FDA Letter API

Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail

Letter data

Company
Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail
Recipient
Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail | United States
Issue date
2018-07-31
Posted date
Not available
FDA office
United States
Subject
Not available
Product
Not available
CMS ID
553196
Reference number
Not available
FEI
Not available
Inspection dates
2018-06-13 to 2018-07-19

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail MARCS-CMS 553196 — July 31, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail 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 Nicholas S. Warrender Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail 12715 210 th Avenue Bristol, WI 53104 info@liftedliquids.com RE: Warning Letter issued to Warrender Enterprise Inc. d/b/a Lifted Liquids and E-Liquid Retail (RW1800864) Dear Nicholas S. Warrender: 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 Vape Heads Sour Smurf Sauce 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 Vape Heads Sour Smurf Sauce 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 2, 2018, June 14, 2018, July 12, 2018, and July 19, 2018, you sent FDA a response to the Warning Letter, and we held teleconferences on June 13, 2018 and July 19, 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: H. Scott Hecker Law Offices of H. Scott Hecker, P.A. 400 Southeast Ninth Street Fort Lauderdale, FL 33316 heckerlawfirm@gmail.com Nicholas Warrender liftedbusiness@gmail.com Network Solutions, LLC abuse@web.com GoDaddy.com, LLC abuse@godaddy.com Amazon Technologies Inc. abuse@amazonaws.com Shopify, Inc. abuse@shopify.com Content current as of: 08/23/2018