FDA issues Structured Product Labeling Guide for cosmetic facilities and products

25 Oct 2023 --- The US FDA has unveiled the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, now encompassing cosmetic facility registrations and product listings in a stride toward enhancing regulatory practices within the industry. This “foundational” resource will guide the transformation of the cosmetic sector as part of MoCRA (Modernization of Cosmetics Regulation Act of 2022).

SPL, a recognized standard for exchanging product and facility-related information, is set to enhance precision and reliability in the cosmetics industry, states the FDA.

The Cosmetic Facility Registration section outlines requirements for registrant information, legal authenticator, facility information, parent company, small business designation and responsible person, among others.

Labeler, registrant, facility product link and submitter name are some details in the Cosmetic Product Listing section.

The FDA says its inclusion of cosmetics product facility registrations and product listings within the SPL framework signifies its commitment to safety, quality and transparency within the cosmetics industry.SPL is set to enhance precision and reliability in the cosmetics industry, states the FDA.

The SPL Implementation Guide empowers industry stakeholders to develop SPL authoring capabilities, facilitating compliance with MoCRA.

A glimpse into digital future
Soon, the FDA will accept SPL-formatted submissions through the Electronic Submissions Gateway and various SPL authoring software, in line with MoCRA mandates. The agency will also introduce the Cosmetics Direct electronic submission portal, offering a user-friendly platform for efficient submissions.

Furthermore, the FDA has been seeking comments on its draft Cosmetics Direct and paper forms (Forms FDA 5066 and 5067).

The portal has the necessary registration and listing submission information from the paper forms in electronic format to help submitters organize the information needed while being able to access previous listing submissions.

The agency is pushing for electronic submissions to facilitate efficiency and timeliness of data submission and management. However, paper submissions will still be accepted.

In related news, we spoke to an expert on whether the industry should seek counsel when navigating regulatory challenges posed by MoCRA.

By Venya Patel

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