US Cosmetic Compliance: FDA Requirements Under MoCRA

The Modernization of Cosmetics Regulation Act (MoCRA) reshaped how the FDA regulates cosmetics sold in the US, introducing mandatory registration and stricter safety expectations for the first time. Here's what compliance actually requires.

The Regulatory Shift Under MoCRA

Before MoCRA, cosmetic registration with the FDA was voluntary. MoCRA made facility and product registration mandatory, gave the FDA recall authority, and introduced formal safety substantiation and adverse event reporting requirements.

Facility and Product Registration

Cosmetic manufacturing and processing facilities must register with the FDA, and each product must be listed with its ingredients disclosed. This applies to both domestic manufacturers and foreign companies selling into the US market.

Safety Substantiation

Companies must maintain records supporting that their product is safe for its intended use, based on adequate testing or other reliable evidence. This documentation needs to exist before the product reaches the market, not be assembled after the fact.

Labeling Requirements

Labels must disclose ingredients, including fragrance allergens above a threshold concentration, and include contact information for reporting adverse events — a new requirement introduced by MoCRA.

Adverse Event Reporting

Serious adverse events must be reported to the FDA within 15 business days, with records retained for several years. Having a reporting procedure in place before you need it is essential — this isn't something to figure out during an actual incident.

How TheMedNerds Helps

We help cosmetic brands navigate MoCRA registration, safety substantiation, and labeling compliance from the ground up. Book a free consultation to assess where your product stands.