. 

_ff 11 U.S. FOOD & DRUG -JC- ADM I NISTRATION . ,, 

May 1, 2018 

VIA UPS and Electronic Mail 

Nicholas S. Warrender 

Warrender Enterprise Inc. 

d/b/a Lifted Liquids and E-Liquid Retail 

12715 210th Avenue 

Bristol, WI 53104 

info@liftedliquids.com 

WARNING LETTER 

Dear Nicholas Warrender: 

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 

websites http://www.liftedliquids.com and https://eliquidretail.com from which you take orders of 

Vape Heads Sour Smurf Sauce e-liquid products. FDA has determined that thee-liquid 

products listed there are manufactured and 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-liquid, 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 Vape Heads Sour Smurf Sauce e-liquid under Section 5 

of the FTC Act, 15 U.S.C. § 45(a). 

FD&C Act Misbranding Violation 

FDA has determined that your Vape Heads Sour Smurf Sauce 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 websites.http://www.liftedliquids.com and https://eliquidretail.com 

revealed that they sell or distribute Vape Heads Sour Smurf Sauce 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 nearly identical to WarHeads Extreme Sour Hard Candy and WarHeads Super 

Sour Double Drops Liquid Candy, which are food products that are marketed toward, and/or 

appealing to, children (see Exhibit B). For example, the labeling and/or advertising of Vape 

Heads Sour Smurf Sauce e-liqi.Jid prominently displays a cartoon of a man's head with a cloud 

emitting from it, which is nearly identical to the Wally Warhead cartoon used by WarHeads 

brand candies. The use of this cartoon further enhances its appeal to children and increases 
Page 2 - Warrender Enterprise Inc. 

the likelihood that children will ingest the product as a food. Additionally, the labeling and 

advertising prominently displays the name "Vapeheads," which is substantially similar to 

"WarHeads," and uses a color scheme that is nearly identical to the candy in Exhibit B. The 

labeling and/or advertising for Vape Heads Sour Smurf Sauce e-liquid also includes the terms 

"Sweet & Sour" and "Smurf Sauce." Further, Vape Heads Sour Smurf Sauce e-liquid has a 

strong scent like sour candy. 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. 

Exhibit A Exhibit B 

Children are at particular risk for ingesting e-liquid products with labeling and/or advertising that 

causes the product to imitate a food or beverage, particularly a food or beverage that is typically 

marketed toward, and/or appealing to, children, and that causes· the product to appear 

appropriate and more appealing to ingest as a food or beverage. Moreover, children are at 

particular risk because exposure to the nicotine in the e-liquid product, even in relatively small 

amounts, could result in acute toxicity. Child poisonings due to ingestion of liquid nicotine have 

recently increased substantially. Severe harms can occur in small children from ingestion of 

liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory 

arrest. 

Given that the labeling and or advertising on Vape Heads Sour Smurf Sauce e-liquid describes 

its nicotine content as 6mg/ml, with a total volume of 120ml, an accidental ingestion of about 

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. 
Page 3 - Warrender Enterprise Inc. 

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 Vape Heads Sour 

Smurf Sauce 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. 

The FD&C Act violation discussed in this letter does not necessarily constitute an 

exhaustive list. You should immediately correct the violation that is referenced above, as 

well as violations that are the same as or similar to the one stated above, and take any 

necessary actions to bring your tobacco products into compliance with the FD&C Act. 

It is your responsibility to ensure that your tobacco products and all related labeling and/or 

advertising on these websites, on any other websites (including e-commerce, social 

networking, or search engine websites), and in any other media in which you advertise, and 

in any retail establishments comply with each applicable provision of the FD&C Act and 

FDA's implementing regulations. Failure to ensure full compliance with the FD&C Act may 

result in FDA initiating further action without notice, including, but not limited to, civil money 

penalties, criminal prosecution, seizure, and/or injunction. Please note that any adulterated 

and misbranded tobacco products offered for import into the United States are subject to 

detention and refusal of admission. 

Unfair or Deceptive Marketing 

In addition, the Federal Trade Commission has reviewed the online marketing of Vape 

heads Sour Smurf Sauce 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'/ 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, Vape Heads Sour Smurf Sauce e-liquid is marketed in packaging that 

resembles WarHeads Extreme Sour Hard Candy and WarHeads Super Sour Double Drops 

Liquid Candy, including the use of a cartoon mascot of a boy that appears nearly identical 

to that used in the advertising and packaging for WarHeads candies. WarHeads candies 

. are especially popular with children and its advertising and marketing on Facebook and 

other social media platforms is targeted to children. Vape Heads e-liquid has a scent very 

similar to WarHeads candies and the odor is detectible without opening the packaging. The 

general appearance and consistency of Vape Heads e-liquid is similar to that for the 

WarHeads liquid candy. Given the significant number of serious child poisonings due to the 

ingestion of liquid nicotine, packaging Vape Heads Sour Smurf Sauce 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 Vape Heads 

Sour Smurf Sauce e-liquid and similarly marketed products and to take swift and 
Page 4 - Warrender Enterprise Inc. 

appropriate steps to protect consumers, especially young children. 

Conclusion and Requested Actions 

With regard to the FD&C Act violation described in this letter, 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, RW1800864, in your response and direct your response to 

the following address: 

DPAL-WL Response, Office of Compliance and Enforcement 

FDA Center for Tobacco Products 

c/o Document Control Center 

Building 71 , Room G335 

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002 

If you have any questions, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at 

CTPCompliance@fda.hhs.gov. 

With regard to the FTC-related issues described in this letter, please notify Rosemary Rosso of 

the FTC via electronic mail at rrosso@ftc.gov within 15 days of receipt of this letter of the 

specific actions you have taken to address the FTC's concerns. 

Sincerely, 

Ann Simon au, J.D. 

Director 

Office of Compliance and Enforcement 

Center for Tobacco Products 

'liL(, {,~~' ~ ,ee__ 

Mary K. ERgle 0 

Associate Director 

Division of Advertising Practices 

Federal Trade Commission 
Page 5 - Warrender Enterprise Inc. 

VIA Electronic Mail 

cc: 

Nicholas Warrender 

liftedbusiness@gmail.com 

Network Solutions, LLC 

abuse@web.com 

GoDaddy.com, LLC 

abuse@godaddy.com 

Amazon Technologies Inc. 

abuse@amazonaws.com 

Shopify, Inc. 

abuse@shopify.com