Cosmetics Under the Microscope: FDA’s Expanding Regulatory Reach Under MoCRA

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marked the most significant expansion of FDA’s authority over cosmetics in 80 years — and the agency is putting that authority to work. From the launch of a new adverse event reporting tool to forthcoming rules on fragrance allergens and good manufacturing practices (GMP), FDA is reshaping the regulatory landscape for manufacturers, packers, and distributors of cosmetic and personal care products.

Industry stakeholders that take proactive steps now will be best positioned to navigate both regulatory scrutiny and any accompanying litigation risks. Below, we identify key action items to consider and the recent and forthcoming FDA actions in the cosmetics space that drive these recommendations.

Action Items

• Review adverse event reporting procedures and monitor trends. Public access to adverse event reports without a Freedom of Information Act (FOIA) request increases litigation exposure. Stakeholders should review internal and FDA adverse event reporting procedures — including complaint receipt and retention practices — and institute plans to monitor trends in adverse event reports and customer claims.
• Prepare for a revised talc-testing rule. Stakeholders should survey current testing methods, including supplier testing of talc-containing ingredients, and ensure they are retaining records documenting testing methods, detection limits, and any false positives.
• Develop internal recall and records request protocols. Stakeholders should establish internal policies for responding to FDA records requests, investigations, voluntary recall proposals, and mandatory recalls before they arise.
• Prioritize compliance reviews for drug and cosmetic products. Stakeholders manufacturing products that qualify as both drugs and cosmetics should review their facility GMPs, labeling and ingredient listing procedures, and ingredient testing protocols, as FDA enforcement may focus on these products and facilities first.
• Engage on upcoming proposed rules Stakeholders should monitor FDA’s forthcoming proposed rules on fragrance allergens and GMPs and consider submitting comments directly or through trade associations to ensure key concerns are on the record.

Recent FDA Actions

Development	Date	Key Details
Adverse Event Reporting Dashboard	September 2025	· FDA launched a public dashboard expanding access to data on mandatory and voluntary serious adverse event reports, which are now searchable by product name.
Withdrawal of Proposed Talc-Testing Rule	November 2025	·FDA withdrew its December 2024 proposed rule for manufacturers to test for asbestos, citing stakeholder feedback, scientific and technical complexities, and concerns about unintended consequences, inconsistent definitions of “asbestos,” and potential for an adulteration provision. ·MoCRA requires FDA to mandate talc-containing cosmetic product asbestos testing — thus, a new proposed rule is forthcoming, but timing is unknown.
Report on the Use of PFAS in Cosmetics	December 2025	· FDA published a MoCRA-mandated report determining that current scientific data is insufficient to assess the overall safety of per- and polyfluoroalkyl substances (PFAS) in cosmetics. Only perfluorohexylethyl triethoxysilane was identified as a potential safety concern, specifically when used in body lotion at the highest level of use.
Draft Guidance for Cosmetic Recalls	December 2025	· FDA published draft guidance on cosmetic recalls affirming that it will first offer the responsible person the opportunity to voluntarily recall. If they do not act, FDA may mandate a recall if it finds the product is adulterated or misbranded and that its use or exposure could cause serious adverse health consequences or death (SAHCOD). Responsible persons subject to a mandatory recall are entitled to an informal hearing within 10 days, after which the commissioner will issue a final determination. · Noncompliance constitutes a violation of the FD&C Act and may result in injunctions or criminal prosecution.
Draft Guidance on Cosmetic Records Access	January 2026	· FDA published draft guidance affirming its authority to access and copy records when it reasonably believes a cosmetic product is likely adulterated and poses a threat of SAHCOD. FDA may access and copy records related to manufacturing, raw materials, distribution, inventory, analytical results, recalls, complaints, adverse events, and safety substantiation. · Triggers for record review include product recalls, adverse event reports, consumer complaints, and inspections or samplings indicating a health threat. · Responsible persons must retain records for six years (three years for small businesses) and make them available upon request. · Refusal to permit access may result in civil or criminal penalties and import refusal.
Recent FDA Warning Letters	Late 2025	· FDA issued several warning letters to manufacturers of products qualifying as both drugs and cosmetics, citing lapses in quality assurance, distribution practices, product listing failures, improper testing practices, and absent or inadequate stability programs. The warning letters all refer to the compliance obligations under MoCRA.

Anticipated Forthcoming Regulations

Under MoCRA, two significant proposed rules are outstanding: (1) fragrance allergen labeling and (2) GMPs. Industry stakeholders should monitor both rulemakings and consider commenting on proposed rules through a trade association or counsel.

May 2026: Proposed Rule on Fragrance Allergen Labeling

MoCRA mandated FDA to issue a proposed rule on fragrance allergen labeling for cosmetic products by June 29, 2024. According to the latest Unified Agenda, FDA is now expected to issue that proposed rule in May 2026. The rule would require cosmetic manufacturers to identify which substances qualify as fragrance allergens and disclose them individually on product labels — a significant departure from the longstanding practice of listing such ingredients collectively under the generic term “fragrance.” Primary compliance costs are expected to center on label reformulation across affected product lines.

Date Unknown: Proposed Rule on GMPs

MoCRA also required FDA to issue a proposed GMP rule by December 29, 2024, and a final rule by December 29, 2025. The latest Unified Agenda reflects a significant delay, with FDA now listing the rule as a “Long-Term Action” with no proposed date. When issued, the GMPs are expected to set out requirements spanning management responsibility, personnel training, production and process controls, environmental monitoring, laboratory controls, corrective and preventive action systems, and documentation practices, drawing primarily on ISO 22716 as a reference standard. While implementation will carry costs, GMPs can also provide critical compliance defenses for industry stakeholders when faced with consumer claims or litigation.