E-Vaperz Spring Hill Location LLC – FDA Warning Letter, Jun 15, 2021

The FDA issued a Warning Letter to e-Vaperz, LLC, following a review of submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically e-Vaperz Aqua Berry Blast 6mg e-liquid. These products are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The e-Vaperz Aqua Berry Blast 6mg e-liquid product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. Prohibited acts include holding for sale adulterated/misbranded products (section 301(k)) and failing to provide required reports (section 301(p)).

e-Vaperz, LLC is a registered manufacturer with over 9,800 listed products. The FDA requires prompt corrective action, including discontinuing the violative sale and distribution of these products, and a plan for maintaining compliance. Failure to address these issues may result in regulatory actions such as civil money penalties, seizure, and/or injunction.