MoCRA Explained: What the New US Cosmetics Law Means for Brands

Spectra Cosmetic Compliance

MoCRA is a different framework from the UK and EU regimes and this is our hub for it. If you sell in the UK or EU to our MoCRA vs UK/EU guide compares them. Note: some MoCRA rules were still being finalised so confirm the current position.

What is MoCRA?

MoCRA (the Modernization of Cosmetics Regulation Act) is a US federal law that changed how the FDA regulates cosmetics. It was signed into law on December 29 / 2022 as part of the Consolidated Appropriations Act 2023. The passage of the Modernization of Cosmetics Regulation Act marked a significant new law for cosmetics and personal care businesses selling into the US.

Before MoCRA US cosmetics rules had barely changed since the Federal Food Drug and Cosmetic Act of 1938 and most safety steps were voluntary. MoCRA made many of those steps mandatory and gave the FDA formally the Food and Drug Administration real enforcement power for the first time.

What does MoCRA require?

MoCRA requires cosmetic companies to:

• Register their manufacturing facilities with the FDA
• List each product they sell in the US
• Prove their products are safe (safety substantiation)
• Report serious health complaints (adverse events) to the FDA
• Follow Good Manufacturing Practice (GMP) rules
• Name a Responsible Person for each product

The FDA can also now order a mandatory recall if a product is unsafe a power it didn't have before MoCRA. Taken together these MoCRA requirements represent a substantial increase in regulatory oversight of the sector.

Who does MoCRA apply to?

MoCRA applies to any cosmetic sold in the US no matter where it's made. So a brand manufacturing in the UK, EU or anywhere else still has to follow MoCRA if it sells into the US market the same as a US-based company.

How does MoCRA compare to EU/UK rules?

MoCRA moves US cosmetics regulation closer to how the EU and UK already regulate cosmetics with mandatory registration safety files and a named responsible party. The systems aren't identical but the direction is the same: less voluntary more enforced. Brands used to meeting EU or UK regulatory requirements will recognise the underlying logic even where the specific MoCRA compliance steps differ.

Facility registration

MoCRA requires facility registration: manufacturers and processors of cosmetics marketed in the US must register their facilities with the FDA. Registration must be renewed every two years and updated within 60 days of significant changes. Foreign facilities must designate a US agent. Registration is submitted through the FDA's electronic Cosmetics Direct portal.

This gives the FDA a map of the facilities making cosmetics for the US market a foundation for its oversight and if needed for recalls. Our guide to facility registration and product listingk covers this requirement in detail.

Product listing

Alongside facility registration MoCRA requires product listing: the responsible person must list each marketed cosmetic product with the FDA including its ingredients and update the listing annually. This applies to each product even free samples and gifts unless an exemption applies giving the FDA visibility of the products on the market and what is in them. Cosmetics manufacturers should treat their product listings as a living record that needs updating whenever the formulation changes.

Product listing and facility registration are linked: a product listing generally includes the registration number of the facility where the product is made. Together they give the FDA the information to identify and act on risky products. This is a core ongoing MoCRA obligation.

The responsible person under MoCRA

MoCRA uses the term responsible person but it means something specific and different from the UK/EU Responsible Person. Under MoCRA the responsible person is the manufacturer packer or distributor whose name appears on the product label. This party carries key MoCRA obligations including product listing safety substantiation and adverse event reporting.

This is an important distinction for brands familiar with the EU/UK system: the MoCRA responsible person is a lighter label based concept not the Established in market entity accountable for a full safety dossier that the EU and UK require. Our Responsible Person guide explains the EU/UK role for contrast.

Safety substantiation

MoCRA requires that the responsible person hold adequate substantiation of the safety of each cosmetic product records supporting that the product is safe. This is a records based safety obligation: the responsible person must be able to demonstrate through tests studies or other evidence that the product is safe for use.

This is broadly analogous to the safety evidence principle behind the EU/UK CPSR though MoCRA does not mandate the same formal report format or a specifically qualified assessor. Our guide to safety substantiation and adverse events covers what this involves.

Adverse event reporting

MoCRA introduced mandatory adverse event reporting. The responsible person must report serious adverse events to the FDA within 15 business days and must keep records of adverse events (for six years or three years for certain small businesses). Product labels must also carry a domestic contact an address phone number or electronic contact through which adverse events can be reported.

This creates a post market safety monitoring system giving the FDA information about problems consumers experience. It is similar in purpose to the serious undesirable effect reporting under the EU/UK regimes and is a genuine ongoing obligation for brands ultimately serving the same goal of consumer safety on both sides of the Atlantic.

Expanded FDA powers and forthcoming rules

MoCRA significantly expanded FDA authority including a power of mandatory recall where a cosmetic is likely to cause serious adverse health consequences the power to suspend a facility's registration and access to certain records. It also directs the FDA to develop further rules on Good Manufacturing Practice (GMP) fragrance allergen labelling and standardised testing for asbestos in talc which have been progressing through the rule making process. Once finalised the good manufacturing practices rules and the requirements around declaring a fragrance allergen in the product will add further detail to what brands must do.

Because several of these rules were still being finalised their detail and timing should be confirmed against the current FDA position. The direction, though, is clear: MoCRA is building a comprehensive actively enforced regulatory framework, and brands should expect these additional requirements to take effect over time.

Small business exemptions

MoCRA exempts certain small businesses from the facility registration and product listing requirements (and from the forthcoming GMP requirements). The exemption is based on average gross annual cosmetic sales below a defined threshold. However the exemption does not apply to certain higher risk products such as those that regularly contact the mucous membrane of the eye are injected are for internal use or alter appearance for more than 24 hours under normal use.

So while some small businesses are relieved of registration and listing the exemption is limited and does not cover every product or obligation. Small brands should check carefully whether they qualify and for which products rather than assuming exemption. The safety substantiation and adverse event obligations in particular are not lifted by the small business exemption.

Why MoCRA is a turning point

MoCRA matters because it fundamentally changed the nature of US cosmetics regulation. For decades the US system was largely voluntary there was no mandatory facility registration no product listing and limited FDA authority over cosmetics compared with medicines or food. MoCRA replaced much of that with binding requirements and real enforcement powers bringing the US closer to the active oversight long seen in the UK and EU.

For brands this means the US can no longer be treated as a lightly regulated market for cosmetics. The requirements are mandatory, the FDA is enforcing them and analyses have found significant non-compliance among products already on the market particularly imports. A brand entering or selling in the US must take MoCRA seriously as a genuine compliance obligation not an optional formality if it wants to secure lasting market access there.

It also reflects a broader global trend toward greater cosmetic regulation and transparency. As the UK, EU US and other markets each strengthen their frameworks brands increasingly operate in a world where every significant market has real requirements and where international standards are converging even as the specific rules differ. MoCRA is the US chapter of that story and it rewards brands that build compliance into how they operate rather than treating it as an afterthought.

The practical takeaway is that MoCRA is here mandatory and enforced and building over time as further rules take effect. Brands that understand it and put the systems in place registration listing substantiation and reporting are well positioned those that assume the US remains lightly regulated risk being caught out. Treating MoCRA as a serious ongoing obligation and working to stay compliant as further rules land is the sound approach.

References: Modernization of Cosmetics Regulation Act of 2022 (amending the US Federal Food, Drug and Cosmetic Act) FDA cosmetics guidance and Cosmetics Direct. Verified July 2026 several implementing rules were still in progress confirm current FDA position. General information only not legal advice.