FDA WARNING_LETTER - Trippy Drips LLC - October 26, 2023

The FDA issued a Warning Letter to Trippy Drips LLC on October 26, 2023, following a review of inspection records. The FDA determined that Trippy Drips LLC manufactures and distributes e-liquid products, 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. Specifically, the e-liquid product "Furberry" was 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 FDA states that manufacturing, selling, or distributing such adulterated or misbranded products is a prohibited act under section 301(k) and failure to provide required reports is a prohibited act under section 301(p). Trippy Drips LLC is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for maintaining compliance. Failure