​Key Provisions of the Enacted Bills:

​This legislation introduces strict regulatory requirements and robust enforcement mechanisms for the personal care industry:

• ​The enacted bills prohibit the manufacture, sale, or distribution of cosmetic and hair care products in Maryland that intentionally contain lead and certain other harmful chemicals.

• ​The Maryland Department of Health is now authorized to actively investigate complaints and enforce compliance with the new restrictions.

• ​Violations of the law are considered unfair trade practices. Businesses found in violation may face significant civil damages, which can include treble and punitive damages in cases of willful non-compliance.

​These new laws underscore the growing trend of state-level scrutiny regarding cosmetic ingredients, emphasizing the immediate need for rigorous formula and supply chain reviews to ensure compliance in the Maryland market.

​To get your formulas reviewed and to ensure compliance, contact us today.

The post Maryland Enacts Ingredient Restrictions for Cosmetics and Hair Care appeared first on Focal Point.

​While the published dates are not legally binding, and cosmetics rulemaking has historically experienced further delays following the publication of these target dates, the agenda outlines the latest thinking from the HHS and FDA regarding their regulatory timelines.

​Key Updates to Proposed Target Dates:

​The agenda highlights new proposed dates for several critical regulatory actions:

• ​Disclosure of Fragrance Allergens: The new proposed date for the disclosure of fragrance allergens in cosmetic labeling is November 2026.

• ​Formaldehyde in Hair Products: The new proposed date for rules addressing the use of formaldehyde and formaldehyde-releasing chemicals as an ingredient in hair smoothing products or hair straightening products is November 2026.

• ​Good Manufacturing Practice (GMP): The new proposed date for Good Manufacturing Practice for cosmetic product facilities is November 2027.

• ​Asbestos Testing in Talc: The new proposed date for testing methods for detecting and identifying asbestos in talc-containing cosmetic products is November 2027.

​What This Means for the Industry:

​These revised target dates indicate continued delays in the finalization of key MoCRA provisions. However, this extension provides manufacturers, brand owners, and regulatory teams with additional time to prepare. Companies should use this window to proactively review their formulations, audit their manufacturing processes, and establish the necessary supply chain transparency to ensure full readiness once the FDA finalizes and enforces these mandates.

​If you have any questions or need assistance with MoCRA listings, label or formulation reviews, reach out today.

The post FDA Update: Revised Timelines for MoCRA Implementation and Cosmetic Regulations appeared first on Focal Point.

The FY 2027 MDF and CMO facility fees represent an increase of approximately 149% from FY 2026. FDA attributes the increase largely to a one-time downward operating reserve adjustment that reduced FY 2026 facility fees.

A key change under OMUFA II is the consolidation of the previously separate facility and OMOR fee announcements into a single annual Federal Register notice beginning with FY 2027. This is intended to provide a more predictable and streamlined fee-setting process for FDA and industry.

The FY 2027 facility fee will be paid in two equal installments: 50% on October 1, 2026 and the remaining 50% on February 1, 2027, subject to the statutory appropriations conditions. From FY 2028 onward, the full facility fee will generally be due October 1. OMOR fees remain payable upon submission of the OMOR.

Companies that own qualifying OTC monograph drug facilities, including eligible CMOs, should assess their FY 2027 fee obligations and budget for the substantially higher facility fees. Companies planning to submit OMORs should also account for the increased OMOR fees. FDA’s OMUFA requirements apply independently of other FDA user fee programs such as PDUFA, GDUFA or MDUFA.

For more such updates, contact us.

The post FDA Announces FY 2027 OMUFA User Fee Rates and Streamlines Fee process appeared first on Focal Point.

The legislation is not currently expected to advance in Congress, but its introduction reflects continued federal scrutiny of PFAS in cosmetics. Companies should continue monitoring federal and state PFAS developments and review formulations, raw materials and packaging for intentionally added PFAS.

For further updates, do reach out to us.

The post US Federal: No PFAS in Cosmetics Act Introduced appeared first on Focal Point.

In granting the injunction, the court determined that the plaintiffs are likely to succeed on their claims that SB 343 infringes on First Amendment commercial speech rights and fails to offer businesses clear, actionable guidance for compliance.

As background, SB 343 restricts the use of “chasing arrows” symbols and recyclability marketing unless packaging meets strict California-specific metrics – such as being collected and processed by facilities serving at least 60% of the state’s population and using non-interfering inks or adhesives. Because these standards conflict with requirements in many other states, companies selling products nationally faced hefty compliance costs, separate inventory requirements, and complete packaging redesigns.

This ruling effectively pauses the law’s upcoming October 4, 2026 compliance deadline and removes the immediate threat of state enforcement while litigation continues. However, it is crucial to remember that this is a temporary hold rather than a final ruling; California may appeal or ultimately win the case.

Additionally, standard false advertising and consumer protection laws remain in full effect, meaning all environmental and recyclability claims must still be truthful, fully documented, and substantiated. Reach out to us if you have any questions regarding this update.

The post Federal Court Temporarily Blocks CA SB 343 appeared first on Focal Point.

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

The post FDA Issues Final rule on Nation Drug Code (NDC) format appeared first on Focal Point.

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.