# FDA WARNING_LETTER - Vapor Candy Inc d/b/a The Vape Stop - December 01, 2022

Source: https://www.keypedia.com/records/warning_letter/vapor-candy-inc-dba-the-vape-stop/f6780d82-d8a4-4657-b229-ba7c6e08fee1

> FDA WARNING_LETTER for Vapor Candy Inc d/b/a The Vape Stop on December 01, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vapor Candy Inc d/b/a The Vape Stop
- Inspection Date: 2022-12-01
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On December 1, 2022, the FDA issued a Warning Letter to Vapor Candy Inc d/b/a The Vape Stop, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product," specifically Vapor Candy Xtra Sweet VS Reserve 6MG e-liquid, without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or 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 failure to provide required notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires the company to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant

## Related Officers

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

Company: https://www.keypedia.com/companies/vapor-candy-inc-dba-the-vape-stop/eba55322-ced9-4442-99fe-60601664197f

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