WARNING LETTER
Virtue Vape, LLC MARCS-CMS 553204 —
- Recipient:
- Virtue Vape, LLC
United States
- Issuing Office:
- Center for Tobacco Products
United States
Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 |
May 10, 2018
VIA UPS and Electronic Mail
Catalina Jimenez
Virtue Vape, LLC
572 NW 23rd St
Miami, FL 33127
catalina@virtuevape.com
WARNING LETTER
Dear Catalina Jimenez:
This is to advise you that the Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.virtuevapewholesale.com and 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-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
Misbranding Violation
FDA has determined that your Unicorn Cakes 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.virtuevapewholesale.com revealed that it sells or distributes Unicorn Cakes e-liquid with labeling and/or advertising that causes it to imitate a food product, particularly one that is marketed toward, and/or appealing to, children (see Exhibit A). Specifically, the labeling and/or advertising of the product uses images and cartoons of pancakes and a strawberry beverage, which are food products that are marketed toward, and/or appealing to, children. For example, the labeling and/or advertising for Unicorn Cakes e-liquid prominently displays on the front of the product the term “UNICORN CAKES,” and features images of blueberry pancakes and strawberry colored liquid. The labeling and/or advertising also includes cartoon imagery of unicorns eating pancakes in a fanciful landscape, which is substantially similar to graphics/images from My Little Pony, an entertainment franchise marketed toward, and popular among, children (see Exhibit B). The use of this cartoon imagery further enhances its appeal to children and increases the likelihood that children will ingest the product as a food. Additionally, the website http://www.virtuevapewholesale.com describes the product as “[a]n incredible blueberry pancake drenched in strawberry milk.” Further, Unicorn Cakes e-liquid has a strong scent like berries and pancakes. This labeling and/or advertising causes the product to imitate breakfast food and cartoon images 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. 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 the 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 Unicorn Cakes e-liquid describes its nicotine content as 3mg/mL, with a total volume of 120mL, an accidental ingestion of slightly 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.
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 Unicorn Cakes 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.
Conclusion and Requested Actions
The 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 this website, on any other websites (including e-commerce, social networking, or search engine websites), 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.
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, RW1800863, 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.
Sincerely,
/S/
Ann Simoneau, J.D.
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS and Electronic Mail
cc:
Catalina Jimenez
Awesome Flavors LLC
572 NW 23rd Street
Miami, FL 33127
572 NW 23rd Street
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