The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites, http://www.2000cigs.com andhttp://www.1001cigarettes.com, and determined that your cigarette products listed there are offered for sale or distribution 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 several cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.
Modified Risk Tobacco Product Violations
Our review of the websites, http://www.2000cigs.com andhttp://www.1001cigarettes.com, revealed that you sell or distribute to customers in the United States the following cigarette products, which are listed or described as being, “Lights,” “Super Light,” “Ultra Lights,” or using similar descriptors, for example: Benson & Hedges (Benson & Hedges Smooth Lights Gold King Box), Bond Street Special Selection (Bond Find Selection (Super Lights)), Chesterfield Classic Silver (Chesterfield Classic Silver (Ultra Lights)), Davidoff Slims (Davidoff Lights Slims), Epique (Epique Superslims Lights), Gitanes (Gitanes Blondes Light), Marlboro Gold Original (Marlboro Light/Gold Box), and Parliament (Parliament Light/Blue). Additionally, you offer for sale cigarette products under a “Lights Cigarettes” category, for example: American Legend White, Camel Light/Blue Subtle Flavour Box, Davidoff Gold Slims, Dunhill King Size Button Blue/Light, Fortuna Blue, Gauloises Blondes Blue, L&M Box Light/Blue White Filter, Lambert & Butler Gold, Lucky Strike Light/Silver, Marlboro Gold 100’s, Next Blue King Size, Parliament Light/Blue, Superkings Blue 100 (Lights), and Winston Balanced Blue. Finally, you offer for sale the following cigarette products under an “Ultra Lights” category, for example: Gauloises Blondes Ultra Light/Yellow.
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)).
The above products are modified risk tobacco products because the websites use the descriptors “Lights,” “Super Light,” “Ultra Lights,” or similar descriptors to describe these products. Because these products are 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)), these products are 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 labeling and/or advertising on these websites, 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Please note your reference number, RW1500327, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement FDA Center for Tobacco Products c/o Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
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.