What Is MoCRA? A Guide to US FDA Cosmetics Compliance

MoCRA Explained: A New Era for Cosmetics Regulation in the U.S.

For over 80 years, cosmetics in the United States operated under a regulatory framework that hadn't changed much since 1938. That changed on December 29, 2022, when Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) as part of the Consolidated Appropriations Act of 2023. It's widely considered the most sweeping update to the FDA's authority over cosmetics in nearly a century, giving the agency real teeth to oversee product safety.

The Gap MoCRA Fills

Before this law, cosmetics companies operated with relatively little federal oversight. There was no requirement to register manufacturing facilities with the FDA, no obligation to report when something went wrong with a product, and no mandate to prove products were safe before selling them. Recalls happened only if a company chose to initiate one.

MoCRA changes that by establishing rules with real enforcement behind them, aimed at making sure the products people put on their skin and bodies every day are held to a higher safety bar.

The Law's Goals

MoCRA has two main aims: strengthen safety protections and transparency for consumers, and bring U.S. regulatory practices closer to what other major markets already require. To get there, it converts what used to be optional best practices into legal obligations, backed by new FDA enforcement powers.

What Companies Now Have to Do

The law introduces several new compliance obligations:

• Registering facilities — Manufacturers and processors generally must register their facilities with the FDA through the Cosmetics Direct portal, with some exceptions.
• Listing products — A responsible person for each product must file a listing with the FDA that includes ingredient information and manufacturer details, subject to exemptions.
• Proving safety — Businesses must hold onto documentation substantiating that their products are safe for use.
• Reporting serious incidents — Serious adverse events tied to a cosmetic must be reported to the FDA within a defined timeframe, giving regulators better insight into problems as they arise.
• Following manufacturing standards — The FDA is tasked with setting binding Good Manufacturing Practice (GMP) rules to keep quality and safety consistent.
• Submitting to recalls and inspections — The FDA can now order a mandatory recall of a dangerous product and can review safety records during an inspection — powers it didn't have before.

Who's on the Hook

Compliance obligations apply across the supply chain, reaching:

• Manufacturers and processors
• The responsible person named for a product
• Companies importing cosmetics into the U.S.

Each of these players has to meet the law's registration, listing, and safety-documentation requirements to keep selling legally.

The Bigger Picture for the Industry

MoCRA effectively ends the era of self-regulation in cosmetics, replacing it with a system where compliance is required, not optional. That translates into more transparency, better consumer protection, and greater accountability across the board.

Companies now need to weave regulatory compliance directly into how they develop, manufacture, and monitor their products after launch. Consumers, in turn, get more confidence that what's on the shelf has actually met a real safety standard.

Bottom Line

MoCRA reshapes the rules for how cosmetics are regulated in America. By handing the FDA broader authority and layering in new compliance requirements, it pushes the entire industry toward higher safety standards. As the rollout continues, it's expected to be a defining force in making the cosmetics industry more transparent, accountable, and centered on consumer protection.