Checklist for Cosmetic OEM/ODM Manufacturers Serving the U.S. Market

1.1 FDA Facility Registration and FEI

Under 21 U.S.C. § 364c, facilities that manufacture or process cosmetic products for distribution in the United States are generally required to register with the U.S. Food and Drug Administration (FDA) and renew their registration as required. FDA uses the FDA Establishment Identifier (FEI) as the facility identifier for cosmetic facility registration.

When selecting an overseas cosmetic manufacturer, brands should confirm whether:

• The manufacturing facility has a valid FEI;
• The manufacturing facility has designated a U.S. Agent;
• The relevant manufacturing facility has completed FDA Cosmetic Facility Registration.

It is important to note that FDA cosmetic facility registration does not mean FDA has approved or certified the facility or its products. FDA has stated that facility registration and product listing are not product approval programs. Brands should therefore be cautious of descriptions such as “FDA Approved Factory.”

1.2 Cosmetic Product Listing: Usually the Brand's Responsibility

MoCRA also requires cosmetic products marketed in the United States to complete Cosmetic Product Listing. This responsibility generally belongs to the Responsible Person, meaning the manufacturer, packer, or distributor whose name appears on the product label.

For OEM or Private Label projects, the Responsible Person is commonly the U.S. brand owner or distributor. However, Product Listing must include information about the facility where the product is manufactured, so the manufacturer's FDA facility registration and FEI are directly relevant to the customer's later product-listing work.

1.3 Registration Does Not Mean the Product Is Automatically Compliant

Completing facility registration is only one of the basic requirements for entering the U.S. market. It does not mean that a specific cosmetic product automatically complies with all applicable U.S. regulations. Under MoCRA, the Responsible Person must ensure that the product has adequate Safety Substantiation supported by scientifically appropriate tests, studies, analyses, or other evidence.

The product's regulatory classification must also be evaluated carefully. Wipes intended primarily for cleansing, beautifying, or maintaining the skin in good condition may qualify as cosmetics. However, claims relating to antimicrobial activity, disinfection, treatment, disease prevention, or affecting the structure or function of the body may place a product on a different FDA regulatory pathway.

3.1 FDA-Registered Manufacturing Facility

VINNER has established the following compliance foundation for cosmetic manufacturing facilities serving the U.S. market:

When customers complete their MoCRA Product Listing, they can reference a manufacturing facility that has already completed FDA registration and has an established FEI, reducing uncertainty during supplier qualification and regulatory preparation.

• FDA Establishment Identifier (FEI);
• FDA Cosmetic Facility Registration;
• Designated U.S. Agent.

3.2 Comprehensive Quality Management and Cosmetic GMP Systems

VINNER's quality management and GMP systems include:

For international brands, a SMETA audit provides visibility beyond traditional product quality and regulatory audits by assessing responsible manufacturing, labor management, and sustainable supply chain capabilities, supporting supplier due diligence and long-term partner evaluation.

For U.S. brands and importers, GSV adds visibility into overseas manufacturing and international logistics. Compliance should help customers reduce risk—not create more work.

• ISO 9001 — Quality Management System: a framework for process control, customer requirement management, corrective actions, risk management, and continual improvement.
• ISO 22716 — Cosmetics Good Manufacturing Practices: guidance covering the production, control, storage, and shipment of cosmetic products, and one of the widely recognized cosmetic GMP frameworks in international markets.
• FDA Cosmetic GMP Guidelines: VINNER's cosmetic manufacturing controls reference FDA cosmetic GMP guidance and relevant inspection expectations, supported by a GMP certificate issued by Intertek.
• ISO 14001 & ISO 45001 — Environmental Management and Occupational Health and Safety Management Systems: additional evidence of environmental management, workplace safety, risk control, and continual improvement.
• SMETA — Social Responsibility and Ethical Trade Audit: an independent third-party assessment of labor standards and occupational health and safety, with environmental management and business ethics covered depending on scope.
• Intertek Global Security Verification (GSV): a supply chain security assessment covering physical facility security, personnel security, container security, seal management, business partner security, cybersecurity, international transportation, and supply chain security.