Companies should begin their portfolio review early to identify discontinued products, formulation or labeling changes, manufacturing-site updates and other changes that may require listing updates. Failure to complete the required annual certification or update during the renewal period can result in inactivation of drug listings, potentially affecting continued US distribution.

Our team can help you manage all your FDA renewals. Reach out to us for more information.

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Why Digital Marketplaces Are Driving Industry Inquiries:

The agency released this public notice following a sharp increase in requests from industry stakeholders seeking government-issued compliance proof. This wave of inquiries has been largely fueled by online retail channels mandating that merchants submit evidence of FDA registration or formal exemption confirmation prior to permitting product listings on their digital storefronts.

Core Obligations Under MoCRA:

While official verification certificates do not exist, mandatory filing rules remain strictly in effect under Section 607 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as updated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA):

• Owners of manufacturing or processing facilities are required to complete and renew their FDA registration on a two-year cycle.
• Designated responsible persons must submit comprehensive product and ingredient listings to the agency every year.
• The FDA underscored that receiving an agency-assigned listing or registration number does not equate to regulatory approval and must not be leveraged for promotional or advertising purposes.

If you need further regulatory details regarding facility registration and product listing protocols, please contact our team.

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Commercial and Consumer Impact:

While this administrative action formally alters the permissible ingredient list for nonprescription sunscreens, its practical disruption to the current retail landscape is minimal:

• Once the final order takes effect, any sunscreen drug formulation incorporating PABA or trolamine salicylate will require formal FDA approval prior to being sold.
• The regulatory change is not anticipated to impact products currently available on store shelves, as the agency has found no evidence that any sunscreens presently sold in the United States contain either ingredient.
• Because existing U.S. formulations do not utilize these substances, no action is required from consumers, whom the FDA encourages to maintain regular sunscreen application alongside broader sun-protective habits to mitigate sun exposure risks.

Regulatory Context and Phased Modernization Under the CARES Act:

This final order represents a key step in the FDA’s broader initiative to overhaul OTC sunscreen monograph requirements utilizing the modernized review framework established by the CARES Act of 2020. After publishing its initial proposed order in September 2021, the regulator received more than 15,000 public comments.

Because of the sheer volume and complexity of stakeholder feedback, the agency opted to advance public health priorities by finalizing the 2021 proposal in stages. Consequently, this initial final order specifically executes two targeted proposals by eliminating both PABA and trolamine salicylate from the OTC sunscreen monograph’s permitted active ingredients list. Meanwhile, the FDA continues to evaluate public comments covering the remaining provisions of the 2021 proposed order, which encompass product dosage forms, SPF levels, and labeling standards.

If you have any questions regarding this update or would like a comprehensive sunscreen formulation/ label review, our team is here to help.

The post OTC Sunscreen Monograph Update: FDA Finalizes Removal of PABA and Trolamine Salicylate appeared first on Focal Point.

AB 1744 builds California’s existing law prohibiting untruthful, deceptive, or misleading environmental marketing claims. Violations would be misdemeanors, creating a new state-mandated local enforcement program. The measure would also clarify that compliance with the new labeling restriction does not replace existing requirements to substantiate environmental marketing claims. Follow us to learn more.

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Regulatory Background: The Lead Interim Policy:

Washington’s Toxic-Free Cosmetics Act (TFCA) establishes a stringent statutory restriction prohibiting cosmetic products containing lead impurities in excess of 1 part per million (ppm), which took effect on January 1, 2025. Recognizing that naturally occurring trace lead in raw materials, particularly mineral pigments and natural clays, presents severe technical hurdles to consistently meeting 1 ppm, Ecology implemented an interim enforcement discretion policy in late 2024.

This interim policy established safe harbor pathways for companies actively working to lower lead levels:

Option 1: Covers general cosmetics with total lead concentrations at or below 2 ppm, as well as color cosmetics and clay-based masks at or below 5 ppm.

Option 2: Accommodates color cosmetics and clay masks with total lead levels between 5 ppm and 10 ppm, provided manufacturers notify the agency, monitor lead across product batches via third-party laboratory testing or raw material verification, and retain testing data for state review.

Key Updates to the Interim Policy:

Ecology’s recent revision modifies the enforcement timeline and establishes direct data auditing:

• The interim safe harbor was originally slated to expire on December 31, 2026. Ecology has lifted this calendar cutoff, allowing the policy to stay active until a permanent administrative rule is adopted or the agency formally rescinds the interim measures.
• Ecology will randomly audit 10 companies registered under Option 2, requiring them to submit their batch-level lead monitoring and testing documentation for state evaluation.

Industry Status and Immediate Action Items:

During a September 3 briefing, Ecology confirmed that notification notices have already been dispatched to the 10 selected companies.

• If your company utilizes Option 2 and has not received a formal call-in directive, you were either not part of the initial random selection or Ecology lacks current contact records.
• Brand owners and manufacturers operating under the interim safe harbor should review their submission records immediately to ensure all primary contact details filed with Ecology are completely up to date. 

If you need any further information regarding this update, contact us today.

The post Washington State Department of Ecology Updates Interim Policy on Lead in Cosmetics appeared first on Focal Point.

Critical Payment Deadlines:

Drug facility owners and regulatory compliance teams should align their accounting schedules to meet the upcoming OMUFA deadlines:

• Initial Payment (50%): The first half of the facility assessment is due on October 1, 2026.
• Final Payment (50%): The concluding 50% balance must be settled by February 1, 2027.

