The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to U.S. cosmetic regulation since the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted in 1938. MoCRA broadens FDA’s authority, expands industry obligations, and is reshaping how cosmetics are brought to market, monitored, and, when necessary, removed from shelves.
Since MoCRA’s passage in 2022, FDA has been phasing in new requirements and issuing guidance documents to help companies comply. This rollout will continue over the next few years. At the same time, FDA is sharpening its focus on “high‑risk” cosmetic ingredients and using public communications and databases to drive transparency and, indirectly, enforcement.
We expect that FDA will continue to increase its attention on cosmetics throughout 2026 and beyond.
Facility Registration and Product Listing
MoCRA added mandatory registration and product listing for cosmetics. As of December 29, 2023 (one year after MoCRA’s enactment), both domestic and foreign manufacturers and processors of cosmetics distributed in the U.S. must register each facility with FDA, ensure foreign facilities designate a U.S. agent, and register new facilities within 60 days of starting manufacturing or processing. Facility registrations must be renewed every two years.
FDA also requires product listings for each cosmetic product, including certain key information about ingredients and where the product is manufactured. These listings must be updated if and when product information changes. As of January 6, 2026, FDA’s system reflects: 14,299 unique, active facility registrations and 992,907 unique, active product listings.[48] These figures highlight that FDA now has much greater visibility into who is manufacturing what, and where. Incomplete or inaccurate product listings risk not only FDA enforcement action, but also – in the case of imported products – possible delayed (or rejected) product entries, as FDA (and by extension, Customs and Border Patrol (“CBP”) will likely increasingly rely on product listing data during random import compliance screenings.
Serious Adverse Event Reporting and Public Transparency
On September 12, 2025, FDA launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, giving the public real‑time access to adverse event data associated with cosmetic products.[2] While adverse event reporting itself is not new, this dashboard makes cosmetic safety issues more visible to consumers, salon professionals, and health care providers, and provides a direct window into product‑specific safety concerns that plaintiffs’ lawyers, retailers, and investors can see as easily as regulators. Moving forward, cosmetic manufacturers and brand owners should regularly monitor the FAERS cosmetic dashboard for trends involving their products and key competitors, and develop internal procedures to investigate, trend, and respond to public adverse event data.
Good Manufacturing Practices (GMP)
MoCRA requires FDA to establish Good Manufacturing Practice (GMP) regulations for cosmetic facilities. These rules will set minimum standards for manufacturing, processing, packing, and holding cosmetics. As of January 2026, FDA has not yet issued final GMP regulations for cosmetics; however, draft regulations or guidance are expected, and once they appear, the comment period will be the industry’s best opportunity to shape the final rules. Final GMP requirements are likely to become a cornerstone of FDA’s inspection and enforcement efforts for cosmetics, similar to FDA’s approach for foods and drugs. FDA has already begun to signal (via Warning Letters to facilities that manufacture both drug and cosmetic products [3]) that it will expect strict compliance with MoCRA’s GMP requirements once finalized.
Therefore, we recommend that companies use this interim period to assess existing quality systems (particularly if they were not built around drug‑ or food‑grade GMPs) and identify where processes, documentation, and training may need to be raised to a more formal, auditable standard. Companies should also consider submitting comments when FDA issues draft guidance to ensure operational realities are reflected in the final regulations.
Mandatory Recalls
Historically, FDA did not have the authority to mandate the recall of cosmetic products. MoCRA changed that by giving FDA explicit authority to mandate recalls of cosmetics that are adulterated or misbranded and present a serious risk of adverse health consequences. On December 18, 2025, FDA issued a draft guidance document titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”[4] The draft guidance explains how FDA will decide when a mandatory recall is warranted, describes the process for implementing such a recall, and outlines FDA’s expectation for industry cooperation and communication. Once finalized, the draft guidance will reflect FDA’s current thinking on when it will use its mandatory recall power and what it expects companies to do. Manufacturers and brand owners should review and, as necessary, update internal recall plans now so they align with FDA’s emerging expectations.
Safety Substantiation
Notably, MoCRA requires that a responsible person (defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product) maintain records demonstrating adequate substantiation of safety of the cosmetic product. “Adequate substantiation of safety” is defined as “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”
The “experts qualified by scientific training and experience” aspect of this substantiation standard should not be overlooked, as FDA considers certain types of studies to be more reliable than others, and companies should not assume that existing literature is always adequate to substantiate safety in lieu of specific product testing. Further, consumer class action plaintiffs that challenge allegedly false or misleading claims on cosmetics products labeling often argue that terms such as “all natural,” “non-toxic,” or “organic” are implicit claims that a product is safe to use. For these reasons, we recommend seeking the advice of qualified counsel on substantiation issues at the initial stages of development for a new cosmetic product. Because FDA is simultaneously increasing transparency around adverse events and high‑risk ingredients, gaps in safety substantiation are more likely to be exposed and to attract regulatory and litigation attention.
“High Risk” Ingredients
In parallel with MoCRA implementation, FDA has demonstrated interest in increasing scrutiny of certain cosmetic ingredients it views as higher risk, either because of toxicity concerns or broader environmental/ health debates. MoCRA directs FDA to examine several specific topics, and FDA is also using testing and public notices to flag issues.
