FDA WARNING_LETTER - EBCREATE Store - September 03, 2024

On August 16, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to an entity operating the website https://ebcreate.store. The FDA determined that the website offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, specifically EBCREATE BC5000 – Cranberry Puncher and EBCREATE BC5000 – Pineapple Orange Mint.

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include products containing nicotine from any source. The FDA found these ENDS products to be "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket 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 absence of required marketing authorization or notice. The letter mandates a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to