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.

The post Reminder: US FDA Drug Listing Renewals 2026 appeared first on Focal Point.

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.

The post Navigating MoCRA Compliance: FDA Confirms No Official Verification Certificates Are Issued for Cosmetic Registrations appeared first on Focal Point.

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.

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.

The post FDA Implements Split Payment Framework for FY 2027 OTC Monograph Facility Fees 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.

The post FDA issues warning letters to OTC companies over talc testing appeared first on Focal Point.

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.

The post FDA Warning Letter Trends appeared first on Focal Point.

​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.