FDA WARNING_LETTER - Edora Solutions, Inc d/b/a JoJo Vapes Brookville - January 18, 2022

The FDA issued a Warning Letter to Edora Solutions, Inc. d/b/a JoJo Vapes Brookville on January 18, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products are tobacco products subject to FDA jurisdiction.

Specifically, the "JoJo Vapes Altitude 15ml 3mg e-liquid product" is cited as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. This product lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

The firm is a registered manufacturer with over 21,600 products listed. A Premarket Tobacco Product Application (STN PM0003754), covering 1,975 products, was submitted but received a Refuse To Accept determination on June 30, 2021. All new tobacco products on the market without premarket authorization are unlawful.

The FDA requires a written response within