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The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.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

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).

The post PFAs in cosmetics 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.

New Requirements for Cosmetics:

1. Adverse Event Record keeping and Serious Adverse Event Reporting:

• Must report to FDA no more than 15 business days of event awareness
• Must maintain all related records
• Cosmetic product labels must list contact information for consumers to report side effects

2. Mandatory Facility Registration and Product and Ingredient Listing:

• Facility Registration by December 29, 2023 – All existing facilities (domestic and foreign) that engage in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA
• Must be renewed every 2 years
• Product Listing must be submitted within 120 days of market launch and it must be renewed annually

3. Cosmetic Safety Substantiation

• Adequate substantiation of safety is required for all cosmetics

4. Cosmetic Labeling and Fragrance Allergen Transparency

• Product labels must be updated to include fragrance allergens
• June 29, 2024 – List of allergens to be declared will be proposed by FDA and finalized within 180 days of the comment period ending
• Labeling must be updated by December 29, 2025

5. Current Good Manufacturing Practices:

• Manufacturers must meet GMP by 2025
• FDA is expected to publish a proposed regulation before December 29, 2024 and finalize it by December 29, 2025

6. Talc rule:

• FDA to publish a proposed test protocol for asbestos in Talc by December 29, 2023
• To be finalized 180 days after comment period ends

7. PFAS Report:

• FDA to assess the use of per- and polyfluoralkyl substances (“PFAS”) in cosmetic products and the scientific evidence regarding the safety of their use in cosmetics products
• FDA will publish the results of this assessment in a public report no later than December 29, 2025

8. Animal testing

• No requirements specific to testing involving animals, but animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances

MoCRA EXEMPTIONS:

• Small business exemptions apply – average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000 AND
• Do not engage in the manufacturing or processing of the cosmetic products listed below:
  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
  • Cosmetic products that are injected.
  • Cosmetic products that are intended for internal use.
  • Cosmetic products that are intended to alter appearance for more than 24 hours.

If you have any questions or would like further information, please contact us.

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