The U.S. Food and Drug Administration (FDA) has published a notice estimating that MoCRA safety substantiation takes one hour per record. That figure matters to any cosmetic company keeping, or building, safety files under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, because it shows how FDA currently understands the work behind them.
The notice was filed July 17, 2026 (Docket No. FDA-2026-N-6739, 91 FR 44850). It is a Paperwork Reduction Act notice, a routine filing in which a federal agency estimates how much time companies spend on required recordkeeping. It creates no new obligations, and the public comment period closed September 15, 2026.
What MoCRA Safety Substantiation Requires
Section 608 of the Federal Food, Drug, and Cosmetic Act, added by MoCRA, requires cosmetic companies to keep records showing their products are safe. This is called safety substantiation, and it has applied since December 29, 2023.
The requirement falls on the responsible person: the manufacturer, packer, or distributor whose name appears on the product label. That company must ensure and maintain records supporting adequate substantiation of safety.
Section 608(c)(1) explains what “adequate” means: tests, studies, research, analyses, or other evidence that qualified experts would consider enough to support a reasonable certainty that the product is safe. Two parts of that definition carry weight. The evidence must support reasonable certainty, and the judgment about whether it is sufficient belongs to experts with the right scientific training and experience.
What FDA’s Estimate Shows
The estimate is about the time companies spend, not the time FDA spends. For MoCRA safety substantiation, it is a single line: 22,564 responsible persons, one record each, one hour per record, for 22,564 hours a year. FDA reasons that section 608(a) leaves companies discretion in deciding which records meet the requirement, so it assumes each will keep at least one.
The same table estimates that those 22,564 companies will each submit an average of 14.64 product listings, at one hour per listing. In FDA’s model, listing a company’s products takes roughly fifteen times more effort than substantiating their safety. Across all activities, FDA estimates 367,777 hours of recordkeeping, and labeling requirements under 21 CFR part 701 add another 676,170 hours.
The notice does not explain how FDA arrived at one hour, and it does not describe what a safety substantiation file should contain. The estimate rests on an assumption about company discretion, not on an assessment of what it takes to meet the section 608(c)(1) standard.
Why It Matters
These figures exist for federal paperwork accounting. They are not compliance benchmarks, and they carry no legal weight on what counts as adequate substantiation. They do show how FDA understands the companies it regulates, and FDA uses burden figures when scoping guidance, allocating inspection resources, and costing future rulemaking.
If the estimate understates the work involved in section 608, guidance could end up calibrated to a lighter version of the requirement than most companies are working to. FDA invited comment on whether the collection is necessary, whether its estimate and assumptions are accurate, how to improve the clarity of the information collected, and how to reduce the burden.
A company that maintains safety files for fifteen or fifty products knows firsthand how long that work takes, which is exactly the kind of evidence a time estimate needs. It is worth keeping in mind for future notices.
What This Means for Your Business
The practical question is not whether your files match FDA’s hour count. It is whether they meet the section 608(c)(1) standard, which the estimate does not address. The standard is performance-based, so defensibility depends on the quality of the evidence and the qualifications of whoever concluded the product is safe. Files also need to be revisited as ingredient safety information or formulations change.
Companies with limited internal capacity often find the qualified-expert element hardest to meet in-house, because it calls for toxicological assessment rather than regulatory review. A product may well be safe, yet the file may not document a qualified expert’s reasoning clearly enough to hold up to FDA review.
Our team at Quality Smart Solutions works with cosmetic companies on building safety substantiation files that hold up against the Section 608(c)(1) standard, from sourcing the right expert review to organizing the evidence into a defensible record. If you’re not sure whether your current files would meet that bar, we can walk through what a compliant file actually looks like for your product line.
Frequently asked questions
Does this notice create new obligations?
No. It is a Paperwork Reduction Act notice, not a rulemaking. Section 608 has applied since December 29, 2023, and the registration, listing, adverse event, and labeling requirements described in the notice are already in force.
Does the notice clarify what "adequate" substantiation means?
No. The definition comes from section 608(c)(1), not from this notice, and the statute prescribes no fixed list of required tests or documents. Companies looking for format guidance should follow FDA’s ongoing MoCRA guidance development rather than reading anything into the burden figures.
Is the comment period limited to the hour estimate?
No. The scope covers necessity and practical utility, accuracy and methodology, quality and clarity, and burden reduction. Comments showing with internal data why FDA’s assumptions understate the real workload fall squarely within that scope.
Key Takeaways
- FDA’s July 17, 2026 PRA notice revises OMB Control Number 0910-0599 and creates no new obligations under MoCRA.
- The agency’s burden estimate allocates one hour per safety substantiation record, roughly fifteen times less effort than it allocates per product listing.
- Section 608(c)(1) still requires evidence sufficient, among qualified experts, to support a reasonable certainty of safety, regardless of what the estimate assumes about the work involved.
- The notice does not define an expected file format, and FDA is unlikely to publish one soon.
- Comments on the notice are open through September 15, 2026, under Docket No. FDA-2026-N-6739.
Conclusion & Next Steps
FDA’s estimate is not a compliance benchmark, but it suggests a model that looks lighter than industry practice on safety substantiation. Section 608(c)(1) still asks for evidence that qualified experts would consider sufficient to support a reasonable certainty of safety, and that is where a file is measured.
If you are building files for the first time or reviewing existing ones, our team works with cosmetic companies on safety substantiation files, from sourcing the right expert review to organizing the evidence into a defensible record. Contact us to talk through what a defensible file looks like for your product line.
