FDA WARNING_LETTER - k & c aitken, llc - December 12, 2023

On December 1, 2023, the FDA issued a Warning Letter to Katy and Casey Aitken regarding e-liquid products sold on https://elysianlabs.co. The FDA determined these products are "tobacco products" under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products with nicotine from any source.

The FDA found that products including "The Nilla - Elysian Labs," "Skadi - Elysian Labs," and "Stra’Nilla Cake - Elysian Labs" are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for not providing required notice under section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.