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

The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.

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 The draft guidance is currently open for public comment.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.

The post FDA Releases Draft Guidance on Mandatory Cosmetics Recalls under MoCRA appeared first on Focal Point.

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.

The post FDA Upgrades Cosmetics Direct Portal Ahead of Biennial Renewals appeared first on Focal Point.

This new, user-friendly dashboard is an interactive tool that allows the public, industry, and researchers to query and download real-time data on adverse events related to cosmetic products. According to the FDA, the reports are updated daily to include the most recent submissions.

The dashboard contains data from two key sources:

• Mandatory Reports: Serious adverse event reports submitted by cosmetic companies (“responsible persons”) as required by MoCRA.
• Voluntary Reports: Reports submitted to the FDA by consumers, healthcare professionals, and others.

Impact on the Industry:

This public-facing tool marks a new era of transparency for cosmetic product safety. It provides a direct view into the safety data being collected by the agency and will be a critical resource for post-market surveillance. Companies can monitor trends related to their own products, ingredients, and entire product categories.

We encourage all industry professionals, particularly those in regulatory, quality, and safety roles, to explore this new dashboard to understand its capabilities and implications for your business.

Please contact us if you require assistance with your adverse event reporting procedures or overall MoCRA compliance strategy.

The post FDA Launches Public Dashboard for Real-Time Cosmetic Adverse Event Data appeared first on Focal Point.

Here are the key takeaways from the latest update:

• Disclosure of Fragrance Allergens in Cosmetic Labeling: The anticipated date for this proposed rule has been moved to May 2026. This is a significant delay from its previous target of January 2025.
• GMP proposed Rule: The proposed rule for cosmetic Good Manufacturing Practices has been moved from the standard agenda to the “long-term actions list.” This indicates that the Agency is unlikely to publish the Notice of Proposed Rulemaking (NPRM) within the next 12 months. The previous anticipated date was October 2025.
• Formaldehyde in Hair Straightening Products: While not a direct provision of MoCRA, the FDA’s intention to ban formaldehyde and formaldehyde-releasers in these products has a new anticipated NPRM date of December 2025. This timeline has been previously pushed back from September 2024 and March 2025.
• Test Methods for Asbestos in Talc: The Final Rule for standardized testing methods for detecting asbestos in talc-containing cosmetic products is now targeted for March 2026.

These adjustments reflect the ongoing complexities of implementing major regulatory changes. Our team at Focal Point Research will continue to monitor these developments and provide updates as they become available.

The post FDA Announces Updated Timelines for Key Cosmetic Regulations appeared first on Focal Point.

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 post MoCRA REMINDER! appeared first on Focal Point.

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.

The post FDA unveils its portal for cosmetic regulation – Cosmetics Direct appeared first on Focal Point.

What you need to know:

• Cosmetics Direct is part of a larger portal known as FDA Direct (previously CDER Direct).
  • If you previously held a CDER Direct Account, you are likely to already have access to FDA Direct. However, you may need to obtain access to Cosmetics Direct. This is yet to be confirmed.
  • First Time Users will need to sign up by selecting ‘Create New Account ‘.
• An account will be needed for your company, but you will be able to add multiple users, who would be able to assist with compilation and filing of your facility registration and/or product listings.
• For Facility Registrations, the following are mandatory fields:
  • Facility Name, FEI No., Street Address, City, State/Province, Country, Zip/Postal Code, Email, Phone No., Name of the Owner and/or Operator of the Facility
  • For foreign companies: US Agent Name, Phone No., Email
  • Brand names of cosmetics manufactured or processed at the facility, the respective Responsible Person (as listed on the label) and the product category
• For Product Listings, the following are mandatory fields:
  • Responsible Person Name (as listed on label) and Phone No.
  • Product Name, confirmation of whether it contains Fragrance or Flavor, Product Category Code, Ingredient UNII Name
    • You will be able to enter each ingredient separately or upload a prefilled ingredients file.  Details of what this file should contain are not yet available.
  • Manufacturing/Processing Facility Name, Street Address, City, State/Province, Country, Zip/Postal Code, Confirmation of if it is a small business, FEI Number

You may view the draft content released for comments by the FDA here or here. If you have any questions at all, please do not hesitate to reach out. 

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