This split-fee structure reflects a key administrative transition under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). Historically, OTC facility fees were payable later in the calendar year (typically June 1). To harmonize OMUFA collection timelines with the start of the federal fiscal year on October 1 alongside other FDA user fee programs (such as PDUFA and GDUFA), the agency adopted this installment approach during FY 2027 to mitigate immediate budgetary impacts on registrants.

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Judicial Ruling and Constitutional Grounding:

The court’s decision turns squarely on First Amendment commercial speech protections:

• The court ruled that based on the current state of scientific evidence, compelling brands to place cancer warnings for DEA cannot be constitutionally enforced. 
• Because the premise that DEA poses a carcinogenic risk to humans is contested rather than purely factual and uncontroversial, mandatory warning statements amount to unconstitutionally compelled commercial speech.
• PCPC filed the initial legal challenge in March 2024, maintaining that requiring warning statements claiming DEA is “known to the State of California to cause cancer” infringes upon commercial First Amendment rights

Industry Context: A Growing Pattern of First Amendment Victories:

This injunction marks a major milestone in a continuous series of successful First Amendment challenges brought by industry against Proposition 65 warning requirements where the underlying toxicology remains debated: 

• The DEA ruling follows successful federal court challenges restricting mandatory cancer warnings for glyphosate, acrylamide, and titanium dioxide (in cosmetic formulations). 
• Courts continue to reject compelled health warnings where authoritative scientific reviews fail to demonstrate a clear, uncontroverted link between consumer exposure and human carcinogenicity.
• While the permanent injunction blocks current enforcement, the state Attorney General retains the statutory ability to petition the court to dissolve the injunction should new scientific evidence establish consensus or if governing legal standards shift.

Strategic Implications and Action Items for Personal Care Brands:

While the ruling provides immediate regulatory relief, legal and regulatory specialists urge companies to approach their compliance strategies with measured caution:

• Audit existing product formulations containing DEA, identify any pending 60-day notices of violation, and evaluate ongoing enforcement threats involving the ingredient. 
• Review master product labels and supply chain compliance documentation concerning DEA to determine whether warning removals or revisions are commercially warranted.

If you need assistance with formulation or label reviews, contact us. 

The post First Amendment Milestone: Federal Court Bars California Prop 65 Cancer Warnings for Diethanolamine (DEA) appeared first on Focal Point.

Cosmetic manufacturers should use these actions as an opportunity to review their talc-related quality systems, testing programs, supplier oversight and documentation to strengthen compliance readiness and quality controls. Reach out to us for more information.

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In an August warning letter, the FDA emphasized that companies remain responsible for product quality even when manufacturing, packaging, or other activities are outsourced. Effective qualification and ongoing oversight of suppliers and contract facilities remain essential. Analytical testing was also a significant focus. The FDA cited deficiencies in testing programs and emphasized that firms relying on supplier Certificates of Analysis (CoAs) must establish and document the reliability of those results. In another warning letter, the FDA further highlighted the need for component-specific acceptance criteria and scientifically sound, appropriately validated analytical methods. A September letter similarly identified testing programs that were inadequate for their intended purpose. A late-July warning letter to a Germany-based manufacturer also noted that failure to correct violations could result in refusal of entry for products manufactured at the facility, including cosmetics – a point of particular interest for companies operating across both drug and cosmetic product lines.

Other recurring observations included:

Inadequate microbiological control programs

Non-compendial or unvalidated analytical methods

Deficiencies in raw material testing

Inadequate cleaning validation

Insufficient stability studies

These warning letters reinforce the FDA’s continued focus on effective supplier oversight, scientifically justified testing programs, and robust supporting quality systems. Companies should evaluate whether their supplier qualification, COA reliance, analytical methods, microbiological controls, cleaning validation, and stability programs are adequately documented and implemented. Should you require assistance with becoming inspection ready, reach out to us.

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Major Regulatory and Operational Reforms:

The modernized guidance addresses long-standing compliance challenges by eliminating redundancies and recalibrating the scope of global surveillance obligations:

• As part of Health Canada’s dedicated red-tape reduction initiative, the agency has reduced the official list of specified foreign regulatory authorities subject to these reporting rules by more than half. 
• MAHs will navigate updated, standardized notification forms and an enhanced reporting tool engineered to streamline intake and data validation.
• The updated text clarifies the precise conditions that require notification, resolving ambiguities that historically drove duplicate submissions and unnecessary reporting overhead. 
• The revised framework reinforces risk-proportionate post-market oversight within Canada’s existing statutory drug provisions.

Stakeholder Consultations and Policy Drivers:

The finalized policy reflects extensive input gathered during a 60-day public consultation launched in September 2025, which drew 184 submissions from industry stakeholders and individual experts. Health Canada adapted both the finalized guidance and its internal administrative workflows around several dominant industry themes: 

• Managing compliance challenges tied to stringent, prescribed notification windows. 
• Strong industry support for international alignment.
• Requests for targeted guidance regarding when foreign labeling revisions formally trigger Canadian notification mandates. 
• Demands for explicit definitions surrounding actionable triggers and risk thresholds.

While Health Canada is not conducting additional formal public consultation rounds prior to implementation, the Marketed Health Products Directorate (MHPD) continues to accept industry feedback to guide prospective revisions via mhpdpolicy-politiquesdpsc@hc-sc.gc.ca. 

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