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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Madeleine Rausis 8/23/12

  

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

AUG 23, 2012


VIA UPS and Electronic Mail

Madeleine Rausis
Raus LTD
Novarrasse 73, Lausanne, Postfach
CH-4002, Switzerland
madrausis@aol.com


WARNING LETTER

Dear Ms. Rausis:

The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your websites, http://www.smoke-cigs.com and http://www.tobacco4you.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, 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 several of your products 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 websites, http://www.smoke-cigs.com and http://www.tobacco4you.com, as being light or ultra light by referring to them as such in product advertising and adding the qualifiers “Lights” or “Ultra Lights” to the product descriptions.  Specifically, our review of your websites revealed that you offer the following cigarettes for sale under the category of “Lights Cigarettes” or “Ultra Lights Cigarettes”: Bond Fine Selection, Bond Special Selection, Camel Black mini, Camel Blue, Camel Silver, Chesterfield Classic Blue, Chesterfield Classic Bronze, Davidoff Blue, Davidoff Gold, Dunhill Fine Cut Azure, Dunhill Fine Cut Dark Blue, Kent Blue Futura Nr. 8, Kent Silver Neo Nr. 4, L&M Silver Label, Lucky Strike Original Silver, Magna Balanced Blue, Marlboro Gold, Marlboro Silver, More Balanced Blue, More Subtle Silver, Pall Mall Azure, Pall Mall Blue, Parliament Aqua Blue, Parliament Silver Blue, Sobranie Blue, Sobranie Gold, Sobranie White Russian, Viceroy Blue, Viceroy Silver, Vogue Super Slims Lilas 100's, Winston Blue, Winston Silver, and Winston Super Slims Blue 100's.

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)).  Because your websites use the descriptor “Lights” or “Ultra Lights” for the above-listed products, the products are modified risk tobacco products.  Because these products are offered for sale 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 your websites, http://www.smoke-cigs.com and http://www.tobacco4you.com, revealed that you offer for sale the following cigarettes: Aroma Rich Apple, Aroma Rich Rum Cherry, Kiss Super Slims Fresh Apple 100s, and Richmond Cherry, 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…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, cherry, or rum cherry as a characterizing flavor of the tobacco products.

You should immediately correct the violations stated above and take any necessary actions 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, and it is your responsibility to ensure that your tobacco products on this website, or any other websites 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 note your reference number, RW1200029, in your response and 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 Electronic Mail


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