FDA WARNING_LETTER - JMJ Howard Enterprises, Inc. d/b/a Netvapes - April 05, 2022

The FDA issued a Warning Letter to Jeremy Howard and Mark Howard of Netvapes on November 24, 2021, following a review of their website, https://www.netvapes.com. The review determined that Netvapes manufactures and offers e-liquid products for sale or distribution in the U.S., which are considered tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the e-liquid products "Sutter Buttes Reserve Blurrr" and "Netvapes Basics Lemonade" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lacked FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Netvapes is a registered manufacturer with over 560 products listed with FDA. Their Premarket Tobacco Product Application (PMTA) STN PM0003486, submitted September 8, 2020, received a Marketing Denial Order on September 16, 2021, covering 148 products. The FDA emphasizes that products with a Marketing Denial Order or no application are high enforcement priorities.

The letter