Purpose and Scope:

The primary goal of this draft is to provide clarity to the industry regarding the FDA’s authority to access and copy records related to cosmetic products. Presented in a Questions-and-Answer format, the guidance specifically addresses three general topic areas:

• Section 605: Authority regarding Adverse Event Reports
• Section 610: Authority regarding Serious Adverse Health Consequences or Death (SAHCOD)
• Confidentiality and Refusal: Procedures regarding the protection of sensitive information and the refusal of access.

Regulatory Status:

Industry professionals are reminded that, like all FDA guidance documents, this draft represents the Agency’s ‘current thinking’. It does not establish legally enforceable responsibilities unless specific regulatory or statutory requirements are cited. Recommendations marked with the word should suggest practices rather than mandatory requirements.

Public Comment Period:

Stakeholders are encouraged to review the draft and submit comments

• Target Publication Date: January 22
• Where to Comment: www.regulations.gov
• Docket Number: FDA-2025-D-2243

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This release is a key step in implementing the Modernization of Cosmetics Regulation Act (MoCRA), aimed at providing the industry with clarity regarding the FDA’s new mandatory recall authority.

What the Guidance Covers

The draft document outlines the specifics of how and when the FDA will exercise its power to force a recall. Key areas of focus include:

Decision Criteria: The specific criteria the FDA will use to determine if a mandatory recall is necessary.

The Process: A step-by-step look at the procedure the FDA will follow when implementing a mandatory recall.

Industry Expectations: Clear guidelines on what is expected from companies regarding compliance with these orders.

Call to Action

Industry stakeholders are encouraged to review the document to understand their new obligations. The draft guidance is currently open for public comment.

Deadline: You must submit your comments by February 17.

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Based on mandatory industry filings, the FDA’s report offers a snapshot of how prevalent these “forever chemicals” are in the supply chain:

• The agency identified 51 different PFAS currently used across 1,744 cosmetic formulations.
• These ingredients are primarily added intentionally to enhance specific product attributes, such as water resistance, durability, and texture.
• The study concentrated on the 25 most common PFAS, which account for approximately 96% of the intentional use reported.

The Safety Verdict: Still “Inconclusive”

Perhaps the most critical takeaway is that the FDA was unable to make definitive safety determinations for the majority of the chemicals identified. The agency cited significant gaps in data and a lack of publicly available toxicological research as the primary reasons for this uncertainty.

While the report noted that five specific PFAS appear to present low safety concerns, at least one was flagged for potential safety issues.

Currently, there are no federal regulations explicitly prohibiting the intentional addition of PFAS to cosmetics in the United States. However, this report signals that scrutiny is increasing. The FDA maintains its authority to take enforcement action should specific safety risks emerge from the data.

Next Steps: Moving forward, the FDA plans to increase its monitoring and surveillance efforts. The goal is to reduce PFAS prevalence across the consumer product supply chain through expanded testing and resource allocation.

The post FDA Release: The State of PFAS in Cosmetics Under MoCRA appeared first on Focal Point.

With the two year mark of the portal’s December 2023 launch approaching, FDA is enhancing compliance support with new features that display real-time facility registration status and renewal dates, send automated renewal reminders, and provide updated user guides and tutorials.

Note – Cosmetic manufacturers and processors must renew their facility registration every two years from the date of initial registration. Companies can choose between Biennial Renewal (for registrations with updates) or Abbreviated Renewal (for no changes), with both electronic and paper options available. Early renewals are also permitted.

Deadlines are closer than you think. If you need guidance navigating Cosmetics Direct or completing your renewal, reach out to us and let’s get it done right.

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A 2021 study revealed that the detected fluorine levels in cosmetics could be a case of trace amounts derived from materials naturally occurring in the environment or resulting from the manufacturing process. This naturally occurring or unintentional presence of trace materials is recognized by the FDA and they offer guidance on the allowable levels. FDA plans to review such compounds and assures to publish a complete report on PFAs in cosmetics by Dec 29, 2025 as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

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The portal is designed to simplify and expedite the registration process for facilities engaged in cosmetic businesses and for listing of products sold in the US. By providing a centralized platform, the FDA aims to enhance the efficiency of regulatory procedures, making it easier for industry professionals to comply with industry standards and guidelines.

The FDA has also extended the deadline for submissions, moving the compliance date from Dec. 29, 2023, to July 1, 2024.  If you require any assistance with filing your submissions via the Cosmetics Direct portal, please reach out to us. Our team is here to guide and support you through the process, ensuring a smooth experience for all stakeholders involved.

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