Modernization of Cosmetics Regulation Act (MoCRA)

US FDA Highlights MoCRA Implementation And New Cosmetics Safety Data

FDA’s Chief Scientist has published a new FDA Voices article outlining three years of implementation of the Modernization of Cosmetics Regulation Act (MoCRA), highlighting mandatory registration and listing, expanded recall and records-access powers, updated adverse-event reporting tools, and new public transparency via an adverse-event dashboard and PFAS safety assessment report. For cosmetics manufacturers and brand owners this confirms that MoCRA’s framework is now fully embedded in FDA oversight, increasing scrutiny and public visibility of safety issues and reinforcing the need for robust registration, reporting, safety substantiation and ingredient risk management even though no new deadlines are introduced in this update.

5 May 2026, 06:57fda.govUnited States

U.S. FDA Refuses Entry to 151 Imported Cosmetic Batches in January 2026

The US FDA refused entry to 151 batches of imported cosmetics in January 2026, citing misclassification, non-compliant color additives, and labeling failures. This enforcement surge signals intensified scrutiny of product categorization and ingredient safety, requiring manufacturers to prioritize rigorous pre-market verification to avoid supply chain disruptions.

11 Mar 2026, 11:53cosmetic.chemlinked.comUnited States

Louisiana HB 930 Proposes Eliminating Cosmetic Product Registration Requirement

Louisiana HB 930 proposes to eliminate state-level registration requirements for cosmetic products and exempt small cottage manufacturers from certain fees. This shift reduces administrative burdens for brands while aligning state oversight with federal MoCRA standards for product safety and compliance.

6 Mar 2026, 13:01legis.la.govUnited States

US Congress Introduces Bill To Treat Hair Straightening Products Containing Formaldehyde As Adulterated Under FD&C Act

A new US House bill proposes to classify hair straightening products containing formaldehyde or formaldehyde-releasers as adulterated under federal law. This move signals a legislative push to eliminate these substances from the cosmetics market, necessitating proactive reformulation and supply chain risk assessments.

4 Mar 2026, 16:07congress.govUnited States

US Study Finds Toxic Chemicals in Hair Extensions, Exposing Gaps in Cosmetics Regulation

A new study identifying hazardous chemicals in hair extensions is intensifying pressure for expanded US federal cosmetics regulation and stricter state-level enforcement. Companies should anticipate broader oversight of cosmetic accessories and ensure compliance with California 2025 chemical bans to manage emerging product liability and market access risks.

27 Feb 2026, 15:38healthpolicy-watch.newsUnited States

US FDA Updates Cosmetics Direct Portal and Materials for MoCRA Biennial Facility Registration Renewal

The US FDA has enhanced its electronic registration portal and guidance to support mandatory biennial facility renewals required under the Modernization of Cosmetics Regulation Act. Businesses must align internal compliance tracking with these new workflows to ensure timely renewals and maintain the legal standing necessary for continued US market access.

17 Feb 2026, 14:06fda.govUnited States

US FDA Issues Draft Guidance on Records Access Authority for Cosmetic Products

The US FDA has issued draft guidance detailing expanded authority to access and copy cosmetic product records during safety investigations under MoCRA. Businesses must ensure rigorous record-keeping and safety substantiation to mitigate significant risks of import refusals, civil injunctions, and criminal enforcement.

4 Feb 2026, 12:59federalregister.govUnited States

US FDA Reports Over 50 PFAS Ingredients In Nearly 1,700 Personal Care Products

The US FDA has identified over 50 PFAS ingredients intentionally added to nearly 1,700 cosmetic products following mandatory reporting under the Modernization of Cosmetics Regulation Act. This official evidence base signals increased federal scrutiny and will likely accelerate state-level bans and market pressure for PFAS-free formulations in the personal care sector.

17 Jan 2026, 19:04fda.govUnited States

US FDA Updates Guidance On Tamper-Resistant Packaging For High-Risk Cosmetics

The US FDA has updated its cosmetics labeling guidance to reinforce mandatory tamper-resistant packaging and labeling requirements for liquid oral hygiene and vaginal products. Impacted businesses should audit packaging designs for these high-risk categories to ensure visible barriers and distinctive labeling are present to mitigate enforcement risks related to misbranding or adulteration.

9 Jan 2026, 15:43fda.govUnited States

US FDA Issues Warning Letter To Private Label Skin Care Inc Over CGMP And OTC Drug Listing Violations

The FDA has intensified enforcement against skincare manufacturers for failing to maintain quality unit oversight and comply with mandatory over-the-counter drug listing requirements. Companies must ensure that administrative registration is accurate to avoid triggering deep-dive inspections that expose broader manufacturing, impurity control, and supply chain vulnerabilities.