PFAS Report
Under MoCRA, Congress mandated FDA to evaluate the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. On December 29, 2025, FDA issued its long-awaited assessment of PFAS in cosmetic products.[5] The PFAS report stated that FDA’s evaluation did not reach definitive safety determinations, and that significant uncertainty remains regarding the safety of PFAS due to gaps in existing data of PFAS exposure through cosmetics. FDA Commissioner Martin Makary, M.D., M.P.H. confirmed that FDA will continue working with the Centers for Disease Control and Prevention (CDC) and U.S. Environmental Protection Agency (EPA) to update and strengthen recommendations on PFAS. Despite the absence of clear safety conclusions, PFAS remain under governmental, industry, and consumer scrutiny. Companies using PFAS in cosmetics should inventory where PFAS appear in their portfolio, evaluate substitution or reformulation options, and monitor evolving federal and state actions that may indirectly impact cosmetic uses.
Fragrance Allergens
Under MoCRA, FDA is required to promulgate regulations to identify fragrance allergens that must be disclosed on cosmetic product labels and establish threshold levels for required disclosure while considering international, state, and local requirements. As of January 2026, FDA has not yet issued fragrance allergen regulations. When it does, many products will likely require labeling changes and, in some cases, reformulation or marketing strategy adjustments. Companies should track ingredient profiles and pay attention to known fragrance allergens to prepare for labeling changes.
Asbestos in Talc-Containing Cosmetics
MoCRA directs FDA to issue regulations establishing standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. FDA issued a proposed rule titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products” on December 27, 2024, but later withdrew it on November 28, 2025, citing agency priorities and public comments received.[6] FDA indicated it will issue a revised proposed rule, but timing is uncertain. Given ongoing litigation involving talc and asbestos, companies that manufacture or market talc‑containing cosmetics face elevated risk even in the absence of final FDA testing rules. Considering both scientific and litigation risk, companies should evaluate reliance on talc and review testing methods and supplier controls.
Hair Smoothing Products and Formaldehyde
FDA has been evaluating whether to propose a rule prohibiting formaldehyde (including formaldehyde‑releasing ingredients such as methylene glycol) in hair smoothing or straightening products applied to the hair and heated under typical use. FDA missed its own December 2025 target for issuing a notice of proposed rulemaking, and it is not yet clear if or when a proposal will be published.[7] However, concerns about formaldehyde emissions from heated hair products have already led to increased scrutiny from regulators, occupational safety agencies, and plaintiffs’ counsel. Companies should closely track FDA’s rulemaking plans and consider reformulation and occupational exposure controls (such as increased ventilation in salons) even before a formal prohibition is in place.
Methylene Chloride in Gel Nail Polish Remover
Under 21 C.F.R. § 700.19, methylene chloride is prohibited as an ingredient in all cosmetic products at any level. Despite that clear prohibition, FDA testing of imported gel nail polish removers in 2024 and 2025 detected methylene chloride in several products, prompting a public notice in April 2025.[8] The notice states that cosmetics containing methylene chloride often fail to identify it as an ingredient on the cosmetic product label and that the ingredient is sometimes listed under other names such as dichloromethane or methyl bichloride. For example, FDA discovered that the gel nail polish removers imported from China contained methylene chloride only via testing. Therefore, companies should track ingredient profiles and pay attention to the use of ingredients FDA has identified as unsafe due to the public health, regulatory, and litigation risks of marketing such products.
Strategic Takeaways from FDA’s 2026 Cosmetics Agenda
MoCRA and FDA’s broader policy priorities are turning cosmetics into a more regulated and more transparent industry. Facility registration, product listing, safety substantiation, and adverse event reporting now create a data‑rich environment that regulators, consumers, retailers, and litigants can all see and use. Over the next few years, companies should expect additional FDA guidance and rulemaking and continued use of public dashboards, safety alerts, and press releases to highlight “high risk” products and ingredients. If you are operating in this space — or planning to expand into the U.S. cosmetic market — now is the time to build a proactive regulatory strategy that keeps pace with FDA’s rapidly evolving approach to cosmetics. Companies should take the time to map MoCRA requirements to existing operations and identify gaps, build compliance systems that can scale as FDA issues new rules, and anticipate ingredient-specific scrutiny and potential labeling or formulation changes.
1. See FDA Registration and Listing Reports (last accessed Jan. 21, 2026), available at https://www.fda.gov/cosmetics/ registration-listing-cosmetic-product-facilities-and-products.
2. See FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products (Sep. 12, 2025), available at https://www.fda.gov/news-events/press-announcements/ fda-launches-real-time-adverse-event-reporting-dashboardcosmetic-products.
3. See, e.g., Warning Letter to CDL Services, Inc. d/b/a Technichem, Nov. 24, 2025, available at https://www.fda.gov/ inspections-compliance-enforcement-and-criminalinvestigations/warning-letters/cdl-services-inc-dbatechnichem-713877-11242025.
4. See FDA Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry (Dec. 2025), available at https://www.fda.gov/media/190625/download.
5. See PFAS Report (December 2025), available at https://www.fda.gov/media/190319/download?attachment; FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products (Dec. 29, 2025), available at https://www.fda.gov/news-events/press-announcements/ fda-finds-insufficient-data-determine-safety-pfas-cosmetic-products.
6. See Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal, 90 Fed. Reg. 54603 (Nov. 28, 2025).
7. See Hair Smoothing Products That Release Formaldehyde When Heated, available at https:// www.fda.gov/cosmetics/cosmetic-products/hair-smoothing-products-release-formaldehydewhen-heated; RIN: 0910-AI83, available at https://www.reginfo.gov/public/do/ eAgendaViewRule?pubId=202504&RIN=0910-AI83.
8. See Cosmetic Products Containing Methylene Chloride, available at https://www.fda.gov/ consumers/health-fraud-scams/cosmetic-products-containing-methylene-chloride.
