FDA WARNING_LETTER - Early to Bed, Inc. - December 01, 2025

The FDA issued a Warning Letter to Early to Bed, Inc. on December 16, 2025, following a review of the company"s website, early2bed.com. The agency determined that breast binders offered for sale, specifically the GenderBender line, are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. These products are intended for purposes such as reducing swelling after surgery and promoting "gender euphoria." The main violation identified is that the manufacturer of these devices, GenderBender LLC, was not properly registered with the FDA, and the devices were not listed as required by section 510 of the Act. This renders the devices misbranded under section 502(o), and their introduction into interstate commerce is a prohibited act under section 301(a) of the Act. Early to Bed, Inc. is required to take prompt action to address these violations. The company must provide a written response to the FDA within fifteen business days, detailing the specific corrective steps, including documentation, and outlining plans to prevent recurrence. Failure to comply may result in further regulatory actions.