# FDA WARNING_LETTER - Wyo Witches Brew LLC - June 29, 2021

Source: https://www.keypedia.com/records/warning_letter/wyo-witches-brew-llc/c50f0098-ee0d-4f5f-ac83-6764ac5252cd

> FDA WARNING_LETTER for Wyo Witches Brew LLC on June 29, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Wyo Witches Brew LLC
- Inspection Date: 2021-06-29
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to Holly Stone regarding e-liquid products sold on https://wyowitchesbrew.company. The FDA determined that products like Wyo Witches Brew Warlock and Wyo Witches Brew Strawberry Ice Cream are "new tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation (21 C.F.R. § 1100.1). These products were found to be marketed without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act for new tobacco products not commercially marketed before February 15, 2007. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required information under section 905(j). The firm, a registered manufacturer with over 9,700 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.

## Related Officers

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

Company: https://www.keypedia.com/companies/wyo-witches-brew-llc/aa45abc9-98e0-4191-bc8f-0eb2918b680e

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