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Why Choose Cosmereg?
- Multilingual team of US, EU, and GCC regulatory experts
- Registered US Agent with direct FDA communication access
- Fast turnaround & transparent pricing
- Trusted by 50+ global cosmetic brands
- Experts in US FDA Cosmetic Regulations
What Changed With MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks the most significant update to US FDA cosmetic Regulations since 1938. Introduced to strengthen oversight and ensure consumer safety, MoCRA transforms what was once a largely self-regulated industry into one governed by mandatory federal requirements. For the first time, cosmetic manufacturers and brand owners are legally required to register their facilities, list marketed products with the FDA, maintain safety substantiation records, and report serious adverse events. The legislation also introduces future requirements such as mandatory Good Manufacturing Practices (GMPs) and the disclosure of fragrance allergens on product labels. MoCRA brings U.S. regulations closer in line with the European Union model, increasing accountability and raising the bar for market entry. For both U.S.-based and foreign companies, MoCRA compliance is no longer optional — it’s essential for accessing and remaining in the U.S. cosmetics market.
Key MoCRA Requirements:
- FDA Facility Registration (renewed biennially)
- Product Listing with full ingredient disclosure
- Serious Adverse Event Reporting
- Mandatory Good Manufacturing Practices (GMP)
- Recordkeeping & FDA recall authority
- Appointment of a US Agent for foreign facilities
US FDA Cosmetic Regulations — A Complete Compliance Guide
Cosmetic products sold in the United States must comply with federal regulations enforced by the U.S. Food and Drug Administration (FDA). Since the passage of the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022, these requirements have expanded significantly — making facility registration, product listing, safety substantiation, and adverse event reporting mandatory for the first time. Cosmereg provides full-service regulatory support for domestic and foreign cosmetic brands entering or operating in the U.S. market.
✅ MoCRA facility registration and biennial renewal
✅ FDA product listing via Cosmetics Direct
✅ Label review and INCI compliance
✅ US Agent services for foreign facilities
✅ Trusted by 50+ global cosmetic brands
What Is a Cosmetic According to the FDA?
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA defines a cosmetic as any article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. This includes products such as moisturizers, makeup, shampoos, conditioners, perfumes, deodorants, skin serums, and nail polish. A critical distinction under US FDA cosmetic regulations is between cosmetics and drugs.
If a product makes therapeutic claims — such as treating acne, reducing wrinkles, or protecting against UV radiation — it may be classified as a drug or as both a drug and a cosmetic, triggering additional regulatory requirements.
Cosmereg helps brands evaluate their product claims to ensure correct regulatory classification.
This includes:
- Creams, lotions, and moisturizers
- Lipsticks and makeup
- Shampoos and conditioners
- Perfumes and deodorants
- Skin lighteners, masks, and serums
It is important to note that if a cosmetic product makes therapeutic claims (e.g., “treats acne” or “repairs skin damage”), it may be reclassified as a OTC drug under FDA law, requiring a New Drug Application (NDA) and clinical testing. At Cosmereg, we assist in ensuring your product claims remain compliant with the appropriate regulatory category.
Federal Laws That Govern Cosmetics in the United States
Two foundational laws govern cosmetic products at the federal level.
The Federal Food, Drug, and Cosmetic Act (FD&C Act)
The FD&C Act (21 USC §§321–392) prohibits the marketing of adulterated or misbranded cosmetics. It gives the FDA authority to take enforcement action against products that are unsafe, contain prohibited ingredients, or carry misleading labeling. The FD&C Act was significantly amended in December 2022 by MoCRA.
The Fair Packaging and Labeling Act (FPLA)
The FPLA (15 USC §§1451–1460) requires cosmetic labels to display accurate, meaningful information so consumers can make informed purchasing decisions. This includes requirements for product identity, net quantity, ingredient listing, and manufacturer information.
MoCRA — The Modernization of Cosmetics Regulation Act
Signed into law on December 29, 2022, MoCRA represents the most significant overhaul of US FDA cosmetic regulations since 1938. For the first time, the law makes facility registration, product listing, safety substantiation, and serious adverse event reporting mandatory.
