FDA WARNING_LETTER - Discreet Vapes - June 22, 2023

The FDA's Center for Tobacco Products reviewed discreetvapes.com and determined it offers electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include nicotine from any source.

The FDA identified two specific ENDS products, "Escobar 2500 Blue Raspberry" and "Elfbar 5000 Mango Peach Apricot," being sold without the required premarket authorization. These are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption.

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 premarket authorization and failure to provide necessary information under section 905(j).

The FDA requires the firm to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also notes that tobacco products offered for import that appear