The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022, represents the most sweeping overhaul of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning cosmetic products since 1938. For nearly a century, the cosmetics industry operated under a largely self-policed regime, with voluntary facility registration and no mandatory adverse-event reporting.
MoCRA changed all of that, granting the U.S. Food and Drug Administration (FDA) broad new powers to regulate cosmetic facility registration, product listing, safety substantiation, labeling, recordkeeping, adverse-event reporting, and mandatory product recalls.
However, MoCRA’s rollout is not a single, instantaneous event. It is a multi-year regulatory process. As of mid-2026, while the core statutory frameworks are active, several of the most controversial and highly anticipated FDA rules remain pending, delayed, or have been withdrawn for reexamination.
For skin clinics, cosmetic brands, formulators, and patients, understanding the exact regulatory status of these rules in 2026 is critical. By analyzing the FDA's own cosmetic adverse-event surveillance database, we can see how the new law is already structurally reshaping the safety landscape.
What MoCRA actually changed (and what 'cosmetic' now means to FDA)
Under the FD&C Act, a "cosmetic" is defined as a product intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. This includes skincare products, makeup, hair care, perfumes, and tattoo inks.
MoCRA fundamentally restructured cosmetic oversight by establishing three core pillars of authority:
- Federal Preemption: MoCRA preempts state and local laws regarding facility registration, product listing, cosmetic good manufacturing practices, allergen labeling, and safety substantiation. This ensures a single national standard, preventing a patchwork of conflicting state rules (though states retain authority to ban specific ingredients, such as California's ban on certain PFAS compounds).
- The "Responsible Person": The law created a legal entity called the "responsible person"—defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label. This person bears direct legal responsibility for safety substantiation, adverse-event reporting, and labeling compliance.
- FDA Enforcement Powers: The FDA now has the authority to suspend a facility’s registration (preventing it from distributing products in the U.S.), review clinical safety records without a warrant during inspections, and order mandatory product recalls if there is a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious adverse health consequences or death.
In force in 2026: facility registration, product listing, 15-day adverse-event reporting, recalls
As of mid-2026, several key provisions of MoCRA have completed their rollout and are being actively enforced by the FDA following the end of compliance grace periods.
Facility registration and product listing
Under section 607 of the FD&C Act, every facility that manufactures or processes cosmetic products for distribution in the U.S. must register with the FDA. In addition, the responsible person must submit a detailed product listing for each cosmetic, including its ingredients and manufacturing location.
- Enforcement status: The FDA's initial enforcement discretion period ended on July 1, 2024. Since that date, all facilities and product listings must be submitted electronically via the FDA's Cosmetics Direct portal.
- Deadlines: Existing facilities had to register by July 1, 2024. New facilities must register within 60 days of beginning operations, and product listings for new cosmetics must be submitted within 120 days of introduction into interstate commerce. Facility registrations must be renewed every two years.
- Small business exemption: Facilities with average annual gross sales of cosmetic products in the U.S. for the previous 3-year period of less than $1,000,000 (adjusted for inflation) are exempt from registration and listing requirements. However, this exemption does not apply to facilities that manufacture injectables, products intended for internal use, products that alter the appearance for more than 24 hours (such as semi-permanent makeup/tattoo inks), or products applied in the eye area.
Mandatory 15-day serious adverse-event reporting
Under section 605, the responsible person must submit a report to the FDA within 15 business days of receiving any report of a serious adverse event associated with the use of a cosmetic product in the U.S.
- Definition of "serious": An adverse event is classified as serious if it results in death, life-threatening experience, inpatient hospitalization, persistent or significant disability, congenital anomaly, third-degree burns, permanent hair loss, or significant and persistent alteration of appearance.
- Records retention: The responsible person must maintain records of all adverse-event reports (serious and non-serious) for 6 years (or 3 years for qualifying small businesses).
Mandatory recall authority
Historically, the FDA had to rely on voluntary cooperation from cosmetic companies to recall contaminated or dangerous products (such as talc contaminated with asbestos or hair-dye formulations causing severe chemical burns). Under MoCRA, the FDA now has the statutory authority to order a mandatory recall if a manufacturer refuses a voluntary request and the product meets the threshold of safety risk.
Still pending: fragrance-allergen labeling, cGMP, and the PFAS report's 'insufficient data' conclusion
While the administrative foundation of MoCRA is complete, several technical rulemakings have faced significant delays or are still working through the federal administrative process in 2026.
