Cosmetic Adverse-Event Records: Six Years or Three Years?
Cosmetic adverse-event records generally have a six-year retention period. A qualifying small responsible person may have a three-year period under the statutory conditions.
The exception needs an eligibility review
The cosmetics statute ties the shorter retention period to small-business status under section 612 and excludes a responsible person engaged in manufacturing or processing the product categories described in that section’s exception. Do not assume that having a small team, using a contract manufacturer, or describing a brand as an indie business establishes eligibility.
Check the current statutory criteria, including the applicable inflation adjustment and product exclusions. Record the basis for the conclusion and revisit it when the business or product range changes. This article does not supply an inflation-adjusted revenue threshold.
Retention and reporting are separate decisions
Keeping an adverse-event file and deciding whether an event is serious enough to require FDA reporting are different tasks. The shorter record-retention provision does not itself remove serious-adverse-event reporting duties. The statutory reporting provision uses a 15-business-day period after receipt by the responsible person and addresses relevant follow-up information separately.
A record should preserve what was actually reported, the product identification available, the review performed, and any follow-up. Do not add a causal conclusion just because a report was received. Association with use and a proven causal relationship are different concepts.
A practical file review
- Find the written retention rule and its legal basis.
- Check whether it addresses records received through distributors, customer service, or a contract manufacturer.
- Confirm that retained files remain readable and retrievable after system or service-provider changes.
- Check the documented rationale before applying the shorter retention period.
- Keep reporting decisions and supporting information with the relevant file.
Do not replace the file with a dashboard count
A count of complaints or submitted reports does not replace the underlying records. For readiness, select a file and trace its intake, assessment, follow-up, and retention location. This is an operational suggestion, not a claim about a required FDA sampling method.
Related inspection resources
Primary sources
- U.S. Code: cosmetics provisions, including adverse-event records
- FDA: MoCRA overview
- FDA: Records Access Authority for Cosmetic Products — draft guidance
Sources reviewed October 20, 2026. The preparation steps above are practical suggestions; the linked regulations and FDA documents define the applicable requirements.