FDA Stops Voluntary Cosmetic Registration Program

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

The U.S. Food and Drug Administration (FDA) has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023. This follows the agency's plans to develop a program for submission of the facility registrations and product listings mandated by the "Modernization of Cosmetics Regulation Act" (MoCRA). According to the agency, the new law gives the FDA new authorities that will help ensure the safety of cosmetic products.

Background

The VCRP was established in 1972 as a way for the agency to obtain the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution, voluntarily, from manufacturers, packers, and distributors of cosmetic products in commercial distribution. The VCRP was also open to foreign cosmetics companies whose products are exported for sale in the U.S. The FDA used the information from the VCRP to assist it in carrying out its responsibility to regulate cosmetics marketed in the U.S. However, it was not an approval system. Because the system was voluntary, the information provided through the VCRP did not present a complete picture of cosmetics in the U.S.

Modernization of Cosmetics Regulation Act

The MoCRA requires certain companies to register their facilities and list their products with FDA. In addition, the agency is creating a new system to handle the large number of submissions that will result. The FDA therefore will no longer use the voluntary registration system, and is no longer accepting and processing submissions to the VCRP.  Instead, the agency requests that cosmetics companies wait to register with FDA until the official announcement of the availability of the new system. Moreover, information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by the MoCRA.

For Additional Information please see the Modernization of Cosmetics Regulation Act of 2022 and the Voluntary Cosmetic Registration Program.