# FDA WARNING_LETTER - Vapors of Ohio Inc d/b/a Nostalgic Vapes - December 08, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/vapors-of-ohio-inc-dba-nostalgic-vapes/7f6b369f-7687-4e20-8d6d-70f865788312

> FDA WARNING_LETTER for Vapors of Ohio Inc d/b/a Nostalgic Vapes on December 08, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vapors of Ohio Inc d/b/a Nostalgic Vapes
- Inspection Date: 2022-12-08
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On December 8, 2022, the FDA issued a Warning Letter to Vapors of Ohio Inc d/b/a Nostalgic Vapes for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that the "FLVR SHOP E-LIQUID GLZD-DNT 6mg 120ml" e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under section 201(rr) of the FD&C Act, e-liquid products are considered tobacco products subject to FDA jurisdiction. The company failed to obtain a premarket authorization order under section 910(c)(1)(A)(i) or demonstrate an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company must submit a written response within 15 working days detailing actions to address violations, including discontinuing violative sales and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/vapors-of-ohio-inc-dba-nostalgic-vapes/be48efdd-2e55-443e-86d3-fdd75a8527c0

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