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MoCRA was the first substantial change to US cosmetics law since 1938. Three and a half years on, this is what it required, what took effect, and what never issued.
MoCRA was enacted on 29 December 2022 — 3.6 years ago — and has produced 0 final rules. Of the 9 obligations tracked here, 5 are in force because the statute made them self-executing. Every one that depends on FDA writing a rule is outstanding.
Before MoCRA, the FDA's authority over cosmetics rested on a 1938 statute that gave it no power to require registration, no access to safety records, and no mandatory recall. MoCRA added eleven new sections to the Food, Drug, and Cosmetic Act, listed below. The question this page answers is a narrow and checkable one: what did it require, by when, and what has actually happened.
| FD&C § | Title |
|---|---|
| 604 | Definitions |
| 605 | Adverse events |
| 606 | Good manufacturing practice |
| 607 | Registration and product listing |
| 608 | Safety substantiation |
| 609 | Labeling |
| 610 | Records |
| 611 | Mandatory recall authority |
| 612 | Small businesses |
| 613 | Exemption for certain products and facilities |
| 614 | Preemption |
Every deadline on this page is computed from the enactment date and the statute's own “not later than” clauses, read in the enrolled text: Public Law 117-328, Division FF, Title III, Subtitle E — U.S. Congress (congress.gov). FDA's own summary pages are not used as a source for any of them.
| Requirement | Cite | Statutory deadline | Status | Detail |
|---|---|---|---|---|
| Facility registration for facilities operating at enactment | FD&C 607(a) | 2023-12-29 | in force | FDA issued a compliance-policy guidance in November 2023 stating it did not intend to enforce registration and listing until 2024-07-01. |
| Cosmetic product listing for products marketed at enactment | FD&C 607(c) | 2023-12-29 | in force | Same November 2023 compliance policy applied. |
| Serious adverse event reports submitted within 15 business days | FD&C 605(b)(1) | 2023-12-29 | in force | |
| Adequate substantiation of safety, with records | FD&C 608 | 2023-12-29 | in force | The statute defines adequate substantiation but sets no test methods and requires no rule, so the standard is in force and undefined in detail. |
| Label must carry a domestic contact route for adverse event reports | FD&C 609(a) | 2024-12-29 | in force | |
| Standardised methods for detecting asbestos in talc-containing cosmetics | MoCRA 3505 | 2023-12-29 | withdrawn | Proposed rule published 2024-12-27, roughly a year past the statutory deadline, then withdrawn on 2025-11-28 without a final rule. No proposal is currently pending. |
| Good manufacturing practice regulations | FD&C 606 | 2024-12-29 | not issued | No proposed rule has appeared in the Federal Register. The only FDA action on the record is an April 2023 listening session. |
| Fragrance allergen labelling, and the regulation defining which substances are fragrance allergens | FD&C 609(b) | 2024-06-29 | not issued | No proposed rule has appeared in the Federal Register. Because the statute leaves the allergen list to be set by regulation, the labelling duty has no operative content. |
| Report assessing use and safety of PFAS in cosmetics | MoCRA 3506 | 2025-12-29 | not confirmed | A report of this kind is published on FDA's own website rather than in the Federal Register, and fda.gov could not be reached from this machine (TLS interception). Recorded as unverified rather than as missing. |
Status is as at 19 August 2026. “Not confirmed” appears once, for the PFAS report, which is published on FDA's own website rather than in the Federal Register — and fda.gov could not be reached from the machine this was built on. It is recorded as unverified rather than as missing, because those are different claims.
| Requirement | Due | Status | Months late |
|---|---|---|---|
| Standardised methods for detecting asbestos in talc-containing cosmetics | 2023-12-29 | withdrawn | 31.7 |
| Fragrance allergen labelling, and the regulation defining which substances are fragrance allergens | 2024-06-29 | not issued | 25.7 |
| Good manufacturing practice regulations | 2024-12-29 | not issued | 19.6 |
Proposed rule published 2024-12-27, roughly a year past the statutory deadline, then withdrawn on 2025-11-28 without a final rule. No proposal is currently pending. Talc's asbestos question is the single most concrete ingredient-safety issue MoCRA named, and one product in this corpus declares talc.
Proposed rule, 2024-12-27 · Withdrawal, 2025-11-28
The statute requires a label to identify each fragrance allergen, but leaves the identity of those allergens to be set by regulation. No proposed rule has issued, so the duty has no list and binds no one. The European Union, over the same period, added 45 substances to its declarable list and let the transition deadline for placing non-compliant products on the market pass on 31 July 2026. Five of the twelve products already declare EU allergens anyway, because global formulas travel with global labels.
12 documents mentioning MoCRA by name have appeared in the Federal Register since enactment: 0 final rules, 1 proposed rule, and 1 withdrawal — of that same proposed rule. The rest is guidance and administrative notices.
Retrieved 2026-08-19. The single proposed rule is the talc testing proposal, and it is also the single withdrawal. Everything else on the record is guidance or an administrative notice. Source: Federal Register full-text search — Office of the Federal Register.
What this does and does not show. A missed rulemaking deadline is a fact about the rulemaking record, not a judgement about the agency, and guidance documents do real work even though they are not rules — the November 2023 compliance policy is why registration and listing became workable at all. What the record does establish is that the parts of MoCRA that need a rule to mean anything still do not have one.