FDA Letter API

Aspen Valley Vapes

Letter data

Company
Aspen Valley Vapes
Recipient
Andrew Flynn | Aspen Valley Vapes | 14 Inverness Drive East | Suite B132 | Englewood | , | CO | 80112 | United States | aflynn@aspenvalleyvapes.com | info@aspenvalleyvapes.com
Issue date
2018-10-26
Posted date
Not available
FDA office
Center for Tobacco Products
Subject
Not available
Product
Not available
CMS ID
563210
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 Aspen Valley Vapes MARCS-CMS 563210 — October 26, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS and Electronic Mail Recipient: Recipient Name Andrew Flynn Aspen Valley Vapes 14 Inverness Drive East Suite B132 Englewood , CO 80112 United States aflynn@aspenvalleyvapes.com info@aspenvalleyvapes.com Issuing Office: Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Andrew Flynn: On September 12, 2018, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter informing you that your Whip'd Strawberry 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 Whip'd Strawberry 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 September 19, 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. 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 cc: GoDaddy.com, LLC abuse@godaddy.com Rackco.com abuse@rackco.com Content current as of: 03/28/2019