SUNJIN NEWSLETTER
The Deadline for Registration of Cosmetic Facilities and Listing of Products is Approaching!
By Kim, Yongsung
Translated By Lim, Julia
April 2024, NO.17
Hi, how are you?
Starting from July 2nd, the regulations regarding facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the United States FDA will come into effect.
The Modernization of Cosmetics Regulation Act (MoCRA) in the United States is a special law enacted to supplement the Federal Food, Drug, and Cosmetic Act (FD&C) of 1938.
This law aims to expand the authority of the FDA over cosmetic regulation and strengthen the responsibilities of cosmetic manufacturers and sellers regarding product safety and compliance with relevant laws. It officially came into effect on December 29, 2023.
On November 8, 2023, the FDA announced a six-month extension for the enforcement of regulations regarding facility and product registration, extending the deadline from December 29, 2023, to July 1, 2024.
The purpose of this extension, as stated by the FDA, is to provide additional time for relevant industries to prepare for regulatory compliance.
Therefore, starting from July 2nd, all facilities manufacturing or processing cosmetics for sale in the US market must be registered with the FDA, and specific information including facility registration numbers, ingredients, and labeling must be submitted.
For detailed explanation on registration, please refer to the guidelines issued by the FDA.
We are in the process of establishing new facilities based on the experience of getting the highest grade, NAI(No Action Indicated), from FDA inspections for Active Pharmaceutical Ingredients(APIs).
From next year, these facilities will enable us to offer products of the highest standard that meet the requirements of cosmetics regulatory authorities worldwide, including the United States.
If you have any inquiries, please feel free to contact us.
Areum Jeong / Regional Sales Manager
E-mail : sales1@sunjinbs.com
