FDA WARNING_LETTER - Flux Lab Pte. Ltd. d/b/a The Fluxion - December 01, 2025

The FDA issued a Warning Letter to Flux Lab Pte. Ltd. d/b/a The Fluxion on December 16, 2025, following a review of the company"s website. The FDA determined that Flux Lab"s breast binders, marketed with claims such as "alleviate gender dysphoria" and "promote overall well-being," are considered medical devices under the Federal Food, Drug, and Cosmetic Act. This classification is due to their intended use to affect the body"s structure or function and to mitigate disease.

A significant violation identified is the company"s failure to meet regulatory requirements for medical device manufacturers. Despite evidence on their website indicating device manufacturing, Flux Lab has not registered its establishment with the FDA annually nor listed its devices for fiscal year 2026. This non-compliance renders the breast binders "misbranded" according to the Act.

Flux Lab is required to promptly address these issues. The company must provide a written response to the FDA within fifteen business days, detailing specific corrective actions, including supporting documentation and a plan to prevent future violations. Failure to comply may result in further regulatory measures, such as product seizure or injunction. The FDA stresses the company"s obligation to ensure complete adherence to all applicable laws and regulations.