FDA Releases Guidance on Cosmetic Product Facility Registrations and Product Listings

15 January 2024

New FDA guidance provides recommendations and instructions for submitting cosmetic product facility registrations and product listings

The Food and Drug Administration (FDA) has recently issued a new guidance document, FDA-2023-D-1716, providing recommendations and instructions for individuals and companies submitting cosmetic product facility registrations and product listings. The guidance aims to clarify the statutory requirements, define key terms, outline responsibilities, specify required information, explain submission processes, and establish timelines for compliance. While the guidance is not legally enforceable, it offers valuable insights into FDA’s current thinking on the matter and serves as a helpful resource for industry professionals seeking to navigate the regulatory landscape.

1: Understanding the Statutory Requirement

The first section of the guidance sheds light on the statutory requirement to submit cosmetic product facility registrations and product listings. It clarifies the legal obligation for manufacturers, packers, and distributors of cosmetic products to register their facilities and list their products with the FDA. By providing a comprehensive overview of the legal framework, this section ensures that stakeholders have a clear understanding of their responsibilities and obligations.

2: Defining Key Terms

To facilitate accurate and consistent interpretation, the guidance includes a section dedicated to defining key terms related to cosmetic product facility registrations and product listings. This section aims to eliminate ambiguity and promote a shared understanding among industry professionals, FDA officials, and other stakeholders. By establishing common definitions, the guidance enhances communication and streamlines compliance efforts.

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3: Responsibilities of Submitters

The guidance outlines the responsibilities of individuals and entities involved in submitting cosmetic product facility registrations and product listings. It clarifies who is responsible for making the submissions and emphasizes the need for accurate and up-to-date information. By clearly delineating the roles and obligations of different parties, the guidance ensures that each stakeholder understands their specific responsibilities and can fulfill them effectively.

4: Required Information for Submissions

This section of the guidance provides detailed instructions on the information that must be included in cosmetic product facility registrations and product listings. It covers essential elements such as the name and address of the facility, the types of products manufactured or distributed, and the contact information of responsible individuals. By specifying the required information, the guidance enables submitters to compile complete and accurate submissions, reducing the risk of errors or omissions.

5: Submission Processes and Timelines

The guidance offers guidance on the submission processes and timelines for cosmetic product facility registrations and product listings. It provides step-by-step instructions on how to make the submissions, whether electronically or in writing. Additionally, it establishes deadlines for compliance, ensuring that submitters are aware of the timeframe within which their submissions must be made. By providing clear guidance on submission processes and timelines, the FDA aims to streamline the regulatory process and facilitate efficient compliance.

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The release of FDA-2023-D-1716 marks a significant step towards enhancing transparency and clarity in the cosmetic industry. By providing comprehensive recommendations and instructions for cosmetic product facility registrations and product listings, the FDA aims to promote compliance and ensure the safety and integrity of cosmetic products in the market. While the guidance is not legally binding, it offers valuable insights and practical guidance for industry professionals. Stakeholders are encouraged to review the guidance and provide feedback during the comment period to contribute to the development of a final version that best serves the needs of the industry and protects public health.

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