On July 1, 2024, the US Food and Drug Administration (FDA) officially invalidated the grace period for cosmetic company registration and product listing under the Modernization of Cosmetic Regulations Act of 2022 (MoCRA). Companies that have not completed FDA registration may face risks of detention or refusal to enter the United States.
1. FDA cosmetics enforcement officially takes effect
On December 29, 2022, US President Biden signed and passed the Modernization of Cosmetic Regulations Act 2022 (MoCRA), which is a significant reform of US cosmetic regulations in the past 80 years since 1938. The new regulations require all cosmetic companies exporting to the United States or domestically to complete FDA registration.
On November 8, 2023, the FDA issued guidance stating that in order to ensure that companies have more sufficient time to submit their registrations, an additional 6-month grace period has been granted for the FDA to complete all compliance requirements by December 31, 2023. By July 1, 2024, companies that have not completed the deadline will face mandatory penalties from the FDA.
The deadline for July 1, 2024 has expired, and the FDA's mandatory enforcement of cosmetics has officially come into effect. All cosmetic companies exporting to the United States should pay special attention to completing enterprise registration and product listing before exporting, otherwise they will face risks such as refusal of entry and seizure of goods.
2. FDA Cosmetic Registration Compliance Requirements
Cosmetic factories engaged in production, processing, and sales in the United States must register as enterprises. A contract manufacturer, regardless of how many brands they contract for, only needs to register once. Non US companies must also appoint a US agent to represent the company in communication and liaison with the US FDA. US agents must be physically located in the United States and able to answer FDA questions on 7/24.
The responsible person must register the product. Manufacturers, packagers, distributors, or brand owners whose names appear on cosmetic labels must list the products and declare the specific formula to the FDA. In addition, the "responsible person" will also be responsible for adverse events, safety certification, labeling, and disclosure and recording of allergens in spices.
The above registered enterprises and products listed on the market must complete compliance before July 1, 2024!
Must comply with the Good Packaging and Labeling Act (FPLA) and other applicable regulations.
Before December 29, 2024, each cosmetic label should indicate the contact person information for adverse event reporting, which is used to receive adverse event reports.
3. FDA Cosmetic Update Requirements
Enterprise registration update requirements:
·Enterprise registration must be updated every two years
·Any changes in information must be reported to the FDA within 60 days, such as:
Contact information
product type
Brand, etc
·All non US companies must designate a US agent, and updates to the US agent service period also need to be confirmed with the agent
✔ Product List Update Requirements:
·The person responsible for product listing must update the product registration annually, including any changes
·The responsible person must submit the listing of each cosmetic product before listing, and can flexibly submit multiple cosmetic product listings at once
·De-List the products that have been discontinued, that is, delete the product list name
Post time: Jul-09-2024
