FDA Asks for Input on Cosmetic Reporting Requirements
Published Date: 7/17/2026
Notice
Summary
The FDA wants your thoughts on new info they might collect about cosmetic products. This affects companies making or selling cosmetics, who may need to share more details soon. You’ve got until September 15, 2026, to send in your comments—no cost yet, just your voice!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
New FDA Reporting and Recordkeeping Burden
If you are a "responsible person" for cosmetics (the manufacturer, packer, or distributor whose name is on the label), FDA is proposing information-collection requirements under MoCRA that would produce about 417,698 total annual responses and an estimated 367,777 annual burden hours across activities like facility registration, product listing, updates, and safety recordkeeping. The notice cites specific statutory sections (e.g., sections 605, 607, 608) and requests public comment by September 15, 2026.
Labeling and Disclosure Hours for Product Labels
If you label cosmetic products, FDA estimates 5,738 respondents will need to make on average 21–24 label disclosures each (declaration of ingredients, statement of identity, name/place of business, net quantity, contact info), resulting in about 676,170 total annual disclosure hours. The notice ties these requirements to 21 CFR 701.3, 701.11-701.13 and section 609(a) of the FD&C Act.
Adverse Event Record Retention Requirement
If you are a responsible person for cosmetics, section 605(e)(1) requires you to keep a record for each adverse event report for six years (or three years for qualifying small businesses). The notice ties cosmetics adverse event reporting to FDA Form 3500A and existing adverse event reporting collections (OMB Control Number 0910-0291).
Safety Substantiation Recordkeeping Obligation
If you are a responsible person, section 608(a) requires you to maintain records supporting the "adequate substantiation of safety." FDA estimates about 22,564 respondents will each maintain one safety substantiation record, totaling 22,564 annual burden hours for this activity.
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