Alohma LLC d/b/a Kure Vaporium – FDA Warning Letter, Jul 23, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Alohma LLC d/b/a Kure Vaporium on July 23, 2024, following a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "Baby Beetle" e-liquid products without the required premarket authorization. These products are considered "new tobacco products" because they were not commercially marketed in the United States as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they 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 absence of required notice or information under section 905(j).

Alohma LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such