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  5. Little Brown Smoke Shack - 12/16/2014
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WARNING LETTER

Little Brown Smoke Shack Dec 16, 2014

Little Brown Smoke Shack - 12/16/2014


Delivery Method:
USPS and Electronic Mail

Recipient:
Recipient Name
Daniel Martinez
Little Brown Smoke Shack

3201 Goodman Road

Yakima, WA 98903
United States

Issuing Office:
Center for Tobacco Products

United States


  

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 

 

DEC 16, 2014

VIA USPS and Electronic Mail
 
Daniel Martinez
Lil Brown Smoke Shack
3201 Goodman Road
Yakima, WA 98903
E-mail: info@lilbrown.com
WARNING LETTER
 
Dear Mr. Martinez:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your website, http://www.lilbrown.com, and determined that the smokeless tobacco products listed there are offered for sale 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 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 certain of your smokeless tobacco products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because the products are new tobacco products that are required to have premarket review and do not have a marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and for which a notice or other information respecting the products has not been provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)). Additionally, FDA has determined that several of 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 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.
 
Premarket Review Violations
 
Section 910(a)(2) of the FD&C Act (21 U.S.C. § 387j(a)(2)) requires premarket review of new tobacco products, subject to certain exceptions. Under section 910(a)(1) of the FD&C Act (21 U.S.C. § 387j(a)(1)), a “new tobacco product” includes “any tobacco product . . . that was not commercially marketed in the United States as of February 15, 2007.”  The FD&C Act permits a tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence (SE) report was submitted by March 22, 2011, to remain on the market pending FDA’s review of the report (“provisional” tobacco products).  In the event that FDA finds under section 910(a)(3) of the FD&C Act (21 U.S.C. § 387j(a)(3)) that the provisional tobacco product is not substantially equivalent to a predicate tobacco product commercially marketed in the United States as of February 15, 2007, and issues an order that the product is not substantially equivalent (NSE), the provisional tobacco product will be subject to premarket review under section 910(a)(2)(A) of the FD&C Act (21 U.S.C. § 387j(a)(2)(A)).  A product that is required by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)) to have premarket review and does not have an order in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(a)).  A product is misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)) if a notice or other information respecting it is not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).
 
Our review of your website, http://www.lilbrown.com, revealed that you sell or distribute to customers in the United States the following smokeless tobacco products for which FDA issued NSE orders on August 28, 2014: Ariva Cinnamon, Ariva Wintergreen, Ariva Mint, Ariva Citrus, Ariva Java, Stonewall Natural, and Stonewall Java. Because these products are required to have premarket review and do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)), they are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)).  In addition, because (subsequent to the NSE orders) a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)), these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)).        
 
FDA posts a list of tobacco products that are adulterated and misbranded due to an NSE order. This list can be found by visiting FDA’s website at http://www.fda.gov/tobacco and searching for “Misbranded and Adulterated NSE Tobacco Products” using the search box.
 
Health Warning Statement Violations
 
FDA has also 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. 
 
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 the website, http://www.lilbrown.com, revealed that you advertise and offer for sale in the United States at least the following smokeless tobacco products without any health warning statements: Cannon Ball Plug, Cotton Boll Plug, Cougar Natural Long Cut, Days Work Plug, Husky Mint L/C, Husky Natural L/C, Husky Natural F/C, Husky Straight L/C, Husky Wintergreen L/C, Lancaster Pouch, Red Seal Natural F/C, Red Seal Natural L/C, Red Seal Straight L/C, Red Seal Wintergreen L/C, Redwood Fine Cut, Silver Creek Cherry L/C, Silver Creek Straight L/C, Silver Creek Wintergreen L/C, Silver Creek Wintergreen F/C, Skoal Apple L/C, Skoal Bandit Mint, Skoal Bandit Wintergreen, Skoal Berry Long Cut, Skoal Cherry L/C, Skoal Citrus L/C, Skoal Classic L/C, W.E. Garrett Scotch Pocket, and W.E. Garrett Sweet Pocket. Because your smokeless tobacco product advertisements do not 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 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 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, RW1400240, 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:
 
Godaddy.com
abuse@godaddy.com
 
Daniel Martinez

Daniel@lilbrown.com