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Draft guidance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

What FDA announced

On January 21, 2026, FDA announced draft guidance about its authority to access cosmetics records under MoCRA. The announcement covers adverse-event records, certain records associated with serious health threats, and inspection authority. Read FDA’s announcement.

Document status

The linked document is labeled draft guidance. It discusses the agency’s interpretation of existing statutory authorities; this announcement is not itself a new final regulation. The draft document and the underlying law should be read separately.

Dates to keep with the source

The Federal Register notice gave March 23, 2026 as the deadline for comments to receive consideration before work began on the final guidance. That date has passed. It should not be presented as a currently open consultation deadline.

Editorial context

This is a useful source for a documentation discussion: which records exist, who holds them, and which authority is being discussed. The exact circumstances for access matter as much as the record category.