Omnia E-Liquid

CLOSEOUT LETTER Omnia E-Liquid MARCS-CMS 553221 — August 22, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Omnia E-Liquid United States Issuing Office: United States Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring, MD 20993 AUG 22, 2018 VIA UPS and Electronic Mail Michael Eshragh Omnia E-Liquid 6000 S Eastern Ave, Suite 5E Las Vegas, NV 89119 michael@omniaeliquid.com RE: Warning Letter issued to Omnia E-Liquid (RW1800862) Dear Michael Eshragh: 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 Twirly Pop 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). Additionally, the Warning Letter informed you that you violated section 201(rr)(4) of the  FD&C Act by marketing your product in combination with food. Specifically, FDA determined that the labeling and/or advertising of your Twirly Pop 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 Twirly Pop e-liquid from your website. Additionally, FDA determined that you marketed and co-packaged Twirly Pop e-liquid in combination with a food, particularly a lollipop, in violation of section 201(rr)(4) of the FD&C Act. On May 1, 2018, July 10, 2018, July 31, 2018, August 8, 2018, and August 15, 2018, you sent FDA a response to the Warning Letter, and we held a teleconference on June 20, 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: Domains By Proxy, LLC omniaeliquid.com@domainsbyproxy.com twirlypopeliquid.com@domainsbyproxy.com GoDaddy.com, Inc. abuse@godaddy.com Shopify, Inc. abuse@shopify.com Content current as of: 08/22/2018