FDA WARNING_LETTER - 10 Days Inc - January 11, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Mohammed Shubyre Humkar on December 15, 2021, following a review of the website https://podjuice55.com. The FDA determined that e-liquid products, including Pod Juice Cotton Carnival, Pod Juice Juicy Apple, and Pod Juice Loops, are manufactured and sold in the U.S. and are considered tobacco products under the 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. The FDA found that these e-liquid products are being marketed without the required premarket authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although a Premarket Tobacco Product Application (PMTA) (STN PM0002258) was submitted on September 9, 2020, it received a Marketing Denial Order on September 14, 2021, covering 334 products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinu