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  5. Mac Vapes LLC d/b/a Oishi Jusu - 585031 - 11/13/2019
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Mac Vapes LLC d/b/a Oishi Jusu MARCS-CMS 585031 —

Delivery Method:
VIA UPS and Electronic Mail
Reference #:

Recipient Name
Frederick McCullough
Mac Vapes LLC d/b/a Oishi Jusu

361 Cleveland Place
Suite 105
Virginia Beach, VA 23462
United States

Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Frederick McCullough:

On August 8, 2019, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued a Warning Letter to you informing you that your The Ronins e-liquid tobacco product is misbranded because its labeling does not display the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3.

We acknowledge receipt of your e-mail correspondences dated August 8, 2019 and September 12, 2019, regarding the Warning Letter and corrective actions taken. In addition, FDA held a teleconference with you on September 11, 2019 to provide clarification regarding 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.

Ele Ibarra-Pratt
Division of Promotion, Advertising and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products

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