FDA Updates Cosmetics Reporting: Comments Welcome Till November
Published Date: 10/14/2026
Notice
Summary
The FDA is updating how companies that make cosmetics must share info about their products, thanks to new rules from the 2022 Modernization of Cosmetics Regulation Act. This affects anyone responsible for cosmetic safety, labeling, and reporting problems. Comments on these info collection changes are open until November 13, 2026, with no new fees but clearer rules to keep cosmetics safe and honest.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 5 costs, 0 mixed.
Cosmetic product listing obligation
Responsible persons must submit cosmetic product listings to FDA. FDA estimates about 22,564 respondents performing initial product listings with an average of 14.64 responses per respondent (total 330,337 responses) at 1 hour per response, plus 25,190 listing renewals (6 minutes each) and 3,020 listing updates (15 minutes each), producing large aggregate reporting burdens (330,337; 2,519; and 6,153 hours respectively).
Mandatory label disclosures increase labeling work
Cosmetic product labels must include required disclosures such as ingredients in order of predominance, statement of identity, name and place of business, net quantity, contact information for sending adverse event reports, and 'professional use only' where applicable. FDA estimates 5,738 respondents will produce 120,498–137,712 ingredient declarations and 137,712 disclosures each for statement of identity, name/place of business, net quantity, and contact information, totaling 676,170 labeling disclosures and 676,170 hours of annual burden.
Facility registration required and timed
If you are the responsible person (manufacturer, packer, or distributor whose name is on the label), you must register your cosmetic facility with FDA. FDA estimates 8,343 initial facility registrations (30 minutes each), 2,107 biennial renewals (10 minutes each), and 3,141 registration updates (15 minutes each), with total estimated annual burden hours of 4,172, 358, and 785 respectively.
Safety substantiation recordkeeping required
Responsible persons must keep records supporting the "adequate substantiation of safety" for their cosmetic products. FDA estimates 22,564 respondents will maintain, on average, one safety substantiation record each, at about 1 hour per record, for a total of 22,564 annual burden hours.
Adverse event records and reporting timeline
Responsible persons must keep a record for each adverse event they are required to submit: records must be kept for six years, or three years for qualifying small businesses. FDA links cosmetics adverse event reports to Form 3500A and estimates adverse event recordkeeping involves about 1,165 respondents with 1,398 total responses at an average of 36 minutes per record (total 839 hours).
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