Key MoCRA requirements include FDA facility registration through Cosmetics Direct (renewed biennially), product listing with full ingredient disclosure, serious adverse event reporting within 15 business days, mandatory Good Manufacturing Practices (GMP — rulemaking in progress), safety substantiation and recordkeeping, FDA mandatory recall authority, fragrance allergen labeling (rulemaking expected 2026), and the appointment of a US Agent for all foreign facilities. The first wave of biennial registration renewals is now underway.
Facilities that registered in early 2024 may already be due for renewal — the FDA updated Cosmetics Direct in February 2026 with new status and renewal date fields to assist registrants.
Key MoCRA Requirements:
FDA Cosmetic Labeling Requirements
All cosmetics sold in the U.S. must comply with specific labeling requirements under the FD&C Act and FPLA. Required label elements include the product identity or name, net quantity of contents, name and address of the manufacturer, packer, or distributor, ingredient listing in descending order of predominance (INCI names), and any required warnings.
Under MoCRA, fragrance allergen disclosure on labels is expected to become mandatory once the FDA finalizes its proposed rule (NPRM anticipated May 2026).
Cosmereg provides comprehensive label review services including INCI compliance checks, claim verification, bilingual formatting, and regulatory feedback before products reach the market.
California Cosmetic Regulations
California imposes additional state-level requirements that go beyond federal FDA law. Brands selling cosmetics in California must comply with the California Safe Cosmetics Program (CSCP), Proposition 65 warning label requirements, and the Toxic-Free Cosmetics Act, which bans 24 ingredients as of January 2025, with 26 more banned from January 2027.
Our US FDA Cosmetic Compliance Services
Cosmereg provides end-to-end support for cosmetic compliance in the United States:
MoCRA Compliance
- Facility registration (US & foreign)
- Product listing with full ingredient breakdown
- MoCRA-compliant documentation & recordkeeping
- Safety substantiation (toxicological and HRIPT data review)
Label Review & INCI Compliance
- FDA label formatting review
- Correction of non-compliant claims
- Label translation and dual-language formatting
US Agent Appointment (MoCRA))
- Official registered US Agent services
- Communication with FDA on your behalf
- Annual representation and FDA inspection assistance
California State Compliance
- Prop 65 ingredient risk analysis
- Label warning statement strategy
- CSCP database submission
Why Choose Cosmereg?
- Multilingual team of US, EU, and GCC regulatory experts
- Registered US Agent with direct FDA communication access
- Fast turnaround & transparent pricing
- Trusted by 50+ global cosmetic brands
- Experts in US FDA Cosmetic Regulations
Frequently Asked Questions About US FDA Cosmetic Regulations
No. Unlike drugs, cosmetic products do not require pre-market approval from the FDA. However, under MoCRA, manufacturers must register their facilities, list their products, maintain safety substantiation, and report serious adverse events. Certain ingredients, such as color additives, do require independent FDA approval.
MoCRA (the Modernization of Cosmetics Regulation Act) was signed into law on December 29, 2022. It is the most significant update to US cosmetic regulations since 1938. Facility registration became mandatory by July 1, 2024, with biennial renewals now underway in 2026.
Yes. Under MoCRA, every foreign facility that manufactures or processes cosmetics distributed in the United States must designate a US-based agent. The US Agent serves as the official point of contact between the foreign facility and the FDA.
The FDA classifies products based on intended use. Products meant to cleanse, beautify, or alter appearance are cosmetics. Products that claim to treat, cure, or prevent a disease or condition are drugs. Some products — such as anti-dandruff shampoos or SPF moisturizers — may be regulated as both.
Cosmetics Direct is the FDA's electronic submission portal for cosmetic facility registration and product listing. It was launched in December 2023 and updated in February 2026 with new features for biennial registration renewals, including registration status and renewal date displays.
Businesses with average annual gross sales under $1 million over the past three years are exempt from facility registration and product listing. However, they are NOT exempt from safety substantiation, adverse event reporting, or compliance with labeling and GMP requirements.
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