FDA WARNING_LETTER - E-Juice Vapor, Inc. - May 31, 2023

On May 31, 2023, the FDA issued a Warning Letter to Hind Malik regarding the sale of electronic nicotine delivery system (ENDS) products on the website https://www.ejuicevapor.com. The FDA determined that "Puff Bar" ENDS products, specifically "Puff Bar 300 Disposable – Cucumber" and "Puff Bar 300 Disposable– Grape," are offered for sale or distribution in the United States.

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 products containing nicotine from any source. The FDA found these products to be "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

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 marketing authorization and failure to provide necessary information under section 905(j). The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales