Neither the FD&C Act nor the FPLA requires cosmetic labeling to undergo pre-market approval by FDA. It is the manufacturer's and/or distributor's responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements results in a misbranded product.

However, manufacturers, packers, and distributors of cosmetic products can voluntary register their products with FDA through the Voluntary Cosmetic Registration Program (VCRP).

Voluntary Cosmetic Registration Program

The Voluntary Cosmetic Registration Program (VCRP) is an FDA reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States. There are two parts to the VCRP, described in detail in the sections below. You may participate in both parts of the program or only one part. No fees are required to participate in this voluntary program.

The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to products that are not for sale, such as hotel samples, free gifts, or cosmetic products you make in your home to give to your friends.

Information from the VCRP database has been used by the Cosmetic Ingredient Review (CIR) an independent, industry-funded panel of scientific experts, to assist the CIR Expert Panel in assessing ingredient safety and determining priorities for ingredient safety review.

By participating in the VCRP you are supporting these safety review processes and ensure compliance with the FDA requirements. There is another benefit that cosmetic companies gain from VCRP participation. Filers can use the database as back-up storage for product information because the FDA server is secured and off-site.

MEDERA Consulting assists companies with the U.S. FDA Cosmetic Product Ingredient Statement (CPIS) filings and Registration of Cosmetic Product Establishments through the U.S. FDA Voluntary Cosmetic Registration Program (VCRP).

Cosmetic color additives are also regulated by the U.S. MEDERA Consulting can help you to determine how U.S. FDA's cosmetic color additive regulations apply to your cosmetic products.

Contact us today to find out how MEDERA can work with you to ensure your cosmetics are registered to FDA and that they are labelled and sold in accordance with the FDA requirements. To receive our free white paper on marketing healthcare products in US, please click here.