The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represented the most significant expansion of the U.S. Food and Drug Administration’s authority over cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was enacted in 1938. MoCRA introduced mandatory facility registration and product listing, serious adverse event reporting, safety substantiation requirements, new labeling obligations, and new FDA authorities for records access and mandatory recalls.
When FDA’s enforcement policy for facility registration and product listing took effect on July 1, 2024, much of the industry’s attention was understandably focused on meeting those initial submission requirements. Two years later, the regulatory picture is broader. Registration and listing are now ongoing obligations, the first biennial facility renewals are approaching or underway, FDA has issued draft guidance explaining how it intends to use its new records access and mandatory recall authorities, and post-market surveillance has become an increasingly important component of cosmetics oversight.
FDA is also continuing work on several rulemakings required by MoCRA, including cosmetic Good Manufacturing Practices (GMPs), fragrance allergen labeling and standardized testing methods for asbestos in talc-containing cosmetics. Meanwhile, FDA has completed its congressionally mandated assessment of per- and polyfluoroalkyl substances (PFAS) in cosmetics and has expanded public access to cosmetics adverse event information.
For cosmetics companies, the practical change is that MoCRA should no longer be viewed primarily as a registration exercise. By 2026, compliance increasingly means maintaining an operating system capable of supporting product safety, responding to adverse events, keeping FDA submissions current and producing relevant records when regulatory concerns arise.
MoCRA was enacted on December 29, 2022, adding a new regulatory framework to the authorities FDA already exercised over cosmetics under the FD&C Act and the Fair Packaging and Labeling Act. Among other changes, the legislation established a statutory definition of a “responsible person” — generally the manufacturer, packer or distributor whose name appears on a cosmetic product’s label — and assigned that entity several important ongoing responsibilities.
The transition was especially visible in 2024. FDA’s compliance policy delayed enforcement of the initial facility registration and product listing requirements until July 1, 2024, while FDA developed the Cosmetics Direct Website Portal and supporting guidance for industry.
FDA’s December 2024 registration and listing guidance subsequently provided detailed instructions concerning who must submit information, what information must be submitted, how submissions can be made and when they are required. The guidance also confirmed that FDA’s former Voluntary Cosmetic Registration Program did not satisfy the new mandatory MoCRA requirements.
By 2026, however, the focus has moved beyond the initial deadline.
FDA’s February 2026 Grand Rounds presentation described cosmetics as a predominantly post-market regulatory environment. Except for color additives, cosmetic ingredients and cosmetic products generally do not undergo FDA premarket approval. FDA therefore emphasized the importance of information collected after products enter the marketplace.
That distinction helps explain where MoCRA implementation is heading.
| Area | Initial MoCRA / 2024 Position | Where Things Stand in 2026 |
| Facility registration | Manufacturing and processing facilities became subject to mandatory FDA registration, with FDA delaying enforcement of initial requirements until July 1, 2024. | Registration is now an ongoing compliance obligation. Facilities must renew registration every two years, and Cosmetics Direct now displays registration status and renewal dates and sends renewal reminders. |
| Product listing | Responsible persons were required to list marketed cosmetic products, including ingredients, with FDA. | Product listings must be maintained and updated annually. Registration or listing does not constitute FDA approval, and FDA reiterated in September 2026 that it does not issue certificates verifying registration or listing compliance. |
| Safety substantiation | Responsible persons became responsible for ensuring and maintaining records supporting adequate substantiation of product safety. | This remains an active obligation. FDA states that no particular test is mandated, but supporting information must be scientifically robust and sufficient to substantiate safety under labeled or customary conditions of use. |
| Adverse events | Serious adverse events became reportable to FDA within 15 business days, with adverse event records generally retained for six years. | Adverse event reporting is now an important source of FDA post-market intelligence. FDA says industry adverse event reports increased more than three-fold following MoCRA, and cosmetics reports are now accessible through the FDA Adverse Event Monitoring System (AEMS). |
| Records access | MoCRA gave FDA expanded statutory authority to access certain cosmetic records under specified circumstances. | FDA issued draft guidance in January 2026 explaining how it intends to implement its records access authorities, including access to adverse event and certain product safety records. |
