Tinted Brew, Inc

CLOSEOUT LETTER Tinted Brew, Inc MARCS-CMS 553052 — July 31, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Tinted Brew, Inc United States Issuing Office: United States Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 July 31, 2018 VIA UPS and Electronic Mail Jonathan Nemr Tinted Brew, Inc. 21416 Chase St.,Ste 1 Canoga Park, CA 91304-2547 info@tintedbrew.com jon@tintedbrew.com RE: Warning Letter issued to Tinted Brew Inc.(RW1800856) Dear Jonathan Nemr: 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 V’Nilla Cookies & Milk 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 V’Nilla Cookies & Milk 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 May 22, 2018, June 7, 2018, July 2, 2018, and July 10, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on June 7, 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. 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: Areta Kupchyk Foley Hoag LLP 1717 K Street NW Washington, DC 20006 akupchyk@foleyhoag.com Domains By Proxy, LLC TINTEDBREW.COM@domainsbyproxy.com GoDaddy.com abuse@godaddy.com Shopify Inc. abuse@shopify.com Content current as of: 08/23/2018