Regulatory & Compliance
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the US federal law, signed December 29, 2022 as part of the Consolidated Appropriations Act, that amended the Federal Food, Drug, and Cosmetic Act to add mandatory facility registration, product listing, adverse event reporting, and safety substantiation requirements for cosmetics sold in the United States.
Each of those requirements is new to US cosmetic law.
MoCRA is the most significant expansion of FDA authority over cosmetics since the original FD&C Act was passed in 1938.
For eighty-four years, US cosmetics operated under a post-market framework with almost no pre-market obligations.
MoCRA changed that architecture, but not uniformly. Some provisions have been fully enforced since 2024. Others are stuck in the FDA’s Unified Agenda with slipping deadlines.
After 30 years in the hair and beauty sector, most recently in private label cosmetics, I can say MoCRA is where I see the most misinformation.
For the broader FDA framework and the global compliance picture, see those guides.
Important disclaimer: I am not a lawyer or US regulatory affairs professional. This is practical industry perspective, not legal advice. For specific questions, work with a qualified US regulatory consultant.
This guide covers what MoCRA requires, registration and listing, adverse event reporting, safety substantiation, GMP, the small business and OTC drug exemptions, and implementation status in April 2026.
MoCRA amended the existing FD&C Act instead of creating a new cosmetic code, adding sections that impose specific obligations on the cosmetic industry. Six requirements are the core of the law. Two exemptions run across them: Section 612 for small businesses, and Section 613 for a cosmetic that is also an over-the-counter drug and answers to the drug rules instead.
Every facility that manufactures or processes cosmetic products for distribution in the US must register with FDA, unless its owner or operator qualifies for the Section 612 small business exemption: average annual US cosmetic sales under the threshold and none of the Section 612(b) product types. The duty sits on whoever owns or operates the plant, not on the brand that has the product made.
Registration is done using Form FDA 5066 (paper) or through the Cosmetics Direct electronic portal. Registration must be renewed biennially. Each facility is issued an FDA Establishment Identifier (FEI) number, which becomes the reference for all compliance activity.
The July 1, 2024 deadline was the compliance target after FDA extended the original December 29, 2023 statutory deadline by six months. Renewal every two years runs from each facility’s own initial registration date rather than as a single group event: a facility registered on 20 February 2024 renews by 20 February 2026, and the ones that went in during the first weeks after the Cosmetics Direct portal opened on 18 December 2023 were already due at the end of 2025. Facilities that manufacture for the US market but failed to register face immediate compliance exposure.
Every cosmetic product sold in the US must be listed with FDA by the responsible person named on the label, unless the same Section 612 exemption applies: sales under the threshold and none of the Section 612(b) product types.
Product listing is done using Form FDA 5067 or through Cosmetics Direct.
Each listing must include the product category, the ingredient list in Structured Product Labeling (SPL) format, and the FEI of the facility where the product is manufactured or processed.
Product listing must be updated annually.
The product listing references the facility registration, which means a brand cannot complete a valid product listing until the manufacturing facility is registered.
MoCRA introduces a formal concept of "responsible person" in US cosmetic law, parallel to but distinct from the EU Responsible Person.
The US responsible person is the manufacturer, packer, or distributor whose name appears on the product label. For US-based brands, this is typically the brand itself. For non-US brands selling into the US, the responsible person is whoever appears on the label, which may be the brand, an importer of record, or a contracted regulatory representative.
The responsible person carries the legal obligations for product listing, adverse event reporting, safety substantiation record-keeping, and label compliance.
Any serious adverse event associated with a cosmetic product in the US must be reported to FDA within 15 business days of the responsible person receiving the information.
MoCRA defines a serious adverse event as one resulting in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, or significant hair loss). It also covers any event that requires, on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes.
Reports are submitted through FDA MedWatch using Form 3500A.
If within one year of the initial report the responsible person receives new medical or material information related to the event, the updated information must be submitted within an additional 15 business days.
Adverse event reporting has been enforceable since December 29, 2023.
The responsible person for each cosmetic product must maintain records supporting the safety of the product.
MoCRA defines safety substantiation as tests, studies, research, analyses, or other evidence or information considered by qualified scientific experts to support a reasonable certainty that the product is safe under its labeled and customary conditions of use.
