- Delivery Method:
- Electronic Mail
- Issuing Office:
- Center for Tobacco Products
| || |
Department of Health and Human Services
|Food and Drug Administration|
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
FEB 5, 2015
VIA Electronic Mail
To: Mary Le
Dear Ms. Le:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.marlborocigaretteselling.com, 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 (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 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. Additionally, FDA has determined that several of your cigarette 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor. 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 cigarette products that you describe on your website, http://www.marlborocigaretteselling.com, as being light, extra light, ultra light, super light, or mild by referring to them as such in product labeling or advertising. Specifically, our review of the website revealed that you sell or distribute cigarette products listed as: Bond Lights (Special Selection), Camel Lights (Blue), Camel Super Lights (Silver), Davidoff Slim Lights (Gold) 100’s, Kent Super Lights Nr. 4 (Neo), L&M Super Lights (Silver Labled) (sic), L&M Lights (Blue), Magna Blue (Lights), Marlboro Accent (Ultra Lights), Marlboro Lights (Gold), Marlboro Ultra Lights (Silver), More Super Lights (Subtle Silver), Pall Mall Blue (Lights), Pall Mall Lights (Blue), Pall Mall Ultra Lights (Amber), Parliament Extra Lights (Silver Blue), Parliament Lights (Aqua Blue), Peter I Lights N8, Peter I Mild N10, Peter I Super Lights N4, Russian Style Lights, Russian Style Super Lights, Sovereign Slim Ultra Lights 100’s, Sovereign Ultra Lights, and Winston Lights (Balanced Blue).
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 descriptors “Extra Lights,” “Lights,” “Super Lights,” “Ultra Lights,” or “Mild,” or similar descriptors for the above listed products, these products are modified risk tobacco 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)).
Flavored Cigarette Violations
Additionally,our review of your website, http://www.marlborocigaretteselling.com, revealed that you offer for sale the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Super Slims Fresh Apple 100’s, Kiss Super Slims Clubnichka 100’s (strawberry), Richmond Cherry, and Sobranie Slim Mints 100’s, which arepurported to contain an artificial or natural flavor that is a characterizing flavor of the products. 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, cigarette tobacco, and roll-your-own tobacco 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 cigarette products areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette products 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)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, strawberry, cherry, or mint as a characterizing flavor of the tobacco products.
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, RW1500259, 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail