- 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
NOV 5, 2015
VIA Electronic Mail
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.shopforsmoke.net and determined that the 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 (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. Additionally, FDA has determined that several 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.
Modified Risk Tobacco Product Violations
Our review of the website, http://www.shopforsmoke.net, revealed that you sell or distribute cigarette products,which arelisted or described as being, lightor using similar descriptors, for example: Bond Street Special Selection (“Bond Lights (Special Selection)”), Camel Blue (“Camel Lights (Blue)”), Camel Silver (“Camel Super Lights (Silver)”), Davidoff Gold Slims (“Davidoff Slim Lights (Gold) 100’s”), Esse One/1 (described as “very light”), Karelia Omé (described as “lighter”), Karelia Slims Ultima (described as “ultra light”), Kent HD (“Kent Premium Lights Nr. 8 (Futura)” and “Kent Super Lights Nr. 4 (Neo)”), L&M Blue Label (“L&M Lights (Blue)”), L&M Silver Label (“L&M Super Lights (Silver Label)”), Lucky Strike Blue (“Lucky Strike Lights (Blue)”), Marlboro Gold Accent (“Marlboro Accent (Ultra Lights)”), Marlboro Gold Original (“Marlboro Lights (Gold)”), Marlboro (“Marlboro Ultra Lights (Silver)”), Muratti Eleganza Zaffiro Slims (described as “Light”), Muratti Silver Slims (described as “very light”), Pall Mall (“Pall Mall Lights (Blue)”), Pall Mall Blue (“Pall Mall Blue (Lights)”), Parliament Aqua Blue (“Parliament Lights (Aqua Blue)”), Parliament Silver Blue (“Parliament Extra Lights (Silver Blue)”), Sovereign Slims Ultra (“Sovereign Slims Ultra Lights 100’s”), Winston Blue (“Winston Lights (Balanced Blue)”), and Winston Silver (“Winston Super Lights (Subtle Silver)”).
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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 listed products are modified risk tobacco products because the website uses the descriptor light 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)).
Flavored Cigarette Violations
Additionally,our review of the website, http://www.shopforsmoke.net, revealed that you offer for sale or distribute the following cigarette products: Aroma Rich Apple, Aroma Rich Rum & Cherry, Kiss Mohito (mini), Kiss Super Slims Clubnichka 100’s (strawberry), Kiss Super Slims Fresh Apple 100’s, Richmond Cherry, Richmond Cherry 4, Richmond Cherry Gold Super Slims 100s, Richmond Cherry Super Slims 100s, and Sobranie Slims Mints 100’s.
These products 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.
Cigarettes that are distributed or 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 theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, mojito, 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 labeling and/or advertising 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 labeling, 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, RW1500413, 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
Nicenic International Group Co., Limited