FDA WARNING_LETTER - Milu 1 Inc. d/b/a Peace Novelty - June 22, 2023

On June 16, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Nilesh Patel and Sandip Patel of Peace Novelty, following a review of their website, peacenovelty.com. The FDA determined that the company was offering for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, specifically Elf Bar BC5000 Mango Peach 5000 Puffs Disposable Vape and Elf Bar BC5000 Blue Razz Ice 5000 Puffs Disposable Vape, which are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These products are deemed "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 ENDS products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires Peace Novelty to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for maintaining compliance. Failure to