MoCRA Facility Registration & Product Listing

Section 607 of the FD&C Act (added by MoCRA, P.L. 117-328) requires every person that owns or operates a facility that manufactures or processes cosmetic products distributed in the United States to register the facility with FDA. The 'responsible person' for each cosmetic product (typically the brand owner whose name appears on the label) must list the product with FDA, including the facility(ies) where it is manufactured/processed and the product's ingredients.

Registration is per facility; listing is per product (per SKU at the formulation level). A contract manufacturer registers its facility; the brand-owner responsible person lists each product manufactured at that facility.

• In scope: facilities manufacturing or processing cosmetic products distributed in the US, foreign and domestic.
• Out of scope: facilities that only label, relabel, package, repackage, hold or distribute cosmetic products (no manufacturing or processing).
• Small business exemption: 'small businesses' (average annual gross receipts in the past 3 years <$1m, indexed) are exempt from registration and listing UNLESS they manufacture products that are injected, intended for use in the eye area, intended for internal use, intended to alter appearance for >24 hours under conditions of use, or that the responsible person knows or has reason to know would have non-routine cleansing or handling.
• Beauty salon services performed on premises are not 'cosmetic products distributed' — the salon does not need to register for those services.

MoCRA set 29 December 2023 as the original registration deadline (one year after enactment) and the same date for first listing of pre-MoCRA products. FDA's November 2023 compliance-policy guidance deferred enforcement of both to 1 July 2024, citing readiness of the Cosmetics Direct submission portal and trading-partner preparation time.

• New facility post-1 July 2024: register within 60 days of first engaging in manufacturing/processing for the US market.
• Facility renewal: every two years (biennial).
• New product post-1 July 2024: list within 120 days of first marketing for the US market.
• Product updates: any change to a listed element (ingredient, manufacturing facility, brand) requires updated listing — annual at minimum.
• Annual listing affirmation: confirm listed products are still being marketed.

• Facility name, address, contact, FEI / DUNS where applicable.
• Owner / operator information.
• All brand names manufactured/processed at the facility.
• Product categories per FDA's category list (e.g. 'Makeup preparations for the eyes', 'Hair preparations (non-coloring)').
• Type of activity (manufacture, package, label, hold, distribute, contract manufacture).
• For foreign facilities — US agent and contact.

• Product name and product category.
• Responsible person name / address.
• Brand name and product identifier.
• List of ingredients, including fragrances, flavors and colors. Order matches the label declaration (descending order of predominance with the standard exceptions).
• Manufacturing facility / facilities (registration number).
• Whether the product is intended for professional use only.

FDA's Cosmetics Direct portal accepts registration and listing submissions in both structured form and SPL (Structured Product Labeling) format. SPL is the preferred path for portfolios with more than a handful of SKUs because of its bulk-submission capability. The portal also supports listing updates, annual affirmation and facility-renewal workflows.

Facility registration and product listing are the backbone for the rest of MoCRA — adverse-event reporting (Section 605) references the listed product; the forthcoming GMP regulation (Section 606, due by December 2024) applies to registered facilities; mandatory recall authority (Section 608) operates on listed products; labelling obligations (Section 609) including the domestic-address-for-adverse-event-reporting on label rely on listed responsible-person data. A facility that is not registered is — in FDA's view — operating in violation, and downstream MoCRA obligations attach regardless.

• Brand-owner responsible person assuming the contract manufacturer's facility registration covers the brand's listing obligation — they are separate.
• Small-business exemption claimed without checking the carve-out categories (eye-area, internal use, injectables, persistent appearance change).
• Ingredients listed in the wrong order or omitting fragrance/color components.
• Annual listing affirmation skipped — affirmation is required even if nothing changed.
• Facility renewal skipped — biennial obligation easy to miss.
• Contract manufacturer facility registered but brand owner unaware of which facility the contract uses for which SKU — listing fails the facility-linkage requirement.