# FDA WARNING_LETTER - Wolfe Trading Company LLC d/b/a East Coast Vapors - November 02, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/wolfe-trading-company-llc-dba-east-coast-vapors/aef64b38-b9fc-4901-8395-c413817a5422

> FDA WARNING_LETTER for Wolfe Trading Company LLC d/b/a East Coast Vapors on November 02, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Wolfe Trading Company LLC d/b/a East Coast Vapors
- Inspection Date: 2023-11-02
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On November 2, 2023, the FDA issued a Warning Letter to Wolfe Trading Company LLC d/b/a East Coast Vapors for manufacturing and distributing e-liquid products, specifically "Katy Perry," without required marketing authorization. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source.

The FDA determined that "Katy Perry" e-liquid products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of premarket authorization or substantial equivalence reports. The failure to provide required reports under section 905(j) is a prohibited act under section 301(p).

Wolfe Trading Company LLC is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/wolfe-trading-company-llc-dba-east-coast-vapors/489e6760-98e1-439d-8072-02a2c9d439e4

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