The U.S. Food and Drug Administration (FDA) has published a Paperwork Reduction Act (PRA) notice that puts a number on something cosmetic companies rarely see quantified: how much time the agency thinks safety substantiation actually takes.
The notice, filed July 17, 2026, under Docket No. FDA-2026-N-6739 (91 FR 44850), revises OMB Control Number 0910-0599, the tracking number the Office of Management and Budget (OMB) assigns to each federal information collection, for the recordkeeping and disclosure requirements under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. It creates no new obligations, and the comment window closes September 15, 2026.
What makes the notice worth reading isn’t the paperwork mechanics. It’s what the numbers inside reveal about how FDA currently models cosmetic compliance work.
What the Estimate Shows
FDA’s estimate for safety substantiation is a single line: 22,564 respondents, one record each, one hour per record, 22,564 burden hours annually. The agency’s reasoning is that section 608(a) leaves responsible persons discretion in determining which records satisfy the requirement, so it assumes each will maintain at least one record for compliance purposes.
For comparison, the same table estimates that those same 22,564 respondents will submit an average of 14.64 product listings each, at one hour per listing. FDA’s model allocates roughly fifteen times more effort to listing a company’s products than to substantiating their safety.
Total recordkeeping burden across all activities is 367,777 hours. Labeling disclosures under 21 CFR part 701 add a further 676,170 hours.
What Section 608 Actually Requires
The section 608 safety substantiation requirement took effect December 29, 2023. It requires the responsible person, meaning the manufacturer, packer, or distributor whose name appears on the label, to ensure and maintain records supporting adequate substantiation of safety.
Section 608(c)(1) defines that as tests, studies, research, analyses, or other evidence considered, among experts qualified by scientific training and experience, sufficient to support a reasonable certainty that the product is safe. Two elements carry weight: the evidence must support reasonable certainty, and the sufficiency judgment belongs to qualified experts.
The notice offers no methodology for the one-hour figure and describes no expected file components. It rests on an assumption about respondent discretion, not on an assessment of what the section 608(c)(1) standard actually takes to meet.
Why It Matters
PRA estimates are prepared for OMB paperwork accounting. They are not compliance benchmarks and carry no legal weight on adequacy. What they do show is how the agency understands the regulated population, and burden figures feed into how agencies scope guidance, allocate inspection resources, and cost future rulemaking.
An estimate that understates the work involved in section 608 may lead to guidance calibrated to a version of the requirement few companies are operating under.
The Comment Window
FDA invites comment on four questions: whether the collection is necessary and has practical utility, the accuracy of the estimate and the assumptions behind it, ways to improve the quality and clarity of what is collected, and ways to reduce burden.
A company maintaining individual safety files across fifteen or fifty products has direct evidence on how long that work takes. That is the most useful input FDA can receive on a burden estimate, and the cosmetics industry submits few such comments. Submissions go through Regulations.gov under Docket No. FDA-2026-N-6739.
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 notice confirms FDA has not published a prescriptive format and is unlikely to soon. The standard remains a performance standard, so defensibility depends on the quality of the evidence and the qualifications of whoever concluded the product was safe. Records also need to be maintained and revisited as ingredient safety information or formulations change.
Responsible persons with limited internal capacity usually find the qualified-expert element hardest to satisfy in-house, since it points toward toxicological assessment rather than regulatory review. That gap is where most safety substantiation files fall short, not because the underlying product is unsafe, but because the file doesn’t document a qualified expert’s reasoning in a way that would hold up to FDA scrutiny.
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 isn’t a compliance benchmark, but it does reveal a model that looks lighter than industry practice on safety substantiation. Section 608(c)(1) still requires evidence sufficient, among qualified experts, to support a reasonable certainty of safety, and that is where a file will actually be measured.
This notice does not change what section 608 requires, but it is a useful moment to check whether your own safety substantiation files would hold up to the standard the statute actually sets, not the one hour FDA has modeled.
If your team is building files for the first time or reviewing existing ones, learn more about our MoCRA cosmetics compliance services, or contact us to talk through what a defensible file looks like for your product line.
