# FDA WARNING_LETTER - Staccato Ventures LLC d/b/a Carolina Vape Kings - August 05, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/staccato-ventures-llc-dba-carolina-vape-kings/4f2ea6fc-c0e2-4fcd-b4d5-786ffb9dde01

> FDA WARNING_LETTER for Staccato Ventures LLC d/b/a Carolina Vape Kings on August 05, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Staccato Ventures LLC d/b/a Carolina Vape Kings
- Inspection Date: 2021-08-05
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Staccato Ventures LLC d/b/a Carolina Vape Kings after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act. The letter states that "THE VAPIN SON Pimp Juice .3% e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). The manufacture, sale, and/or distribution of this product without authorization constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA notes that the firm is a registered manufacturer with over 22,000 listed products and is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective

## Related Documents

- [WARNING_LETTER - 2022-09-08](https://www.globalkeysolutions.net/records/warning_letter/staccato-ventures-llc-dba-carolina-vape-kings/815ce88e-78b2-45dc-9b26-6ef0dd7fda61)
- [WARNING_LETTER - 2022-09-22](https://www.globalkeysolutions.net/records/warning_letter/staccato-ventures-llc-dba-carolina-vape-kings/c99572f7-4264-4373-a016-923acc1ee7ea)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/staccato-ventures-llc-dba-carolina-vape-kings/5437e0f6-e096-4625-a194-ebb4d8625317

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