If you have questions or would like guidance on how this change may impact your registrations, please reach out to our team.

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The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.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

Bemotrizinol, also known as BEMT or Tinosorb S, is a broad spectrum, photostable UV filter that has been widely used in Europe and Asia for years. It protects against both UVA and UBV rays, which are responsible for sunburn, premature aging, and skin cancer. Unlike some older UV filters, bemotrizinol does not degrade in sunlight, meaning it remains effective for longer. It is also more fat-soluble, which helps it to provide better broad-spectrum protection.

The approval of bemotrizinol would give sunscreen manufacturers a new, effective tool to create safer and more effective products. It could also lead to more cosmetically elegant formulas that are less likely to leave a white cast on the skin, which would be a major benefit for people with darker skin tones.

If the FDA approves bemetrizinol, it could still be several months or even years before it is available in sunscreens on the U.S. market. This is due to the time it takes for manufacturers to formulate new products. Conduct stability testing and get them on store shelves. However, the potential approval of this new ingredient is a significant step forward for sun protection in the United States.

The post New Sunscreen Filter, Bemotrizinol, on track for FDA Approval appeared first on Focal Point.

Key takeaways:

• No Animal Testing Mandate for Marketed Sunscreens: The FDA does not require animal testing for individual sunscreen products that are marketed under the current monograph. Companies can rely on existing data on active ingredients to formulate their products.
• Minimizing Animal Testing for New Ingredients: For new sunscreen active ingredients to be considered ‘generally recognized as safe and effective’ (GRASE), some animal testing has been historically necessary. However, the FDA is actively working to reduce this reliance. For instance, they do not request testing in large animals like dogs or non-human primates, and for ingredients with minimal skin absorption and limited safety concerns, they do not require fertility or extensive cancer studies.
• Call for Innovation: The FDA is strongly urging companies to invest in and develop new, reliable non-animal testing methods. The goal is to have alternative methods that can provide the necessary data for the FDA to make GRASE determinations for new sunscreen active ingredients without the use of animals.
• Collaboration: The FDA is collaborating with other federal partners, including the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), to advance this goal.

The FDA is signaling a clear move towards reducing and ultimately replacing animal testing for sunscreens and is looking to the industry to help lead the way in developing and validating new alternative testing methods.

Read the full article here.

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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.

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