On Cloud Vape

CLOSEOUT LETTER On Cloud Vape MARCS-CMS 548412 — July 13, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: On Cloud Vape United States Issuing Office: United States U.S. Food & Drug Administration Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 VIA UPS and Electronic Mail Jin Back On Cloud Vape 808 Western Ave Suite 101 Los Angeles, CA 90005 oncloudvape@outlook.com RE: Warning Letter issued to On Cloud Vape (RW1800845) Dear Jin Back: 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 Candy King Batch and Candy King Sour Worms e-liquid products are misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because their labeling and/or advertising is false or misleading . The Warning Letter also informed you that these products are misbranded under section 903(a)(7)(B) because you sold them 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 Candy King Batch and Candy King Sour Worms e-liquids is misleading under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because it causes the products 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 Candy King Batch and Candy King Sour Worms e-liquids 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. 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: Jin Back 341 S. Kenmore Ave. Apt. 121 Los Angeles, CA 90020 jin.k.back@outlook.com Godaddy.com, LLC abuse@gdaddy.com Site Group Chicago abuse@siteground.com Content current as of: 08/23/2018