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  5. Elite Vaporworks - 553054 - 07/13/2018
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CLOSEOUT LETTER

Elite Vaporworks MARCS-CMS 553054 —

Recipient:
Elite Vaporworks

United States

Issuing Office:

United States

   

Department of Health and Human Services logo

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

 

JUly 13, 2018
 
VIA UPS and Electronic Mail
 
Jayson Vaughn
Elite Vaporworks
1905 Schuetz Road
St. Louis, MO 63146
info@elitevaporworks.com
 
RE: Warning Letter issued to Elite Vaporworks (RW1800855)
 
Dear Jayson Vaughn:
 
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 Whip’d Strawberry 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 is misbranded under section 903(a)(7)(B) because you soldit to 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 Whip’d Strawberry 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 Whip’d Strawberry e-liquid from your website.
 
On July 11, 2018, you sent FDA a response to the Warning Letter. 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 violations 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:
 
Jayson Vaughn
2306 Ball Drive
St. Louis, MO 63146
jaysonvaughn@gmail.com  
 
Timothy Vaughn
Elite Vaporworks, LLC
26 Stone Mill Lane
St. Peters, MO 63376
 
GoDaddy.com, LLC
abuse@godaddy.com  
 
DigitalOcean, LLC
abuse@digitalocean.com
 

 

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