Issued to Lean Rx, Inc. dba SkinnyRx. Serious post-market compliance violation.
Issued
February 20, 2026Product
False & Misleading Claims/Misbranded (Telehealth)
Company
Lean Rx, Inc. dba SkinnyRx
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Lean Rx, Inc. dba SkinnyRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on February 20, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.