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  5. On Cloud Vape - 548412 - 07/13/2018
  1. Warning Letters

CLOSEOUT LETTER

On Cloud Vape MARCS-CMS 548412 —

Recipient:
On Cloud Vape

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
U.S. Food & Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

VIA UPS and Electronic Mail
 
Jin Back
On Cloud Vape
808 Western Ave Suite 101
Los Angeles, CA 90005
oncloudvape@outlook.com
 
 
RE: Warning Letter issued to On Cloud Vape (RW1800845)               
 
Dear Jin Back:
 
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 Candy King Batch and Candy King Sour Worms e-liquid products are misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because their labeling and/or advertising is false or misleading. The Warning Letter also informed you that these products are misbranded under section 903(a)(7)(B) because you soldthem 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 Candy King Batch and Candy King Sour Worms e-liquids is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the products 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 Candy King Batch and Candy King Sour Worms e-liquids from your website.
 
On May 3, 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:
 
Jin Back
341 S. Kenmore Ave. Apt. 121
Los Angeles, CA 90020
jin.k.back@outlook.com
 
Godaddy.com, LLC
abuse@gdaddy.com
 
Site Group Chicago
abuse@siteground.com
 

 

 
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