Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stash-e-liquids-573179-03042019
Timestamp: 2019-08-22 22:37:11
Document Index: 189465500

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

Stash E-Liquids - 573179 - 03/04/2019 | FDA
Stash E-Liquids - 573179 - 03/04/2019
Stash E-Liquids MARCS-CMS 573179 — Mar 04, 2019
Joshua Siegel and Vicky Siegel
6921 Vickie Circle
info@stasheliquids.com
Dear Joshua Siegel and Vicky Siegel:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.stasheliquids.com and determined that the e-liquid products listed there are manufactured, 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 the 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 your website regarding e-liquid products fails to include the required nicotine warning statement for these e-liquid products.
Our review of the website https://www.stasheliquids.com revealed that the labeling and/or advertising for the following e-liquid products that you manufacture, advertise, and offer for sale or distribution in the United States, does not include the required nicotine warning statement: PB & Jam, Valhalla, Lushington, Dark Star, Aiko, My Sweet One, Forever Young, Cinnamon Girl, Suspicious Minds, Golden Road, Blue Sky, Southbound, Farmhouse, Sleeping Monkey, Front Porch, Chilly Water, Soulshine, Bliss, Dark Star Reserve, Funkin’ Gonuts, Fluffhead, Vacation, and Alligator Alley. Under 21 C.F.R. § 1143.3, labeling and 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 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 to following required warning statement on the package label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical” (21 C.F.R. § 1143.3(a)). It also is unlawful for such 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)). Under 21 C.F.R. § 1140.3, 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(a) and/or 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)).
The violation discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
Please note your reference number, RW1901030, in your response and direct your response to the following address: