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

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