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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.desismokes.com 7/26/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229

JUL 26, 2013

VIA Electronic Mail
 
To: contactus@desismoke.com
 
 
WARNING LETTER
 
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites, http://www.desismoke.com and http://www.wantsmokes.com, and determined that your cigarette products and/or smokeless tobacco products listed there are promoted for sale to customers in the United States. FDA believes these websites are affiliated with one another because the websites include the same contact information. 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, the products you advertise on your website are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes and smokeless tobacco, 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. Additionally, FDA has determined that several of your 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)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
FDA has also determined that “bidis” meet the definition of a cigarette under section 900(3) of the FD&C Act. Pursuant to section 900(3) of the FD&C Act the term “cigarette --- (A) means a product that (i) is a tobacco product; and (ii) meets the definition of the term cigarette in section 3(1) of the Federal Cigarette Labeling and Advertising Act (FCLAA).” Section 3(1) of FCLAA (15 U.S.C. § 36) defines “cigarette” to mean: “(A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and (B) any roll of tobacco wrapped in any substance contain tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarettes described in subparagraph (A).” Therefore, bidis meet the definition of “cigarette” under the FD&C Act, and are subject to FDA jurisdiction under section 901(b) of the FD&C Act.
 
Modified Risk Tobacco Product Violations
 
You describe products that you offer for sale to customers in the United States on the websites, http://www.desismoke.com and http://www.wantsmokes.com, as being light or mild by referring to them as such in product labeling or advertising and adding the qualifiers “Lights,” or “mild” to the product descriptions. Specifically, our review of the websites revealed that you offer for sale a cigarette product, displayed under the category “Indian Cigarettes” and listed as: “Gold Flake Lights” (Gold Flake Honeydew Blend). In addition, our review of your websites revealed that you offer for sale the following cigarettes, displayed under the category “Flavored Bidis” and described as “The bidis are mild…”: “Bali-Hai Clove – Canela”; “Bali-Hai Cinnamon - Cravo”; “Bali-Hai Grape - UVA”; “Bali-Hai Mint - Menta”; and “Bali-Hai SAMPLER.”  
 
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 the websites use the descriptors “Lights,” “mild,” or similar descriptorsfor the above listed products, these products are modified risk tobacco products. Because these products are offered for sale 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 websites, http://www.desismoke.com and http://www.wantsmokes.com, revealed that you offer for sale to customers in the United States the following cigarettes described as “FLAVORED BIDIS”: “Bali-Hai Cherry - Cereja”; “Bali-Hai Clove – Canela”; “Bali-Hai Cinnamon – Cravo”; “Bali-Hai Grape - UVA”; “Bali-Hai Mint - Menta”; “Bali-Hai SAMPLER,” which is described as containing cinnamon, clove, grape, mint and strawberry flavored cigarettes; “Bali Hai Strawberry - Morango”; and “Gold Flake Honeydew Blend,” which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product(s). 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 marketed and sold in the United States in violation of Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.
 
If, however, these cigarettes 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, cherry, clove, cinnamon, grape, mint, strawberry, or honeydew, as a characterizing flavor of the tobacco product(s).
 
Health Warning Statement Violations
 
FDA has determined that your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you failed to include in your smokeless tobacco product advertisements any warning label statements. Such statements are required under section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846). 
 
Under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. 387c(a)(7)(A)), a tobacco product is misbranded if, in the case of any tobacco product distributed or offered for sale to customers in the United States, its advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), in determining whether labeling or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product.
 
Our review of your websites, www.desismoke.com and www.wantsmokes.com, revealed that you advertise and promote for sale to customers in the United States the following smokeless tobacco products without warning statements: “BABA 120 Prem chewing Tob with silver (Tin Pack)” and “BABA 160 Flavored Saffron Blended (Tinned Pack).”  Section 3(b) of the Smokeless Tobacco Act, as amended, requires that advertisements for smokeless tobacco products bear one of the following warning labels:
 
WARNING: This product can cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss.
WARNING: This product is not a safe alternative to cigarettes.
WARNING: Smokeless tobacco is addictive.
 
Because your smokeless tobacco product advertisements do not include any warnings, your smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).   
 
In addition, we note that you are required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Smokeless Tobacco Act requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” and approved by FDA. 
 
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 these websites, or any other websites or 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 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 and your plan for maintaining compliance with the FD&C Act.
 
Please note your reference number, RW1300105, in your response and 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 CTPCompliance@fda.hhs.gov.     
 
Sincerely,
/S/
 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
VIA Electronic Mail
 
cc:
 
support@desismoke.com
wantsmokes.com@domainsbyproxy.com
DESISMOKE.COM@domainsproxy.com
legal@godaddy.com 
abuse@godaddy.com
abuse-mh@peer1.com
dhswip@peer1.com