Sell Cosmetics in the US, MoCRA Compliant

MoCRA, signed into law in December 2022, represents the most significant expansion of FDA cosmetics oversight in 85 years. Under MoCRA, manufacturers, processors, packers, and distributors of cosmetics for sale in the United States must register their facilities with the FDA, list their products through FDA's Notified Importers and Exporters system, maintain safety substantiation for every product, and establish procedures for reporting serious adverse events. The law applies to both domestic and foreign establishments that manufacture cosmetics for US distribution. For Amazon sellers and DTC brands sourcing cosmetics from overseas manufacturers, the registration obligation applies to your US importer or distributor, not just the overseas factory. Understanding precisely which entity bears the registration obligation under your specific supply chain structure is a critical first step that our team addresses in every engagement.

Cosmetic facility registration is completed through FDA's Cosmetics Direct electronic submission portal. Every facility that manufactures, processes, packs, or holds cosmetics for US distribution must submit an initial registration and renew it biennially. The registration requires specific information about the facility including its exact address, facility manager contact details, all cosmetic product categories manufactured at the facility, and the responsible person associated with each product. For overseas manufacturing facilities, registration submissions must be made in English with specific data elements formatted to FDA's exact specifications. Our team prepares and submits facility registrations for clients whose overseas manufacturers have not yet registered, coordinates with manufacturers to obtain required facility data, and manages the biennial renewal process to ensure registrations never lapse. We maintain a registration tracking system for every facility in your supply chain, providing certificate documentation needed for marketplace compliance and customs clearance.

In addition to facility registration, MoCRA requires responsible persons to submit a product listing for every cosmetic product sold in the United States through FDA's NIE (Notice of Intent to Export) or equivalent domestic submission pathway. Product listings must include the product name, brand name, applicable cosmetic categories, list of ingredients in descending order of predominance, and contact information for the responsible person. Safety substantiation is the most substantive new obligation under MoCRA. Responsible persons must maintain adequate safety substantiation for each product, evidence that the product is safe as marketed and used. This does not necessarily require pre-market clinical testing, but it does require a documented safety assessment that accounts for ingredient safety profiles, product formulation, intended use, and intended consumers.

MoCRA introduces a new mandatory serious adverse event reporting obligation for cosmetics. Responsible persons must submit reports of serious adverse events, those requiring hospitalization, causing persistent disability, or resulting in death - to FDA within 15 days of becoming aware of the event. Non-serious adverse events must be recorded and retained, and records must be made available to FDA upon request. Establishing the operational procedures to receive, evaluate, and report adverse events before they occur is essential. Attempting to build these systems after an adverse event is reported creates serious compliance risk. We design adverse event intake systems, evaluation criteria, and FDA reporting workflows that integrate into your customer service and quality management operations. Annual training for customer-facing staff ensures that adverse event reports are recognized and escalated correctly.