FDA WARNING_LETTER - Eleaf USA - July 20, 2020

The FDA Center for Tobacco Products reviewed eleafus.com and determined that the website offers unauthorized Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are deemed tobacco products under the FD&C Act.

The identified violations include offering "new tobacco products" without required premarket authorization, specifically: Remit Orange Cream Pod Packs, Remit Orange Dream Nic Salt Pod Packs, Remit Tropical Blend Pod Packs, Remit Tropical Oasis Nic Salt Pod Packs, and Yami Vapor Ninja Man. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern about the Yami Vapor Ninja Man product due to its graphic image imitating cartoons appealing to children, which raises concerns about youth appeal and use of ENDS products.

The company is required to correct all violations and submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.