Virtue Vape LLC MARCS-CMS 553204 — July 13, 2018

CLOSEOUT LETTER

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• Recipient: Virtue Vape LLC; United States

• Issuing Office: United States

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	U.S. Food & Drug Administration Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993

 

VIA UPS and Electronic Mail

 

Catalina Jimenez

Virtue Vape LLC

105 Oak Park Drive, Suite A

Mooresville, NC 28115

catalina@virtuevape.com

 

 

RE: Warning Letter issued to Virtue Vape LLC (RW1800863)

 

Dear Catalina Jimenez:

 

On May 10, 2018, the United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Unicorn Cakes e-liquid is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because its labeling and/or advertising is false or misleading. Specifically, FDA determined that the labeling and/or advertising of your Unicorn Cakes e-liquid is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.   

 

On May 30, 2018, June 28, 2018, and July 11, 2018 you sent FDA a response to the Warning Letter, and we held a teleconference on June 11, 2018 and July 15, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violation identified in the Warning Letter. We note that you may have other tobacco products with labeling and/or advertising that causes the product to be misbranded for similar reasons to those discussed above. You are responsible for taking any necessary actions to bring your tobacco products into compliance with the requirements of the law.

 

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.

 

Should you have any questions or concerns, please contact me at (301) 796-9235 or by email at elenita.ibarrapratt@fda.hhs.gov.

 

 

Sincerely,
/s/
Ele Ibarra-Pratt

Division Director

Office of Compliance and Enforcement

Center for Tobacco Products

 

 

VIA Electronic Mail

 

cc:

 

Virtue Vape LLC

Attn: Paul Kettlewell

paul@virtuevape.com

 

Virtue Vape LLC

Attn: John Abbey

john@virtuevape.com

 

GoDaddy.com, Inc.

abuse@godaddy.com

 

Big Commerce

abuse@bigcommerce.com