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# HHS Restores its Delegation of Authority to FDA
- URL: https://www.fdaweb.com/hhs-restores-its-delegation-of-authority-to-fda/
- Published: 2021-09-03T12:00:00.000Z
- Updated: 2026-09-14T17:13:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150076

FDA’s authority to issues regulations without HHS authority has been restored. A 9/2 HHS *Federal Register* [notice](https://public-inspection.federalregister.gov/2021-18985.pdf?ref=fdaweb.com) says such authority that is normally delegated to the agency level was rescinded 9/15/2020 during the previous administration. The notice notes that such delegation to FDA “shall be exercised in accordance with the department’s applicable policies, procedures, and guidelines. For internal department management purposes, this delegation is subject to certain reservations of authority for the secretary to approve FDA regulations. Specifically, the secretary reserves the authority to approve regulations of FDA, except regulations to which sections 556 and 557 of Title 5 U.S.C. apply, which **(1)** establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, tobacco products, or other subjects of regulation; or **(2)** present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, tobacco products, or other subjects of regulation.”