FDA sends warning letters to twelve chest-binder sellers
- Date
- Actor
- FDA
- Agency
- Food and Drug Administration (FDA)
- Type
- Enforcement/investigation
Summary
As part of the December 2025 HHS enforcement package, FDA issued warning letters to twelve companies marketing chest/breast binders, asserting deceptive advertising to children and treating marketed binders as unapproved/misbranded devices; the same December 16, 2025 letters gave each recipient — including at least one retailer, a Philadelphia boutique — 15 days to correct the violations; press coverage of that retailer's letter did not appear until early January 2026. This is the first FDA enforcement campaign aimed at a transition-related product category.
Status
Warning letters outstanding; no litigation outcome identified. (No FDA action restricting puberty blockers or hormone therapy labeling had been verified as of Aug. 2026 — see Unverified leads.)
As recorded in the data of . Check the sources for anything newer.
Sources
- natlawreview.com/article/gender-affirming-care-minors-cms-and-hhs-propose-limit…(opens another site)
Cite this action
see, e.g., Letter from Food & Drug Admin., U.S. Dep't of Health & Hum. Servs., to TOMSCOUT (Dec. 16, 2025), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tomscout-720850-12162025.
Short form: Letter from Food & Drug Admin., U.S. Dep't of Health & Hum. Servs., to TOMSCOUT (Dec. 16, 2025), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tomscout-720850-12162025.