FDA Issues Final Guidance on Cosmetic Product Facility Registrations and Product Listings

24 January 2024

Streamlining Compliance and Transparency in the Cosmetics Industry

The United States Food and Drug Administration (FDA) has recently released its final guidance for the cosmetic industry on facility registrations and product listings. This guidance, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), aims to improve compliance and transparency in the cosmetics sector. The FDA’s recommendations and instructions provide valuable insights for manufacturers, distributors, and other stakeholders on how to submit facility registrations and product listings. Additionally, the FDA has introduced an electronic submission portal called Cosmetics Direct, which is designed to streamline the submission process. This article examines the key takeaways from the FDA’s guidance and its implications for the cosmetics industry.

Definitions and Obligations under Section 607 of the FDCA

Under the FDA’s guidance, the same definitions listed in Section 607 of the Federal Food, Drug and Cosmetic Act (FDCA) will apply. These definitions include terms such as Contract Manufacturer, Cosmetic Product, Duns Number, Facility, FEI, Manufacturing or Processing of a Cosmetic Product, Operator, Owner, Responsible Person, and Small Business. It is crucial for industry players to familiarize themselves with these definitions to ensure compliance with the registration and listing requirements.

The FDA emphasizes that every person who owns or operates a facility engaged in the manufacturing or processing of cosmetic products for distribution in the U.S. must register each facility and submit a cosmetic product listing, with limited exceptions. This obligation applies to both manufacturers and distributors, underscoring the FDA’s commitment to enhancing oversight and accountability in the cosmetics industry.

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Confidentiality and Disclosure of Information

While the FDA is committed to transparency, it recognizes the need to protect certain information. The guidance clarifies that the FDA will not disclose information on the brand names under which cosmetic products are manufactured or processed at a facility or the facility registration numbers associated with a particular product listing. However, it is important to note that all other information from a cosmetic product listing and facility registration could be disclosed under a Freedom of Information Act (FOIA) request. This balance ensures that the public has access to relevant information while safeguarding proprietary and confidential data.

Streamlined Submission Process through Cosmetics Direct

To facilitate compliance with the registration and listing requirements, the FDA has developed an electronic submission portal called Cosmetics Direct. The portal aims to simplify the submission of registration and product listing information under Section 607 of the FDCA. The FDA strongly encourages industry stakeholders to utilize this portal for efficient and streamlined compliance. Additionally, the FDA has also announced the availability of paper forms, such as Form FDA 5066 and Form FDA 5067, as an alternative submission tool. These forms provide an additional option for those who may face challenges with electronic submissions.

Enforcement Delay and Fee Exemption

Recognizing the need for industry adaptation, the FDA has announced an enforcement delay for the requirements regarding cosmetic product facility registration and listings. The FDA does not intend to enforce these requirements until July 1, 2024. This delay allows manufacturers, packers, and distributors ample time to understand and comply with the new obligations outlined in the guidance.

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Furthermore, the FDA has confirmed that there is no fee associated with submitting a registration or product listing under Section 607 of the FDCA. This exemption alleviates financial burdens for industry stakeholders and promotes broader compliance.

Conclusion:

The FDA’s final guidance on cosmetic product facility registrations and product listings marks a significant step towards enhancing compliance and transparency in the cosmetics industry. By providing clear instructions and recommendations, the FDA aims to streamline the submission process and ensure that manufacturers, distributors, and other stakeholders meet their obligations under Section 607 of the FDCA. The of the Cosmetics Direct portal and the availability of paper forms offer flexible options for submission. With the enforcement delay and fee exemption, the FDA demonstrates its commitment to supporting industry adaptation and facilitating compliance. Industry players should review the guidance, consult legal counsel, and take necessary actions to ensure compliance with the new requirements. By doing so, they can contribute to a safer and more transparent cosmetics market.

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