FDA WARNING_LETTER - Ejuicesteals.com - September 22, 2020

On July 31, 2020, the FDA issued a Warning Letter to Remon Hanna regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products on ejuicesteals.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and require premarket authorization.

The website offered new tobacco products, including Phix Hard Strawberry Pods, Plus Pods Lemonade, VQ Salty Pods, Johnny Creampuff – Lemon, and Uwell AMULET Watch Pod System, without the required marketing authorization orders. These products are deemed 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 Johnny Creampuff – Lemon product due to its packaging imitating food products appealing to children, and the Uwell AMULET Watch Pod System, which resembles a smartwatch, allowing concealment from adults. These designs are concerning due to rising youth appeal and use of ENDS products.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.