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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Joanne M. Tovar 4/2/13

  

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

APR 2, 2013

VIA Electronic Mail
 
Joanne M. Tovar
Philip Morris Products,
4205 Hilltop Haven Drive,
Newark, NJ 07102
To: support@philipmorris-products.net
 
 
WARNING LETTER
 
Dear Ms. Tovar:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website http://www.philipmorris-products.net, 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Modified Risk Tobacco Product Violations
 
You describe products that you offer for sale on your website,http://www.philipmorris-products.net, as being light or ultra light by referring to them as such in product labeling or advertising and adding the qualifiers “Lights” or “Ultra Lights”to the product descriptions. Specifically, our review of your website revealed that you offer for sale the following cigarettes described as “LIGHTS CIGARETTES”: “Bond Special Selection,” “Camel Blue,” “Chesterfield Classic Blue,” “Davidoff Gold,” “Dunhill Fine Cut Dark Blue,” “Kent Blue Futura Nr.8,” “Lucky Strike Original Silver,” “Marlboro Gold,” “Pall Mall Blue,” “Parliament Aqua Blue,” “Sobranie Classic Silver,” “Winston Blue,” “Winston Super Slims Blue 100’s,” “Magna Balanced Blue,” “More Balanced Blue,” “Sobranie Blue,” “Sobranie White Russian,” and “Viceroy Blue.” In addition, our review of your website revealed that you offer for sale the following cigarettes described as “ULTRA LIGHTS CIGARETTES”: “Bond Fine Selection,” “Camel Silver,” “Chesterfield Classic Bronze,” “Davidoff Blue,” “Dunhill Fine Cut Azure,” “Kent Silver Neo Nr. 4,” “L&M Silver Label,” “Parliament Silver Blue,” “Vogue Super Slims Lilas 100’s,” “Winston Silver,” “Camel Black Mini,” “Marlboro Silver,” “More Subtle Silver,” “Pall Mall Azure,” “Sobranie Gold,” and “Viceroy Silver.”
 
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 the website uses the descriptor “Light,” “Super Lights,” or “Extra Lights” or similar descriptors, these 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)).
 
Flavored Cigarette Violations
 
Additionally,our review of your website, http://www.philipmorris-products.net, revealed that you offer for sale the following cigarettes: Aroma Rich Apple, Aroma Rich Rum Cherry, Kiss Super Slims Fresh Apple 100s, Kiss Super Slims Clubnichka 100s (Strawberry), and Richmond Cherry, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product(s). 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)) or 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, apple, strawberry, rum cherry or cherry, as a characterizing flavor of the tobacco products.
 
Conclusion and Requested Actions
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, or any other websites or 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 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 and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1300074, 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 CTPCompliance@fda.hhs.gov.   
 
 
Sincerely,
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
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