MoCRA for cosmetics: registration, listing, and the Responsible Person

For eighty years, US cosmetics were among the least-regulated consumer products the FDA oversaw. That era is over. The Modernization of Cosmetics Regulation Act — MoCRA — gave the FDA real authority over cosmetics for the first time, and as enforcement ramps up, every brand selling cosmetics in the US has new obligations to meet. Here is what MoCRA requires.

What MoCRA changed

The Modernization of Cosmetics Regulation Act, enacted in 2022, is the most significant overhaul of US cosmetics regulation in decades. Before it, the FDA's authority over cosmetics was minimal — registration was voluntary, and the agency had limited tools. MoCRA replaced that with mandatory obligations and gave the FDA new powers, including the authority to order recalls.

For brands used to the old light-touch regime, this is a fundamental shift from voluntary to mandatory.

Facility registration

MoCRA requires facilities that manufacture or process cosmetics for the US market to register with the FDA. Registration is done on a defined form, requires identifiers, and must be renewed periodically and kept current as things change. A facility that is not properly registered puts the products made there at risk of being considered non-compliant.

Product listing

Alongside facility registration, MoCRA requires that cosmetic products be listed with the FDA. The listing includes information about the product, including its ingredients, and has to be kept up to date. The product listing ties back to the facility, so the two obligations are connected.

This listing requirement means the FDA now has visibility into what cosmetic products are on the US market and what is in them — a major change from the voluntary past.

The Responsible Person

MoCRA centres obligations on the Responsible Person — the entity accountable for the product. The Responsible Person carries duties including ensuring safety substantiation, handling adverse event reporting, and maintaining records. This mirrors, in concept, the Responsible Person idea familiar from the EU, though the US requirements are their own.

Identifying who the Responsible Person is, and ensuring they can meet the obligations, is a foundational step for any brand.

Safety substantiation and adverse events

MoCRA requires that there be adequate substantiation of the safety of cosmetic products, and it introduces requirements around reporting serious adverse events and keeping related records for a defined period. Safety is no longer something a brand can simply assert — it has to be supported and the relevant records maintained.

Because MoCRA's requirements and timelines are detailed and still being implemented, confirm the current obligations and deadlines for your specific situation rather than relying on a general summary.

Where the data burden lands

Running through all of MoCRA's obligations is data: the ingredient information for product listing, the composition behind safety substantiation, the records that have to be kept current. As under the EU's cosmetics regime, the practical challenge is keeping this information accurate and consistent with products that change over time.

When the composition lives as structured data, the ingredient information a listing needs and the safety data substantiation rests on can be drawn from the product rather than reassembled from scattered files.

The takeaway

MoCRA ended the era of lightly regulated US cosmetics, introducing mandatory facility registration, product listing, a Responsible Person, safety substantiation, and adverse event reporting — with enforcement now active. Meeting these obligations rests heavily on keeping accurate, current product data. Brands that hold their composition and ingredient information as structured data are best placed to register, list, and substantiate without scrambling.

Lemoniq keeps your cosmetic composition and ingredient information as structured, current data, so the details behind MoCRA product listing and safety substantiation can be drawn straight from the product. We solve this exact problem. See how it works