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CLOSEOUT LETTER

Vapor Unlimited, LLC d/b/a Fogworks MARCS-CMS 562953 — Nov 06, 2018

Vapor Unlimited, LLC d/b/a Fogworks - 562953 - 11/06/2018

Delivery Method:
VIA UPS and Electronic Mail
Reference #:
1800941
Product:
Tobacco

Recipient:
Recipient Name
Trevor Campbell
Vapor Unlimited, LLC d/b/a Fogworks

32733 Eiland Blvd.
Ste 102
Wesley Chapel, FL 33545
United States

vaporunlimtedllc@gmail.com
Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Trevor Campbell:

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 Candy King Sour Worms 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 Candy King Sour Worms 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 September 13, 2018, September 17, 2018, and September 27, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on September 13, 2018 and October 16, 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 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/
Ele lbarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products

VIA UPS and Electronic Mail

cc:

Azim Chowdhury
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
chowdhury@khlaw.com

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