Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/black-axis-juice-company-llc-589306-09272019
Timestamp: 2020-04-06 02:43:34
Document Index: 662875546

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 1140', '§ 1140', '§ 1100', '§ 1100', '§ 1100', '§ 387', 'art 1140', '§ 1140', '§ 387', '§ 1143', '§ 1143', '§ 1143', '§ 1143', '§ 1100', '§ 1100', '§ 1100', '§ 387', 'art 1143', '§ 1143', '§ 387', '§ 1143', '§ 1143', '§ 387', 'art 1143', '§ 1143', '§ 387']

Black Axis Juice Company LLC - 589306 - 09/27/2019 | FDA
Black Axis Juice Company LLC - 589306 - 09/27/2019
Black Axis Juice Company LLC MARCS-CMS 589306 — September 27, 2019
Black Axis Juice Company LLC
117 Watercourse Way
blackaxisjuice@gmail.com
Dear Jonathan Deutsch:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.blackaxisjuice.com and determined that the e-liquid products listed there are manufactured and 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, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquids, 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 Subversion e-liquid 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. Additionally, FDA has determined that several e-liquid products advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because (1) your product package and (2) your website advertising the e-liquid products fail to include the required nicotine warning statement.
FDA’s investigation of the website https://www.blackaxisjuice.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of https://www.blackaxisjuice.com, a person younger than 18 years of age purchased Subversion e-liquid from your website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (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 product cited in this violation is a “covered tobacco product.” 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 this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
E-Liquid Products with Packages that Fail to Include the Required Nicotine Warning Statement are Misbranded
FDA’s investigation of the website https://www.blackaxisjuice.com revealed that the package for an e-liquid product that you manufacture, package, sell, offer to sell, distribute, and/or import for sale or distribution into the United States does not include the required nicotine warning statement, specifically Subversion e-liquid. Under 21 C.F.R. § 1143.3(a), packages for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the required warning statement on the package label (21 C.F.R. § 1143.3(a)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(a)(2). Under 21 C.F.R. § 1143.1, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 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 product cited in this violation is a “covered tobacco product.” 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 1143. Because your e-liquid product does not include the required nicotine warning statement on the package, in violation of 21 C.F.R. § 1143.3(a), your e-liquid product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Additionally, our review of the website https://www.blackaxisjuice.com revealed that the labeling and/or advertising for several e-liquid products that you manufacture, package, import, distribute, or retail in the United States does not include the required nicotine warning statement, for example: Amish Crack, Muffin Maid, Liquid Neon, Oma’s Apple Pie, Rawberry, and Subversion. Under 21 C.F.R § 1143.3(b), advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for a tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)). As described above, 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 1143. Because your website regarding e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your e-liquid 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, RW1901144, in your response and direct your response to the following address:
Attn: Jonathan Deutsch
617 Old Augusta Road
jon06019@aol.com