WARNING LETTER
Warrender Enterprise Inc. MARCS-CMS 553196 —
- Recipient:
-
Recipient NameNicholas S. Warrender
- Warrender Enterprise Inc.
12715 210th Avenue
Bristol, WI 53104
United States
- Issuing Office:
- Center for Tobacco Products
United States
| DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION SILVER SPRING, MD 20993 | UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 |
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 the e-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-liquid 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 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.
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.
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’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, 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 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
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,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
VIA Electronic Mail
cc:
Nicholas Warrender
liftedbusiness@gmail.com
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