# FDA WARNING_LETTER - Cool Vapes Allison Park - August 26, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/cool-vapes-allison-park/808f307a-ce32-4d43-8024-d1f9b4a0ddcc

> FDA WARNING_LETTER for Cool Vapes Allison Park on August 26, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cool Vapes Allison Park
- Inspection Date: 2021-08-26
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Cool Vapes, LLC, identifying that their e-liquid products, specifically "Cool Vapes Looper 30ml 0.3% e-liquid," are tobacco products subject to FDA jurisdiction. The letter states that this product is a "new tobacco product" as it was not commercially marketed in the U.S. before February 15, 2007.

The primary violation is that Cool Vapes, LLC manufactures, sells, and/or distributes this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided. Prohibited acts under sections 301(k) and 301(p) of the FD&C Act are cited.

Cool Vapes, LLC, a registered manufacturer with over 19,400 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for maintaining compliance. Failure to address these issues may result in regulatory actions such as civil

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.globalkeysolutions.net/companies/cool-vapes-allison-park/1290480b-d1bd-46a5-b050-7b3460951b6e

Office: https://www.globalkeysolutions.net/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374