FDA WARNING_LETTER - Vape Planet Direct d/b/a Eliquid Vape Juices - August 27, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Eliquid Vape Juices on August 27, 2020, based on a review of their website, https://www.eliquidvapejuices.com. The letter states that the company is offering Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the U.S., which are considered tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation identified is the sale of a "new tobacco product" without required premarket authorization. Specifically, the product "PHIX Pods Lemon Tart By Dinner Lady" was found to be a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires the company to promptly correct these violations and submit a written response within 15 working days from receipt of the letter. The response must describe corrective actions taken, including dates of discontinuation of violative sales and a plan for maintaining compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.