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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.mrsnuff.com 9/5/14

  

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

Public Health Service
Food and Drug Administration
 
Center for Tobacco Products
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

SEPT 5, 2014

VIA Electronic Mail
 
David Anderson
Mr. Snuff
mrsnuff@gmail.com
 
WARNING LETTER
 
Dear Mr. Anderson:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.mrsnuff.com and http://www.mrsnuff.co, and determined that your smokeless tobacco products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with one another because they contain the same contact information, and because hyperlinks on http://www.mrsnuff.co point to pages hosted at http://www.mrsnuff.com. 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 (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 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 your “Thunder Frosted” smokeless tobacco product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(a). Additionally, 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 they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Finally, FDA has determined that several of your smokeless tobacco products aremisbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you fail to include in your smokeless tobacco product advertisements any health warning label statements. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Sales to Minors Violations
 
FDA’s investigation of your website, http://www.mrsnuff.co, revealed that you sold a tobacco product to a minor. Specifically, during our investigation of http://www.mrsnuff.co, a minor purchased a tobacco product from this website. No retailer may sell cigarettes or smokeless tobacco to a person younger than 18 years of age under 21 C.F.R. § 1140.14(a).  Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1140.  A person younger than 18 years of age purchased “Thunder Frosted” smokeless tobacco from the website http://www.mrsnuff.co.  Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(a), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
 
Modified Risk Tobacco Product Violations
 
You sell or distribute smokeless tobacco products that you describe on your websites, http://www.mrsnuff.com and http://www.mrsnuff.co, as being less harmful than one or more commercially marketed tobacco products by referring to them as such in product labeling or advertising. Specifically, our review of your websites revealed that you sell or distribute snuff tobacco products and that you make the following claims in reference to these tobacco products:
 
  • “Snuff is healthier than smoking . . . .”
  • “There is no known scientific literature linking entorrhinal cancer (cancer of the nasal cavity) to the use of nasal snuff. It is by far the safest form of tobacco use.”
  • “Although it contains substances that are potentially carcinogenic, at present, there is no firm evidence, relating the use of nasal snuff to a higher incidence of head and neck or other malignancies.”
  • “Snuff allows you to experience nicotine without the potentially lethal effects of the tar . . . contained in cigarettes.”
 
A tobacco product is 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)). Because your websites, http://www.mrsnuff.com and http://www.mrsnuff.co, make claims that the products sold present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco 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)).
 
Health Warning Statement Violations
 
FDA has also determined that your smokeless tobacco products aremisbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because you fail to include in your smokeless tobacco product advertisements any health warning label statements.  Section 3(b) 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), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
 
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.
 
A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act, (21 U.S.C. § 387c(a)(7)(A)), if, in the case of any tobacco product distributed or offered for sale in any State, 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 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, http://www.mrsnuff.com and http://www.mrsnuff.co, revealed that you advertise and offer for sale in the United States the following smokeless tobacco products without any health warning statements including, but not limited to: Abraxas Café 11, De Kralingse Choco, Dholakia Taj, FUBAR Grunt, Makla Neffa Ifrikia, NTSU Green, Oliver Twist Arctic Tobacco Bits, Paul Gotard Pear Snuff Bottle, Thunder Frosted, and Xuefu Mint.  Because your smokeless tobacco product advertisements donot include any health warnings, your smokeless tobacco products aremisbranded 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 (15 U.S.C. § 4402), 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, 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,RW1400194, 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/ 
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
 
VIA Electronic Mail
 
cc:
 
cs@mrsnuff.com
 
Domains by Proxy, LLC
mrsnuff.co@domainsbyproxy.com
 
GoDaddy.com, Inc.
abuse@godaddy.com

 

 
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