Inspections, Compliance, Enforcement, and Criminal Investigations

www.smokers-mall.com 1/11/16

  

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

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

JAN 11, 2016

VIA Electronic Mail
 
To: support@smokers-mall.com
 
 
WARNING LETTER
 
The Center for Tobacco Products and the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.smokers-mall.com and determined that your cigarette, cigarette tobacco and/or roll-your-own tobacco products, and other tobacco-containing products listed there are offered for sale or distribution to customers in the United States. As further discussed below, although your Merilyn Blue Slims and Merilyn Pink Slims contain tobacco, they are currently marketed as drug-device combination products, as defined under sections 201(g)(1)(B) and (h) of the Federal Food, Drug, and Cosmetic Act (FD& C Act) (21 U.S.C § 321(g)(1)(B) and (h)). The remainder of the products offered on your website are tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, cigarette tobacco, and roll-your-own tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and other applicable provisions under the FD&C Act.
 
FDA has determined that the website, http://www.smokers-mall.com, offers for sale or distributes cigarette tobacco and/or roll-your-own tobacco products. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.”
 
We note that on the website, you present a loose tobacco product containing the package description “Hand Rolling Tobacco” that is offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, specifically, including George Karelias and Sons Hand Rolling Tobacco. The overall presentation of this producton the websitestrongly suggests that it is intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Therefore, the product meets the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that several cigarette products areadulterated 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 and cigarette tobacco and/or roll-your-own tobacco 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.
 
FDA also has determined that the Merilyn Blue Slims and Merilyn Pink Slims offered for sale on your website are unapproved new drugs in violation of section 505(a) of the FD&C Act (21 U.S.C. § 355(a)).
 
Please note that this letter is not inclusive of all the products your firm manufactures and/or distributes and may not represent all violations.
 
Modified Risk Tobacco Product Violations
 
Our review of the website, http://www.smokers-mall.com, revealed that you sell or distribute cigarette products,which arelisted or described as being “mild,” “light,” “ultra lights,” or using similar descriptors, for example: Brass (described as “light”); Djarum (described as “lighter”); Djarum LA Lights, Djarum LA Lights Menthol, and Gudang Garam Signature Lights (described as “mild, light”); Chesterfield Blue (described as “ultra lights”); Lambert & Butler Gold (described as “gold (lights)”); Lucky Strike Original Silver/Blue (“Lucky Strike Original Silver/Lucky Strike Lights”); Marlboro (“Marlboro Lights Gold”); Marlboro Gold Original (“Marlboro Gold/ Marlboro Lights”); Marlboro Gold 100’s (“Marlboro Gold/ Marlboro Lights”); Muratti (described as “mild”); Plaza (described as “light”); Next Blue (“Next Blue Edition/Next Lights”); R1 (described as “mildness”); Rothmans King Size (“Rothman’s Red Special Mild”); Superkings (described as “milder”); Vogue Super Slims Lilas (“Vogue Super Slims Lilas/Vogue Super Slims Ultra Lights”); West (described as “light”); and Winston Silver (“Winston Silver/Winston Super Lights”). In addition, you sell or distribute cigarette products described as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance. Specifically, the website includes the following claims for the products or brands listed:

  • Bond Street Special (described as having the “lowest nicotine tar concentration”);
  • Djarum LA Lights, Djarum LA Lights Menthol, and Gudang Garam Signature Lights (described as “contain[ing] low tar” and “with less nicotine”);
  • Djarum (described as “mild on the throat”);
  • Gala (described as “low nicotine”);
  • Golden Gate (described as “low tar and nicotine”);
  • Kent (described as having a “reduced level of nicotine” and “takes out more nicotine and tars”);
  • Kim (described as having a “nicotine level [that] is mild”); and
  • Silk Cut (described as having “low tar and nicotine”).
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)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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 descriptors “mild,” “light,” or similar descriptors to describe these products or describes them as being less harmful than one or more other commercially marketed tobacco products or having a reduced level of/exposure to a substance. 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
 
