MoCRA compliance checklist for cosmetics

This page is general educational information, not legal or regulatory advice, and it is not a complete statement of the law. Requirements, thresholds, and deadlines change and can depend on your specific products and business. Confirm your obligations with the FDA’s official guidance and qualified professionals. Using FormuLabz does not by itself make any product, label, claim, or business compliant.

MoCRA checklist — the main areas

• Facility registration. Manufacturers and processors of cosmetic products generally must register their facilities with the FDA and keep registrations renewed.
• Product listing. Cosmetic products and their ingredients generally must be listed with the FDA, with listings kept current.
• Responsible Person. Each product must identify a Responsible Person who carries certain obligations, including for labeling and adverse-event handling.
• Safety substantiation. You must maintain records supporting an adequate substantiation of safety for your cosmetic products.
• Adverse event recordkeeping. Keep records of, and where required report, serious adverse events associated with your products.
• Labeling. Labels must carry required elements, including contact information for adverse-event reporting and applicable fragrance-allergen disclosures.
• Good manufacturing practice. Be prepared for GMP expectations as they are established and phased in.
• Recordkeeping overall. Maintain organized, retrievable records across formulas, ingredients, batches, testing, and suppliers.

How FormuLabz helps you stay organized

FormuLabz checks are rule-based and explainable rather than an AI guess, so you can see why something was flagged. They are decision-support to help you catch problems early — they do not certify, approve, or guarantee compliance, and they do not replace registration, listing, safety substantiation, or professional review.