# FDA WARNING_LETTER - VapeHub Incorporated d/b/a VapeHub - February 22, 2024

Source: https://www.keypedia.com/records/warning_letter/vapehub-incorporated-dba-vapehub/d38dd015-ee9c-4394-bdb1-11cc46bbbed4

> FDA WARNING_LETTER for VapeHub Incorporated d/b/a VapeHub on February 22, 2024. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: VapeHub Incorporated d/b/a VapeHub
- Inspection Date: 2024-02-22
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On February 22, 2024, the FDA issued a Warning Letter to VapeHub Incorporated d/b/a VapeHub for manufacturing and distributing e-liquid products, specifically "Fusion," without required marketing authorization. The FDA determined these e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

The violations cited include:
- **Adulteration:** The products are adulterated under section 902(6)(A) of the FD&C Act because they lack FDA marketing authorization orders under section 910(c)(1)(A)(i) and are not otherwise exempt.
- **Misbranding:** The products are misbranded under section 903(a)(6) of the FD&C Act because required notice or information under section 905(j) was not provided.
- **Prohibited Acts:** The sale of adulterated/misbranded products (section 301(k)) and failure to provide required reports (section 301(p)) are prohibited.

VapeHub is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales/distribution and a plan for maintaining compliance. Failure to comply may result

## Related Officers

- [Acting Director](https://www.keypedia.com/people/ele-ibarra-pratt/c1e13bd6-9779-4877-a361-7b4bac089697)

Company: https://www.keypedia.com/companies/vapehub-incorporated-dba-vapehub/84a56e9f-8688-44df-afc3-059442273165

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