MoCRA Overview
Cosmetics in the United States are regulated under the Modernization of Cosmetics Regulation Act (MoCRA), enacted in 2022. This landmark reform shifted the regulatory framework from a reactive, post-market model to a proactive, prevention-based approach.
MoCRA establishes new obligations including facility registration, product listing, safety substantiation, and adverse event reporting, all under FDA oversight and enforcement authority.
OTC Drug (Over-the-Counter Drug)
The United States does not have a "Functional Cosmetics" category. Products are classified as either Cosmetics or Drugs based on their intended use and claims.
Sunscreens, dandruff shampoos, toothpastes, and topical ointments are classified as Over-the-Counter (OTC) Drugs — available without a prescription. Products meeting FDA's OTC Drug Monograph standards may enter the market without a New Drug Application (NDA).
MoCRA Key Requirements for the U.S. Market
Facility Registration
All facilities — including importers — must register with the FDA. Foreign facilities must designate a U.S. Agent. Registration must be renewed biennially.
Product Listing
The Responsible Person (RP) must submit ingredient and product information for all cosmetics to the FDA. Updates required at least once per year.
Safety Substantiation
Scientific evidence substantiating product safety must be obtained and maintained. Supporting documentation must be retained on file.
Adverse Event Reporting
Serious adverse events must be reported to the FDA within 15 business days of becoming aware. Records must be retained for 3 to 6 years.
Our Services
Our Services
1. Product Registration & U.S. Agent Services
- Facility registration and product listing filing
- U.S. Agent designation and regulatory correspondence support
2. Safety & Regulatory Compliance
- Safety substantiation documentation review and preparation
- MoCRA and OTC regulatory compliance strategy development
3. Ingredient & Labeling Review
- Ingredient regulatory compliance screening
- FDA-standard labeling review and guidance
4. Additional Support Services
- Adverse event reporting system development and response
- FDA regulatory consulting and inspection readiness support
- PCPC INCI registration and UNII Code compliance
- Regulatory advisory by former FDA reviewers
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