Cosmetics Regulatory Compliance in North America: MoCRA, FDA, Canada

By July 1, 2026, every cosmetic manufacturing facility that registered with the FDA under the Modernization of Cosmetics Regulation Act of 2022 by the original July 1, 2024 deadline must complete its first biennial renewal under Section 607(a)(2) of the FD&C Act. On February 11, 2026, FDA updated its Cosmetics Direct portal with new renewal-status fields and began sending automated reminders, a signal that the agency expects widespread non-compliance if it does not push. Six months later, on January 1, 2027, twenty-six additional ingredients become illegal in any cosmetic sold in California under Assembly Bill 496, layering a second state-specific prohibition on top of the PFAS ban that already took effect there on January 1, 2025.

For cosmetics manufacturers, importers, and responsible persons selling into the United States and Canada, this is the defining pattern of the current compliance landscape: the federal regime created by MoCRA is still under construction, with several statutory rulemakings years overdue, while individual states and Health Canada keep advancing their own binding deadlines regardless of Washington's pace. A compliance calendar built only around FDA's published timeline will miss the obligations that are actually enforceable today.

Which regulators actually drive cosmetics enforcement in North America?

Three authorities set the pace. The FDA's Office of Cosmetics and Colors, which moved from the Center for Food Safety and Applied Nutrition to the Office of the Chief Scientist as part of MoCRA implementation, administers facility registration, product listing, safety substantiation, and adverse event reporting under the FD&C Act as amended by MoCRA. California's Department of Toxic Substances Control and the California Safe Cosmetics Program run an entirely separate ingredient-prohibition track through the Health and Safety Code, independent of anything FDA does federally. Health Canada's Consumer and Hazardous Products Safety Directorate regulates cosmetics under the Food and Drugs Act and the Cosmetic Regulations, centered on the Cosmetic Notification Form and the Cosmetic Ingredient Hotlist.

There is no single federal ingredient-prohibition list comparable to the EU's Annexes II and III. FDA's authority under MoCRA is largely procedural, registration, listing, records access, and future GMP and labeling rules, while the substantive ingredient bans that are actually in force today came from California's legislature, not from FDA rulemaking. A team monitoring only the Federal Register will miss the fastest-moving part of the North American cosmetics regime.

What MoCRA deadlines are actually due in 2026?

Two recurring obligations, both created by MoCRA, are live right now. Facility registration renews every two years from each facility's initial registration date under Section 607(a)(2): since the first registrations were due by July 1, 2024, renewals for that cohort fall throughout 2026 on a rolling, facility-specific date, with July 1, 2026 as the outer deadline for anyone who registered right at the original cutoff. Separately, product listing, a distinct filing tied to the responsible person rather than the facility, must be updated annually and within 120 days of a reformulation or a change of manufacturing site, regardless of the facility's renewal date. FDA's abbreviated renewal option under Section 607(a)(5) lets a facility with no changes since its last submission file a shorter form, but only if the underlying registration data has stayed accurate, and a facility must notify FDA of any change to its name, address, contact information, or product categories within 60 days of that change.

Missing either deadline is a prohibited act under Section 301(hhh) of the FD&C Act, exposing the facility or responsible person to the same enforcement tools FDA already uses for drugs: warning letters, mandatory recalls where FDA has reasonable belief a product is adulterated or misbranded and poses a health risk, and referral for injunction or seizure.

Which FDA cosmetics rulemakings under MoCRA are still outstanding?

MoCRA set statutory deadlines for four major rules, and FDA has missed every one of them. The fragrance allergen labeling rule, required under Section 609(b) by June 29, 2024, is now targeted for a proposed rule in May 2026 according to the Fall 2025 Unified Agenda, with a final rule and compliance not expected before late 2026 or 2027. The Good Manufacturing Practice regulation for cosmetic facilities under Section 606, meant to align with ISO 22716, has been moved to the Unified Agenda's long-term actions list with its proposed-rule date listed as "to be determined," meaning FDA does not expect to publish it within twelve months. The standardized testing rule for asbestos in talc-containing cosmetics, first proposed December 27, 2024, was withdrawn entirely on November 28, 2025 after FDA received 49 comments raising concerns about the proposed testing methodology and definitions; the agency says a revised proposal is coming but has given no date. And the proposed ban on formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products has now missed six separate target dates since October 2023, most recently December 31, 2025, with FDA telling reporters only that the rule "remains a priority."

