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The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.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 The draft guidance is currently open for public comment.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.

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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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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.

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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This guidance is comparable to one which was published in 2014 concerning cosmetic products. For the sale of cosmetic products containing nanomaterial ingredients, the FDA published recommendations for safety assessments for cosmetics to address certain important factors including characterizations of the nanomaterial ingredient, the safety assessment of nanomaterials and considerations for its toxicology when developing cosmetic products containing nanomaterials.

This guidance, which was initially drafted in 2017 will be concerning the development of OTC drug products in which a nanomaterial is present in the finished dosage form. It should be noted that this guidance should be viewed as recommendations for monograph drug manufacturers unless specific regulatory requirements are cited.

The guidance highlights the need to obtain further understanding of the interactions of nanomaterials within the body, including both intrinsic and extrinsic factors, as well as how these attributes will impact the overall product quality, safety and efficacy. These considerations presented in this guidance include drug development, safety evaluation and quality considerations

The FDA proposes a risk-based approach when developing nanomaterial-containing drugs, with a focus on the following risk factors:

• Adequacy of characterization and function of the nanomaterial
• Complexity of the nanomaterial structure
• Understanding of the mechanism by which the physiochemical properties of the nanomaterial impact its biological effects
• Predictability of in vivo release based on in vitro methods
• Physical and chemical stability
• Route of administration

The information of the structure of a specific nanomaterial can be referenced within the appropriate letter of authorization as part of the drug application or to a drug master file. This is to ensure adequate characterization of the nanomaterial and understanding of the nanomaterial’s intended use and application. It should be noted that this list is not comprehensive and other risk factors may need to be evaluated during product development.

Moreover, as a guidance document, the information issued are considerations for the industry for drug manufacturers when submitting applications, including Investigational New Drug Applications, New Drug Applications, Biological License Applications, Abbreviated New Drug Applications and Drug Master Files. The FDA suggests that as the drug product development progresses, more information will be obtained about the nanomaterial and understanding will continue to be revised based on findings.

If you need any assistance or have any questions about whether this applies to your company or have any concerns, do not hesitate to contact us.

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As a DIN Owner, you should have received your Annual DIN Renewal package from Health Canada. These are due to be submitted by July 29, 2022. Should you require assistance with this, please reach out.

FDA User Fees For OTC Monograph Drug Facility

On June 1^st 2022, OTC Monograph Drug Facility User Fees for the fiscal year of 2022 were due to the US FDA. The fee for 2022 is $24,178 for facilities that manufacture or process a finished dosage form and $16,119 for contract manufacturing facilities. The annual facility fees for covered OTC drug facilities were introduced in 2021 to help fund FDA regulatory activities.

Facilities that are exempt from these fees include sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency as well as facilities that only manufacture active pharmaceutical ingredients, produce clinical research supplies, or conduct testing.

If you are unsure about whether your US-based drug facility has any fees due to the FDA, we can help determine which applicable fee applies to your establishment. Feel free to contact us.

Reminder for Drug Listings

Should you have any Drug Listing updates, now is a good time to file. If you require assistance, we are happy to help.

The post Reminders appeared first on Focal Point.

The state government aims to have this act become effective July 1, 2022. However, it should be noted that this bill has only passed the first reading in the house (on April 13, 2021). Since then, there has been no update. The bill must still undergo Referral to Committee and its Second and Third Readings prior to approval.

Since this bill has only passed the initial reading, there is no action needed as yet. However, once this act becomes effective, your company will be required to update your website if selling cosmetic products in North Carolina.

If you have any questions on this, please do not hesitate to contact us.

The post New Legislation for North Carolina appeared first on Focal Point.

Spoiler alert: The FY 2022 facility fees rates are an increase of approx. 19% in comparison to the FY 2021 facility fee rates.

Application fees are as follows:

• Monograph Drug Facility (MDF) Facility Fee – USD 24,127
• Contract Manufacturing Organization (CMO) Facility Fee – USD 16,119

The fees also apply to the submitter of OTC Monograph Order Request (OMOR) and is as follows:

• Tier 1 Monograph Fee – USD 507,021
• Tier 2 Monograph Fee – USD 101,404

The OTC monograph drug facility fees are due on June 1, 2022.

If you need any assistance or have any questions related to whether this fee program applies to your company or have any concerns about payment options, do not hesitate to contact us.

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