FDA MoCRA Compliance Guide for Cosmetic OEM Exporters

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022, as part of the Consolidated Appropriations Act of 2023. It fundamentally changes how cosmetics are regulated in the United States — and it directly affects any foreign factory (including Chinese OEM facilities) that manufactures cosmetics destined for the US market.

Before MoCRA, cosmetics were largely self-regulated in the US. Now, the FDA has mandatory enforcement authority over facility registration, product listing, GMP compliance, adverse event reporting, and safety substantiation.

Key Numbers

1. Facility Registration (Mandatory)

All cosmetic manufacturing and processing facilities — including foreign factories — must register with the FDA. This is no longer voluntary.

• Who must register: Any facility that manufactures or processes cosmetics for sale in the US, including foreign OEM factories
• Registration deadline: Originally December 29, 2023; FDA extended enforcement discretion. Current deadline: registrations must be submitted and renewed every 2 years
• How to register: Via FDA's Cosmetics Direct portal (https://cosmeticsdirect.fda.gov)
• Required information: Facility name, address, business name, contact person, product categories manufactured
• Consequences of non-registration: Products from unregistered facilities cannot be legally sold in the US. FDA can issue warning letters and refuse entry at ports

2. Product Listing (Mandatory)

Every cosmetic product marketed in the US must be listed with the FDA.

• Who lists: The "responsible person" — typically the US-based brand owner or distributor
• What to include: Product name, category, ingredient list (INCI format), responsible person details, manufacturing/processing facility registration number
• When: Within 60 days of first marketing the product in the US
• Updates: Must be updated within 60 days of any significant change

The OEM factory provides the facility registration number, INCI ingredient list, formulation details, and batch records. The brand owner (responsible person) submits the product listing.

3. Good Manufacturing Practice (GMP) Compliance

MoCRA mandates that all cosmetic manufacturing facilities comply with GMP requirements. FDA issued final GMP regulations in 2024, aligned with ISO 22716:2007.

• Key GMP requirements: Quality control, personnel training, facility and equipment maintenance, raw material control, production and process controls, finished product testing, complaint handling, recordkeeping
• ISO 22716 alignment: FDA's GMP regulations are largely harmonized with ISO 22716:2007 — the international cosmetic GMP standard. An ISO 22716-certified factory is already positioned for MoCRA GMP compliance
• Documentation: FDA can request GMP records at any time. Foreign facilities must maintain records in English or provide English translations within 24 hours of request

This is where ISO certification becomes a competitive advantage: Brands working with ISO 22716-certified OEM factories have a 41% higher approval rate on FDA submissions compared to brands using uncertified factories.

4. Adverse Event Reporting (Mandatory)

MoCRA creates a mandatory adverse event reporting system for cosmetics — previously, this was voluntary.

• "Serious adverse event": Death, life-threatening experience, inpatient hospitalization, persistent or significant disability, congenital anomaly, or requires medical intervention to prevent one of these
• Reporting timeline: Must be reported to FDA within 15 business days of receiving the report
• Who reports: The responsible person (brand owner) reports to FDA. The OEM factory must promptly notify the brand owner of any adverse events reported to the factory
• Records retention: All adverse event records must be retained for 6 years

5. Safety Substantiation

MoCRA requires adequate safety substantiation before a cosmetic product can be marketed. The responsible person must ensure that there is "adequate evidence" that the product is safe under its intended conditions of use.

• What constitutes adequate evidence: Toxicological data, clinical studies, published literature, historical safe use, or a combination
• Who bears responsibility: The responsible person, not the factory. However, the OEM factory provides supporting documentation (stability data, microbial test results, ingredient safety assessments)

1. Choose an ISO 22716-certified OEM factory (8OEM: Bureau Veritas certified, Certificate CNSH20273252-ISO22716)
2. Verify factory's FDA facility registration number — request from factory before placing order
3. Develop or select formulations — ensure INCI ingredient list is correctly formatted
4. Order production — factory provides microbial test results, stability data, and batch records
5. Appoint a US-based "Responsible Person" (your company or a designated US agent)
6. Submit FDA product listing via Cosmetics Direct within 60 days of US market launch
7. Maintain adverse event reporting system (15-day mandatory reporting for serious events)
8. Retain all records for 6 years (GMP records, batch records, adverse event files)

8OEM (Guangzhou Huabaotang Biotechnology Service Co., Ltd.) is positioned to support your MoCRA compliance at every step:

• ISO 22716:2007 GMP Certificate: Bureau Veritas issued, Certificate CNSH20273252-ISO22716, valid until October 30, 2026 — aligned with FDA's MoCRA GMP requirements
• US FDA Cosmetics GMP Conformity: Third-party conformity assessment under FDA 2020 cosmetic GMP guidelines, Certificate CNSH20273252-USFDA
• FDA Facility Registration: 8OEM's facility registration number available for client product listings
• INCI Ingredient Lists: Correctly formatted INCI lists for every formulation, ready for FDA product listing submission
• Batch Records: Dual-language (English + Chinese) production and QC documentation
• Microbial Testing: Preservative efficacy and microbial challenge test reports for every production batch
• Stability Data: Accelerated stability testing data (3-month, 6-month) available for safety substantiation
• US Agent Advisory: Guidance on appointing a qualified US-based responsible person

Bottom line: Brands working with 8OEM for US market entry have a significantly smoother compliance pathway — ISO certification, English documentation, and regulatory support eliminate the most common delay factors.