VallHund Vapes Inc.

CLOSEOUT LETTER VallHund Vapes Inc. MARCS-CMS 553031 — July 13, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: VallHund Vapes Inc. United States Issuing Office: United States U.S. Food & Drug Administration Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 VIA Electronic Mail Michael De Pinto VallHund Vapes Inc. vallhundvapes@gmail.com RE: Warning Letter issued to VallHund Vapes Inc. (RW1800854) Dear Michael De Pinto: On May 10, 2018, the United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Chill Purple Grape 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 sold it 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 Chill Purple Grape 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 Chill Purple Grape e-liquid from your website. On May 10, 2018, you sent FDA a response to the Warning Letter, and we had a teleconference on May 11, 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 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 Electronic Mail cc: GoDaddy.com, LLC abuse@godaddy.com Shopify, Inc. abuse@shopify.com Content current as of: 08/23/2018