Nelson Endeavors, LLC d/b/a Liberty Vape Co. – FDA Warning Letter, May 27, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Christian Jackson of Liberty Vape Co. after reviewing their website, libertyvapeco.com, which revealed the manufacture and sale of e-liquid products in the U.S. The FDA determined these e-liquids, including "Blue Razz," "Pink Lemonade," and "Bubble Gum," are "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA regulation since August 8, 2016. The primary violation is offering these new tobacco products for sale without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). As a registered manufacturer with over 60 listed products, Liberty Vape Co. is responsible for ensuring all products comply with the FD&C Act and FDA regulations. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative activities and a plan for sustained compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or import detention.