FDA WARNING_LETTER - ECBlend LLC - March 08, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Carol Williams and Bob Foote of ECBlend Flavors, LLC, following a review of their website, ecblendflavors.com. The FDA determined that e-liquid products, including "Baja Burst," "Fruit Rainbow," and "Sweet and Tart," are manufactured and offered for sale in the U.S. and are considered tobacco products under the FD&C Act.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

While ECBlend is a registered manufacturer with over 21,000 products listed and submitted Premarket Tobacco Product Application (PMTA) STN PM0001733 for 11,297 products, this application received a "Refuse to File" determination on September 2, 2021.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as