FDA WARNING_LETTER - E Cigarette Empire LLC - July 20, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Iyad Sabbah regarding electronic nicotine delivery system (ENDS) products sold on ecigaretteempire.com. The FDA determined that products like "Kilo 1K Replacement Pods – Strawberry Milk" and "Drip Fried Cream Cakes E Juice By Fryd" are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack required premarket authorization under section 910(a) of the FD&C Act.

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 absence of marketing authorization orders or substantial equivalence reports. The FDA expressed particular concern about "Drip Fried Cream Cakes E Juice By Fryd" because its packaging imitates food products appealing to children, raising concerns about youth appeal and use of ENDS.

The letter mandates prompt correction of all violations, including discontinuing the sale and distribution of non-compliant products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.