Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm605397.htm
Timestamp: 2019-04-20 18:16:18+00:00

Document:
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 (FTC) recently reviewed the website http://www.sugoivapor.com from which you take orders for Pink Sticks 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 reviewed your marketing for Pink Sticks e-liquid under Section 5 of the FTC Act, 15 U.S.C. § 45(a).
FDA has determined that your Pink Sticks e-liquid is 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)) because its labeling and/or advertising is false or misleading.
FDA’s investigation of the website http://www.sugoivapor.com revealed that it sells or distributes Pink Sticks 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 very similar to Pocky Strawberry biscuit sticks (see Exhibit B), a product that is marketed toward, and/or appealing to, children. For example, the labeling and/or advertising for Pink Sticks e-liquid includes the appearance of a box of biscuit sticks that is substantially similar to the packages in which biscuit sticks are sold, an image of arrayed biscuit sticks, and a color scheme that is substantially similar to the biscuit stick package in Exhibit B. Also, your website describes Pink Sticks e-liquid as “a delicious flavor of ripe strawberries blended into a sweet pink cream that covers a crispy cookie biscuit.” Further, Pink Sticks e-liquid has a strong scent like Pocky Strawberry biscuit sticks that is easily detected without opening the package. 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.
Given that the labeling and/or advertising on Pink Sticks e-liquid describes its nicotine content as 6mg/mL, with a total volume of 60mL, an accidental ingestion of approximately half a teaspoon would reach the lower end of the fatal dose range for an average two-year-old. Additionally, an accidental ingestion of approximately 2% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old.
The FD&C Act provides, in part, that a tobacco product shall be deemed to be misbranded (1) if its labeling is false or misleading in any particular (section 903(a)(1)), or (2) if the tobacco product is distributed or offered for sale in any State and its advertising is false or misleading in any particular (section 903(a)(7)(A)). The labeling and/or advertising for Pink Sticks e-liquid is misleading because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children. Therefore, the product is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act.
Additionally, FDA has determined that your Pink Sticks e-liquidismisbranded 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.sugoivapor.com revealed that you sold an e-liquidproductto a minor. Specifically, during our investigation of http://www.sugoivapor.com, a person younger than 18 years of age purchased Pink Sticks 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)).
In addition, the Federal Trade Commission has reviewed the online marketing of Pink Sticks e-liquid. Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks. Commission Policy Statement on Unfairness, 104 F.T.C. 1070, 1071 (1984) (appended to Int’l Harvester Co., 104 F.T.C. 949 (1984)), available at https://www.ftc.gov/public-statements/1980/12/ftc-policy-statement-unfairness. Preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities. FTC Strategic Plan for 2018-2022, at 6; Philip Morris, Inc., 82 F.T.C. 16 (1973).
As noted above, Pink Sticks e-liquid is marketed in packaging that resembles Pocky Strawberry biscuit sticks. Pink Sticks e-liquid has a scent similar to Pocky Strawberry biscuit sticks and the odor is detectible without opening the packaging. Given the significant number of serious child poisonings due to the ingestion of liquid nicotine, packaging Pink Sticks e-liquid in a manner that is likely to be particularly appealing to young children could present an unwarranted risk to health and safety.
The FTC strongly urges you to review your marketing, including packaging, for Pink Sticks e-liquid and similarly marketed products and to take swift and appropriate steps to protect consumers, especially young children.

References: § 321
 § 387
 § 45
 § 387
 § 387
 § 387
 § 1140
 § 1140
 § 1100
 § 1100
 § 1100
 § 387
 § 1140
 § 387