# FDA WARNING_LETTER - YCE DREAM LLC, d/b/a Space Vapor - May 02, 2025

Source: https://www.keypedia.com/records/warning_letter/yce-dream-llc-dba-space-vapor/2faddb9d-ab6d-4d5f-bd79-48e401a0d6e2

> FDA WARNING_LETTER for YCE DREAM LLC, d/b/a Space Vapor on May 02, 2025. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: YCE DREAM LLC, d/b/a Space Vapor
- Inspection Date: 2025-05-02
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On May 1, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to YCE DREAM LLC, d/b/a Space Vapor, for manufacturing, selling, and/or distributing e-liquid products without required marketing authorization. The FDA determined that Space Vapor's e-liquid products, specifically "SPACE VAPOR PEANUTBUTTER 3MG," are "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine.

The key violation is the lack of a premarket authorization order as required by section 910(a) 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, as no notice or information was provided per section 905(j).

The FDA mandates that YCE DREAM LLC submit a written response within 15 working days from receipt of the letter. This response must detail actions taken to address the violations, including dates of discontinued sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter emphasizes the firm's responsibility to

## Related Officers

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

Company: https://www.keypedia.com/companies/yce-dream-llc-dba-space-vapor/d9ffce4e-ff25-4005-b7f1-ecaf5ea9238f

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