MoCRA Checklist for Brand Owners

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This checklist is interactive with JavaScript, but every item is listed below. The eight readiness items from our MoCRA guide: facility registration verified current; every SKU listed with the FDA; safety substantiation on file per product; label review completed; adverse event process written and staffed; manufacturer GMP procedures reviewed; written agreement assigning each MoCRA task; record-keeping system in place.

The readiness checklist

1. Facility registration verified current — Facilities that manufacture or process cosmetic products for distribution in the United States must register with the FDA, and renew that registration every two years. Evidence to hold: registration confirmation and renewal date. Owner: brand owner 2. Every SKU listed with the FDA — List each marketed cosmetic product with the FDA, including its ingredients and where it is manufactured. Update the listing when a product is discontinued or its formulation changes in a way that affects the listing. Evidence to hold: listing confirmations per product. Owner: brand owner 3. Safety substantiation on file per product — Make sure adequate substantiation exists that the product is safe for its intended use, and keep the supporting records available to the FDA. A product without adequate safety substantiation must carry a warning statement. Evidence to hold: studies, assessments, or other supporting records. Owner: brand owner 4. Label review completed — Labels must carry the responsible person's contact information for adverse event reporting, an accurate ingredient declaration, and disclosure of fragrance allergens where required. Have every label reviewed against current requirements before printing. Evidence to hold: approved label artwork and review notes. Owner: brand owner 5. Adverse event process written and staffed — Report serious adverse events to the FDA within 15 business days of receiving the report, and maintain records of adverse events. You need a way for consumers to reach you and a written internal process before you sell. Evidence to hold: written procedure and a named contact. Owner: brand owner 6. Manufacturer GMP procedures reviewed — Until a final GMP rule is in force, the practical standard is documented procedures, controlled ingredients and processes, batch records, and quality checks. When evaluating a manufacturer, its GMP discipline is one of the most informative things you can examine. Evidence to hold: procedures summary and batch-record example. Owner: brand owner 7. Written agreement assigning each MoCRA task — An agreement can assign the work — filing a listing, keeping records, registering a facility — but the legal responsibility remains with the responsible person if the work is not done or is done wrong. Your agreement should state each duty explicitly, row by row. Evidence to hold: signed agreement with row-by-row responsibilities. Owner: both 8. Record-keeping system in place — The FDA may access certain records, including safety substantiation and adverse event records. MoCRA also gave the FDA mandatory recall authority if the agency determines a cosmetic has a reasonable probability of causing serious adverse health consequences and the responsible person refuses a voluntary recall. Evidence to hold: where records live and how long they are kept. Owner: brand owner

Who does what

In most private-label arrangements the manufacturer does the making and much of the filing, while the brand owner carries the legal duties. The manufacturer registers its facility and often files listings on the brand owner's behalf; the brand owner verifies the facility is registered and current, ensures every SKU is listed accurately, holds the safety records, receives and reports serious adverse events, approves final labels, and maintains records. "The manufacturer handles compliance" is not a plan — a row-by-row assignment is. Spas launching their own line face the same split of duties — the private-label page for estheticians and day spas walks through what a small practice confirms before its first sale.

Small brands are not automatically exempt. A narrow exemption from facility registration and product listing exists for very small businesses, based on average annual sales, but it does not cover every product type and it does not remove the other obligations. Do not assume your brand qualifies — check the current criteria or get professional advice.

General information, not legal advice. This checklist is general educational information about MoCRA as publicly described by the FDA. Cosmetics regulation is detailed and fact-specific. For decisions about your products, consult a regulatory professional or attorney who works with cosmetics.

Frequently asked questions

Who is the 'responsible person' under MoCRA?

The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. For a private-label brand, that is usually the brand owner — not the contract manufacturer that made the product. The responsible person's duties cannot be handed off by contract alone.

Can my manufacturer handle all the MoCRA paperwork?

A manufacturer can do much of the practical work — registering its facility, listing products, keeping records — but the legal duties of the responsible person stay with the brand owner. If the paperwork is wrong or missing, the brand owner answers for it. Confirm in writing who does what, and verify it.

Related tools: the launch cost calculator, the MOQ planner, the launch timeline planner, the brief scorer, and the first-run budget builder.

Launch with the paperwork in order

Work the checklist, ask the six questions in our MoCRA guide, and start the manufacturer conversation with responsibilities assigned in writing — before the first sale, not after it.

Start with the Renaud funnel → Read the full MoCRA guide →

Is your launch MoCRA-ready?

The readiness checklist

Who does what

Frequently asked questions

Launch with the paperwork in order