Fragrance-allergen labeling rule (Delayed)
MoCRA section 609(b) required the FDA to issue a proposed rule to establish substances that must be disclosed on cosmetic labels as fragrance allergens. Historically, cosmetic brands could hide specific fragrance ingredients under the generic terms "Fragrance" or "Parfum" to protect trade secrets.
- Status in 2026: The FDA missed its statutory deadline to publish the proposed rule (which was June 29, 2024). Per the Spring 2025 Unified Agenda (RIN 0910-AI90), the publication of the Notice of Proposed Rulemaking (NPRM) has slipped, with publication expected to occur in approximately May 2026.
- 欧盟(EU)对比 (Comparison with EU): The FDA’s proposed rule is expected to draw heavily from the European Union's cosmetic allergen registry. While the EU expanded its allergen list to 81 substances in 2023, the FDA’s initial list is projected to focus on the core 26 fragrance allergens (including linalool, limonene, citral, and geraniol) that have the strongest clinical association with contact dermatitis.
Cosmetic Good Manufacturing Practices (cGMP) (Pending)
Under section 606, the FDA is required to establish national cGMP regulations for cosmetic manufacturing facilities, consistent with national and international standards (such as ISO 22716).
- Timeline: MoCRA required the proposed cGMP rule by December 29, 2024, and the final rule by December 29, 2025. The rulemaking has faced administrative delays, with the final rule still pending in 2026. Once finalized, facilities will have up to two years to comply.
The FDA PFAS report: 'Insufficient Data' (Dec 29, 2025)
Section 611 of MoCRA required the FDA to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and submit a report summarizing their safety and prevalence. PFAS are often added to cosmetics (such as waterproof mascara, long-wear lipsticks, and foundations) to improve durability, spreadability, and water resistance.
On December 29, 2025, the FDA officially published its report, titled "Report on the Use of PFAS in Cosmetic Products and Associated Risks." The agency's primary conclusion was a statement of safety uncertainty: FDA found insufficient scientific data to establish a clear safety profile or determine the long-term risk of PFAS in cosmetics.
Key findings from the FDA’s report include:
- Prevalence: As of August 31, 2024, the FDA identified 51 unique PFAS compounds that were intentionally added to 1,744 cosmetic products registered in the U.S. market.
- Data Gaps: The report highlighted a severe lack of data regarding dermal absorption rates, systemic bioaccumulation, and inhalation toxicity of cosmetic-formulated PFAS, noting that most existing PFAS toxicology studies focus on oral exposure in drinking water.
- Regulatory stance: Because there is insufficient data to support a federal ban, the FDA has not issued a restriction on PFAS under MoCRA as of 2026. However, state-level bans (such as California's AB 2771, which bans intentionally added PFAS in cosmetics) remain active and are driving industry reformulation.
Withdrawn: the talc/asbestos testing rule and what it means for powder cosmetics
Perhaps the most significant regulatory retreat under MoCRA occurred regarding the proposed standard for detecting asbestos in talc-containing cosmetics (such as baby powder, face powders, and eyeshadows). Talc is a naturally occurring mineral that is frequently mined in close proximity to asbestos, leading to risks of cross-contamination.
On December 27, 2024 (89 FR 105490), the FDA issued a highly anticipated proposed rule establishing standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. The proposed rule advocated for the use of Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) with strict counting criteria.
However, the rule faced intense opposition from cosmetic manufacturers, testing laboratories, and legal groups, who argued that the specific microscopy criteria were overly burdensome, lacked reproducibility, and would lead to false-positive readings that would disrupt the supply chain.
- The Withdrawal (Nov 28, 2025): In a surprising move published in the Federal Register (Document 2025-21407), the FDA officially withdrew the proposed talc-asbestos testing rule on November 28, 2025.
- The current status: The FDA stated that it withdrew the proposed rule to "reexamine the scientific feedback and microscopy criteria" and plans to issue a revised proposal. As of mid-2026, no new timeline has been set for this rule. This leaves talc cosmetics in a regulatory gray zone: they are subject to general adulteration laws, but there is no standardized, federally mandated testing protocol.
