The U.S. Food and Drug Administration (FDA) published a Paperwork Reduction Act notice on July 17, 2026 (Docket No. FDA-2026-N-6739, 91 FR 44850) revising OMB Control Number 0910-0599, which covers information collection under the Modernization of Cosmetics Regulation Act of 2022. It creates no new obligations. Comments close September 15, 2026.
The numbers inside it are worth reading, because they show how the agency 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.
Set that against product listing in the same table. The same 22,564 respondents are estimated to submit an average of 14.64 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 describes no expected file components and offers no methodology. The one-hour figure rests on an assumption about respondent discretion, not on an assessment of what the section 608(c)(1) standard 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. QSS works with cosmetic companies on building safety substantiation files that hold up against the section 608(c)(1) standard.
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. The notice contains no description of expected file components. 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.
Conclusion
FDA’s estimate is not a compliance benchmark, but it does show 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 be measured.
If you want to review whether your records meet that standard, or you are building a file from the ground up, learn more about our Modernization of Cosmetics Regulation Act FDA MoCRA Cosmetics services or contact us to talk through where your program stands.
