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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.vietnamtobacco.net 8/8/12

  

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 8, 2012

VIA UPS, and Electronic Mail
 
Tran Dang Phuc                       
129, 23 Street
Ward 11, District 6
Ho Chi Minh City
Vietnam
kogiay@yahoo.com
 
 
WARNING LETTER
 
Dear Mr. Phuc:
 
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website, http://www.vietnamtobacco.com, and determined that your cigarette products listed are offered for sale to U.S. customers.  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 your Marlboro Gold cigarettes are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as a modified risk tobacco product without an FDA order in effect that permits such promotion. 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 by referring to them as such in product advertising and adding the qualifier “light” to the product name. Specifically, our review of your website revealed that you offer for sale Marlboro Gold cigarettes described as “VIETNAM MARLBORO LIGHT WHITE CIGARETTES CARTON.”
 
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 website uses the descriptor “light” or similar descriptors for the above-listed product, the product is a modified risk tobacco product. Because this products is offered for sale to U.S. customers without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
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, RW1200026, 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
 
cc:
 
Protected Domain Services
compliance@protecteddomainservices.com
vietnamtobacco.com@protecteddomainservices.com
 
Name.com LLC
support@name.com
 
WebsiteWelcome.com
support@websitewelcome.com