Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/little-brown-smoke-shack-12162014
Timestamp: 2020-08-12 06:33:36
Document Index: 57516794

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

Little Brown Smoke Shack - 12/16/2014
Little Brown Smoke Shack December 16, 2014
3201 Goodman Road
E-mail: info@lilbrown.com
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.
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 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.
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)).
Please note your reference number, RW1400240, in your response and direct your response to the following address:
Daniel@lilbrown.com