FDA Letter API

Ultimate Vape Deals

Letter data

Company
Ultimate Vape Deals
Recipient
Ultimate Vape Deals | United States
Issue date
2018-07-13
Posted date
Not available
FDA office
United States
Subject
Not available
Product
Not available
CMS ID
553198
Reference number
Not available
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: 21-CFR-1140.14(b)(1)

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 Ultimate Vape Deals MARCS-CMS 553198 — July 13, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Ultimate Vape Deals 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 Ultimate Vape Deals 7600 Chevy Chase Drive Building 2, Suite 300 Austin, TX 78752 ultimatevapedeals@gmail.com sales@ultimatevapedeals.com info@ultimatevapedeals.com RE: Warning Letter issued to Ultimate Vape Deals (RW1800865) Dear Ultimate Vape Deals: 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 . 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 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. FDA also determined that a person younger than 18 years of age was able to purchase Vape Heads Sour Smurf Sauce e-liquid from your website. On May 9, 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 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. 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: Ultimate Vape Deals 1499 Pomona Road Corona, CA 92882 pw-4d775ac8bddfaf8fd1b67fb84e1dd276@privacyguardian.org Sean R. Kelley Kelley Law 1147 Railroad Street Corona, CA 92882 sean@srkelleylaw.com NameSilo, LLC abuse@namesilo.com Shopify, Inc. abuse@shopify.com Content current as of: 08/23/2018