Cosmetics | Cosmetics Registration

Are Cosmetic Manufacturers required to register with FDA? Does FDA require Cosmetic Registration of ingredients or formulas? No.

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FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations. As its name indicates, this program is voluntary. The VCRP system is designed to help FDA keep track of cosmetic product manufacturers, and the ingredients used in cosmetic products. Although the Drug Facility Registration, Medical Device Registration, and Food Establishment Registration programs are mandatory for domestic and foreign firms exporting drugs, medical devices or foods to the U.S., Cosmetic Facility Registration is completely voluntary.

FDAImports.com, LLC often receives questions about whether cosmetics must be registered or listed with FDA or if cosmetic manufacturers or importers are subject to FDA registration. These questions often arise because some consulting firms in the United States either imply, or state explicitly, that FDA requires cosmetic registration for cosmetic manufacturing facilities and listing of cosmetic ingredients. This is false. Neither federal regulations nor FDA require cosmetic manufacturers to register their facilities. Although this may change in the future, current federal law and FDA cosmetic regulations do not require cosmetic manufacturers or cosmetic importers to register with FDA or to list or submit their cosmetics for FDA review prior to marketing in the U.S. As long as your cosmetic is not also a drug (i.e., cosmetics that bear SPF labeling claims), the manufacturer is not required to register.

You may be wondering why we at FDAImports.com, LLC are telling you this, rather than just selling you a cosmetic registration process. The answer is that we do not want to charge you for performing unnecessary services. We certainly do not want you to be misled into believing that you must pay for certain services which are not necessary. Rather, we want to you help you understand and comply with the actual requirements of U.S. law and FDA cosmetic regulations so you may successfully export your cosmetics here and build an impressive brand and business.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.