Cajun Vapes LLC – FDA Warning Letter, Oct 26, 2023

The FDA issued a Warning Letter to Cajun Vapes LLC on October 26, 2023, following a review of inspection records. The FDA determined that Cajun Vapes LLC manufactures and distributes e-liquid products, including "Strawberry Cheesecake," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. The "Strawberry Cheesecake" e-liquid product was not commercially marketed by the February 15, 2007, deadline and lacks the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) 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). Prohibited acts include holding for sale adulterated or misbranded products (section 301(k)) and failing to provide required reports (section 30