Safety substantiation records are not submitted to FDA pre-market. They must be producible on FDA request, typically during inspection or in response to an adverse event investigation. The records must cover every product sold.
For brands with existing EU compliance, the CPSR and supporting documentation from the PIF usually form the core of a US safety substantiation record. The content overlap is high, though the US substantiation standard is less prescriptive than the EU Annex I format.
MoCRA required FDA to publish a proposed GMP rule for cosmetic facilities by December 29, 2024, with a final rule by December 29, 2025.
Both deadlines passed without rulemaking. The current status of the GMP rule is covered in detail in the implementation section below.
These two requirements generate most of the operational compliance activity for brands entering the US market in 2026.
For a facility registering for the first time, the process is simple but needs preparation.
Establish the FEI. Every facility registered with FDA has a unique FDA Establishment Identifier, and for a first-time registrant it has to be requested before the registration starts, not during it: the request goes to feiportal@fda.hhs.gov and takes roughly seven to ten working days. Starting the registration without it is where a first-timer loses two weeks. Existing FEIs from prior FDA relationships (for example, drug manufacturing facilities) carry over.
Access Cosmetics Direct. The FDA’s Cosmetics Direct portal is the preferred submission channel. Access requires an FDA account and credential setup. Paper submission via Form FDA 5066 remains available for facilities that cannot use the electronic system.
Submit the registration. The registration captures the facility’s legal name, physical address, a US agent if the facility is non-US, the product categories manufactured, and contact information for FDA communications.
Receive confirmation and FEI. Registration confirmation typically arrives within a few weeks for electronic submissions.
Renew biennially. Registration must be renewed every two years. The first renewal cycle for facilities registered by July 1, 2024 opened in 2026.
Product listing is separate from facility registration and is filed by the responsible person.
Confirm facility FEI. The product listing requires the FEI of every facility where the product is manufactured or processed. The brand must obtain this from the manufacturer before listing.
Prepare the SPL content. Product listings are submitted in Structured Product Labeling (SPL) format, an XML standard previously used for pharmaceutical labeling. The Cosmetics Direct portal provides a user interface that assembles the SPL submission in the background.
Identify the responsible person. The brand or entity whose name appears on the product label is the responsible person for product listing purposes.
Submit via Cosmetics Direct or Form 5067. Electronic submission is strongly encouraged by FDA. Paper submission through Form FDA 5067 remains available.
Update annually. Product listings must be updated annually to confirm formulation accuracy and facility linkage. Formulation changes, packaging changes, and facility changes trigger interim updates.
The practical allocation of registration work varies.
US-based manufacturer serving US brands. The manufacturer handles its own facility registration. The brand handles the product listing, referencing the manufacturer’s FEI.
Non-US manufacturer serving US brands. The manufacturer handles facility registration (typically with a US agent designated). The brand, which is the responsible person, handles the product listing. International manufacturers that are FDA-registered and export-experienced usually have established compliance processes.
Bundled compliance service. Some contract manufacturers and regulatory service providers offer bundled facility-plus-product compliance packages. For brands without internal regulatory capacity, this is often the practical choice.
The question I get from European founders is always "can I just pay my US importer to handle all this." The answer is yes on the facility side, but no on the responsible person side. The name on the label determines who is legally accountable for the product listing, the adverse event reports, and the safety substantiation records. You can outsource the filing work. You cannot outsource the responsibility.
Before signing with a US distributor or importer who offers to "handle MoCRA," read the contract carefully. The brand usually remains the responsible person even when the distributor files the paperwork.
The registrations themselves are free. FDA does not charge for facility registration, product listing, or adverse event reporting.
Service providers charge for handling the filings. Typical ranges: facility registration service 500 to 1,500 EUR/USD one-time plus 200 to 500 USD for biennial renewal; product listing per SKU 200 to 500 USD one-time plus 100 to 300 USD for annual update; a full bundled compliance package 2,000 to 8,000 USD per year for a small brand catalog. (All cost figures in this article are indicative estimates that vary by provider, region, and project scope.)
Serious adverse event reporting is the MoCRA provision that generates the most confusion in practice, and the one with the clearest enforcement posture.
MoCRA’s definition is specific and narrower than everyday "customer complaint."
A serious adverse event is an adverse event that results in: death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement. It also covers any event that requires, on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes.
