FDA WARNING_LETTER - Elite Brothers, LLC - January 09, 2025

On January 7, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Elite Brothers, LLC, located at 472 Amherst Street, Unit 3, Nashua, NH 03063. The letter states that Elite Brothers, LLC manufactures, sells, and/or distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include products containing nicotine from any source.

The FDA determined that Elite Brothers, LLC is marketing a "new tobacco product," SaltBae50 – Strawberry Lemonade 50mg, without the required premarket authorization order. This product is considered "new" because it was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt.

Consequently, the product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). The FDA requires Elite Brothers, LLC to submit a written response within 1