FDA WARNING_LETTER - For Them, Inc. - December 01, 2025

The FDA issued a Warning Letter to For Them, Inc. on December 16, 2025, following a review of their website. The letter identifies various breast binders sold by the company as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This classification is based on website statements indicating the binders" intended use for managing chest dysphoria, preventing anatomical issues, and affecting body structure, thus aligning with disease treatment or affecting body function. The main violation cited is the company"s failure to comply with regulatory requirements for medical device manufacturers. For Them, Inc. has not registered its establishment or listed its breast binder products with the FDA for fiscal year 2026, as mandated by the FD&C Act. Consequently, these devices are considered misbranded.

The FDA requires For Them, Inc. to take immediate action to correct these violations. The company must submit a written response within fifteen business days detailing the specific steps taken to address the issues and prevent their recurrence. This response should include supporting documentation and a timetable for any ongoing corrective actions. Failure to adequately address the violations may lead to further regulatory actions, including seizure or injunction.