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 soldthem 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.