# FDA WARNING_LETTER - Exotic Wholesale LLC - September 16, 2024

Source: https://www.keypedia.com/records/warning_letter/exotic-wholesale-llc/453690aa-24ff-43a5-b2f1-d58357f6cafa

> FDA WARNING_LETTER for Exotic Wholesale LLC on September 16, 2024. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Exotic Wholesale LLC
- Inspection Date: 2024-09-16
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to Exotic Wholesale LLC, identifying that the company sells and distributes e-liquid products, specifically "Cloud Nurdz SALTS GUAVA PASSIONFRUIT 50mg 30ml," in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, especially after the 2022 amendment extending jurisdiction to products with nicotine from any source. The FDA determined that the aforementioned e-liquid product is a "new tobacco product" because it was not commercially marketed before February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 absence of required notice under section 905(j). Exotic Wholesale LLC is required to submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may lead to regulatory actions such as civil money penalties, product seizure, or injunction.

## Related Officers

- [Director](https://www.keypedia.com/people/john-e-verbeten/80be3640-a657-41ff-92c0-f6178bd12378)

Company: https://www.keypedia.com/companies/exotic-wholesale-llc/82b48dcc-0fea-4835-a519-35335cd28169

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