Selon Company Limited d/b/a Elf Bar Flavors – FDA Warning Letter, Jun 22, 2023

On June 16, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to the manufacturer of products sold on elfbarflavors.com. The FDA determined that Electronic Nicotine Delivery Systems (ENDS) products listed on the website, specifically "Elf Bar BC5000 – Summertime" and "Elf Bar BC5000 - Rainbow Cloudz," are manufactured and offered for sale or distribution in the United States.

These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to 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. The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure