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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Malton International LTD 5/16/11

  

Department of Health and Human Services logoDepartment 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 UPS and Electronic Mail 

Hellen Wallis
Malton International, Ltd.
306 Victoria House
Victoria, Mahe
Seychelles

To: themalton@gmail.com
dmkcity@yahoo.com
support@cigs4girls.com
support@cigarette-store.org
support@cigarettespub.com
support@mycigaretteshop.com
support@mydiscountcigarette.com
support@oralcigarettes.com
support@tobaccoandcigarettes.com
support@tobaccopub.com
support@topcigarettes.net

WARNING LETTER

Dear Ms. Wallis:

The Food and Drug Administration (FDA) recently reviewed your websites, http://www.cigs4girls.com, http://www.tobaccopub.com, http://www.cigarette-store.org, http://www.cigarettespub.com, http://www.mydiscountcigarette.com, http://www.mycigaretteshop.com, http://www.tobaccoandcigarettes.com, http://www.oralcigarettes.com, and http://www.topcigarettes.net, and determined that you offer cigarettes for sale to U.S. customers. FDA believes these websites are affiliated with one another because they have the same website registrant.  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 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 Kiss Superslims Fresh Apple, Kiss Superslims Strawberry, Lady Rose, Rich Apple, Rich Rum & Cherry, Richmond Cherry, and Sobranie Slims Mints cigarettes are adulterated under section 902(5) of 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 websites as being light, ultra light, or mild by referring them as such in product advertising and by adding the qualifiers “Lights,” “Ultra Lights,” or “Mild” to the product names.  Specifically, our review of the websites revealed that you offer for sale products listed as “Camel Blue (former Lights),” “Camel Silver (former Ultra Lights),” “Chesterfield Blue (Lights),” “Chesterfield Bronze (Ultra Lights),” “Marego Legato (Lights),” “Marlboro Gold – former Marlboro Lights,” “Marlboro Silver – former Marlboro Ultra Lights,” “Parliament Aqua Blue – former Lights,” “Parliament Silver Blue – former Ultra Lights,” “Pall Mall Blue – (Lights),” and “Pall Mall Amber – (Ultra Lights).”  You also offer for sale L&M products with advertising that reads “Light and Mild,” and Pall Mall products with advertising that reads “They are MILD.” The websites also feature the following articles:

• “Changes in Cigarette Names. Is It Good or Bad” that identifies the name change from Marlboro Ultra Light to Marlboro Silver.
• “June 22 – The Beginning of New FDA Tobacco Regulation” that reads “For example, Marlboro lights are in the present called Marlboro Gold.”
• “Why Did Marlboro Lights Cigarettes Become Marlboro Gold Cigarettes” that reads “Marlboro Lights…was renamed as Marlboro Gold Cigarettes and Marlboro Ultra Lights were changed to Marlboro Silver Cigarettes.”
• “Cigarette makers switch to colors as new cigarette names” that reads, “look more carefully, and you will find the well-known blue packs of Pall Mall lights, but with a new name – Pall Mall Blue.”

In addition, your websites contain the following statements:

• “Kent Cigarettes – Safe Smoke Filter”
• “Kent cigarettes became well known by all smokers because of there [sic] Micronite filter which can remove seven times more tar and nicotine than any other cigarette.”
• “The MT yellow filter was designed to reduce the amount of dangerous elements which appear in the process of smoking.”
• “[Parliament] brand gained its high grade among smokers because of its special recessed filter which along with the mild flavor and smooth taste made Parliament cigarettes smoking safe and one of the most famous brands.”
• “Winston cigarettes, less toxic product than other cigarette brands can be found on our online cigarettes store in seven varieties…”
• “It is not enough that [Kent cigarettes] consist of natural tobacco, they also possess special filter, which is considered to be ‘safer’ for people who smoke.”

A tobacco product with a label, labeling, or advertising that uses the descriptors “light,” “mild,” or “low,” or similar descriptors 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 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)) if its label, labeling, or advertising explicitly or implicitly represents such product as containing a reduced level of a substance, presenting a reduced exposure to a substance, or being less harmful than one or more other commercially marketed tobacco products. 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 websites use the descriptors “Light” and “Mild” or similar descriptors for the above-listed products and include claims that the products contain a reduced level of a substance, present a reduced exposure to a substance, or are less harmful than other commercially marketed tobacco products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

Additionally, our review of the websites revealed that you offer for sale the following cigarettes: Kiss Fresh Apple, Kiss Strawberry, Lady Rose, Rich Apple, Rich Rum & Cherry, Richmond Cherry, 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 apple, strawberry, rose, rum and cherry, cherry, and mint as characterizing flavors 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 these websites, or any other websites 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