Mocra Compliance: Fda Registration, Safety, and Enforcement Risk

MoCRA requires every facility that manufactures or processes cosmetics for the U.S. .arket to register with the FDA. The registration requirement applies to domestic and foreign facilities alike. Facilities already in operation when MoCRA was enacted had to register by December 29, 2023. New facilities must register within 60 days of first engaging in the manufacturing or processing of cosmetics. Registration must be renewed biennially. A facility whose registration is suspended may not introduce cosmetics into interstate commerce. Registration is not a one-time event. It is an ongoing obligation with real consequences for non-renewal.

FDA product registration counsel manages the initial registration submission, prepares the biennial renewal filings, monitors FDA guidance on registration requirements, and advises companies on the suspension risk factors that apply to their specific manufacturing operations.

Every cosmetic product marketed in the United States must be listed with the FDA. The listing must include the product name, cosmetic category, INCI ingredient list, responsible person contact information, and the facility registration number. Existing products had to be listed by July 1, 2024. New products must be listed within 120 days of first being marketed. The listing must be updated whenever a product formulation or labeling change occurs. The responsible person is defined as the manufacturer, packer, or distributor whose name appears on the label.

Regulatory laws counsel evaluates the company's full product portfolio for listing completeness, identifies products that require listing updates due to reformulation or relabeling, and manages the ongoing FDA product listing compliance calendar.

Cosmetics must be safe under labeled conditions. A cosmetic lacking safety substantiation is adulterated under the FD&C Act. The responsible person must maintain safety substantiation records for each product for three years following the last sale. Good Manufacturing Practice (GMP) regulations will govern facility conditions, personnel qualifications, equipment standards, and quality control procedures once finalized. A company that cannot document the basis for its safety conclusions faces immediate adulteration exposure in the event of an FDA inspection.

Consumer protection investigations counsel evaluates the company's safety substantiation records for each product, identifies gaps in the safety assessment documentation, and advises on the record retention obligations that apply during the three-year post-sale period.

MoCRA's restrictions cover prohibited substances such as bithionol and hexachlorophene, and color additives lacking specific FDA approval. An unapproved color additive makes the product adulterated per se. MoCRA added PFAS disclosure requirements for cosmetics where these substances are detected above defined concentration thresholds. Drug-cosmetic classification risk is the most significant ingredient-related compliance issue for companies making performance claims. A product whose ingredient claims imply a physiological effect risks being reclassified as a drug, triggering pre-market approval requirements.

Compliance enforcement through courts counsel evaluates the ingredient composition of each product against the FDA prohibited and restricted ingredients list, identifies PFAS disclosure obligations, and advises on the drug-cosmetic classification risk created by specific ingredient claims.

Cosmetic labeling under MoCRA is governed by the FD&C Act and the Fair Packaging and Labeling Act (FPLA). MoCRA requires that professional cosmetics, distributed exclusively to licensed professionals, include a professional use only label statement. MoCRA also requires disclosure of fragrance allergens on cosmetic labels when present above a defined concentration threshold. INCI names remain the required nomenclature for ingredient disclosure. A product that does not meet all labeling requirements is misbranded and subject to seizure, import refusal, and warning letter.

Global data compliance counsel evaluates current product labels against MoCRA's new labeling requirements, identifies professional use statement obligations and fragrance allergen disclosure gaps, and advises on the label update timeline required before FDA begins enforcement of the new MoCRA labeling provisions.

MoCRA created a mandatory adverse event reporting obligation that did not exist before 2022. Responsible persons must report serious adverse events to FDA within 15 business days of receipt. A serious adverse event is one resulting in death, hospitalization, significant disability, or an outcome requiring medical intervention to prevent those consequences. Records of all adverse events must be maintained for six years. A pattern of non-serious adverse events can itself be grounds for an FDA investigation or recall determination. Companies without an adverse event monitoring system are exposed to reporting failures from day one.

Consumer class actions counsel evaluates the company's adverse event monitoring system for compliance with MoCRA's reporting timeline and record retention requirements, identifies systemic reporting deficiencies that create class action exposure, and advises on the MedWatch submission process for serious adverse events.

MoCRA gave FDA mandatory recall authority over cosmetics for the first time. FDA may order a mandatory recall when it determines that a cosmetic has a reasonable probability of causing serious adverse health consequences or death. A company that refuses a voluntary recall request faces a mandatory recall order, public announcement, and potential seizure. Consent decrees of permanent injunction impose ongoing compliance monitoring obligations and can restrict the company's ability to manufacture or distribute cosmetics. Warning letters are FDA's primary pre-enforcement communication. Import alerts allow FDA to detain and refuse imported cosmetics. A company whose product is subject to an import alert cannot import that product until the alert is lifted.

Consent decree counsel responds to FDA warning letters and mandatory recall requests, negotiates consent decree terms to preserve the company's ability to operate, and advises on the remediation steps required to lift import alerts and restore compliance standing.

A MoCRA compliance program begins with a complete inventory of products and manufacturing facilities. The inventory identifies which facilities require registration, which products require listing, and which lack adequate safety substantiation. A compliance calendar maps all upcoming registration renewals, listing updates, and mandatory reporting deadlines. Written procedures must govern adverse event monitoring, safety substantiation documentation, GMP implementation, and label review. Internal audits must verify that registration and listing records are current and that safety substantiation files are complete for each product.

Compliance program design counsel designs the MoCRA compliance program, implements the facility registration and product listing calendar, prepares the adverse event monitoring and reporting procedures, and advises on the internal audit schedule required to maintain continuous compliance with all MoCRA obligations.