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U.S. FDA Cosmetics Regulations


The U.S. Food and Drug Administration (FDA) regulates cosmetic products intended for use in the United States, and the State of California has imposed additional requirements for cosmetic products intended for use in California. Registrar Corp provides Registration, Ingredient Statement filing, and Labeling Assistance for U.S. and Non-U.S. companies in the Cosmetic Products Industry.

Cosmetic Labeling and Ingredient Review

Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify their cosmetic labeling to comply with FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.

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California Safe Cosmetics Act Reporting

Certain cosmetic companies intending to sell in the state of California, USA are required to report ingredients in their products that may cause cancer, birth defects, or other reproductive harm. Registrar Corp helps companies determine which ingredients in their products may be subject to this requirement and reports them to California.

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Cosmetic Product Registration and Reporting

Registrar Corp assists companies with reporting required by the California Safe Cosmetics Program as well as FDA Cosmetic Product Ingredient Statement (CPIS) filings and Registration of Cosmetic Product Establishments through the FDA Voluntary Cosmetic Registration Program (VCRP).

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Cosmetic/Drug Product Registration and Listings

Cosmetic products are regulated as drugs if they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or if they are intended to affect the structure or any function of the body of humans or animals.

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Cosmetic Color Additives and Cosmetic Color Batch Certification

A cosmetic color additive is any dye, pigment, or other substance that can impart color to a cosmetic product. Cosmetic color additives are regulated by FDA.

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Certificate of Registration issued by Registrar Corp

Cosmetic companies registered with FDA often are asked by their customers and suppliers to verify their FDA registrations. A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA registration.

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Detention Without Physical Examination ("DWPE") Assistance

Companies shipping products to the United States may find their shipments subject to Detention Without Physical Examination (“DWPE”) by FDA. Products subject to DWPE are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from DWPE may be lengthy for businesses anxious to deliver products on schedule.

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