FDA WARNING_LETTER - GlenVape, Inc - May 01, 2024

The FDA issued a Warning Letter to Edwin Baghdasaryan, operating Glencape.com, on April 30, 2024, after reviewing the website and determining that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the U.S. These products are considered 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 "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products "FUNKY Republic / FUNKY Lands Ti 7000 Puff Ice Mint" and "ELFBAR / EB BC5000 Miami Mint" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

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