Inspections, Compliance, Enforcement, and Criminal Investigations
Karl Bergman 6/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
JUN 29, 2012
VIA UPS and Electronic Mail
Bd. Moscovei 15/1, 17
Chisinau, MD-2045, Moldova
Dear Mr. Bergman:
The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your websites, http://www.pennycigarettes.com and http://www.saveonfags.com, and determined that your cigarette products listed are offered for sale to U.S. customers. FDA believes these websites are affiliated with one another because both sites are registered under your name and mailing address. 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 Hilton Platinum cigarettes 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 a product that you offer for sale on your website http://www.saveonfags.com as being light by referring to it as such in product advertising and adding the qualifier "Lights" to the product name. Specifically, our review of your websites revealed that you offer for sale Hilton Platinum ("Hilton Lights"). 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, the product is a modified risk tobacco product. Because this product 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)), it is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally, our review of your websites, http://www.pennyciqarettes.com and http://www.saveonfags.com, revealed that you offer for sale the following cigarettes: Kiss Super Slims Fresh Apple, Richmond Cherry, and Sobranie Mints cigarettes, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product. 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, and mint as characterizing flavors 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 these websites, 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, RW1200018, 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 Elenita.lbarraPratt@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
The Endurance International Group, Inc.