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  5. 8937001 Canada Inc. d/b/a Chill E-Liquid - Close Out Letter 7/13/18
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CLOSEOUT LETTER

8937001 Canada Inc. d/b/a Chill E-Liquid Jul 13, 2018

8937001 Canada Inc. d/b/a Chill E-Liquid - Close Out Letter 7/13/18


Recipient:
8937001 Canada Inc. d/b/a Chill E-Liquid


United States

Issuing Office:

United States


 

  

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

 

VIA Electronic Mail
 
Lie Lu and Abbas Dattu
8937001 Canada Inc. d/b/a Chill E-Liquid
 
RE: Warning Letter issued to 8937001 Canada Inc. d/b/a Chill E-Liquid (RW1800859)
 
Dear Lie Lu and Abbas Dattu:
 
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 Chill Purple Grape 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 misleadingSpecifically, FDA determined that the labeling and/or advertising of your Chill Purple Grape 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 31, 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 violation 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 
 
 
 
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Thompson Hine LLP
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