Edora Solutions, Inc d/b/a JoJo Vapes Vandalia – FDA Warning Letter, Sep 2, 2021

The FDA issued a Warning Letter to Edora Solutions, Inc d/b/a JoJo Vapes Vandalia for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that JoJo Vapes Candy Cane 12mg 120ml e-liquid is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for not providing required information under section 905(j). The failure to provide such a report is a prohibited act under section 301(p).

Edora Solutions, Inc. is a registered manufacturer with over 21,600 products listed. Their Premarket Tobacco Product Application (PMTA), STN PM0003754, submitted on September 9, 2020, received a refuse to accept determination on June 30, 2021, covering 1,975 products. The FDA emphasizes that all new tobacco products without required marketing authorization are adulterated and misbranded.

The company must submit a written response within 15 working days detailing actions to address violations, including discontinuing violative sales