The Vapor Studio LLC

CLOSEOUT LETTER The Vapor Studio LLC MARCS-CMS 562776 — October 24, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS and Electronic Mail Recipient: Recipient Name Earl Wilson, Delia Wilson, and C.J. Wilson The Vapor Studio LLC 11139 N. IH 35 Suite 176 Austin , TX 78753 United States thevaporstudio@gmail.com Issuing Office: Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Earl Wilson, Delia Wilson, and C.J. Wilson: On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Candy King Batch 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. Specifically, FDA determined that the labeling and/or advertising of your Candy King Batch 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 September 27, 2018 and September 28, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on October 10, 2018 to discuss the Warning Letter and your response. 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. 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 cc: Azim Chowdhury Keller and Heckman LLP 1001 G Street NW, Suite 500 West Washington, DC 20001 chowdhury@khlaw.com GoDaddy.com, LLC abuse@godaddy.com Bigcommerce, Inc. abuse@bigcommerce.com Content current as of: 03/28/2019