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CLOSEOUT LETTER

13th Floor Elevapors LLC - s Jul 31, 2018

13th Floor Elevapors LLC - Close Out Letters 7/31/18


13th Floor Elevapors LLC - s

  

Department of Health and Human Services logo

 
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

 
July 31, 2018
 
VIA UPS and Electronic Mail
 
Chris Warkenton and Randall Dalby  
13th Floor Elevapors, LLC  
3303 Harbor Blvd Suite F5
Costa Mesa, CA 92626
 
RE: Warning Letter issued to 13th Floor Elevapors, LLC (RW1800861)
 
Dear Chris Warkenton and Randall Dalby:
 
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 Frank ‘N Vape 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 Frank ‘N Vape 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 26, 2018, May 30, 2018, July 5, 2018, and July 19, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on June 14, 2018 and July 19, 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.
 
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 UPS and Electronic Mail
 
cc:
 
Phil Daman
Daman and Associates, LLP
1455 Pennsylvania Ave, Suite 400
Washington, D.C. 20004
 
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