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MoCRA at the End of 2026: What Is Already in Force and What FDA Has Not Issued Yet

Three years after MoCRA's main duties took effect, several of its promised rules are still missing. Here is a clear status check for foreign cosmetic brands: what you must already be doing, what changed in 2026, and what is still pending.

Author:
FDABridge Regulatory Team
Published:
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4 minutes

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was the biggest change to US cosmetics law since 1938. Its main company duties took effect at the end of 2023, and FDA has issued guidance on several of them since. But some of the rules Congress told FDA to write have still not appeared. Brands outside the United States often find it hard to tell what is law today and what is still a proposal. This is where things stand in November 2026.

In force now

  • Facility registration. Covered facilities that manufacture or process cosmetics for the US must register, renew every two years from the initial registration date, and amend required changes, generally within 60 days. See our guide to MoCRA facility registration renewal in 2026.
  • Product listing. The label-named responsible person lists each marketed product with its ingredients and updates the listing annually. Our product listing guide covers the details.
  • Serious adverse event reporting. Serious adverse events must be reported to FDA within 15 business days, and records kept. Our article on the 15-business-day rule explains the deadline.
  • Safety substantiation. The responsible person must keep records showing each product is safe. See MoCRA safety substantiation records.
  • Label contact. US labels must carry a domestic address, phone number or electronic contact through which adverse events can be reported.
  • FDA's new powers. FDA can access certain records, suspend a facility registration when the legal conditions are met, and order a mandatory recall.

What changed in 2026

  • October 2026: FDA finalized its guidance on mandatory cosmetic recalls under section 611, which sets out the two-part test, the 10-day informal hearing and the public notice steps. Our mandatory recall guide explains each step.
  • Early 2026: FDA published draft guidance on its records-access authority for cosmetics.
  • December 29, 2025 (just before 2026): FDA published its report on the use of PFAS in cosmetic products and associated risks. Several US states have separate PFAS restrictions with their own dates.

Still pending

  • Good manufacturing practice (GMP) regulations. MoCRA required FDA to propose GMP rules by December 29, 2024 and finalize them by December 29, 2025. No proposed or final GMP rule appears on FDA's MoCRA page. Its older draft GMP guidance remains the best indicator. See our article on preparing for MoCRA GMP.
  • Fragrance allergen labeling. MoCRA requires FDA to identify fragrance allergens that must be named on US labels. FDA lists the regulation as required, but it has not been issued.
  • Talc asbestos testing. FDA proposed standardized asbestos testing for talc-containing cosmetics in December 2024, then withdrew the proposal in November 2025. No replacement rule has been issued.

What this means for a foreign brand

Missing regulations do not excuse the duties already in force. The most common gaps we see are not about pending rules. They are about the basics: a facility registration that was never renewed or amended, product listings that were never updated after a reformulation, and label contacts that lead to an unmonitored inbox. Fix those first.

For the pending rules, prepare sensibly rather than waiting. Brands that already follow ISO 22716 or EU cosmetic GMP are in a strong position for US GMP. Brands that already name fragrance allergens under EU rules will find the US change easier, whatever list FDA chooses. Talc users should already test for asbestos with appropriate methods, since contaminated talc can make a product adulterated whether or not a testing rule exists.

FDABridge handles cosmetic facility registration, product listing, label review and adverse event management for brands outside the United States. When the pending rules are published, we will cover them on this blog.

Sources

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