FDA WARNING_LETTER - Marli Washington Design, LLC - December 01, 2025

On December 16, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Marli Washington Design, LLC, operating as gc2b, following a review of their website. The FDA determined that the company"s breast binders, including products like the "Black Half Binder (Classic 2.0)," are medical devices. This classification stems from website statements indicating the products" intended use to "relieve dysphoria for trans folks," which the FDA interprets as affecting the body"s structure or function, or mitigating a disease, under the Federal Food, Drug, and Cosmetic Act. The main violations identified are the company"s failure to comply with medical device manufacturing regulations. Marli Washington Design, LLC has not registered annually with the FDA as a medical device manufacturer, nor has it listed its devices for fiscal year 2026. These omissions render the products "misbranded" under regulatory framework sections 502(o) and 510 of the Act. The FDA requires Marli Washington Design, LLC to take prompt corrective action. A written response detailing specific steps taken to address these violations, an explanation of how future occurrences will be prevented, and supporting documentation must be submitted to the FDA within fifteen business days. Failure to adequately resolve these issues could result in further regulatory actions, such as product seizure or injunction.