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
The Food and Drug Administration (FDA) recently reviewed the website, http://www.Cigarettes-Online.biz, and determined that the cigarette products listed there 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 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. You can find the FD&C Act and Tobacco Control 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 extra light, light, premium light, super light, or ultra light by referring to them as such in product advertising and adding the qualifiers “Extra Light,” “Light,” “Premium Light,” “Super Light,” or “Ultra Light” to the product names. Specifically, our review of your website revealed that you offer for sale products listed as “Bond Special Selection (Lights),” “Bond Fine Selection (Super Lights),” “Camel Blue Subtle Flavor (Lights),” “Camel Silver Refined Flavor (Super Lights),” “Chesterfield Classic Blue (Lights),” “Chesterfield Classic Silver (Ultra Lights),” “Davidoff Gold (Lights),” “Davidoff Slim Gold 100’s (Lights),” “Gauloises Blondes Red (Lights),” “Gauloises Blondes Yellow (Ultra Lights),” “Gitanes Blondes White (Lights),” “Kent White Infina N1 (Lights),” “Kent Silver Neo N4 (Super Lights),” “Kent Blue Futura N8 (Premium Lights),” “L&M Blue Label (Lights),” “L&M Silver Label (Super Lights),” “Lucky Strike Original Silver (Lights),” “Marlboro Gold pack (Lights brown filter),” “Marlboro Silver pack (Ultra Lights),” “Monte Carlo Balanced Blue (Lights),” “Monte Carlo Subtle Silver (Super Lights),” “Next Blue Edition (Lights),” “Next Azure Edition (Super Lights),” “Parliament Aqua Blue (Lights),” “Parliament Silver Blue (Extra Lights),” “Viceroy Blue (Lights),” “Viceroy Silver (Ultra Lights),” “Vogue Super Slims Lilas 100’s (Ultra Lights),” “West Silver (Lights),” “Winston Balansed [sic] Blue (Lights),” and “Winston Subtle Silver (Super 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) of the FD&C Act (21 U.S.C. § 387k(b)(2)). 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 “mild” or “low” or similar descriptors for the above-listed products, the products are modified risk tobacco products. Because these products are offered for sale 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)).
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 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
Ciripescu str, 21/1
Brasov, 45321, Romania