What is MoCRA, and what does it require?

MoCRA introduced five core obligations for the cosmetics industry:

• Facility registration with the FDA, renewed every two years.
• Product listing for every cosmetic product placed on the US market, per facility.
• Naming a Responsible Person (the entity whose name appears on the label) accountable for safety and labelling.
• Reporting serious adverse events to the FDA within 15 business days.
• Holding records that adequately substantiate the safety of each product.

Cosmetic GMP, fragrance allergen labelling and PFAS reporting are also in scope, with implementing regulations rolling out on staggered timelines.

Every facility that manufactures or processes cosmetic products for the US market must register with the FDA and renew biennially. Each product made at that facility is listed individually, with category code, ingredients and the Responsible Person. Manufacturers and brand owners often disagree about who lists what; MoCRA allows either party to do it, but only one listing per product per facility is permitted.

The Responsible Person is the manufacturer, packer or distributor whose name appears on the product label. They carry the legal duty for safety substantiation, adverse event reporting, label compliance and recordkeeping. For a brand using a manufacturer, the brand is usually the Responsible Person. For a private-label arrangement, it is the entity named on the front of the pack.

Serious adverse events must be reported to the FDA within 15 business days, with records retained for six years. A serious event is anything resulting in death, hospitalisation, significant disfigurement, persistent disability or a congenital anomaly, plus events requiring medical intervention. The Responsible Person must maintain a contact for receiving reports (usually printed on the label or website).

MoCRA requires "adequate substantiation of safety", defined as tests, studies or other evidence that an expert qualified by training and experience would accept as supporting safety. In practice this looks similar to the EU Cosmetic Product Safety Report (CPSR) but is less prescriptive. For brands already selling into the EU, the existing CPSR usually meets the bar with light adaptation.

Worldover holds your formula, ingredient and facility data as the source of truth, then generates FDA facility registrations, product listings and adverse event records from that data. When the formula changes, the listing surfaces for update. When a serious event is logged, the 15-day clock starts visibly with the right evidence pre-attached.

MoCRA requires cosmetics manufacturers to maintain records sufficient to support an adverse event investigation, which means batch traceability that connects ingredient lot numbers to finished product and distribution records. Facility registration and product listing data also has to stay current as your portfolio moves.

Worldover tracks batch genealogy from raw material lot to finished product and distribution, with the records structured to support MoCRA adverse event reporting. Facility registration and per-SKU product listing data live alongside the formulation record, and Willow monitors for new MoCRA guidance and flags operational impacts automatically.