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Philippine exporters of cosmetics products to the US are advised to review the US Food and Drug Administration’s guidance on registration and licensing requirements for such products
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The guidance will assist persons submitting cosmetic product facility registrations and product listing submissions to the FDA under the Modernization of Cosmetics Regulation Act of 2022
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The DTI-Export Management Bureau encouraged all Philippine exporters of cosmetic products to carefully review the recent issuance to ensure compliance
Philippine exporters of cosmetics products to the United States are advised to review the US Food and Drug Administration’s (US FDA) guidance on registration and licensing requirements for cosmetic products intended for the US market.
The US FDA recently released the final Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products, which outlines the requirements and processes in registering and listing of cosmetic product facilities and products intended for the US market, the Department of Trade and Industry (DTI) said in an advisory.
The guidance also contains market information important for exporters of cosmetic products to the US.
According to the US FDA, the guidance will assist persons submitting cosmetic product facility registrations and product listing submissions to the FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The DTI-Export Management Bureau encouraged all Philippine exporters of cosmetic products to carefully review the recent issuance to ensure compliance with the registration and listing requirements when exporting cosmetic products to the US.
DTI said one of the key points from the recent issuance is that the MoCRA has added section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing requirements for cosmetic product facility registration and product listing. This means that a person who owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US must register each facility with the US FDA. Additionally, for each cosmetic product, the responsible person must submit to the US FDA a cosmetic product listing
On the submission process, the US FDA encouraged electronic submissions through the Cosmetics Direct electronic submission portal using the structured product labeling (SPL) format. This is intended to streamline the submission and receipt of registration and product listing information. The US FDA has provided detailed instructions on how to submit registration and product listing information electronically, including how to create an account, how to prepare and submit SPL files, and how to track the status of submissions.
Cosmetic product facilities are also required to renew their registration biennially from the date of initial registration.
