Elite Vaporworks

CLOSEOUT LETTER Elite Vaporworks MARCS-CMS 553054 — July 13, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Elite Vaporworks United States Issuing Office: United States Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 JUly 13, 2018 VIA UPS and Electronic Mail Jayson Vaughn Elite Vaporworks 1905 Schuetz Road St. Louis, MO 63146 info@elitevaporworks.com RE: Warning Letter issued to Elite Vaporworks (RW1800855) Dear Jayson Vaughn: 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 Whip’d Strawberry 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 . The Warning Letter also informed you that this product is misbranded under section 903(a)(7)(B) because you soldit 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 Whip’d Strawberry 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. FDA also determined that a person younger than 18 years of age was able to purchase Whip’d Strawberry e-liquid from your website. On July 11, 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: Jayson Vaughn 2306 Ball Drive St. Louis, MO 63146 jaysonvaughn@gmail.com Timothy Vaughn Elite Vaporworks, LLC 26 Stone Mill Lane St. Peters, MO 63376 GoDaddy.com, LLC abuse@godaddy.com DigitalOcean, LLC abuse@digitalocean.com Content current as of: 08/23/2018