The US Food and Drug Administration (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 U.S. market. It also contains market information that are important for exporters of cosmetic products to the US.
The following are the key points from the recent issuance:
1. Registration and Listing Requirements: The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) 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 every 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
2. Submission Process: The US FDA strongly encourages electronic submissions through the Cosmetics Direct electronic submission portal using 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.
3. Renewal of Registration: Cosmetic product facilities are required to renew their registration biennially or every two years from the date of initial registration. The US FDA will send a reminder to the email address associated with the registration account 60 days prior to the registration expiration date. The person responsible must review and update the registration information, as necessary, and submit the renewal electronically through the Cosmetics Direct portal.
The DTI-EMB encourages all Philippine exporters of cosmetic products to carefully review this recent issuance to ensure compliance with the registration and listing requirements when exporting cosmetic products to the US.
The full guidance document is available on the US FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products
In addition, the DTI-EMB recognizes the importance of compliance with international regulations and is committed to providing support and guidance to Philippine exporters in navigating these requirements.
For further information and assistance, please do not hesitate to contact our Market Officers at the Market Innovation Division at MID@dti.gov.ph and Product Officers at the Consumer and Industrial Division at CID@dti.gov.ph ♦
Date of release: 04 January 2024
