FAQ

The RP is required for all cosmetic products and ensures product safety, maintains substantiation records, reports adverse events, and complies with labeling requirements. They must reside in the U.S. and appear on product labels.

A U.S. Agent is required for foreign facilities manufacturing cosmetics for U.S. distribution. They act as a communication liaison with the FDA but do not handle product safety or appear on labels.

FDC Corp. can serve as both your RP and U.S. Agent to meet MoCRA requirements seamlessly.

MoCRA requires businesses to maintain:

• Safety substantiation records proving product safety.
• Adverse event reports for issues related to product use.
• Facility registration and product listing information, including detailed ingredient data.
• Labeling documentation, ensuring compliance with updated FDA rules.

FDC Corp. can assist in preparing and organizing these documents to ensure full compliance with MoCRA regulations.

Under MoCRA, cosmetic companies must:

• Register their manufacturing facilities with the FDA.
• Submit product listings, including detailed information on ingredients.
• Report serious adverse events to the FDA within 15 days.
• Ensure products are manufactured under GMPs.
• Comply with updated labeling requirements, including allergen disclosures.

Facilities manufacturing cosmetics for U.S. distribution must register and submit product listings unless exempt. Registration involves providing the facility’s FEI number, while product listing requires detailed ingredient information. Small businesses may have exemptions, but safety substantiation and adverse event reporting are still mandatory.

MoCRA applies to all cosmetic companies, regardless of size. Small businesses must comply with facility registration, product listing, and safety requirements. The FDA may offer tailored guidance or exemptions to reduce compliance burdens for small companies, but it’s essential to seek professional assistance to navigate these regulations effectively.