Source record

Jurisdiction
United States
Issuing authority
U.S. Food and Drug Administration
Document status
Draft guidance
FDA announcement
Source checked
Initial comment deadline in the Federal Register

Original documents

FDA announced draft guidance on its cosmetics records-access authority under MoCRA on 21 January 2026. The announcement discusses adverse-event records, certain records associated with serious health threats, and inspection authority. Read the agency announcement.

What the draft means

The guidance document is labelled draft and explains the agency’s interpretation of existing statutory authorities. Read those legal provisions alongside it. The draft’s publication does not enact a new final regulation.

The stated comment deadline has passed

The Federal Register notice gave 23 March 2026 as the deadline for comments to receive consideration before work on final guidance began. It should not be repeated as a currently open deadline.

When checking whether a record falls within the authority, identify the record category and the conditions for access described in the draft and underlying law.