FDA WARNING_LETTER - ShapeShifter Apparel, LLC - December 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to ShapeShifter Apparel, LLC on December 16, 2025, following a review of their website. The FDA determined that the company"s breast binders, marketed with claims suggesting use for conditions like gender dysphoria and affecting body function, classify them as medical devices under the Federal Food, Drug, and Cosmetic Act. The core violation identified is ShapeShifter Apparel"s failure to adhere to federal requirements for medical device manufacturers. Specifically, the company has not annually registered its establishment with the FDA nor listed its devices for fiscal year 2026, as mandated by Section 510 of the Act. This oversight renders the breast binders "misbranded" under Section 502(o) of the Act. ShapeShifter Apparel is required to take immediate corrective action to resolve these compliance issues. The company must submit a comprehensive written response to the FDA within fifteen business days. This response needs to outline the specific actions taken to address the identified violations, provide documentation of corrections, and detail a robust plan to prevent similar issues from reoccurring. A timeline is necessary if corrections extend beyond the initial 15-day period. The FDA warns that failure to adequately address these violations may result in severe regulatory actions, including product seizure or injunctions, and impact federal contract awards. The letter underscores the company"s ongoing responsibility to ensure full compliance with all FDA regulations.