FDA WARNING_LETTER - dripcratevapeshop.com - April 15, 2025

The FDA's Center for Tobacco Products issued a Warning Letter on April 04, 2025, to Dripcratevapeshop.com after reviewing its website and determining that electronic nicotine delivery system (ENDS) products were offered for sale to U.S. customers. These products, including those containing nicotine from any source, are regulated as tobacco products under section 201(rr) of the FD&C Act. The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as stipulated by section 910(a) of the FD&C Act. Specifically, products like Elf Bar TE5000 – Strawberry Swirl and Elf Bar BC5000 Ultra – Tropical Prism Blast were cited as lacking FDA marketing authorization. Consequently, these unauthorized products are considered 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 notification under section 905(j). The FDA requires the firm to submit a written response within 15 working days, detailing corrective actions, including the discontinuation of violative sales and a plan for maintaining compliance. Failure to address these violations could lead to significant regulatory actions, such as civil money penalties, product seizure, injunctions, and import detentions.