If an FDA inspector asked for your records today, how quickly could you find them?
Under MoCRA, that question is no longer hypothetical.
In January 2026, the FDA published draft guidance on its records access authority for cosmetic products. It is still a draft, but it shows how inspections are likely to work.
Two situations to know about
The first involves adverse event records. During an inspection, the FDA can access and copy them. That includes your communications about complaints and your assessments of each case.
The second is a serious health threat. If the FDA reasonably believes a cosmetic is adulterated and could cause serious adverse health consequences or death, it can request a wider set of records.
Those can include manufacturing, raw material receipt, distribution, analytical, recall, complaint and safety substantiation records.
How long records must be kept
Adverse event records must be kept for six years. Small businesses have a shorter period of three years.
Keeping them is only half of the job. The FDA expects a company to produce them when asked.
Refusing is not an option
Under MoCRA, refusing to provide records the FDA is entitled to see is a prohibited act. A missing or disorganized file can become a compliance problem of its own.
What this means for your brand
Most of this comes down to daily habits, not a special project.
Log every consumer complaint when it arrives, including how it was handled. Keep batch and raw material records in one place, so one person can pull them without a search. Decide in advance who handles an FDA request, and make sure your contract manufacturer can support you with documentation.
Final thought
Records are easy to ignore until someone asks for them.
A brand that can answer an inspector in minutes looks prepared, and a brand that cannot may look careless, even if the product itself is safe.
Does your brand know where its records are?