FDA WARNING_LETTER - FLAVNT Streetwear, LLC - December 01, 2025

The FDA issued a Warning Letter to FLAVNT Streetwear, LLC on December 16, 2025, after reviewing their website. The agency concluded that the company"s breast binders, such as "Birch Bareskin 2.0" and "Bone Bareskin 2.0," are considered medical devices. This classification is based on claims on the company"s website that the products are intended to affect body structure or function, or to mitigate conditions like gender dysphoria. The main violations identified stem from the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically sections concerning medical devices. FLAVNT Streetwear failed to annually register its establishment as a medical device manufacturer and did not list these devices for fiscal year 2026, leading to the products being deemed "misbranded." The FDA requires FLAVNT Streetwear to take prompt action to address these violations. The company must provide a written response within fifteen business days detailing the specific corrective steps taken, an explanation of how similar violations will be prevented, and supporting documentation. Failure to comply may result in further regulatory actions, including product seizure or injunction.