U.S Cosmetics Require FDA Registration for Customs Clearance

Cosmetics Exported to the U.S. Must Comply with FDA Requirements. Recently, the U.S. Food and Drug Administration (FDA) has implemented a new cosmetics regULation aimed at strengthening supervision over the cosmetics industry and safeguarding consumers' health rights and interests.

The introduction of this new U.S. cosmetics regulation stems from the amendment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). It should be noted that these requirements apply to sellers of numerous product categories, covering a wide range of cosmetics such as skin care products, lotions, perfumes, lipsticks, nail polishes, eye creams, permanent hair dyes, toothpaste, and deodorants.

Specifically, starting from July 1, 2024, all cosmetics exported to the U.S. must complete FDA registration before they can undergo customs clearance and be sold. UnregisteRED cosmetics will face the risk of sales prohibition. Meanwhile, FDA registration for cosmetics has been upgraded from a voluntary program to a mandatory requirement.

To strictly enforce the act and prevent any impact on the normal sales of related products, Alibaba AliExpress previously issued an announcement on strengthening the qualification control of cosmetics exported to the U.S., stating that the platform will block and regulate non-compliant products starting from July 1, 2024.

Major cross-border e-commerce platforms including Amazon, TEMU, and SHEIN have also required sellers/enterprises in the cosmetics category on their U.S. sites to provide information such as facility registration numbers and product listings.

FDA Registration Requirements for Cosmetics

01 Facility Registration

All enterprises manufacturing or processing cosmetics for sale in the U.S. must register their factory facilities with the FDA. In case of any changes to the registered information, updates must be submitted to the FDA within 60 days, and the registration must be renewed every two years.

For enterprises whose production facilities are located outside the U.S., they are required to provide details of a U.S. Agent (including name, email address, and phone number), who will represent the enterprise in communications with the FDA. If the FDA determines through investigation that the products manufactured by a registered enterprise pose safety risks, it has the authority to suspend the facility’s registration and prohibit the sale of products produced by that facility in the U.S.

02 Product Listing

The responsible parties for cosmetics (including manufacturers, packagers, distributors, and other entities named on product labels) must submit specific information about each cosmetic product placed on the market to the FDA, including manufacturing location, ingredients, and labeling. This listing information must be updated annually.

The responsible parties are obligated to:

①　Submit cosmetic product listings to the FDA

②　Report adverse events related to the products

③　Verify the safety of the products

④　Ensure compliance with labeling requirements and disclose/record fragrance allergens

03 Safety Certification

Companies and individuals manufacturing or selling cosmetics are responsible for ensuring the safety of their products. Only products that have been tested and proven safe are allowed to be marketed. The responsible parties must conduct necessary tests and retain complete test records as sufficient evidence to confirm the safety of their cosmetics.

FDA Registration Process for Cosmetics

①　Submit the registration application along with required documents, such as the application form and business license.

Note: Cosmetics registration information is not publicly searchable. To check the registration status, log in to your FDA official website account and enter the relevant registration number.

Apply for FDA Registration for Cosmetics

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