Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville MD 20850-3229
VIA Electronic Mail
DEC 20, 2013
To: Xuan Yang
Dear Xuan Yang:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.cheapcigarettes2013.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 (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 Regular Cigarettes" are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because it is a modified risk tobacco product sold or distributed without an FDA order in effect that permits such sale or distribution. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Modified Risk Tobacco Product Violations
You sell or distribute products that you describe on your website, http://www.cheapcigarettes2013. net, as being light, by referring to them as such in product labeling or advertising and adding the qualifier "Lights" to the product name. Specifically, our review of your website revealed that you sell or distribute the following product listed as: "Marlboro Gold Regular Cigarettes," explaining that "In the United States, effective June 2010, 'Medium' and 'Lights' will be rebranded into 'Blue' and 'Gold' respectively."
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 "Lights," or similar descriptors for the above listed product, that product is a modified risk tobacco product. Because the product is sold or distributed 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)), the product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
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, on any other websites (including e-commerce, social networking, or search engine websites), and in any other 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 import 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, RW1300145, 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 lbarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail