Announcing the move, FDA official Dr. Marty Makary said the agency is taking firm steps to prevent the improper commercialization of products aimed at minors. According to the FDA, the companies targeted were promoting chest binders for children in a manner that suggests medical use for treating gender dysphoria—claims that fall outside approved indications and violate regulatory standards.
Dr. Makary emphasized that the FDA’s priority is to protect children’s health and wellbeing, stating that the agency will not allow illegal medical products to be marketed to minors. He added that the FDA is committed to ensuring that devices presented as medical interventions meet all legal and scientific requirements before reaching consumers.
The warning letters instruct the manufacturers and retailers to immediately correct their marketing practices. The FDA cautioned that failure to comply could lead to stricter enforcement measures, including potential legal action. Such steps may involve product seizures, injunctions, or other penalties permitted under federal law.
The enforcement action reflects broader regulatory scrutiny over how products related to health and medical treatment are advertised, particularly when children are involved. By intervening at the marketing level, the FDA aims to prevent consumer confusion and reduce the risk of harm associated with unapproved or improperly promoted medical devices.
The agency’s move sends a clear signal to the industry that marketing products to minors—especially under the guise of medical treatment—will be closely monitored and, where necessary, met with decisive regulatory action.
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