Our review of the website, http://www.smokers-mall.com, revealed that you offer for sale or distribute cigarette products, for example: Bentoel brand (clove), Class Mild (clove), Djarum (clove), Djarum Black Cappucino (sic) (clove and cappuccino), Extreme Mild (clove), Gudang Garam (clove), Sampoerna brand (clove), U Mild (clove), and Wismilak brand (clove). Our review also revealed that you offer for sale or distribute the following cigarette tobacco and/or roll-your-own tobacco product: George Karelias and Sons Hand Rolling Tobacco (“fruity”).
 
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 and cigarette tobacco and/or roll-your-own tobacco 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 and cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
 
If, however, these cigarette and cigarette tobacco and/or roll-your-own tobacco 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, clove, cappuccino, or fruit as a characterizing flavor of the tobacco products.
 
Unapproved New Drug Violations
 
Our review of the website, http://www.smokers-mall.com, revealed that you offer for sale or distribute Merilyn Blue Slims and Merilyn Pink Slims. Statements in labeling materials, including your website at http://www.smokers-mall.com, that reflect the intended use of Merilyn Blue Slims and Merilyn Pink Slims include, but are not limited to, the following:
 
[R]esearch has revealed that smoking of cheap Merilyn cigarette has some beneficial side effect on pregnant women . . . studies have also indicated that for every smoking woman who buys Merilyn cigarette from both online and offline is at the risk of developing pre-eclampia (sic) and eclampia (sic) which is minimized by 30% to 50%. Besides, it has been discovered that among smokers, hypertension less usually occur during smoking . . . It has also revealed that it is beneficial to smoke cheap Merilyn cigarette because tobacco acts as an anti-estrogen. Hence . . . minimizes the chances of growing fibrosis of the uterus and possibly endrometriosis.  
 
Both the drug and device definitions under sections 201(g)(1)(B) and 201(h) of the FD&C Act (21 U.S.C. §§ 321(g)(1)(B) and (h)) encompass products such as the Merilyn Blue Slims and Merilyn Pink Slims that are labeled, represented, or promoted as addressing conditions of pregnancy, or hypertension, or other estrogenic effects, because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.  Based on our review of the Merilyn Blue Slims and Merilyn Pink Slims, it appears that these products are drug-device combination products, with the primary mode of action being that of a drug.
 
Furthermore, it appears that these products are “new drugs” under section 201(p) of the FD&C Act (21 U.S.C. § 321(p)) because they are not generally recognized among scientific experts as safe and effective for the drug uses described above and in the products’ labeling. With certain exceptions not applicable here, “new drugs” may not be legally marketed in the United States absent approval of an application filed in accordance with section 505 of the FD&C Act (21 U.S.C. § 355). Neither the Merilyn Blue Slims nor the Merilyn Pink Slims marketed by your firm is so approved; therefore, marketing these products as drug-device combination products in the United States violates sections 505 and 301(d) of the FD&C Act.
 
If these products are not drugs, devices, or combination products, they would be cigarette products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products, and therefore modified risk tobacco products. 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)). 
  
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 and drug products into compliance with the FD&C Act. 
 
It is your responsibility to ensure that your tobacco and drug 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, including FDA orders for modified risk tobacco products and new drug approval requirements. 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, RW1500350, 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.   
 
 
Sincerely,
/S/ 
Ilisa Bernstein, J.D.
Deputy Director
Office of Compliance
Center for Drug Evaluation and Research
 
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
 
 
VIA Electronic Mail
 
cc:
 
Domains by Proxy, LLC
smokers-mall.com@domainsbyproxy.com
 
GoDaddy.com, LLC
abuse@godaddy.com
 

Raxia Commerce Ltd. – Bucharest
gabi@alsysdata.net
ness@alsys.ro
 
Alsys Data SRL
alsys@alsys.ro
alsys.service@alsys.ro
alsys@alsysdata.com

 

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