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The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.

The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

The post FDA Announces Fiscal Year 2026 OMOR Fee Rates: Costs to Increase 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 The draft guidance is currently open for public comment.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 proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

Effective January 1, 2026, non-compliant products found in Washington State will be in violation of state law, regardless of when they were purchased or manufactured.

All stakeholders with physical inventory should take the following steps:

–Audit ‘Existing Inventory’ (Acquired Before Jan. 1, 2025): If you are holding stock acquired prior to 2025 that contains restricted substances:

• Through Dec. 31, 2025: You may continue to sell these items or use them in professional services.
• Starting Jan. 1, 2026: All sales and usage must cease. You must remove these products from shelves and service areas immediately.

–Audit ‘New Inventory’ (Acquired On/After Jan. 1, 2025): Any non-compliant inventory acquired during the 2025 calendar year is already in violation. If any such stock is identified, it must be removed from sale immediately to mitigate enforcement action.

Disposition of Unsold Inventory:

The Department of Ecology has provided specific guidance for handling non-compliant goods starting January 1, 2026:

• Redistribution: Companies are permitted to move this inventory to retail locations or distribution centers outside of Washington State, provided those jurisdictions do not have similar prohibitions.
• Disposal: If redistribution is not possible, the product must be disposed of according to local waste management regulations.

Critical Warning: Do Not Donate! Companies are prohibited from donating these non-compliant cosmetic products.

If you require assistance identifying restricted chemical classes or determining compliance of specific formulations, please contact us.

The post Washington State TFCA Sell-Through Period Expires December 31 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.

-Ban the sale of plastic glitter in personal care products by January 1, 2030.

In his veto message, Governor Newsom explained that while he supports the goal of protecting California’s waterways from microplastics, he was not supportive of the approach this bill takes. He expressed concerns that the bill’s ban on specific ingredients, such as glitter, may incidentally result in a prohibition on biodegradable or natural alternatives.

What this means for the Industry?
This veto means the specific bans and compliance deadlines outlined in AB 823 will not become law at this time. The immediate pressure to reformulate away from plastic glitter based on this bill has been lifted. However, this topic remains a high priority issue for legislators and consumers. Our team will continue to monitor any furfure legislative efforts to regulate microplastics in cosmetics.

The post California Governor Vetoes Bill to Ban Plastic Glitter (AB 823) appeared first on Focal Point.

The establishment of these NSRLs provides a clear ‘safe harbor’ threshold for businesses. If exposure from a product is below these levels, a Prop 65 warning for cancer risk is not required.

The New NSRLs:

The OEHHA has set two distinct daily exposure limits based on particle size:

• 440 micrograms per day for airborne, unbound titanium dioxide particles with diameters of 10 micrometers or less
• 44 micrograms per day for airborne, unbound titanium dioxide particles with diameters of 08. micrometers or less

Please contact us if you would like assistance with formula reviews or exposure assessments to ensure compliance with Prop 65.

The post California Finalizes Prop 65 Safe Harbor Levels for Titanium Dioxide appeared first on Focal Point.