Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ecigrus-llc-512740-12162016
Timestamp: 2019-09-15 06:58:14
Document Index: 396481552

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

ECIGRUS LLC - 512740 - 12/16/2016 | FDA
ECIGRUS LLC - 512740 - 12/16/2016
ECIGRUS LLC MARCS-CMS 512740 — December 16, 2016
EcigRus, LLC
d/b/a ELiquid-USA
d/b/a UnoVapor
Attn: Barak Beleli and Tal-Or Zafrir
sales@eliquid-usa.com
info@eliquid-usa.com
service@unovapor.com
Dear Mr. Beleli and Mr. Zafrir:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the websites http://www.eliquid-usa.com and http://www.unovapor.com and determined that the e-liquids and electronic nicotine delivery systems (ENDS) listed there are 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 (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 and ENDS, 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 of your e-liquid and ENDS products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age.
FDA’s investigation of the websites http://www.eliquid-usa.com and http://www.unovapor.com revealed that you sold e-liquid and ENDS productsto a minor. Specifically, during our investigation of http://www.eliquid-usa.com and http://www.unovapor.com, a person younger than 18 years of age purchased Uno Vapor Lemonade e-liquid, a Disposable e-Cigar 1000 Puffs (menthol) ENDS, and Uno Vapor Apricot e-liquid from the websites. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as 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 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 1140. Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), these 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, RW1600649, in your response and direct your response to the following address:
Attn: Tal-Or Zafrir
934 Doveplum Ct.
shablulny@gmail.com
3980 SW 53rd Court
c/o KSDT & Co.