NEwhere Inc. d/b/a Mad Hatter Juice

CLOSEOUT LETTER NEwhere Inc. d/b/a Mad Hatter Juice MARCS-CMS 548076 — July 13, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: NEwhere Inc. d/b/a Mad Hatter Juice 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 Ali Esmaili NEwhere Inc. d/b/a Mad Hatter Juice 19801 Nordhoff Pl #107 Chatsworth, CA 91311 info@MadHatterJuice.com ali@newhere.com RE: Warning Letter issued to NEwhere Inc. d/b/a Mad Hatter Juice (RW 1800836) Dear Ali Esmaili: 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 One Mad Hit Juice Box 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 One Mad Hit Juice Box 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 10, 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 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 VIA UPS and Electronic Mail cc: VapeCo Distribution LLC Attn: Jameson Rodgers 9301 Oakdale Ave Suite #104 Chatsworth, CA 91311 One Hit Wonder Holdings, LLC Attn: Andrew Gale 1820 W. Orangewood Ave, Ste 104B Orange, CA 92868 GoDaddy.com, LLC abuse@godaddy.com Shopify Inc. abuse@shopify.com Content current as of: 08/23/2018