WARNING LETTER
CheapCigStore.com
MARCS-CMS 630802 —
April 08, 2022
Delivery Method:
VIA Electronic Mail
Product:
Tobacco
Recipient:
CheapCigStore.com
United States
support@CheapCigStore.com
Issuing Office:
Center for Tobacco Products
United States
April 8, 2022
WARNING LETTER
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed http://cheapcigstore.com 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 cigarette products, 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
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.
Our review of the website http://cheapcigstore.com revealed that you sell or distribute cigarette products while explicitly or implicitly representing that: (1) the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; (2) the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance; or (3) the products or their smoke do not contain or are free of a substance. Additionally, the labeling or advertising of these cigarette products uses the descriptors “light” or “mild.” For example, the website http://cheapcigstore.com includes the following claims regarding your cigarette products, such as, Bentoel Club, Djarum Coklat, Gudang Garam International, Sampoerna A, and Wismilak Kretek:
“lighter and mild”
“contain low tar”
“mild, light, and with less nicotine”
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 modified risk tobacco product application under section 911(d) of the FD&C Act (21 U.S.C. § 387k(d)) is required to provide scientific evidence and other information to support issuance of an order 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)).
Flavored Cigarette Violations
Additionally, our review of the website http://cheapcigstore.com revealed that you offer for sale or distribute the following cigarette products: Bentoel Biru (clove), Djarum Black (clove), Djarum Black Cappucino [sic] (cappuccino, clove), Extreme Mild (clove), Gudang Garam Neslite (clove), Sampoerna Avolution (clove), U Mild (clove), and Wismilak Diplomat (clove).
These products are purported 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 offered for sale 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 are adulterated 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, clove or cappuccino as a characterizing flavor of the tobacco products.
Conclusion and Requested Actions
It is your responsibility to ensure that all of 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), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, 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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA’s homepage at
http://www.fda.gov
.
Please note your reference number, RW2201761, 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 Bryan Hills at (301) 796-9367 or via email at CTPCompliance@fda.hhs.gov.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
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Content current as of:
04/12/2022
Regulated Product(s)
Tobacco