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FDA Cosmetics Registration

By law, manufacturers are not required to register cosmetics or submit product formulations to the FDA, nor do they need a registration number to import cosmetics into the United States. However, the FDA encourages cosmetics companies to participate in the Voluntary Registration Program for Cosmetics (VCRP) using the online registration system

FDA's Office of Cosmetics and Colorants developed a voluntary registration program for cosmetics at the request of the cosmetics industry. The scheme consists of two parts: voluntary registration of cosmetic manufacturers and declaration of cosmetic ingredients.

Benefits of participating in VCRP

A manufacturer's voluntary registration and acquisition of a registration number does not imply FDA approval of the manufacturer or its products, nor does FDA allow manufacturers to use their participation in the VCRP or the obtained registration number or listing number for commercial promotion; However, manufacturers can directly benefit from participating in VCRP by:

To obtain important information about cosmetic ingredients, FDA enters all information from the VCRP into a computer database. If a cosmetic ingredient currently in use is deemed to be harmful and should be banned, FDA notifies the manufacturer or seller of the product through the directory in the VCRP database. FDA will not be able to notify you if your product is not in the registration database. Avoid product recall or import impoundment due to ingredient problems. If cosmetic manufacturers file their product formulations with the VCRP, the FDA will alert them whenever they are found to have used an unapproved color additive or other banned ingredient in their formulations. This allows manufacturers to modify product formulations before they are imported or sold, eliminating the risk of recall or seizure due to improper use of ingredients. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes ask the FDA if a cosmetics company is registered with the FDA. Although registration does not indicate FDA approval, it indicates that your product has been reviewed by the FDA and entered into a government database. The FDA will notify you if you submit a product that has an incomplete formulation or contains a banned ingredient or unapproved color additive.

FDA Cosmetics Registration

The decision to collect samples is based on the nature of the product; FDA focus issues; Past history of the product. FDA takes a physical sample and sends it to an FDA regional laboratory for analysis

If the FDA finds that the sample meets the requirements, it sends a "release notice" to THE U.S. Customs and the importer, respectively.

If the FDA determines that a sample "appears to violate the FDCA and other applicable laws," it sends a "notice of seizure and hearing" to CBP and the importer, respectively. The notice details the offence and nature and gives the case and the importer 10 working days to provide evidence of the approval of the consignment.

Impounded imports must be trimmed, returned, or destroyed under FDA or U.S. Customs supervision

The hearing is the only opportunity for the importer to defend the import or provide evidence that will enable the goods to be repaired and fit for entry.

If the importer and the underwriter, shipper, importer or a designated representative do not respond to the notification, FDA sends a "notice of refusal" to the CBP and the importer. Then the products in question are returned or destroyed.

If the case and the underwriter, shipper, importer, or a designated representative respond to a Notice of Seizure and hearing, FDA will hold a hearing on the seized product when the importer provides evidence that the product "meets the requirements" or submits a request to repair the product.

If the firm provides evidence that the product meets the requirements, the FDA will collect follow-up samples. After analysis, the product is either released or denied entry.

FDA reviews the importer's proposed modification procedure and approves or disapproves it as the case may be. Once approved, FDA will conduct follow-up testing/sample collection to determine eligibility. If the sample is acceptable, send "release notice" to US Customs and importer. Notice of rejection will be issued if the sample is unqualified.

FDA Cosmetics Registration

FDA Cosmetics Registration

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