| Mandatory recalls | MoCRA authorized FDA to order a recall under specified serious-risk conditions if the responsible person refuses to conduct a voluntary recall. | FDA issued draft guidance in December 2025 explaining the criteria, process and industry expectations associated with mandatory cosmetics recalls. |
| GMPs | MoCRA directed FDA to establish mandatory cosmetic GMP regulations. | FDA’s rulemaking remains under development. FDA’s existing cosmetic GMP guidance remains draft guidance rather than the final MoCRA GMP regulation. |
| Fragrance allergens | MoCRA directed FDA to identify fragrance allergens that must be disclosed on labels through regulation. | FDA continues to identify fragrance allergen labeling as a regulation required under MoCRA; FDA’s February 2026 presentation stated that the proposed rule was still in development. |
| Talc/asbestos | MoCRA required FDA to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. | FDA proposed testing requirements in December 2024 but withdrew that proposed rule in November 2025 after determining that public comments warranted further consideration and assessment. A final standardized testing regulation therefore remains outstanding. |
| PFAS | MoCRA directed FDA to assess the use and safety of PFAS in cosmetic products and publish a report. | FDA published its report in December 2025. The agency found substantial data gaps and did not reach definitive safety determinations for most PFAS evaluated; FDA says it will continue monitoring emerging data. |
The initial July 2024 deadline created a clear compliance event: facilities needed to determine whether they were required to register, and responsible persons needed to determine which products required listing.
In 2026, the expectations are more continuous.
MoCRA requires facilities subject to registration to renew every two years from their initial registration date and any updates to the facility registration information required within 60 days of the change. Product listings are an annual obligation for the responsible persons, meaning the submission made for the July 2024 compliance date should be reviewed against their current products, formulations or business arrangements, and updated if product listing information changes (including if the product is discontinued).
FDA updated Cosmetics Direct in February 2026 specifically to support the first cycle of biennial renewals. The portal now provides registration status and renewal date information, and FDA sends automated reminders to relevant contacts before renewal dates.
This also makes accurate contact and submission information increasingly important. A registration is not simply a one-time number obtained from FDA; it is part of an ongoing regulatory record.
FDA has also recently warned industry about another misconception: facility registration and product listing are not FDA approvals, and FDA does not provide certificates or verification documents establishing MoCRA compliance.
Section 608 of MoCRA requires the responsible person to ensure and maintain records supporting adequate substantiation of safety. This statute defines adequate substantiation as tests, studies, research, analyses or other evidence considered sufficient by appropriately qualified experts to support a reasonable certainty that the cosmetic product is safe.
Importantly, this does not mean MoCRA prescribes one universal battery of clinical or laboratory tests for every cosmetic.
FDA states that neither the law nor its regulations require specific tests for individual cosmetic products or ingredients. Existing relevant safety information may be used, but the evidence supporting the safety determination should come from scientifically-robust methods.
The practical question for a responsible person is therefore not simply whether testing was performed. It is whether the company can demonstrate why the available evidence adequately supports the safety of the finished product and its ingredients under the intended or customary conditions of use.
MoCRA requires serious adverse events to be submitted to FDA within 15 business days after the responsible person receives the report. New and material medical information received within one year of the initial submission must also be provided to FDA within 15 business days of receipt.
Records associated with adverse events generally must be maintained for six years, with a three-year period applying to qualifying small businesses.
For consumer reporting purposes, MoCRA also requires each cosmetic product label to include a domestic address, domestic phone number or electronic contact information (which may include a website) through which the responsible person can receive adverse event reports. Companies should ensure that this contact route feeds into their complaint assessment and reporting process.
The significance of this requirement is becoming clearer as FDA accumulates post-market data. According to FDA, adverse event reports submitted by industry increased more than three-fold following implementation of MoCRA.
