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TOMSCOUT, a Singapore-based manufacturer, was warned for offering breast binders for sale without proper FDA registration and device listing, in violation of Section 510 of the Federal Food, Drug, and Cosmetic Act. The company's website contained statements indicating the products were intended to treat gender dysphoria and affect body function—claims that classify the binders as medical devices requiring FDA registration. The FDA found that TOMSCOUT had not submitted required annual establishment registration and device listing information despite manufacturing these devices, and the products were misbranded based on therapeutic claims made on the company's website.