"Significant disfigurement" covers serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance, and only where the change is other than as intended, under conditions of use that are customary or usual: a permanent color or a lash tint doing exactly what it was sold to do is not a serious adverse event.
Ordinary consumer complaints about product performance, fit, scent preference, or mild irritation do not meet the serious adverse event threshold. Those complaints are documented as part of the broader adverse event record-keeping requirement but are not reported to FDA in the 15-business-day window.
The clock starts when the responsible person receives information about the adverse event, not when the event occurs.
"Receives" means any channel through which the report reaches the responsible person: customer service contact, social media complaint, legal claim, medical professional report, distributor notification. Which desk inside the company takes it in does not matter. A report that stays with a retailer or distributor and never reaches the responsible person does not start the clock.
The 15 business days work out to approximately three weeks of calendar time, once weekends and US federal holidays are counted. Within that window, the responsible person must submit the report, with a copy of the label on or within the retail packaging, via FDA MedWatch Form 3500A. Section 605 asks for no investigation and no causality finding before filing.
If new medical or material information related to the event arrives within one year of the initial report, that new information must also be submitted within 15 business days of receipt.
MoCRA separately requires the responsible person to maintain records of all adverse events, not only the serious ones reportable to FDA.
Standard retention: 6 years for most businesses. A small business under Section 612 that makes none of the Section 612(b) product types may retain adverse event records for 3 years instead.
Records should include the consumer’s report details, the investigation conducted, the seriousness assessment, the outcome or resolution, and any FDA report filed. These records must be producible on FDA inspection.
MoCRA’s adverse event framework creates specific operational requirements most cosmetic brands have never had to meet.
Intake process. Someone in the organization must own adverse event intake. For small brands, this is typically a customer service or operations person with documented training on the seriousness threshold.
Triage and seriousness assessment. The duty to file depends on whether a report crosses the seriousness threshold, so the call has to be made inside the 15-business-day window. A triage protocol should be written down, not improvised case by case.
Documentation and record-keeping. Every adverse event, serious or not, generates a record retained for 6 years, or for 3 years where the Section 612 exemption applies. This requires a structured system, not email threads.
MedWatch submission capability. Someone in the organization, or a regulatory service provider on retainer, needs to be able to complete and submit MedWatch Form 3500A when required.
For brands already operating cosmetovigilance under the EU framework, the MoCRA requirements partially overlap but are not identical. An EU "serious undesirable effect" report under Article 23 of Regulation 1223/2009 is not a MoCRA serious adverse event report. The two regimes must be handled in parallel for products sold in both markets.
Two MoCRA requirements sit in very different places as of April 2026: safety substantiation is fully in force, GMP is delayed indefinitely.
Section 608 of the amended FD&C Act requires the responsible person to ensure, and maintain records supporting, "adequate substantiation of safety" for each cosmetic product.
"Adequate substantiation" means tests, studies, research, analyses, or other evidence or information considered by qualified scientific experts to support a reasonable certainty that the product is safe under its labeled and customary conditions of use.
The standard is deliberately flexible. Unlike the EU’s Annex I format for the CPSR, MoCRA does not prescribe a specific document structure. What it requires is that the evidence exist, be scientifically credible, be maintained by the responsible person, and be producible on FDA request.
FDA has not issued binding guidance specifying exact content, but established industry practice identifies several categories of evidence that typically form the core of a substantiation file.
Ingredient-level safety data. Toxicological data, supplier safety data sheets, historical use in cosmetics, and regulatory status (FDA-permitted color additive, CIR-reviewed ingredient, established cosmetic use).
Formulation-level assessment. A safety evaluation considering the complete formula, not just the ingredients individually. Interactions, concentration effects, and exposure considerations.
Stability testing. Evidence that the product remains safe and functional through its shelf life, including accelerated and real-time stability protocols.
Preservative efficacy testing. Microbiological challenge testing (commonly ISO 11930 or USP <51>) confirming the preservative system prevents microbial contamination.
Packaging compatibility. Evidence that the container does not compromise product safety over shelf life.
Use-specific data. Clinical or consumer testing data when the product’s claims require substantiation, particularly for sensitive product categories (eye products, children’s products, leave-on products with potentially irritating actives).
