FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
Cosmetics
Understanding and adhering to recently enacted FDA’s MoCRA regulations is essential for cosmetic manufacturers and distributors. At FDA Listing Inc., we specialize in helping you meet these requirements and ensure your products’ safety, quality, and compliance for the U.S. market.
From cosmetic facility and product registrations to ingredients review and labeling compliance, our expert team provides comprehensive guidance through the entire MoCRA compliance process. We ensure your products align with FDA standards for a smooth market entry.
Cosmetics
Understanding and adhering to recently enacted FDA’s MoCRA regulations is essential for cosmetic manufacturers and distributors. At FDA Listing Inc., we specialize in helping you meet these requirements and ensure your products’ safety, quality, and compliance for the U.S. market.
From cosmetic facility and product registrations to ingredients review and labeling compliance, our expert team provides comprehensive guidance through the entire MoCRA compliance process. We ensure your products align with FDA standards for a smooth market entry.
Cosmetic Facility Registration & Product Listing (MoCRA)
Under the newly approved Modernization of Cosmetics Regulation Act of 2022 – MoCRA, most cosmetic facilities.
FDA Cosmetic
Labeling Requirements
Accurate and FDA-compliant cosmetic labels and claims are essential for achieving commercial success in the United States.
FDA Cosmetic Color Additives Requirements
All cosmetic color ingredients and additives must be FDA-approved for their specific intended use and cosmetic formulation.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
FDA
Export Certificate
The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA.
Cosmetic Facility Registration
& Product Listing (MoCRA)
Under the newly approved Modernization of Cosmetics Regulation Act of 2022 – MoCRA, most cosmetic facilities.
FDA Cosmetic
Labeling Requirements
Accurate and FDA-compliant cosmetic labels and claims are essential for achieving commercial success in the United States.
FDA Cosmetic
Color Additives Requirements
All cosmetic color ingredients and additives must be FDA-approved for their specific intended use and cosmetic formulation.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
FDA
Export Certificate
The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA.
Frequently Asked Questions (FAQ)
Who is required to register a cosmetic facility and list products under MoCRA?
Facility owners or operators who manufacture or process cosmetics for U.S. distribution must complete FDA facility registration. Additionally, the “Responsible Person” (the brand name owner, manufacturer, or distributor on the label) must submit a product listing for every cosmetic formula sold in the U.S.
What are the essential labeling requirements for cosmetic products in the U.S.?
Cosmetic labels must include the product’s statement of identity, net quantity of contents, a complete ingredient list using standard INCI names in descending order of predominance, safety warnings, and the contact information of the Responsible Person (including a U.S. address or electronic contact for adverse event reporting).
Which color additives require FDA batch certification for use in cosmetics?
Synthetic dyes derived from petroleum (such as FD&C Red No. 40 or D&C Yellow No. 10) require mandatory FDA batch testing and certification before being added to cosmetic products. Natural or mineral pigments (such as iron oxides or titanium dioxide) are exempt from batch certification but must still comply with FDA purity specifications.
What is an FDA Export Certificate for cosmetics, and how do you obtain one?
An FDA Export Certificate (such as a Certificate of Free Sale) is an official government document verifying that a cosmetic product and its manufacturing facility comply with U.S. FDA regulatory standards, allowing brand owners to clear foreign customs during international export.
Does the FDA issue official "FDA Registration Certificates" for cosmetic facilities?
No, the FDA does not issue physical or digital registration certificates, official seals, or approval badges. Successfully completing MoCRA facility registration assigns an FDA Establishment Identifier (FEI) number, which serves as official proof of facility registration in the FDA database. Third party US Agent service providers often issue a registration certificate as a proof upon successful registration.
How do you resolve an FDA import detention for a cosmetic shipment?
If a cosmetic shipment is detained at the U.S. border due to alleged non-compliance (such as missing facility registration, uncertified color additives, or misbranded labeling), the importer must submit formal testimony, private lab analysis, or corrected packaging evidence to the FDA Division of Import Operations within the specified deadline to secure product release.