What the 2024 reporting surge in 85,511 adverse-event reports reveals about the new regime
To understand how MoCRA is changing cosmetic safety monitoring, we can analyze the openFDA cosmetic adverse-event surveillance database, which contains 85,511 historical reports. (For the full product-by-product and reaction breakdown of these same reports — which hair-care, talc, and tattoo-ink categories drive the most complaints — see our companion analysis of what 85,511 FDA cosmetic adverse-event reports reveal.) A year-by-report-type aggregation of the raw data reveals a massive reporting shift that coincides directly with MoCRA taking effect:
COSMETIC ADVERSE-EVENT REPORTING SURGE (2023 vs. 2024)
2023 (Pre-enforcement):
Pre-MoCRA (Voluntary): ██████████████ 3,632
Direct (Consumer): ██ 615
Expedited (15-Day): ▏ 158
Total: 4,405
2024 (First Full MoCRA Year):
Expedited (15-Day): ████████████████████████████████████████████████████ 25,142
Direct (Consumer): █ 338
Non-Expedited (Periodic): ▏ 6
Total: 25,486
The 5.8x reporting explosion
In 2023, before MoCRA's mandatory reporting provisions were fully established, the FDA received a total of 4,405 reports, with only 158 classified as expedited.
In 2024, the first full year under the MoCRA reporting framework, the total number of reports exploded to 25,486—a 5.8x year-over-year increase. Crucially, 25,142 of these reports were Expedited (15-Day) submissions from cosmetic companies. This surge is not a sign that cosmetic products suddenly became more dangerous; it is direct evidence that manufacturers are complying with their new legal duty to report serious adverse events within the 15-business-day window.
The talc-litigation database footprint
While the 25,486 reports in 2024 suggest a massive wave of cosmetic injuries, a closer look at the database reveals a major data artifact that distorts the most alarming-looking numbers.
An outcomes-level query of the 85,511-row database shows that the outcomes field lists 26,542 "Death" entries. On its surface, this is an alarming statistic, suggesting that tens of thousands of Americans have died from cosmetics.
However, filtering those "Death" outcomes against the product-name field reveals the true cause:
- Total deaths in database: 26,542
- Talc or powder-related deaths: 26,479 (99.76% of all death reports)
The product names associated with these deaths are almost exclusively:
- Shower To Shower No Upc / Johnsons Powder No Upc (6,042 reports)
- J And J Baby Powder (5,500 reports)
- Johnsons Powder No Upc (5,005 reports)
- J And J Baby Powder / Shower To Shower Powder (2,889 reports)
This demonstrates that almost every single death entry in the openFDA cosmetics database is associated with talcum-powder litigation (specifically claims linking talc to ovarian cancer or mesothelioma). These historical reports were submitted in bulk by law firms and litigation registries, rather than representing acute clinical toxicities reported by medical professionals.
This data artifact explains why the FDA talc/asbestos testing rule is such a high-stakes, politically charged issue. The legal and financial liability surrounding talc-associated cancer claims is the dominant force in cosmetic safety data, representing nearly all of the severe outcomes in the federal registry.
What skin clinics, brands, and patients should actually do differently now
The shifting status of MoCRA rules in 2026 means that businesses and clinicians must maintain active compliance protocols.
For aesthetic clinics and med spas
- Identify your role: If your clinic custom-formulates skincare creams, private-labels serums, or blends active ingredients in-house, you may be classified as a manufacturer under MoCRA. If your annual sales of these products exceed $1,000,000, you must register your facility and list your products with the FDA.
- Keep an adverse-event log: Even if you do not private-label, your clinic should maintain an internal log of patient adverse reactions to cosmetic treatments (such as chemical peels, PMU inks, or professional-grade topicals). Voluntary reporting of suspect inks or materials via MedWatch helps the FDA identify broader supply-chain issues, such as the contaminated permanent makeup inks cited in recent Class I recalls.
- Ingredient vetting: Proactively screen the brands you carry for compliance with state-level ingredient restrictions. With the FDA's PFAS report highlighting data gaps and state bans coming into effect, ensure your suppliers provide written verification that their long-wear and waterproof products are PFAS-free.
For cosmetic brands and formulators
- Review your safety substantiation files: Ensure you have documented toxicology reports, patch testing, and stability data for every product listed in the Cosmetics Direct portal. MoCRA requires that safety substantiation be based on "competent and reliable scientific evidence."
