# FDA WARNING_LETTER - ECIGRUSA LLC, d/b/a Worldwide Vape Distribution - May 16, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/ecigrusa-llc-dba-worldwide-vape-distribution/89e91291-d084-4d03-9ebb-acf851377350

> FDA WARNING_LETTER for ECIGRUSA LLC, d/b/a Worldwide Vape Distribution on May 16, 2025. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ECIGRUSA LLC, d/b/a Worldwide Vape Distribution
- Inspection Date: 2025-05-16
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On May 15, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to ECIGRUSA LLC, d/b/a Worldwide Vape Distribution, for selling and distributing unauthorized electronic nicotine delivery system (ENDS) products. The FDA determined that the company offers for sale the "FRIOBAR DB7000 Peach Ice 50mg/mL 16mL (5 PCS)" ENDS product, which is considered a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

This product lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The letter emphasizes that ENDS products, including those containing nicotine from any source, are subject to FDA jurisdiction and must comply with the FD&C Act and its implementing regulations.

ECIGRUSA LLC must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ecigrusa-llc-dba-worldwide-vape-distribution/c351bf44-6f21-40d8-a41f-0889989558d8

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