FDA WARNING_LETTER - FLVRS US, Inc. - March 07, 2024

On March 7, 2024, the FDA issued a Warning Letter to FLVRS US, Inc. for manufacturing and distributing unapproved e-liquid products. The FDA determined that FLVRS US, Inc. manufactures and distributes e-liquid products, including "PROPYLENE GLYCOL SALT NIC 100mg DV LABS 60mL," which are considered tobacco products under section 201(rr) of the FD&C Act. These products are subject to FDA jurisdiction and must comply with the FD&C Act.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified tobacco product marketed after this date. The identified e-liquid product was not commercially marketed by the specified date and lacks an FDA marketing authorization order, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The introduction or delivery of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act. Failure to provide a required report under section 905(j) is also a prohibited act under section 30