Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smoketipcom-llc-593444-09302019
Timestamp: 2020-01-20 13:16:28
Document Index: 662487094

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

SmokeTip.com, LLC - 593444 - 09/30/2019 | FDA
SmokeTip.com, LLC - 593444 - 09/30/2019
SmokeTip.com, LLC MARCS-CMS 593444 — September 30, 2019
SmokeTip.com, LLC
100 Naamans Road, Unit 5-C
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.smoketip.com 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-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
Our review of the website http://www.smoketip.com revealed that the labeling and/or advertising for several ENDS and e-liquid products 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: Disposable Electronic Cigarette Menthol and Fresh Vaping E-Liquid – Fruity Pebbles. 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 waterpipe tobacco products, must bear the following warning statement:
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 do 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)).
In addition, a tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Because your website regarding ENDS and e-liquid products do not include the required nicotine warning statement for these products, your ENDS and e-liquid products are misbranded under 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)).
Cloudeflare, Inc.
abuse@cloudeflare.com