FDA WARNING_LETTER - humocase.com - October 01, 2025

On October 09, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to humocase.com following a review of their website. The agency determined that humocase.com is offering for sale or distribution unauthorized electronic nicotine delivery system (ENDS) products, specifically "Humocase iPhone 15 Pro Max – Watermelon Ice" and "Humocase iPhone 16 Pro Max – Blue Razz Ice." These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and require premarket authorization, which they lack. Consequently, these products are considered adulterated and misbranded under the FD&C Act.

The FDA expressed significant concern regarding the products" design, which resembles cell phone cases. This design feature may entice youth by concealing the products" true nature as tobacco products from parents or educators, thus contributing to public health and safety concerns associated with youth ENDS use. humocase.com is required to take prompt action to address these violations, including immediately discontinuing the sale and distribution of all unauthorized tobacco products. The company must submit a written response within 15 working days, detailing the corrective actions taken and their plan for ensuring ongoing compliance with the FD&C Act and its regulations. Failure to comply may result in further regulatory actions such as civil money penalties, seizure, or injunction.