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  5. Ultimate Vape Deals - Close Out Letter 7/13/18
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CLOSEOUT LETTER

Ultimate Vape Deals Jul 13, 2018

Ultimate Vape Deals - Close Out Letter 7/13/18


Recipient:
Ultimate Vape Deals


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
 
Ultimate Vape Deals
7600 Chevy Chase Drive
Building 2, Suite 300
Austin, TX 78752
 
RE: Warning Letter issued to Ultimate Vape Deals (RW1800865)
 
Dear Ultimate Vape Deals:
 
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 Vape Heads Sour Smurf Sauce 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 Vape Heads Sour Smurf Sauce 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 Vape Heads Sour Smurf Sauce e-liquid from your website.
 
On May 9, 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. 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 Ibarra-Pratt
Division Director
Office of Compliance and Enforcement
Center for Tobacco Products 
 
 
 
VIA UPS and Electronic Mail
 
cc:
 
Ultimate Vape Deals
1499 Pomona Road
Corona, CA 92882
 
Sean R. Kelley
Kelley Law
1147 Railroad Street
Corona, CA 92882
 
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