FDA first launched a public cosmetics adverse event dashboard in September 2025 and in March 2026 incorporated adverse event information into its broader FDA Adverse Event Monitoring System (AEMS). The system is intended to improve data integration, analytics, trend identification and safety surveillance.
For companies, adverse event handling therefore needs to function as more than a consumer-service process. Complaints must be appropriately assessed, serious events identified quickly, reporting timelines controlled and supporting information retained.
FDA’s 2026 Grand Rounds presentation provides perhaps the clearest indication of how the agency views cosmetics regulation after MoCRA.
Because cosmetics generally do not undergo FDA premarket approval, FDA describes post-market activities as particularly important. The agency identified activities such as analyzing adverse event reports for potential health issues and following up on product complaints for possible quality problems key actions under their purview.
MoCRA gives FDA considerably more information with which to conduct this surveillance.
Facility registration tells FDA who is manufacturing or processing cosmetic products and where. Product listings provide information about what is being marketed and its ingredients. Serious adverse event reports provide an additional stream of post-market safety information. Safety substantiation and adverse event records may become relevant when FDA exercises its authority to access records.
FDA has described these datasets as valuable resources for monitoring the cosmetics marketplace.
This represents an important development from the pre-MoCRA system. FDA is not simply collecting registrations; it is developing a substantially larger regulatory dataset that can support its surveillance and compliance activities.
One of MoCRA’s important enforcement changes was FDA’s expanded records access authority.
In January 2026, FDA issued draft guidance specifically addressing this authority. The guidance discusses FDA’s ability under sections 605, 610 and 704 of the FD&C Act to access and copy certain records associated with cosmetic products.
Under MoCRA, FDA inspections may extend to adverse event information where the statutory requirements apply. Under certain conditions, FDA can also access and copy records relating to a cosmetic product, including relevant safety records.
FDA’s 2026 Investigations Operations Manual further instructs investigators conducting cosmetics inspections to request processing, packaging and labeling, raw-material, finished-product testing, batch-release, complaint and adverse-event records when evaluating manufacturing and monitoring systems. The precise legal basis for obtaining particular records depends on the circumstances and does not mean the FDA is compelled to review evert category. MoCRA provides FDA access to adverse-event records during an inspection and access to certain other product records when its serious-risk conditions are met. Companies should understand which records are subject to those authorities and keep relevant quality and safety documentation organized and retrievable. The direction of FDA oversight is clear: documentation increasingly matters because it demonstrates how the company manages product quality and safety.
Before MoCRA, FDA generally relied on voluntary cosmetic recalls.
MoCRA gave FDA authority to order a mandatory recall when it determines there is a reasonable probability that a cosmetic is adulterated or misbranded and exposure would cause serious adverse health consequences or death, if the responsible person does not voluntarily recall the product.
In December 2025, FDA issued draft guidance explaining this new authority, including the circumstances under which FDA may determine a mandatory recall is necessary, the process the agency expects to follow and its expectations regarding compliance with a recall order.
Most cosmetics recalls continue to occur voluntarily. However, companies now operate within a regulatory framework in which FDA has a statutory mechanism to compel action when the applicable threshold is met.
That increases the importance of having effective complaint investigation, escalation, traceability and recall procedures in place before a serious issue occurs.
Not every element envisioned in the 2022 legislation has reached its final regulatory form:
MoCRA directed FDA to establish GMP regulations for facilities manufacturing or processing cosmetic products. The statute instructed FDA to consider the size and scope of businesses, public-health risks and appropriate flexibility, including simplified requirements where appropriate for smaller businesses.
FDA’s February 2026 Grand Rounds presentation confirmed that this rulemaking remained ongoing.
Companies should distinguish these forthcoming mandatory regulations from FDA’s existing 2013 draft Cosmetic Good Manufacturing Practices guidance, which FDA has stated it intends to withdraw or revise and reissue as appropriate based on the MoCRA rulemaking.
