Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm605899.htm
Timestamp: 2018-10-18 22:01:41
Document Index: 153646837

Matched Legal Cases: ['§ 321', '§ 387', '§ 45', '§ 387', '§ 1140', '§ 1140', '§ 1100', '§ 1100', '§ 1100', '§ 387', 'art 1140', '§ 1140', '§ 387']

Elite Vaporworks 5/1/18
This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission recently reviewed the website http://www.elitevaporworks.com, from which you take orders for Whip’d Strawberry e-liquid products. FDA has 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)). In addition, the FTC has reviewed your marketing for Whip’d Strawberry e-liquid under Section 5 of the FTC Act, 15 U.S.C. § 45(a).
FDA’s investigation of the website http://www.elitevaporworks.com revealed that it sells or distributes Whip’d Strawberry e-liquid with labeling and/or advertising that causes it to imitate food products, particularly ones that are marketed toward, and/or appealing to, children (see Exhibit A). Specifically, the labeling and/or advertising of the product looks substantially similar to Reddi Wip whipped cream, a food product that is marketed toward, and/or appealing to, children (see Exhibit B). For example, the labeling and/or advertising for Whip’d Strawberry e-liquid includes an illustration depicting a strawberry dunked in whipped cream, displays a color scheme that is substantially similar to the labeling and/or advertising of Reddi Wip whipped cream, and includes in the product name the terms “Whip’d,” and “Strawberry”. In addition, the labeling and/or advertising of Whip’d Strawberry e-liquid includes a cylindrical bottle and a swirled bottle cap that are substantially similar to Reddi Wip’s bottle and cap, and your website describes the product as “Ripe strawberry and whipped cream.” Further, Whip’d Strawberry e-liquid has a strong scent like strawberries and whipped cream. This labeling and/or advertising causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children and is therefore misleading.
Additionally, FDA has determined thatyour Whip’d Strawberry e-liquid ismisbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this productto a person younger than 18 years of age.
FDA’s investigation of the website http://www.elitevaporworks.com revealed that you sold an e-liquid productto a minor. Specifically, during our investigation of http://www.elitevaporworks.com, a person younger than 18 years of age purchased Whip’d Strawberry 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)).
With regard to the FD&C Act violations, please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Please note your reference number, RW1800855, in your response and direct your response to the following address: