For decades, the U.S. cosmetics industry operated under a regulatory framework largely unchanged since 1938. That era is over. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — signed into law by President Biden on December 29, 2022 — represents the most sweeping overhaul of U.S. cosmetics regulation in modern history, and the FDA has spent the past three years putting its teeth into enforcement. For importers, customs brokers, freight forwarders, and global brands shipping beauty and personal care products into the United States, understanding MoCRA is no longer optional. It is a core compliance requirement.
Why MoCRA Matters: A Landmark Shift in FDA Authority
Before MoCRA, the FDA’s authority over cosmetics was surprisingly limited. The agency could not require pre-market safety testing, could not mandate facility registration, and lacked mandatory recall authority. MoCRA changes all of that. The law grants the FDA significant new powers and imposes substantial new obligations on everyone in the cosmetics supply chain — from manufacturers and processors to distributors and importers.
The FDA’s Office of Cosmetics and Colors, which in 2024 was transferred to the Office of the Chief Scientist for better alignment with its core public health mission, has been actively issuing guidance, launching new digital portals, and stepping up enforcement activity. The pace of implementation is accelerating — and compliance deadlines are already in the rearview mirror for many requirements.
Key MoCRA Requirements Already in Effect
Several MoCRA provisions have crossed their enforcement thresholds. Importers and compliance officers should verify full adherence to the following:
- Mandatory Facility Registration: All facilities that manufacture or process cosmetic products for U.S. distribution — including foreign facilities — were required to register with the FDA by July 1, 2024. New facilities must register within 60 days of beginning operations, and registrations must be renewed biennially. The FDA’s Cosmetics Direct portal, as well as the Electronic Submissions Gateway Next Generation (ESG NextGen), are the primary submission channels. As of early 2025, over 9,500 unique facility registrations and nearly 590,000 product listings are on record.
- Mandatory Product and Ingredient Listing: The “responsible person” — typically the manufacturer, packer, or distributor whose name appears on the product label — must submit a product listing for each cosmetic product marketed in the U.S., including a full ingredient list. This requirement became enforceable on July 1, 2024. New products must be listed within 120 days of being marketed. The FDA has clarified that every product requires a separate listing, even those previously submitted through the former voluntary program.
- Serious Adverse Event Reporting: Companies must report serious adverse events — including death, life-threatening experiences, inpatient hospitalization, and significant disability — to the FDA within 15 days of receiving the report. All adverse event records must be retained for six years (three years for certain small businesses). The FDA has updated its tools and systems to process these mandatory submissions electronically.
- Responsible Person Contact Information on Labels: As of December 29, 2024, all cosmetic product labels must display the name and address of the responsible person. Brands should audit their product packaging to confirm compliance — especially for imported goods where labels may have been set before this deadline.
- Active Prohibited Ingredient Enforcement: The FDA is actively using its new authorities. In 2025, the agency issued a consumer alert after detecting methylene chloride — a prohibited ingredient at any concentration in cosmetics — in several gel nail polish removers marketed as cosmetic products. Import shipments containing non-compliant ingredients are increasingly subject to detention and refusal.
What’s Still Coming: GMP, Fragrance Allergens, and PFAS
Not all MoCRA provisions are fully implemented yet, but companies should not interpret pending rulemaking as a reason to wait.
- Good Manufacturing Practices (GMP): Prior to MoCRA, cosmetics manufacturing was not subject to mandatory GMP regulations. MoCRA directs the FDA to establish binding GMP standards consistent with national and international norms. A proposed rule was published in December 2024, with a public comment period that closed in March 2025. The final rule is expected by December 2025. Once finalized, products manufactured under non-compliant conditions will be deemed adulterated and cannot be legally sold in the U.S. Companies should begin gap analyses now.
- Fragrance Allergen Labeling: The FDA is working to establish which fragrance allergens must be disclosed on product labels, taking into account international standards including EU requirements. Rulemaking on this requirement has experienced delays, with both the June 2024 and revised January 2025 deadlines having passed. Updated timelines are expected. Global brands that already comply with EU fragrance allergen rules will be better positioned when U.S. requirements are finalized.
- PFAS Safety Assessment: MoCRA required the FDA to assess the use of per- and polyfluoroalkyl substances (PFAS) — commonly called “forever chemicals” — in cosmetic products. In December 2025, the FDA published its assessment, which included safety reviews of the 25 most commonly used PFAS in cosmetics marketed in the U.S. The data was drawn directly from the new mandatory product listings. PFAS-containing products represent approximately 0.41% of all listed products as of August 2024. Brands using PFAS ingredients should closely monitor developments from this report.
Implications for Importers and Cross-Border Shipments
MoCRA’s reach extends well beyond domestic manufacturers. Foreign facilities that produce cosmetics for the U.S. market are fully subject to registration and listing requirements. Distributors and importers who serve as the “responsible person” on product labels bear direct compliance obligations, including adverse event reporting and safety substantiation.
From a customs and trade compliance perspective, MoCRA has real entry implications. Products from facilities that are not registered with the FDA, or that contain prohibited ingredients, are subject to detention and refusal at the border. The FDA’s expanded record access authority also means that importers may face greater scrutiny during regulatory investigations — and the supply chain documentation required to demonstrate compliance is now more important than ever.
State-level regulations add another layer of complexity. While MoCRA creates a uniform federal framework that preempts many state laws, states retain the authority to ban or restrict specific cosmetic ingredients. California, Washington, and New Hampshire, among others, have enacted ingredient restrictions that exceed the federal baseline. Importers shipping to multiple U.S. markets must navigate both federal MoCRA compliance and applicable state-level rules.
Recommended Steps for Compliance
Whether you are a domestic distributor, a foreign manufacturer, or a customs broker managing cosmetics shipments, the following steps are critical:
- Conduct a compliance gap analysis to identify which MoCRA requirements apply to your business and what systems, records, and processes need to be implemented or updated.
- Verify that all relevant manufacturing facilities are registered with the FDA through Cosmetics Direct, and confirm that product listings with complete ingredient disclosures are on file.
- Audit product labels to ensure responsible person contact information is displayed as required since December 29, 2024.
- Establish adverse event reporting protocols with clear internal workflows to capture, document, and report serious adverse events to the FDA within the 15-day window.
- Begin GMP readiness planning by reviewing the FDA’s draft guidance on cosmetic GMP and assessing personnel, facility, and quality system requirements before the final rule takes effect.
- Screen product formulations for prohibited ingredients and those under active FDA scrutiny, including PFAS and methylene chloride, before products enter U.S. commerce.
How Alba Can Help
Navigating MoCRA’s requirements is not just a regulatory challenge — it is a supply chain and customs challenge. At Alba Wheels Up International, our team combines deep expertise in FDA-regulated product compliance, customs brokerage, and international freight forwarding to help cosmetics importers and exporters stay ahead of evolving requirements.
From pre-shipment compliance review and FDA entry filing to post-market recordkeeping support and regulatory monitoring, we work with clients across the beauty and personal care sector to ensure their supply chains are compliant, efficient, and ready for what comes next.
Contact us: https://albawheelsup.com/contact-us/
