FDA WARNING_LETTER - Northwest Freedom Vape LLC d/b/a Northwest Freedom Vape - April 15, 2025

The FDA issued a Warning Letter to Northwest Freedom Vape LLC d/b/a Northwest Freedom Vape on April 10, 2025, following a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Camp Leader" e-liquid is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product 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 as required by section 905(j).

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement. Northwest Freedom Vape LLC is required to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15