FDA's Guide: How We Peek into Your Lipstick Lab Records
Published Date: 1/22/2026
Notice
Summary
The FDA just dropped a draft guide to help cosmetic companies understand how the agency can check their product records. If you make or sell cosmetics, this guide explains what info the FDA might ask for and how the process works. You’ve got until March 23, 2026, to share your thoughts before the FDA finalizes the rules—no extra costs yet, just clear steps ahead!
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
FDA can copy records if SAHCODH suspected
Under section 610 (21 U.S.C. 364f), if FDA reasonably believes a cosmetic (or an ingredient) is likely adulterated and presents a threat of serious adverse health consequences or death (SAHCODH), FDA may access and copy certain records. The draft guidance explains how FDA applies that authority and what records may be copied.
Inspection authority extended to manufacturer records
Section 704(a)(1) of the FD&C Act, as amended by MoCRA (section 3504), extends FDA's inspectional authority to all records and information described in sections 605 and 610 from facilities that manufacture and process cosmetic products. The draft guidance discusses how that expanded inspection authority is applied.
FDA access to adverse event records
If you make or sell cosmetics, FDA can access adverse event records during an inspection under section 605 (21 U.S.C. 364a) and section 704 of the FD&C Act. The draft guidance explains FDA's criteria, process, and expectations for that access.
Draft guidance available — comment deadline
The FDA released a draft guidance titled "FDA Records Access Authority for Cosmetics: Guidance for Industry" and is asking for comments. You may submit electronic or written comments by March 23, 2026; the guidance is not binding and explains FDA's current thinking on criteria, process, and expectations.
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