- Prepare for fragrance allergen labeling: Even though the FDA's proposed rule is delayed to May 2026, begin auditing your fragrance formulations now. Work with your fragrance houses to identify which of the 26 standard allergens are present in your concentrates, so you can update your labels as soon as the rule is finalized.
- Assess talc safety: If your brand sells powder products containing talc, you cannot rely on a federal standard for testing. You must maintain strict internal testing records (using both PLM and TEM) to demonstrate that your raw talc is free of asbestos fibers, as you remain subject to general product liability and adulteration laws.
FAQs
Does MoCRA require my med spa or skin clinic to register as a cosmetic facility?
Generally, no. A retail establishment (such as a med spa, dermatology clinic, or beauty salon) that applies cosmetic products to consumers as part of a professional service is not required to register under MoCRA.
However, this exemption only applies if the facility does not manufacture or process products. If your clinic purchases bulk cosmetic ingredients and repackages them into take-home jars under your own clinic brand, or if you hire a contract manufacturer to private-label a skincare line for your spa, your brand acts as the "responsible person." If your sales of these private-label products exceed the $1,000,000 small-business threshold, you must ensure that the contract facility is registered and your products are listed.
When will the FDA fragrance-allergen labeling rule actually take effect, and which ingredients will it cover?
The FDA's proposed rule is expected to be published in May 2026 (RIN 0910-AI90). Once the proposed rule is published, there will be a public comment period (usually 60 to 90 days), after which the FDA will evaluate the feedback and issue a final rule.
Historically, the FDA allows a transition period of 180 days to one year after the final rule is published before enforcement begins. The rule is expected to cover a list of standard chemical allergens (such as amyl cinnamal, benzyl alcohol, citral, eugenol, geraniol, limonene, and linalool). If any of these substances are present in your product above a specific threshold (likely 0.001% for leave-on products and 0.01% for rinse-off products), they must be listed individually on the ingredient label.
Is talc in cosmetics banned, and what did FDA do with the asbestos-testing rule?
No, talc is not banned in cosmetics in the United States. It remains a legally permitted cosmetic ingredient.
However, the talc must be free of asbestos contamination. The FDA’s proposed rule to mandate standardized asbestos-testing methods for talc cosmetics was withdrawn on November 28, 2025. The agency is currently reexamining the science and has not set a new date to reissue the rule. In the absence of a federal testing standard, cosmetic brands must establish their own internal testing protocols to ensure safety, as they remain subject to civil litigation and general FDA laws prohibiting the sale of adulterated products.
How is MoCRA adverse-event reporting different from the old voluntary system, and where do I see the data?
Prior to MoCRA, cosmetic manufacturers were not required to report adverse events to the FDA. The system relied entirely on voluntary submissions from consumers and healthcare providers. Under MoCRA, serious adverse-event reporting is mandatory for the "responsible person" (the manufacturer or distributor) and must be submitted within 15 business days.
This change led to a 5.8x surge in reports, with 25,486 reports recorded in 2024 alone. The public can query and download this data through the FDA's CFSAN Adverse Event Reporting System (CAERS), exposed via the openFDA cosmetics adverse-event API. However, users must be careful when interpreting the data, as bulk litigation reports (such as the 26,479 talc-related ovarian cancer/mesothelioma death reports) can distort the statistics. Understanding these data patterns is key to distinguishing between real-time product hazards and long-term epidemiological trends in the public registry.
Sources
- U.S. Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
- U.S. Food and Drug Administration. Report on the Use of PFAS in Cosmetic Products and Associated Risks. Published December 29, 2025. fda.gov/news-events/press-announcements/fda-finds-insufficient-data-determine-safety-pfas-cosmetic-products
- Office of Information and Regulatory Affairs. RIN 0910-AI90: Fragrance Allergen Labeling. reginfo.gov/public/do/eAgendaViewRule?pubId=202410&RIN=0910-AI90
- Federal Register. Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal of Proposed Rule. Document 2025-21407. Published November 28, 2025. federalregister.gov/documents/2025/11/28/2025-21407/testing-methods-for-detecting-and-identifying-asbestos-in-talc-containing-cosmetic-products
- U.S. Food and Drug Administration. Registration and Listing of Cosmetic Product Facilities and Products. fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
- U.S. Food and Drug Administration. FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System. open.fda.gov/apis/cosmetics/event/
