” “Marlboro Gold (Lights),” “Next Blue Edition (Lights),” “Next Azure Edition (Super Lights),” “Next Slims Vio 100s (Lights),” “Next Slims Ros 100s (Super Lights),” “Parliament Aqua Blue (Lights),” “Parliament Silver Blue (Extra Lights),” “Viceroy Blue (Lights),” “Vogue Super Slims Lilas 100’s (Ultra Lights),” “West Silver (Lights),” “Winston Subtle Silver (Super Lights),” “Winston Super Slims Blue (Lights),” “Winston Super Slims Silver (Super Lights),” and/or “Winston Super Slims Fresh Menthol (Lights Menthol).” In addition, the website http://www.cigbuynow.com contains the statement, “Due to new European regulations that interdict the use of such words like ‘light’, ‘ultra light’ or ‘mild’ on cigarettes packs, some cigarettes have their names changed. The old brand names are indicated in parentheses.”

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) of the FD&C Act (21 U.S.C. § 387k(b)(2)). 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, the products are modified risk tobacco products. Because these products are offered for sale 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 websites also revealed that you offer for sale the following cigarettes: Marlboro Fresh Mint, Marlboro Crisp Mint, and Sobranie Mints, 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:

[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.

As of September 22, 2009, cigarettes 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 are adulterated.

If, however, these cigarettes 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)) as their labeling is false and misleading because it makes the representation that the products contain mint as a characterizing flavor of the tobacco products.

You should immediately correct the violations stated above and take any necessary action to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list of your violations, and it is your responsibility to ensure that your tobacco products on this, or any other website that you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. 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 importation into the United States are subject to detention and refusal of admission.

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products.

Please direct your response to the following address:

PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850

If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.

Sincerely,

/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products

VIA UPS, Electronic Mail, and Fax

cc:

Anatolii Larionov

12 Krasnoarmeiskay 2,

Lit. A, of 2-H
St. Petrsburg 190005
Russian Federation

support@cigdot.com