# FDA WARNING_LETTER - lousquare.com - June 17, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/lousquarecom/7b6415b2-20ba-4406-a507-b869ea83ec97

> FDA WARNING_LETTER for lousquare.com on June 17, 2025. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: lousquare.com
- Inspection Date: 2025-06-17
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On June 13, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on the website https://lousquare.com. The FDA determined that products offered for sale, specifically Fume Infinity Plus 4500 Puffs – Miami Mix and Fume Recharge 5000 Puffs – Peach Watermelon, are "new tobacco products" as defined by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)), meaning they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 38

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/lousquarecom/d00f9bdb-9fac-4156-9985-07eb8f7d7033)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/lousquarecom/6eafd4ac-2a99-413b-9b90-b7a61730bf5e

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