# FDA WARNING_LETTER - Twisted Tongue Inc. - April 05, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/twisted-tongue-inc/7ef60f32-70ee-4d1b-9ae2-2a7a5a41afcc

> FDA WARNING_LETTER for Twisted Tongue Inc. on April 05, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Twisted Tongue Inc.
- Inspection Date: 2022-04-05
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to William and Kimberly Hollman of Twisted Tongue Vapor on November 24, 2021, following a review of their website, https://www.twistedtonguevapor.com. The FDA determined that their e-liquid products, including "Twisted Tongue Fruit Cereal Milk" and "Twisted Tongue Something Fruity," are "new tobacco products" under the FD&C Act (21 U.S.C. § 321(rr)) because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being marketed without the required premarket authorization order (21 U.S.C. § 387j(c)(1)(A)(i)), rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA noted that while the firm is a registered manufacturer with over 90 products listed, their multiple Premarket Tobacco Product Applications (PMTAs) submitted on September 8 and 9, 2020, covering 99 products, received Marketing Denial Order determinations on September 13 and October 5, 2021.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [William Hollman](https://www.globalkeysolutions.net/people/william-hollman/bf11e24a-310b-4a18-83ea-2185bc5695bb)
- [Kimberly Hollman](https://www.globalkeysolutions.net/people/kimberly-hollman/280c6c98-9159-4b09-84e4-506f8934b379)

Company: https://www.globalkeysolutions.net/companies/twisted-tongue-inc/16738f5f-8828-4349-96d6-8b053f0a9f08

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