Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hakooh-llc-589377-09272019
Timestamp: 2020-05-28 19:59:42
Document Index: 43536716

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

Hakooh LLC - 589377 - 09/27/2019 | FDA
Hakooh LLC - 589377 - 09/27/2019
Hakooh LLC MARCS-CMS 589377 — September 27, 2019
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.hookahshisha.org and determined that the electronic nicotine delivery system (ENDS) and 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 ENDS and 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 ENDS and 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 ENDS and e-liquid products fails to include the required nicotine warning statement.
ENDS and E-Liquid Products with Labeling and/or Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded
Our review of the website https://www.hookahshisha.org revealed that the labeling and/or advertising for several ENDS and e-liquid products that you manufacture, package, import, distribute, or retail does not include the required nicotine warning statement, for example: Logic Disposable Hookah - Strawberry, Myle Midnight Black Starter Kit, Sigma Disposable E-Hookah – Double Apple, Drippy Fruit E-Juice, Liquid State Vapors – Apple Butter, Myle Pods – Tropical Mango, and Snap Liquids – Apple Snap. 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 ENDS and 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 ENDS and 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 ENDS and 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, RW1901149, in your response and direct your response to the following address:
SiteGround Chicago
mm@1h.com