CLOSEOUT LETTER
Fog It Up MARCS-CMS 553051 —
- Recipient:
- Fog It Up
United States
- Issuing Office:
United States
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Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
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July 13, 2018
VIA USPS and Electronic Mail
Fog It Up
P.O Box 9418
Fountain Valley, CA 92728
admin@fogitup.com
RE: Warning Letter issued to Fog It Up (RW1800857)
Dear Fog It Up:
On May 1, 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 & 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. The Warning Letter also informed you that this product ismisbranded under section 903(a)(7)(B) because you sold itto a person younger than 18 years of age, in violation of 21 C.F.R. § 1140.14(b)(1). Specifically, FDA determined that the labeling and/or advertising of your V’Nilla Cookies & Milk 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. FDA also determined that a person younger than 18 years of age was able to purchase V’Nilla Cookies & Milk e-liquid from your website.
Based on our evaluation, it appears that you have taken steps to address the violations 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/
/S/
Ele Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
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