The practical takeaway is that everything with an actual enforcement mechanism today, registration, listing, adverse event reporting, and records access, was already in force by December 29, 2023 or July 1, 2024. The rules that would add substantive product-safety requirements, GMP, fragrance disclosure, talc testing, and the formaldehyde ban, remain proposals or drafts with no binding compliance date. Treating the absence of a final rule as an absence of risk misreads the situation: FDA already has inspection and records-access authority under MoCRA and has begun issuing warning letters to facilities that also manufacture drug products, signaling how it intends to enforce cosmetics GMP once the rule exists.

How are individual states moving faster than the FDA on cosmetics ingredients?

California's Toxic-Free Cosmetics Act, as amended, has already banned thirteen ingredients including the full class of PFAS and their salts since January 1, 2025, and will add twenty-six more, covering formaldehyde-releasing preservatives, certain parabens, and other substances, under Assembly Bill 496 starting January 1, 2027. California is not alone: PFAS-specific cosmetics bans took effect in Colorado, Maryland, Minnesota, and Washington alongside California on January 1, 2025, and Connecticut, Maine, and Vermont added their own PFAS prohibitions on January 1, 2026. Five more states have bans scheduled for 2027 and beyond. None of these are pre-empted by MoCRA, which explicitly preserves state authority over cosmetic ingredient safety even as it occupies the field for facility registration and product listing.

For a manufacturer selling nationally, this means the binding ingredient restriction that determines a formulation's legality today is very likely a state statute, not a federal rule, and the compliance calendar has to be built state by state rather than assuming a single national reformulation deadline.

What does Health Canada require for cosmetics sold in Canada?

Canada takes a lighter pre-market approach than California's outright bans but backs it with a hard notification clock. Under Section 30 of the Cosmetic Regulations made under the Food and Drugs Act, every manufacturer and importer must submit a Cosmetic Notification Form to Health Canada within 10 days of first selling a product in Canada, and file a revised notification within 10 days of any change that makes the original filing inaccurate; if that revised notification is not filed in time, the product cannot legally continue to be sold. Health Canada does not pre-approve cosmetics, but Section 16 of the Food and Drugs Act prohibits selling a cosmetic that may injure the user's health, enforced against the backdrop of the Cosmetic Ingredient Hotlist, the list of prohibited and restricted substances that Health Canada updates periodically, most recently in August 2025.

A consultation on the next Hotlist update ran from November 19, 2025 to February 17, 2026, proposing to reclassify brucine from restricted to prohibited, tighten the entry for Symphytum officinale after new evidence of a hepatotoxic alkaloid, and restrict Basic Violet 4, Basic Blue 7, and polyaminopropyl biguanide. Health Canada has not yet published the final updated list, so companies selling into Canada are working against a moving ingredient baseline that can shift with only a notice to the cosmetics mailing list, not a formal rulemaking process comparable to FDA's.

What should a compliance team do next?

The gap between what MoCRA promised and what FDA has delivered means a North America cosmetics compliance program cannot be built around the federal statute alone. The facility registration renewal cycle and product listing updates are enforceable now and carry real prohibited-act exposure. The GMP, fragrance allergen, talc, and formaldehyde rules are not yet binding but are close enough to warrant getting ahead of them, particularly by adopting ISO 22716-aligned manufacturing practices before FDA's GMP rule eventually arrives. And the fastest-moving, most consequential ingredient restrictions right now are coming from California and a handful of other states, with Health Canada's Hotlist moving on its own separate, less predictable schedule.

Obsidian tracks each of these threads at the source: FDA's Unified Agenda entries and Federal Register notices for the outstanding MoCRA rules, state legislative and regulatory text for PFAS and ingredient bans, and Health Canada's Hotlist consultations and Gazette notices. Teams juggling federal, state, and Canadian cosmetics obligations at once can set up per-jurisdiction monitoring that flags a missed FDA deadline, a new state ban, or a Hotlist consultation the moment it publishes, rather than finding out from a trade association email weeks later. The AI companion can answer direct questions about a specific state's ingredient list or a rulemaking's current status straight from Obsidian's verified regulatory database, and teams running their own compliance tooling can pull the same underlying data through the MCP integration. Given how many MoCRA deadlines have already slipped, the safer planning assumption for any cosmetics compliance team is that state and Canadian requirements, not the federal rulemaking calendar, will keep setting the pace through 2027.