US-CONGRESS BILLS-119hr2821eh: FDA Modernization Act 3.0
The FDA Modernization Act 3.0 (H.R. 2821) updates the Federal Food, Drug, and Cosmetic Act to modernize cosmetic regulation under MoCRA, including new requirements for facility registration, product listing, safety substantiation, adverse event reporting, fragrance allergen labeling, PFAS and talc monitoring, and good manufacturing practices. It also imposes stricter penalties for non-compliance.
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 22, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Indie beauty brands, contract manufacturers, private-label makers, importers/distributors should confirm how it applies to their specific situation before acting. There is a time constraint attached: Facility registration and product listing deadlines are within 60 days of enactment; GMP compliance within 18 months; other provisions phased over 1-3 years.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The Act codifies and expands MoCRA requirements, including mandatory facility registration with FDA, product listing with ingredient disclosures, safety substantiation documentation, adverse event reporting within 15 days, fragrance allergen labeling, PFAS and talc testing/reporting, and adherence to GMPs. Penalties for non-compliance include fines up to $10,000 per violation and potential product seizure.
Who it affects
Indie beauty brands, contract manufacturers, private-label makers, importers/distributors
What you must do
Ensure all facilities are registered with FDA, submit product listings with full ingredient and allergen data, maintain safety substantiation records, establish adverse event reporting systems, test for PFAS and talc, and implement GMPs.
Deadline
Facility registration and product listing deadlines are within 60 days of enactment; GMP compliance within 18 months; other provisions phased over 1-3 years.
Source: https://www.govinfo.gov/app/details/BILLS-119hr2821eh
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