For brands with existing EU compliance, the CPSR (Part A data and Part B conclusion) typically forms the spine of a MoCRA safety substantiation file, with some US-specific additions (color additive FDA approval references, any US-specific ingredient status documentation).
MoCRA Section 606 required FDA to propose GMP regulations by December 29, 2024 and finalize them by December 29, 2025.
Neither deadline was met.
No proposed rule has been published and no new date has been announced.
The practical industry response in 2026 has converged on a clear default.
ISO 22716 as the working standard. The international cosmetic GMP standard remains the de facto reference. Any MoCRA final rule is widely expected to draw heavily on ISO 22716, so facilities operating to this standard now will be in compliance or close to it when the rule arrives.
Documentation discipline. Regardless of the GMP rule’s status, MoCRA’s other requirements (safety substantiation, adverse event records, product listing accuracy) assume a functioning documentation system. Whatever the final rule says, a documented quality system will be needed, so building one now is preparation rather than over-investment.
Supplier and manufacturer audits. Verify that your manufacturer operates to ISO 22716, has current facility registration, and maintains the documentation that will populate your safety substantiation file.
The GMP delay has opened a window. Brands whose manufacturers already operate to ISO 22716 are effectively ahead of whatever final rule arrives, and brands whose manufacturers do not are accumulating risk they cannot see yet. Anyone reading the delay as a grace period will meet a steep adaptation curve when the rule lands.
This is the one MoCRA area where I consistently push back on "wait and see." The cost of implementing ISO 22716 operationally is much lower than the cost of implementing it reactively under deadline pressure after the FDA rule finalizes.
Three additional elements complete the practical MoCRA picture.
MoCRA Section 612 exempts small businesses from specific requirements.
A small business under Section 612 is a company with average gross annual cosmetic product sales in the US of less than 1 million USD over the previous three years, adjusted for inflation.
Qualifying small businesses are exempt from: facility registration (Section 607), product listing (Section 607), and GMP requirements (Section 606 when finalized). Adverse event record retention drops from 6 years to 3 years, and that reduction carries the same Section 612(b) condition, so it is not available to a small business that makes one of those product types.
Safety substantiation, adverse event reporting, and label compliance requirements apply regardless of small business status.
The exclusions from exemption. Small business exemption does not apply, regardless of sales volume, to products that: regularly come into contact with the mucus membrane of the eye under customary use, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours where consumer removal is not part of customary use. These excluded product categories must meet full MoCRA compliance regardless of company size.
Practical implication. A small brand with US sales under 1 million USD and outside those excluded categories has a light-touch option on facility registration, listing and GMP but still must meet adverse event reporting, safety substantiation, and label rules. FDA does not require formal documentation to claim the small business exemption, but the brand should maintain sales records that prove eligibility if FDA requests.
The second exemption: Section 613. A cosmetic product or facility also subject to subchapter V, the drug part of the FD&C Act, sits outside MoCRA’s adverse event reporting, GMP, facility registration, product listing, safety substantiation, records, mandatory recall and Section 609(a) label contact (21 U.S.C. 364i). That is sunscreens, anti-dandruff shampoos, fluoride toothpastes, antiperspirants and anti-acne products. There is no turnover test, and it is not relief: those products answer to the drug regime instead, with its own establishment registration, listing and CGMP. A facility that also makes ordinary cosmetics stays inside MoCRA for those products.
MoCRA preempts state and local rules on registration, listing, GMP, records, recalls, adverse events and safety substantiation (21 U.S.C. 364j). It expressly leaves states free to ban an ingredient or cap its amount, and that is where California bites.
California’s ingredient prohibitions (24 substances from January 1, 2025 under Assembly Bill 2762, the Toxic-Free Cosmetics Act, plus a second list from January 1, 2027 that Assembly Bill 496 added and Assembly Bill 60 of 2025 extended to thirty numbered entries), California Proposition 65 warning requirements, state-level PFAS bans in Colorado, Minnesota, Washington and Maine, which prohibit the whole class of intentionally added PFAS, alongside the different Maryland rule, which bans thirteen named PFAS inside a closed list of twenty-four ingredients and leaves a PFAS outside that list legal there, and state-level animal testing prohibitions all operate in parallel with MoCRA.
