Philadelphia 7, Inc d/b/a Passional Boutique Warning Letter Details

Summary

Philadelphia 7, Inc d/b/a Passional Boutique was cited for distributing breast binders, including the UNTAG line marketed for reducing gender dysphoria, which the FDA classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The company failed to register its manufacturing establishments and list its devices as required by section 510 of the Act, resulting in the products being misbranded under section 502(o). The FDA determined that the firm violated section 301(a) of the Act by introducing misbranded devices into interstate commerce through its website and warned that failure to promptly correct these violations could result in further regulatory action.