The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to U.S. cosmetic law in over 80 years. It requires facility registration, product listing, safety substantiation, adverse event reporting, and GMP compliance for every cosmetic sold in the United States. Cosmetica automates the entire process — from generating SPL XML files to submitting directly through the FDA's ESG NextGen gateway — so your team can focus on products, not paperwork.
MoCRA amends the Federal Food, Drug, and Cosmetic Act to give the FDA new authority over cosmetic products. Here are the six core requirements every cosmetic company must understand.
Every facility that manufactures or processes cosmetics for the U.S. market must register with the FDA and obtain a Facility Establishment Identifier (FEI) number. Registration must be renewed biennially, and any changes to ownership, address, or operations must be updated within 60 days. Failure to register can result in products being considered misbranded under federal law.
All cosmetic products marketed in the United States must be listed with the FDA. Listings require detailed information including product name, category, ingredients (in descending order of predominance), and the responsible person's contact information. Submissions are made as SPL XML files through the FDA's Electronic Submissions Gateway (ESG NextGen). Each product must be updated annually or whenever the formulation changes.
Responsible persons must ensure adequate evidence of safety exists for each cosmetic product. This includes toxicological assessments, clinical studies, ingredient safety data, and historical use records. The FDA can request safety substantiation at any time, and products without adequate safety data may be considered adulterated under the FD&C Act.
Serious adverse events associated with cosmetic products must be reported to the FDA within 15 business days of the responsible person becoming aware of the event. Reports are submitted using MedWatch Form 3500A and must include the product name, event description, consumer information, and any relevant medical records. Records must be maintained for 6 years.
Cosmetic manufacturers must follow Good Manufacturing Practices (GMP) consistent with national and international standards. This includes documented procedures for production, quality control, personnel training, facility maintenance, and complaint handling. The FDA has indicated alignment with ISO 22716 as the baseline GMP standard for cosmetics.
MoCRA reinforces existing labeling requirements under the Fair Packaging and Labeling Act and adds new provisions. Products must include a complete ingredient list using INCI nomenclature, allergen and fragrance disclosures where applicable, appropriate warnings, and contact information for adverse event reporting. Professional-use-only products have specific additional labeling requirements.
Five capabilities that replace manual compliance work with automated, auditable workflows. Every feature is built specifically for MoCRA and FDA cosmetic regulations.
Cosmetica's Claude-powered analysis engine reviews every ingredient in your formulation against FDA regulations, 21 CFR Parts 700-740, and the latest MoCRA requirements. Upload a formulation and receive a comprehensive compliance report in minutes — not weeks. The AI checks for restricted substances, required warnings, concentration limits, and category-specific rules across all 15 supported markets simultaneously.
Cosmetica integrates directly with the FDA's Electronic Submissions Gateway (ESG NextGen) API. Instead of manually navigating the FDA portal, generating SPL XML files by hand, and troubleshooting submission errors, Cosmetica automates the entire process. Facility registrations, product listings, and updates are submitted programmatically with built-in validation that catches errors before they reach the FDA.
Every compliance finding in Cosmetica is linked to an actual FDA regulation, CFR section, or official guidance document. Unlike generic AI tools that can hallucinate regulatory text, Cosmetica's citation engine cross-references findings against a curated database of federal regulations (21 CFR), FDA guidance documents, and published Federal Register notices. You can click any citation to read the source text directly.
MoCRA's 15-business-day reporting deadline is non-negotiable and carries significant legal exposure. Cosmetica tracks every adverse event from intake through submission, automatically generating MedWatch 3500A forms, monitoring deadline compliance with calendar-aware business day calculations, and submitting reports via SES email. Dashboard alerts ensure your team never misses a reporting window.
Cosmetica's milestone visualizer tracks every product through its full registration lifecycle: Draft, Validation, Submitted, Acknowledged, and Approved. Filter your portfolio by registration status, identify products that need updates, and get proactive alerts when biennial renewals are approaching. For brands with dozens or hundreds of SKUs, this replaces error-prone spreadsheet tracking entirely.
MoCRA requirements are rolling out in phases. Some are already in effect. Others are approaching fast. Here is the complete timeline your compliance team needs to know.
FDA began accepting cosmetic facility registrations. All facilities manufacturing or processing cosmetics for the U.S. market must register and obtain an FEI number.
FDA began accepting cosmetic product listings via ESG NextGen. All cosmetic products marketed in the U.S. must be listed with ingredient and labeling information.
Most small business exemptions under MoCRA expire on this date. Businesses previously exempt from facility registration and product listing requirements must now comply. Only businesses with less than $1M in annual cosmetic sales retain a limited exemption.
Good Manufacturing Practices (GMP) requirements take effect. Facilities must demonstrate compliance with standards consistent with ISO 22716 and FDA guidance. This includes documented procedures, quality control systems, and personnel training programs.
Serious adverse events must be reported to the FDA within 15 business days. This requirement has no exemptions — it applies to all responsible persons regardless of company size or revenue. Records must be maintained for 6 years.
MoCRA applies broadly across the cosmetic supply chain. Whether you manufacture, brand, or distribute cosmetics in the U.S., you likely have compliance obligations.
If you manufacture, process, pack, or hold cosmetic products for distribution in the United States, you must register your facility with the FDA. This includes contract manufacturers, co-packers, and any facility where cosmetics undergo processing steps. Each physical location requires separate registration, and facilities must renew biennially.
If your brand name appears on a cosmetic product sold in the U.S., you are the "responsible person" under MoCRA — even if you don't manufacture the product yourself. Responsible persons must submit product listings, maintain adverse event records, ensure safety substantiation exists, and keep labeling compliant. This applies to DTC brands, retailers with private label lines, and any entity whose name appears on the label.
Businesses with less than $1 million in annual cosmetic sales qualify for limited exemptions from facility registration and product listing. However, small businesses are NOT exempt from adverse event reporting, safety substantiation, GMP, or labeling requirements. If your products use certain ingredients (like color additives) or make drug claims, additional exemptions may not apply.
Between regulatory consultants, submission services, and internal staff time, manual compliance is expensive and error-prone. Cosmetica consolidates everything into a single platform at a fraction of the cost.
| Compliance Activity | Manual / Consultant | Cosmetica |
|---|---|---|
Facility Registration Registrar Corp charges $1,449 per facility | $1,500 - $3,000 | Included |
Product Listing (per product) SPL XML generation, validation, and ESG submission | $500 - $800 | Included |
Safety Assessment AI analysis with toxicologist review option | $2,000 - $5,000 | Included |
Adverse Event Report MedWatch 3500A generation and submission | $500 - $1,500 | Included |
Annual Compliance (10 products) Starter plan: $199/mo billed monthly | $25,000 - $50,000 | $2,388/yr |
Cosmetica starts at $199/month for up to 25 products
Includes facility registration, product listing, AI analysis, and adverse event reporting. No per-product fees.
Facility registration and product listing are already open. GMP requirements take effect in 2026. Don't wait until the FDA comes knocking — get compliant now with Cosmetica.
