MoCRA is the Modernization of Cosmetics Regulation Act of 2022, signed into law on December 29, 2022. It amended the Federal Food, Drug, and Cosmetic Act to give the FDA far broader authority over cosmetics, including facility registration, product listing, adverse event reporting, safety substantiation, records access, and mandatory recall powers. It is the most significant change to U.S. cosmetics law since 1938.

Anyone placing cosmetic products on the U.S. market. That includes brand owners acting as the Responsible Person, manufacturers and contract manufacturers, private label suppliers, importers, and distributors. Foreign facilities have the same obligations as domestic ones and must designate a U.S. agent.

Alongside existing FDA labeling requirements, labels must carry a domestic address, phone number, or electronic contact for reporting adverse events – a requirement in force since December 29, 2024. Products intended for professional use only must carry a statement to that effect. Fragrance allergen disclosure is coming but is not yet a federal requirement.

Not yet. FDA missed the June 29, 2024 statutory deadline to propose fragrance allergen disclosure rules, and the target has moved several times. FDA's 2026 Regulatory Plan and Unified Agenda targets a proposed rule in November 2026, which means a final rule is unlikely to take effect before 2027. Brands selling into Canada and the EU are already subject to allergen disclosure obligations, so many are aligning ahead of the U.S. rule rather than waiting.

Businesses with average annual gross U.S. cosmetic product sales under $1 million over the previous three years are exempt from facility registration, product listing, and the eventual GMP requirements. The exemption does not apply to certain product categories, including products that come into contact with the mucous membrane of the eye, products that are injected, ingested, or intended for internal use, and products intended to alter appearance for more than 24 hours. Exempt businesses still have to meet adverse event reporting, safety substantiation, and labeling requirements.

Manual, file-based processes make large-scale relabeling slow and error-prone. A component-based labeling system lets you change an ingredient declaration, warning, or contact statement at source and propagate it automatically to every label that uses it, with version control and approval records maintained throughout – which is what makes staged changes like the incoming fragrance allergen and GMP rules manageable rather than disruptive.

MoCRA preempts state and local requirements that differ from its provisions on registration, product listing, GMP, labeling, packaging, adverse event reporting, and safety substantiation. It expressly preserves state authority in other areas, including California Proposition 65 and state ingredient restrictions and reporting programs – so state-level PFAS bans and warning obligations continue to apply alongside MoCRA.

Products can be deemed misbranded or adulterated, which exposes them to import detention, seizure, and FDA's mandatory recall authority. FDA can also suspend a facility's registration, which prohibits distribution of any product from that facility until the suspension is lifted.

Enterprise artwork and labeling management software such as Kallik's Veraciti™ helps cosmetics companies meet MoCRA requirements by storing every label element – ingredient declarations, warnings, claims, professional use statements, adverse event contact details – as a controlled, reusable asset. Templates apply those elements consistently across every SKU and market, and when requirements change, the update is made once and applied across the affected portfolio with a full audit trail.