SWMO Vape Shop, LLC – FDA Warning Letter, Sep 8, 2022

On September 8, 2022, the FDA issued a Warning Letter to SWMO Vape Shop, LLC, following a review of submissions and inspection records. The FDA determined that SWMO Vape Shop manufactures and distributes e-liquid products, specifically "SWMO VaPE SHOP Rock Flag and Eagle 1mg/120ml e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "SWMO VaPE SHOP Rock Flag and Eagle 1mg/120ml e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided under section 905(j).

The letter states that the failure to provide a required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in adulterated or misbranded products held for sale after interstate shipment is prohibited under section 301(k).

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