6 Jan 2026, 08:19fda.govUnited States

US FDA Publishes MoCRA-Mandated Report on PFAS Safety in Cosmetic Products

The US FDA has released its mandated assessment of PFAS in cosmetics, concluding that significant data gaps prevent a definitive safety determination for the majority of substances identified in formulations. While no immediate federal ban has been issued, the report signals a shift toward heightened regulatory scrutiny and potential enforcement actions, requiring manufacturers to audit portfolios and address toxicological data deficiencies.

4 Jan 2026, 11:27fda.govUnited States

US States Implement and Expand PFAS Bans in Cosmetics From 2025 Onwards

Multiple US states are implementing bans on intentionally added PFAS in cosmetics starting January 2025, with further state prohibitions and a federal safety report expected through 2026. This expanding patchwork of regional restrictions requires immediate supply chain mapping and product reformulation to maintain market access and manage compliance risks across the United States.

23 Dec 2025, 15:35morganlewis.comUnited States

US FDA Issues Draft Guidance on Mandatory Cosmetics Recalls Under MoCRA

The US FDA has issued draft guidance detailing its new authority under MoCRA to mandate cosmetic product recalls for items posing serious health risks. Companies must ensure internal safety monitoring and recall readiness are robust enough to preempt mandatory enforcement and mitigate significant reputational risk.

17 Dec 2025, 14:14public-inspection.federalregister.govUnited States

US FDA Withdraws Proposed Rule on Asbestos Testing in Talc-Containing Cosmetics

The US FDA has withdrawn its proposed rule for standardized asbestos testing in talc-containing cosmetics to address technical complexities and policy alignment. While immediate compliance requirements are paused, manufacturers should prepare for a revised proposal as the agency remains legally mandated to establish these safety standards.

8 Dec 2025, 10:18federalregister.govUnited States

FDA Launches Dashboard for Real-time Cosmetic Safety Data

The FDA has launched a real-time public dashboard for cosmetic adverse event reporting, centralizing safety data under the Modernization of Cosmetics Regulation Act. This increased transparency will likely accelerate regulatory enforcement and heighten litigation risks, requiring brands to adopt more proactive safety signal monitoring and data-driven compliance strategies.

25 Sept 2025, 11:50cosmeticsdesign.comUnited States

Commentary: US States Lead Regulatory Push to Ban PFAS in Cosmetics

Multiple US states are implementing bans on intentionally added PFAS in cosmetics starting in 2025, ahead of federal FDA safety reports. Manufacturers must prioritize supply chain transparency and rapid reformulation to manage fragmented compliance deadlines and mitigate significant litigation risks.

11 Aug 2025, 23:00jdsupra.comUnited States

US House Introduces Safer Beauty Bill Package to Enhance Cosmetic Safety

US lawmakers have reintroduced a legislative package proposing federal bans on 18 hazardous chemicals in cosmetics and mandatory full-ingredient transparency starting in 2027. This initiative signals a move toward stricter federal alignment with state-level bans, requiring companies to accelerate reformulation efforts and strengthen supply chain data disclosure protocols.

31 Jul 2025, 22:00schakowsky.house.govUnited States

U.S. Lawmakers Reintroduce Safer Beauty Bill Package to Regulate Toxic Chemicals

U.S. lawmakers have reintroduced the Safer Beauty Bill Package to ban 18 hazardous chemicals and mandate full ingredient transparency across the cosmetics supply chain. This move signals a shift toward federal alignment with stricter international standards, requiring manufacturers to accelerate reformulation and supply chain mapping beyond existing MoCRA compliance.

16 Jul 2025, 23:00schakowsky.house.govUnited States

FDA Releases Updated Summary on Cosmetic Facility and Product Registrations under MoCRA

The FDA has published the first comprehensive data on cosmetic facility registrations and product listings, confirming broad industry compliance with MoCRA requirements. This data establishes a baseline for federal oversight, enabling the FDA to transition from implementation to targeted market surveillance and safety enforcement.

27 Mar 2025, 19:06fda.govUnited States

New FDA Summary on Cosmetic Product Registration and Listing Data

The FDA has released initial summary data from mandatory cosmetic facility registrations and product listings required under the Modernization of Cosmetics Regulation Act. This transparency marks the transition to active federal market surveillance, requiring companies to maintain rigorous data accuracy and safety substantiation to ensure uninterrupted U.S. market access.

20 Mar 2025, 15:33fda.govUnited States