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  5. FireVapor.com - 563335 - 11/14/2018
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CLOSEOUT LETTER

FireVapor.com MARCS-CMS 563335 — Nov 14, 2018

FireVapor.com - 563335 - 11/14/2018

Delivery Method:
Electronic Mail
Reference #:
1800961
Product:
Tobacco

Recipient:
Recipient Name
Jason Ogden
FireVapor.com

United States

ceo@firevapor.com
inquiry@firevapor.com
Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Jason Ogden:

On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your V'Nilla Cookies and Milk e-liquid product 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 V'Nilla Cookies & Milke-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 September 12, 2018, October 22, 2018, and November 8, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on October 22, 2018, and November 8, 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 violation 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

 

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