FDA WARNING_LETTER - willyanjel enterprises llc - October 06, 2022

The FDA issued a Warning Letter to WillyAnjel Enterprises LLC d/b/a Emote Vapes on October 6, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "BLUE MOON e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "BLUE MOON e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed 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 FDA states that the failure to provide the 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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