FDA WARNING_LETTER - KL Labs, LLC, d/b/a Known Distro - October 19, 2023

The FDA issued a Warning Letter to KL Labs, LLC, d/b/a Known Distro, on October 19, 2023, based on a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Sorbet Mango Jackfruit Nectarine, 3 mg 100 ml" was cited as a new tobacco product that was not commercially marketed before 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 introduction or delivery into interstate commerce of adulterated or misbranded tobacco products is a prohibited act under section 301(a), and failure to provide a required report under section 905(j) is a prohibited act under section 301(p).

KL Labs, LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation of viol