In thirty seconds
The plain version
- The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to US cosmetics law since 1938 — it converted a voluntary registration program into a mandatory one with real enforcement teeth.
- Facility registration (Form FDA 5066) and product listing (Form FDA 5067) have been mandatory and actively enforced since July 1, 2024 — there is no grace period left to claim.
- For the first time, the FDA can mandate a recall of a misbranded or adulterated cosmetic, rather than relying on a manufacturer to do it voluntarily.
- A binding cosmetics GMP rule is still in development; FDA has already signalled — via warning letters — that it expects strict compliance once it lands.
What it actually requires
Two filings, one identifier, and a clock that doesn't pause.
- An FDA Establishment Identifier (FEI) — obtained before any registration can be submitted; required across multiple FDA-regulated industries, not unique to cosmetics.
- Facility registration (Form 5066) — mandatory for manufacturers, renewed every two years, filed through the Cosmetics Direct portal. New facilities must register within 60 days of starting operations.
- Product listing (Form 5067) — the Responsible Person's obligation, updated annually, including the facility's FEI and a full ingredient list in SPL format.
- Foreign facilities must designate a US agent who can respond to FDA and assist with inspection scheduling.
- Safety substantiation — the Responsible Person must maintain adequate substantiation that the product is safe, available to FDA on request.
Missing registration or listing doesn't just risk a warning — it makes the product misbranded or adulterated by definition, which is what opens the door to border holds, recalls, and listing removal independent of whether anything is actually wrong with the formula.
Who enforces it
U.S. Food and Drug Administration (FDA), Office of Cosmetics and Colors
FDA enforcement runs through warning letters, mandatory recall authority (new under MoCRA), facility registration suspension, and import holds at the border via Customs and Border Protection, which increasingly cross-references FDA's own product-listing data during screening.
What it costs to get wrong
The exposure compounds because the data is now public and growing fast.
As of January 2025, FDA had logged 9,528 active facility registrations and 589,762 product listings. A year later, in January 2026, that had grown to 14,299 facilities and 992,907 listings — FDA's visibility into who is manufacturing what, and where, is compounding faster than most brands have adjusted to. A November 2024 analysis by Registrar Corp found that 48% of imported cosmetics sold at America's top 25 retailers were not compliant with MoCRA registration and listing requirements — at the time, spanning more than 135,000 products.
What actually happens when it's missed
Unregistered facility or unlisted product — the product is misbranded/adulterated as a matter of law; FDA can suspend the registration entirely, and Customs can hold the shipment at the border on import screening.FD&C Act §607; Foley & Lardner, "How MoCRA Is Reshaping FDA Oversight," 2026
Drug-adjacent product mislabelled as cosmetic, or vice versa — FDA has issued warning letters to drug manufacturers reminding them that some of their products are regulated as cosmetics and subject to MoCRA in full, regardless of how the company classified them internally.Crowell & Moring, "MoCRA Under the Trump Era," March 2025
Undisclosed restricted ingredient — FDA's 2024–2025 testing of imported gel nail-polish removers found undeclared methylene chloride in several products, despite a clear prohibition; the agency issued a public notice naming the issue directly.FDA public notice, April 2025
Where Ayin fits
Map → Clear → Hold
Registration and listing are mechanical once you know the sequence — Ayin maps your FEI and filing status first, clears any gap, and can hold the listing current through the two-year renewal cycle so it never lapses quietly. The GMP rule is still moving; this is exactly the kind of regime where a Hold engagement earns its fee.
Ambition Begins