- Delivery Method:
- VIA UPS and Electronic Mail
- Reference #:
Recipient NameFrederick McCullough
- Mac Vapes LLC d/b/a Oishi Jusu
361 Cleveland Place
Virginia Beach, VA 23462
- Issuing Office:
- Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
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.
Division of Promotion, Advertising and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail