# FDA WARNING_LETTER - willyanjel enterprises llc  - October 06, 2022

Source: https://www.keypedia.com/records/warning_letter/willyanjel-enterprises-llc/3edc5bb4-bc2f-4698-a4f6-07441582a694

> FDA WARNING_LETTER for willyanjel enterprises llc  on October 06, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: willyanjel enterprises llc 
- Inspection Date: 2022-10-06
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to WillyAnjel Enterprises LLC d/b/a Emote Vapes on October 6, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "BLUE MOON e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "BLUE MOON e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA states that the failure to provide the required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in adulterated or misbranded products held for sale after interstate shipment is prohibited under section 301(k).

WillyAnjel

## Related Officers

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

Company: https://www.keypedia.com/companies/willyanjel-enterprises-llc/59935b31-0f10-41b6-9f0b-d82ee682c790

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