FDA WARNING_LETTER - Caribbean Cloud Dot Com d/b/a Gorilla Vapes LLC - September 21, 2023

The FDA issued a Warning Letter to Caribbean Cloud Dot Com d/b/a Gorilla Vapes on September 21, 2023, based on a review of inspection records. The company manufactures and distributes e-liquid products, including "GRAPE," which are considered tobacco products under the FD&C Act, specifically section 201(rr), due to containing nicotine.

The primary violation 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 "GRAPE" e-liquid product was not commercially marketed by the February 15, 2007, predicate date and lacks FDA marketing authorization.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided. Prohibited acts include holding for sale adulterated or misbranded products (section 301(k)) and failing to provide required reports (section 301(p)).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and