A product compliant with MoCRA but non-compliant with California’s ingredient list cannot legally be sold in California. This creates the practical effect that nationally distributed products must meet the strictest applicable state ingredient standard, not just the federal MoCRA baseline.
For the broader state-level picture, see the FDA cosmetics regulations guide.
Five specific status points matter for brands planning their 2026 US compliance.
Facility registration and product listing: fully enforced. Selling a cosmetic in the US without current facility registration and product listing is a prohibited act under Section 301(hhh) of the FD&C Act, not in itself a ground of adulteration or misbranding, and not among the grounds for refusing admission under Section 801(a). The enforcement route is the ordinary chain against prohibited acts: warning letters, injunction under Section 302, and criminal liability under Section 303. No published FDA warning letter has charged a failure to register or to list so far.
Adverse event reporting: fully enforced since December 29, 2023. The 15-business-day clock is real. FDA responds to non-reporting with warning letters, and where it has credible evidence that the responsible person has not complied with Section 605 or has not allowed access to the records that section requires, it can refuse admission of the product at the border under Section 801(a).
Safety substantiation: fully enforced. Records must exist and be producible. FDA has authority to request them during inspection or adverse event investigation.
GMP rule: delayed to Long-Term Actions. No proposed rule within twelve months. ISO 22716 is the de facto interim standard.
Fragrance allergen disclosure rule: still unproposed. MoCRA’s June 29, 2024 statutory deadline passed with no proposed rule, and the Unified Agenda has moved the target more than once since. The final rule is unlikely before 2027. EU-style allergen tracking now is the safest preparation.
Talc-asbestos testing rule: proposal withdrawn on November 28, 2025. The December 2024 proposed rule was withdrawn by Federal Register 2025-21407, and the FDA has said it intends to reconsider and republish. Polarized Light Microscopy and Transmission Electron Microscopy with EDS/SAED were the testing methods it referenced.
Formaldehyde in hair smoothing: still unproposed. The December 2025 target passed with no proposed rule published. A separate FDA action, not core MoCRA, but relevant to brands in the hair category.
What works in April 2026 is to file the registrations, build the adverse event system, maintain safety substantiation files, run to ISO 22716, track the Unified Agenda each quarter, and adjust as rules finalize.
What does MoCRA require of my cosmetic brand right now?
As of April 2026, four of the six requirements are enforceable around a cosmetic product sold in the US. Good Manufacturing Practices are still in rulemaking, and the responsible-person designation says who carries the other obligations instead of adding one of its own. First, facility registration, owed by whoever owns or operates the plant that manufactures or processes the product (FDA Form 5066 or Cosmetics Direct), renewed biennially; a brand that owns no plant has nothing to register. Second, product listing for every cosmetic product, owed by the responsible person named on the label (FDA Form 5067 or Cosmetics Direct), updated annually. Registration and listing are both lifted for a Section 612 small business that makes none of the Section 612(b) product types. Third, mandatory adverse event reporting to FDA within 15 business days for any serious adverse event, using MedWatch Form 3500A. Fourth, safety substantiation records for every product, producible on FDA request; the standard has no specific format requirement but must demonstrate qualified scientific support for the product’s safety under labeled use. A cosmetic product that is also an over-the-counter drug, a sunscreen or a fluoride toothpaste for instance, is outside all four under Section 613 and answers to the drug rules instead. The GMP requirements under MoCRA Section 606 are delayed and no proposed rule is expected within twelve months; ISO 22716 functions as the interim industry standard.
Who is the "responsible person" under MoCRA?
Under Section 604 of the amended FD&C Act, the responsible person is the manufacturer, packer, or distributor whose name appears on the product label under Section 609(a) or Section 4(a) of the Fair Packaging and Labeling Act. For US-based brands, this is typically the brand itself. For non-US brands selling into the US, the responsible person may be the brand, a US-based importer of record, or a contracted regulatory representative, but only the one whose name appears on the label as manufacturer, packer, or distributor. The responsible person carries legal obligations for product listing, adverse event reporting, safety substantiation record-keeping, and label compliance. These obligations cannot be transferred through a contract alone; whoever is named on the label is accountable to FDA. This differs from the EU Responsible Person concept, which is a legally designated entity established in the EU, typically separate from the brand itself.
Am I a small business under MoCRA and what does that exempt me from?