MoCRA requires FDA to determine through regulation which fragrance allergens must be disclosed on cosmetic labels. In developing the regulation, Congress directed FDA to consider international, state and local requirements, including those of the European Union.
FDA stated in its February 2026 Grand Rounds presentation that it was still in the process of developing the proposed rule.
The status of talc testing has changed significantly since 2024.
FDA proposed a rule in December 2024 that would have required standardized asbestos testing for talc-containing cosmetic products, including specified microscopy methods and associated recordkeeping requirements.
In November 2025, however, FDA withdrew the proposed rule, explaining that comments received warranted further consideration and assessment before final regulations are issued.
As a result, the MoCRA-mandated standardized testing regulation remains an area companies should continue to monitor.
MoCRA required FDA to assess the use of PFAS in cosmetics and the scientific evidence regarding their safety.
FDA published that report on December 29, 2025. The assessment examined commonly used PFAS identified in part through the product information now available to FDA and highlighted significant gaps in available toxicological and exposure data. FDA did not reach definitive safety determinations for most of the PFAS evaluated and stated that further research is needed.
This illustrates another consequence of MoCRA that extends beyond individual compliance obligations: mandatory product listings give FDA substantially greater visibility into the ingredients present in the U.S. cosmetics marketplace.
FDA reported in 2026 that the mandatory system had produced vastly more information than its former voluntary registration program, reinforcing the agency’s ability to identify ingredients and product categories for further assessment.
The most useful way to approach MoCRA in 2026 is as an ongoing compliance system rather than a completed regulatory project.
Companies should know which entity is the responsible person for each product, which facilities require registration and when those registrations renew. Product listings should remain current, and annual updates should be incorporated into normal regulatory operations. Safety substantiation should be documented and capable of supporting the product as it is actually formulated, labeled and used.
Adverse event and complaint procedures should be capable of identifying serious events quickly enough to meet the 15-business-day reporting requirement. Relevant records should be organized and retrievable, and recall procedures should account for FDA’s expanded authority.
At the same time, companies should continue monitoring the regulatory pieces that remain under development — particularly GMPs, fragrance allergen labeling and talc/asbestos testing.
For qualifying small businesses, exemptions may apply to GMP, registration and product listing requirements, but those exemptions are not universal. MoCRA specifically excludes certain higher-risk product categories from the small-business exemption, including products that regularly contact the mucous membrane of the eye, injected products, products intended for internal use and certain products intended to alter appearance for more than 24 hours.
The transition from MoCRA’s initial deadlines to ongoing FDA oversight can create challenges for companies that manufacture, market or import cosmetic products into the United States.
dicentra can support cosmetics companies with determining applicable MoCRA obligations, facility registration and renewal, cosmetic product listings and annual updates, safety substantiation strategies, label compliance, adverse event reporting procedures, and preparation for evolving FDA requirements.
For organizations entering the U.S. market, regulatory planning can also help establish these systems before products are commercialized rather than addressing individual requirements after launch.
Learn more about dicentra’s Cosmetics Regulatory Consulting services and how our experts can help you navigate MoCRA and FDA cosmetics requirements.
July 1, 2024 was an important milestone for MoCRA, but it was not the end of implementation.
By 2026, MoCRA has moved into a more mature phase. Registration and listing have become recurring responsibilities. Serious adverse event reporting is supplying FDA with substantially more post-market safety information. FDA has developed guidance around records access and mandatory recalls, launched more transparent adverse event monitoring tools, completed its PFAS assessment and continued work on several regulations required by the legislation.
The underlying expectation is increasingly clear: companies should be able not only to submit information to FDA, but also to demonstrate an ongoing system for maintaining product safety and regulatory compliance.
For cosmetics manufacturers, responsible persons and companies selling products into the United States, MoCRA compliance should therefore be treated as a continuing lifecycle responsibility — one that begins before a product reaches the market and continues for as long as that product remains there.