The US FDAs Latest Guidelines for Cosmetics Factory Registration and Product Listing Will Be Released Soon

As the US Food and Drug Administration (FDA) is about to issueCosmetics & Personal Carethe final guidelines for factory registration and product listing, the industrys attention continues to rise. The following is a summary of the latest progress:

The FDA released draft guidance on cosmetic facility registration and product listing on August, 2023, which has already attracted over 40 comments and suggestions. These feedbacks cover various concerns, and the FDA is currently evaluating these recommendations before issuing final guidance. The final release will provide businesses with clearer direction for completing facility registration and product listing requirements.

In October this year, the FDA introduced the Structured Product Labeling (SPL) guidelines related to cosmetics. The use of SPL documents makes the information more standardized, facilitating the automatic processing of the FDAs database, and thus enabling timely and efficient updates of factory registration and product listing. The FDA has confirmed that in the near future, a new reporting system will be launched, and the specific start date will be announced in the next few weeks.

Enterprises should closely follow the updates regarding the launch of the electronic platform or the templates for submitting paper materials (Forms FDA 5066 and 5067). Although the FDA does not require the upload of SPL documents in the electronic system, and enterprises can also directly fill in the relevant information online, the standardized SPL documents are still the recommended option. For the traditional mode, the FDA still accepts the submission of paper materials.