If you launched a cosmetics brand before 2023, your regulatory obligations were minimal. MoCRA changed that. The U.S. now has a cosmetics regulatory framework that approaches — though does not match — the EU's. Every cosmetics brand operating in the U.S. needs to understand five core MoCRA requirements:

• Facility registration: Every facility that manufactures or processes cosmetics for U.S. distribution must register with FDA. Renewal every two years.
• Cosmetic product listing: Each cosmetic product marketed in the U.S. must be listed with FDA, including the product name, manufacturer, responsible person, ingredients, and product category.
• Safety substantiation: The responsible person (typically the brand) must maintain records substantiating the safety of each cosmetic product. "Substantiation" is not narrowly defined but generally includes ingredient safety data, stability data, and challenge testing for preservation.
• Adverse event reporting: Serious adverse events (death, hospitalization, disfigurement, persistent disability, congenital anomaly) must be reported to FDA within 15 business days. Records of all adverse events must be retained for 6 years.
• Good Manufacturing Practices: FDA is authorized to establish GMP regulations for cosmetics. The reference standard is ISO 22716.

MoCRA also gives FDA mandatory recall authority for cosmetics for the first time. Previously, cosmetics recalls were voluntary.

The "responsible person" concept is key. The brand whose name is on the label is the responsible person under MoCRA, even if a contract manufacturer produced the product. The brand cannot push compliance onto the manufacturer — the brand is on the hook.