# FDA WARNING_LETTER - Hookies and Bookies - February 03, 2022

Source: https://www.keypedia.com/records/warning_letter/hookies-and-bookies/fde0772a-0d59-41c4-954e-f2d960bdb8aa

> FDA WARNING_LETTER for Hookies and Bookies on February 03, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hookies and Bookies
- Inspection Date: 2022-02-03
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On February 3, 2022, the FDA issued a Warning Letter to Hookies and Bookies for manufacturing and distributing e-liquid products, specifically "Red Apple Nic 0.3salt e-liquid," without required premarket authorization. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The "Red Apple Nic 0.3salt e-liquid" product is classified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. The company failed to obtain a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or demonstrate an exemption. Consequently, the product is 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 notice or information under section 905(j).

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act for holding for sale an adulterated or misbranded product and failing to provide a required report, respectively. Hookies and Bookies is a registered manufacturer with over 1,300 listed products. The FDA emphasized that

## Related Officers

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

Company: https://www.keypedia.com/companies/hookies-and-bookies/792917b6-d7e6-4fa3-ba53-247f97eb3bbf

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