Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tca-vapor-09122018
Timestamp: 2020-04-08 05:58:47
Document Index: 512028074

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

TCA Vapor - 09/12/2018 | FDA
TCA Vapor - 09/12/2018
TCA Vapor September 12, 2018
tcavapor@gmail.com
chris.fujiyama@gmail.com
Dear Chris Fujiyama:
This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://tcavapor.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 https://tcavapor.com revealed that it sells or distributes Candy King Batch 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 imitates the labeling and/or advertising for candy that is commonly marketed toward, and/or appealing to, children, such as Sour Patch Kids candy (see Exhibit B). For example, the labeling and/or advertising for this e-liquid includes the term “Candy King,” prominently placed on the front of the product. In addition, the labeling and/or advertising of Candy King Batch e-liquid includes representations of the product name and color scheme that are substantially similar to Sour Patch Kids candy (see Exhibit B). Further, Candy King Batch e-liquid has a strong scent like candy. This labeling and/or advertising causes the product to imitate candy, particularly ones that are marketed toward, and/or appealing to, children and is therefore misleading.
Given that the labeling and/or advertising of Candy King Batch e-liquid describes its nicotine content as 3mg/mL, with a total volume of 100mL, an accidental ingestion of slightly less than less than a teaspoon would reach the lower end of the fatal dose range for an average two-year-old. Additionally, an accidental ingestion of approximately 3% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old.
FDA’s investigation of the website https://tcavapor.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of https://tcavapor.com, a person younger than 18 years of age purchased Candy King Batch 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, RW1800934, in your response and direct your response to the following address: