Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vallhund-vapes-inc-553031-05102018
Timestamp: 2020-04-02 20:10:31
Document Index: 340260233

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

VallHund Vapes Inc. - 553031 - 05/10/2018 | FDA
VallHund Vapes Inc. - 553031 - 05/10/2018
VallHund Vapes Inc. MARCS-CMS 553031 — May 10, 2018
Michael Mario De Pinto
Dear Michael Mario De Pinto:
This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.vallhundvapes.com and determined that the e-liquid products 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, 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’s investigation of the website http://www.vallhundvapes.com revealed that it sells or distributes Chill Purple Grape e-liquid with labeling and/or advertising that causes it to imitate a food or beverage, particularly one that is marketed toward, and/or appealing to, children (see Exhibit A). Specifically, the labeling and/or advertising of the product looks very similar to the labeling and/or advertising for grape soda products that are marketed toward, and/or appealing to, children (see Exhibit B). For example, the labeling and/or advertising for Chill Purple Grape e-liquid includes statements and representations, such as “Purple Grape,” “Refreshing Soda Flavor,” an illustration depicting a bunch of purple grapes, as well as a label on the back that is substantially similar to a food Nutrition Facts label. In addition, the labeling and/or advertising of Chill Purple Grape e-liquid includes a cylindrical shape and design that is substantially similar to a soda can; a foil covering on the top of the can that is substantially similar to soda cans in Exhibit B; the appearance of a soda-can tab when the foil covering is removed; and a color scheme that is substantially similar to soda cans in Exhibit B. Further, Chill Purple Grape e-liquid has a strong scent like grape soda. This labeling and/or advertising causes the product to imitate a food or beverage, particularly one that is marketed toward, and/or appealing to, children and is therefore misleading.
Additionally, FDA has determined that your Chill Purple Grape e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age.
FDA’s investigation of the website http://www.vallhundvapes.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of http://www.vallhundvapes.com, a person younger than 18 years of age purchased Chill Purple Grape e-liquid from your website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (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 product cited in this violation is a “covered tobacco product.” 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 this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is 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, RW1800854, in your response and direct your response to the following address:
VallHund Vapes Inc. - Close Out Letter 7/13/18