SUNJIN NEWSLETTER
Will the FDA Have Authority to Regulate General Cosmetics?
By Jeong, Areum
Translated By Lee, James
Aug 2023, NO.29
Hi, how are you?
We will talk about the ‘Beauty Cosmetic Regulation Modernization Act in U.S, MoCRA(Modernization of Cosmetics Regulation Act of 2022)’ in this issue. After MoCRA goes into effect on 29th Dec, the products which are not registered with the FDA can no longer be sold in the United States.
Actually, the FD&C(Federal Food, Drug, and Cosmetic Act) which was enacted in 1938 mainly regulated OTC(Over The Counter) products. However, MoCRA which is designed to complement the FD&C is expected to expand the FDA’s authority to include not only OTC products but also general cosmetic categories.
Under the implementation of MoCRA, all manufacturing and processing facilities, as well as product ingredients, will be required to be registered. It also demands compliance with the regulation of GMP(Good Manufacturing Practice).
MoCRA does not have specific regulations on cosmetic raw material manufacturers actually. However, OEM/ODM companies and brand owners who engage in product listing should use raw materials that are manufactured in facilities compliant with GMP regulations.
SUNJIN BEAUTY SCIENCE has received the highest NAI(No Action Indicated) rating without any observations during the U.S. FDA inspection for API and also obtained the ISO 22716 certification which is an international standard for excellent manufacturing and quality management practices(GMP) in the cosmetics industry. Therefore, if you use cosmetic raw materials from SUNJIN BEAUTY SCIENCE, you can navigate the complicated MoCRA regulations more smoothly.
If you have any inquiries about the product or need more information, please contact us at the following contact information.
Areum Jeong / Regional Sales Manager
E-mail : sales1@sunjinbs.com
