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  5. Sugoi LLC - Close Out Letter 7/13/18
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CLOSEOUT LETTER

Sugoi LLC Jul 13, 2018

Sugoi LLC - Close Out Letter 7/13/18


Recipient:
Sugoi LLC


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 Electronic Mail
 
Albert Shu and Jason Lee
Sugoi LLC
d/b/a Sugoi Vapor
 
RE: Warning Letter issued to Sugoi LLC d/b/a Sugoi Vapor (RW1800845)
 
Dear Albert Shu and Jason Lee:
 
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 Pink Sticks 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 sold it 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 Pink Sticks 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 Pink Sticks e-liquid 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.  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:
 
Sugoi LLC d/b/a Sugoi Vapor
Attn: Albert Shu
6216 Harvey Way
San Gabriel, CA 91775
 
Jason Lee
 
GoDaddy.com, LLC
 
Shopify, Inc.