Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cube-one-enterprises-inc-511431-12082016
Timestamp: 2019-10-24 04:35:44
Document Index: 537487539

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 1140', '§ 1140', '§ 1100', '§ 1100', '§ 1100', '§ 387', 'art 1140', '§ 1140', '§ 387']

Cube One Enterprises, Inc. - 511431 - 12/08/2016 | FDA
Cube One Enterprises, Inc. - 511431 - 12/08/2016
Cube One Enterprises, Inc. MARCS-CMS 511431 — December 08, 2016
Robert M. Lemus
Cube One Enterprises, Inc.
1970 State Road 44
d/b/a www.billboardtobacco.com
d/b/a www.billboardcigars.com
d/b/a Tobacco Leaf
Attn: Robert M. Lemus
tobaccoleaf@cfl.rr.com
tobaccoleaf@hotmail.com
Dear Mr. Lemus:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.billboardtobacco.com and http://www.billboardcigars.com and determined that the e-liquid and electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution 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 e-liquids and ENDS products, 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 Buck Naked Fruit Mix e-liquid from the website http://www.billboardtobacco.com 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. Additionally, your Voodoo E-Hookah Bewitched Blueberry and Voodoo E-Hookah Sinful Strawberry ENDS products and Buck Naked Cherry e-liquid from the website http://www.billboardcigars.com are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age.
FDA’s investigation of the website http://www.billboardtobacco.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of http://www.billboardtobacco.com, a person younger than 18 years of age purchased Buck Naked Fruit Mix e-liquid from the website. Additionally, FDA’s investigation of the website http://www.billboardcigars.com revealed that you sold ENDS products and an e-liquid to a minor. Specifically, during our investigation of http://www.billboardcigars.com, a person younger than 18 years of age purchased Voodoo E-Hookah Bewitched Blueberry and Voodoo E-Hookah Sinful Strawberry ENDS products and two Buck Naked Cherry e-liquids from the website. You also sent a complimentary White Rhino Liquid E-Juice (berry) e-liquid. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as ENDS products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The products cited in this violation are “covered tobacco products.” 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. Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), these products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Please note your reference number, RW1600604, in your response and direct your response to the following address:
c/o R. G. Petree
abuse@contactprivacy.com
billboardtobacco.com@contactprivacy.com