E-Vaped Co – FDA Warning Letter, Sep 29, 2020

The FDA issued a Warning Letter to Stacey Arrecis of E-Vaped Co. on July 31, 2020, following a review of the website https://www.evapedstore.com. The review determined that e-liquid products, specifically "E-Vaped Pacman," were manufactured and offered for sale or distribution in the U.S. and are considered tobacco products under the FD&C Act.

The letter identified three primary violations:

1. **New Tobacco Product Without Required Marketing Authorization:** The "E-Vaped Pacman" e-liquid is a new tobacco product, as it was not commercially marketed in the U.S. as of February 15, 2007. It lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated (section 902(6)(A)) and misbranded (section 903(a)(6)). Failure to provide a required report under section 905(j) is also a prohibited act (section 301(p)).

2. **Tobacco Product Sold to a Person Under the Age of 21:** An investigation revealed that "E-Vaped Pacman" e-liquid was sold to a person younger than 21 years of age, violating section 906(d)(5