Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kingpin-cigarettes-inc-dba-blackhat-vapor-company-597033-11262019
Timestamp: 2020-07-11 22:10:42
Document Index: 772545003

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

KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company - 597033 - 11/26/2019 | FDA
KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company - 597033 - 11/26/2019
KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company MARCS-CMS 597033 — November 26, 2019
KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company
5191 Shawland Rd. Ste A.
sales@blackhatcigs.com
gnewman@energylabsinc.com
Dear Glen Newman:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.blackhatcigs.com and determined that the e-liquid products listed there are advertised 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 Glas Basix - Cinnamon Sweet Sugar Cookie 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 an e-liquid product advertised and offered for sale or distribution on your website is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website advertising an e-liquid product fails to include the required nicotine warning statement.
FDA’s investigation of the website https://www.blackhatcigs.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of https://www.blackhatcigs.com, a person younger than 18 years of age purchased Glas Basix - Cinnamon Sweet Sugar Cookie 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)).
Additionally, our review of the website https://www.blackhatcigs.com revealed that the advertising for an e-liquid product that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3(b), for example: Glas Basix - Cinnamon Sweet Sugar Cookie e-liquid. 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 an e-liquid product, must bear the following warning statement:
Please note your reference number, RW1901214, in your response and direct your response to the following address:
KingPin Cigarettes, Inc.
Attn: Lance Culver and Glen Newman
lculver@blackhatcigs.com
Attn: Glen Newman
4534 Verona Avenue