Overview
On March 27, 2023, The Food and Drug Administration (FDA) also referred to as ‘The Agency’ announced they will no longer accept submissions into the Voluntary Cosmetic Registration Program (VCRP).
Introduction
In 1972, the FDA set up the Voluntary Cosmetic Registration Program is a voluntary program The program was developed so the Agency could get best-guess estimates on cosmetic products and ingredients in the US marketplace. It was also used by the Cosmetic Ingredient Review Experts Panel to determine current usage rates of various cosmetic products and ingredients for use in their ingredient reviews.
FDA used the information from the VCRP to assist it in carrying out its responsibility to regulate cosmetics marketed in the U.S However the portal 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. marketplace.
Because MoCRA requires certain companies to register their facilities and list their products with FDA, FDA 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.
This is the first notable motion in preparation for implementation of the Modernization of Cosmetics Regulation (MoCRA).
MoCRA has a section in it which requires that cosmetic companies register their facilities and products with the FDA. The Act states that facilities must register “within one year” of the passage of the Act – so by last December 2024.
In order to prepare, the FDA is creating a brand-new system to handle the upcoming required product and facility registrations. Information currently in the VCRP will not be transferred into the new system.
More about MoCRA
- Regulations Act of 2022 was signed into law as part of the Omnibus Spending Bill last December.
- MoCRA, the Modernization of Cosmetic Regulations Act of 2022 was signed into law as part of the Omnibus Spending Bill last December.
- Busineses making less than $1 million annually from cosmetic sales are exempt from the most burdensom required – good manufacturing practices and the need to register facilities and products.
- Companies will have a period of 3 – 5 years before the actual regulations come into effect to prepare and know what the actual regulations are long before that.
What is the Time Frame?
MoCRA updates the Federal Food Drug and Cosmetic Act. Changes become effective December 2023 or 2024 (depending on the change). The FDA is tasked with coming up with the detailed regulations which put it all into place. It’s a long, slow process.
Effective Date
As part of the final rule there is usually an effective date at which time the regulations actually go into effect. This gives everyone time to make the necessary changes and updates. The effective date can be anywhere from 6 months to 3 years from the time the final rule is issued. Likely 1 – 2 years.
Learn More About Cosmetic Legislation
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References
Learn more about FDA. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.