FDA Letter API

8937001 Canada Inc. d/b/a Chill E-Liquid

Letter data

Company
8937001 Canada Inc. d/b/a Chill E-Liquid
Recipient
8937001 Canada Inc. d/b/a Chill E-Liquid | United States
Issue date
2018-07-13
Posted date
Not available
FDA office
United States
Subject
Not available
Product
Not available
CMS ID
Not available
Reference number
Not available
FEI
Not available
Inspection dates
Not available

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 8937001 Canada Inc. d/b/a Chill E-Liquid July 13, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: 8937001 Canada Inc. d/b/a Chill E-Liquid 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 Lie Lu and Abbas Dattu 8937001 Canada Inc. d/b/a Chill E-Liquid sales@chilleliquid.com RE: Warning Letter issued to 8937001 Canada Inc. d/b/a Chill E-Liquid (RW1800859) Dear Lie Lu and Abbas Dattu: 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 . 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. On May 31, 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. 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: Eric Heyer Thompson Hine LLP 1919 M Street N.W. Washington, D.C. 20036-3537 eric.heyer@thompsonhine.com Domains By Proxy, LLC Chilleliquid.com@domainsbyproxy.com GoDaddy.com, LLC abuse@godaddy.com Amazon Technologies Inc. abuse@amazonaws.com Content current as of: 08/23/2018