Section 612 defines a small business as a company with average gross annual cosmetic product sales in the US of less than 1 million USD over the previous three years, adjusted annually for inflation. Qualifying small businesses are exempt from facility registration, product listing, and GMP requirements (once finalized). Adverse event record retention is reduced from 6 years to 3 years. However, the small business exemption does not apply regardless of sales volume to products that contact the eye’s mucus membrane, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours where consumer removal is not part of customary use. Serious adverse event reporting, safety substantiation, and label compliance apply regardless of small business status. FDA does not require formal documentation to claim the exemption, but maintain sales records that prove eligibility. Section 613 is a separate exemption with no turnover test: a cosmetic that is also an over-the-counter drug is outside MoCRA registration, listing, GMP, adverse event reporting, safety substantiation, records and recall.
When do I have to report a serious adverse event to the FDA?
Within 15 business days of the responsible person receiving information about the event. The clock starts when the report reaches the responsible person, through whatever channel (customer service, legal team, distributor, medical professional contact), not when the event occurred. Reports are submitted through FDA MedWatch using Form 3500A. A serious adverse event is defined as one resulting in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, or significant hair loss), or as one requiring, on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes. Ordinary consumer complaints about product performance or mild irritation do not meet the threshold, though they must still be documented as part of the broader adverse event record-keeping obligation. If new medical information arrives within one year of the initial report, it must be submitted within an additional 15 business days.
What is safety substantiation under MoCRA and how is it different from an EU CPSR?
Section 608 of the amended FD&C Act requires the responsible person to maintain "adequate substantiation of safety" records for each cosmetic product. MoCRA defines adequate substantiation as tests, studies, research, analyses, or other evidence considered by qualified scientific experts to support a reasonable certainty that the product is safe under labeled and customary use. Unlike the EU’s CPSR, which must follow the prescribed format in Annex I of Regulation 1223/2009 and be signed by a qualified safety assessor, MoCRA does not prescribe a document structure or signature requirement. The standard is flexible: the evidence must exist, be scientifically credible, be maintained by the responsible person, and be producible on FDA request. For brands with existing EU compliance, the CPSR typically forms the core of a MoCRA safety substantiation file, with some US-specific additions (color additive FDA approval references, any US-specific documentation).
What is the status of the MoCRA GMP rule in 2026?
As of April 2026, there is no proposed GMP rule under MoCRA Section 606. FDA’s Spring 2025 Unified Agenda moved the GMP rulemaking to the "Long-Term Actions" list, meaning no Notice of Proposed Rulemaking is expected within twelve months, and the Fall 2025 Unified Agenda confirmed this status. MoCRA’s statutory deadlines (proposed rule by December 29, 2024 and final rule by December 29, 2025) both passed without rulemaking. Executive Order 14192 (the "one-in, ten-out" regulatory framework) has been cited as a contributing factor slowing rulemaking. In the interim, ISO 22716 is the de facto industry standard and is widely expected to be the reference point for whatever final rule eventually arrives. Brands whose manufacturers already operate to ISO 22716 are positioned well for the final rule; brands whose manufacturers do not are accumulating compliance risk.
I am an EU brand with CPSR, PIF, and CPNP. What do I need to add for MoCRA?
Existing EU compliance covers a significant portion of MoCRA’s requirements but not all. You need to add: registration of every facility that manufactures or processes the product for US distribution, which the plant’s owner or operator files (through Cosmetics Direct or Form 5066); product listing for each SKU sold in the US, which is yours as the responsible person (through Cosmetics Direct or Form 5067, using the manufacturer’s FEI); a US-style adverse event reporting system capable of meeting the 15-business-day MedWatch submission window and maintaining 6-year records; verification that your CPSR content meets MoCRA safety substantiation standards, with any US-specific additions (color additive FDA status, US-specific ingredient classifications); label review against US 21 CFR 701 requirements (identity statement, English language requirements, business address format, MoCRA adverse event reporting contact). Your existing EU cosmetovigilance system does not automatically satisfy MoCRA adverse event reporting; the two regimes must be handled in parallel with distinct submission channels and different definitions of "serious." All of this assumes the product is only a cosmetic in the US. A sunscreen is not: it is an over-the-counter drug there, so Section 613 takes it out of MoCRA and the drug rules apply instead.
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