Requests that the FDA Reverse its decision to classify desiccated thyroid extract (DTE) as a biological product under the PHS Act; Clarify that the August 6, 2025 Notice to Industry; Affirm that natural thyroid products should, if approved, proceed through the drug approval pathway under section 505 of the FD&C Act; regarding the classification and regulation of DTE products
🏛 Food and Drug Administration (FDA)FDA-2026-P-1307
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Rules, notices, and supporting material — the primary rule pinned first.
- Other· Feb 5, 2026No comment period
