Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-texas-vapor-shop-589383-09272019
Timestamp: 2020-08-05 15:06:44
Document Index: 392173803

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

North Texas Vapor Shop - 589383 - 09/27/2019 | FDA
North Texas Vapor Shop - 589383 - 09/27/2019
North Texas Vapor Shop MARCS-CMS 589383 — September 27, 2019
347 East Hickory Street
BigTexVaporShop@gmail.com
Dear Jeremy Speight:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://bigtexvaporshop.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 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)) because your website advertising the e-liquid products fails to include the required nicotine warning statement.
Our review of the website https://bigtexvaporshop.com revealed that the labeling and/or advertising for several e-liquid products that you manufacture, package, import, distribute, or retail does not include the required nicotine warning statement, for example: Bavarian Cream, Gummy Bear, Candy Apple Rancher, Cinna-Bomb, and Banana Nut Bread. 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)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(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 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, RW1901147, in your response and direct your response to the following address:
Big Tex Vapor Bar
Attn: Thao M. Huynh
324 E. McKinney Street
North Texas Vapor Shop, LLC d/b/a Big Tex Vapor Shop
Attn: Jeremy K. Speight
Denton, Texas 76202-1733