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)

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Here is a simplified breakdown of what has changed and what it means for your product labels:

Sunscreen Monograph Updates:

• Nano Ingredients Recognized: The monographs now explicitly include data on nano titanium dioxide and nano zinc oxide, covering acceptable quantities, dosage forms, and specifications.
• New Filters Added: Bemotrizinol and Bisoctrizole have been added to the Secondary Sunscreen monograph.
• Testing Standards: New in vitro methods for SPF and broad-spectrum testing (e.g., ISO 23675, ISO 23698) are now referenced.
• PA Ratings (UVA Protection): For NHPs and Non-prescription Drugs (NPDs), PA ratings are now permitted as “additional information” on the label. For NPDs, data must be provided to support any additional information regarding the PA rating prior to its use on labels. The PA rating is acceptable as additional information on the label for NHPs containing Zinc Oxide or a combination of Zinc Oxide and Titanium Dioxide. It does not apply to Titanium Dioxide alone (due to lower efficacy against long-wave UVA).

Acne Therapy Monograph Updates:

• More flexibility for marketing claims (expanded terminology): You are no longer restricted to just “acne pimples.” The monograph now allows interchangeable terms such as “zits,” “blemishes,” “spots,” “blackheads,” “whiteheads,” and “comedones.”
• New Performance Claims: Added support for claims regarding mechanism of action, such as “Penetrates pores to eliminate most acne pimples” or “For the management of acne breakouts.”
• Quantity Labeling: You now have the option to express quantity as % w/w or % w/v, depending on your specific formulation.

General Updates for Both Categories:

• Product Facts Table: A standardized Product Facts Table has been added for NHPs in these categories to improve consumer readability.
• Dosage Forms: An updated list of acceptable dosage forms is now included.

The NNHPD has indicated that under this Monograph Update Project, no modifications are anticipated that would necessitate mandatory product license amendments or label revisions. Essentially, these updates are intended to offer more flexibility and modernization rather than forcing a compliance overhaul of existing products. However, if you are launching new products, you should align with these new standards immediately.

Need help navigating these changes? Do you have questions about how these monograph updates affect your specific formulations or labeling strategies? Feel free to reach out to us.

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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.

This guidance is intended for market authorization holders (for drugs) and licence holders (for NHPs), providing detailed information on how to comply with Canadian regulations, including the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Product Regulations.

The draft guidance clarifies the expected content, format, and submission procedures for two key types of reports:

1. Annual Summary Report (ASR): A comprehensive assessment of all known safety information for a product currently on the market.
2. Issue-Related Summary Report (IRSR): A concise, critical analysis of a specific safety or effectiveness issue, which is prepared upon request from Health Canada.

The primary goal of this update is to enhance clarity and efficiency. Key objectives include consolidating current guidance documents, converting text to plain language, addressing stakeholder questions, and updating submission processes.

A significant change in this draft is the separation of guidance for drugs and NHPs. This change is intended to better address the distinct regulatory and operational considerations for these different product lines.

Health Canada is seeking feedback from stakeholders on the proposed changes. Interested parties are encouraged to review the draft guidance and an associated draft form (“Notifying Health Canada of a significant change in what is known about the risks and benefits of a product”). Feedback can be submitted via email until the December 23, 2025, deadline.

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Bemotrizinol, also known as BEMT or Tinosorb S, is a broad spectrum, photostable UV filter that has been widely used in Europe and Asia for years. It protects against both UVA and UBV rays, which are responsible for sunburn, premature aging, and skin cancer. Unlike some older UV filters, bemotrizinol does not degrade in sunlight, meaning it remains effective for longer. It is also more fat-soluble, which helps it to provide better broad-spectrum protection.

The approval of bemotrizinol would give sunscreen manufacturers a new, effective tool to create safer and more effective products. It could also lead to more cosmetically elegant formulas that are less likely to leave a white cast on the skin, which would be a major benefit for people with darker skin tones.

If the FDA approves bemetrizinol, it could still be several months or even years before it is available in sunscreens on the U.S. market. This is due to the time it takes for manufacturers to formulate new products. Conduct stability testing and get them on store shelves. However, the potential approval of this new ingredient is a significant step forward for sun protection in the United States.

The post New Sunscreen Filter, Bemotrizinol, on track for FDA Approval appeared first on Focal Point.

Key takeaways:

• No Animal Testing Mandate for Marketed Sunscreens: The FDA does not require animal testing for individual sunscreen products that are marketed under the current monograph. Companies can rely on existing data on active ingredients to formulate their products.
• Minimizing Animal Testing for New Ingredients: For new sunscreen active ingredients to be considered ‘generally recognized as safe and effective’ (GRASE), some animal testing has been historically necessary. However, the FDA is actively working to reduce this reliance. For instance, they do not request testing in large animals like dogs or non-human primates, and for ingredients with minimal skin absorption and limited safety concerns, they do not require fertility or extensive cancer studies.
• Call for Innovation: The FDA is strongly urging companies to invest in and develop new, reliable non-animal testing methods. The goal is to have alternative methods that can provide the necessary data for the FDA to make GRASE determinations for new sunscreen active ingredients without the use of animals.
• Collaboration: The FDA is collaborating with other federal partners, including the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), to advance this goal.

The FDA is signaling a clear move towards reducing and ultimately replacing animal testing for sunscreens and is looking to the industry to help lead the way in developing and validating new alternative testing methods.

Read the full article here.

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A significant change is that private parties can now apply directly to the Competition Tribunal to file case against a business, which may increase litigation risks. The guidelines emphasize that all environmental claims must be truthful, substantiated, and backed by “adequate and proper” testing or evidence.

The guidelines also outline six key principles for business to follow when vetting their environmental claims:

1. Truthful and not misleading: Claims should not be false or exaggerated.
2. Properly substantiated: Environmental benefits should be backed by reliable testing and evidence.
3. Specific comparative claims: When comparing products, be clear about what is being compared and the extent of the difference.
4. Avoid exaggeration: Claims should not overstate environmental benefits, considering both the literal meaning and general impression.
5. Clear and specific: Vague statements should be avoided.
6. Substantiated future claims: Any claims about future environmental benefits must be supported by a clear plan and evidence.

While the guidelines are not legally binding, they are a crucial resource for companies as they review their environmental and sustainability messaging.

If you require any assistance, have any questions or would like to understand more about how this impacts your business, please do reach out to us.

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Key updates in the final version:

• Clarity on Evidence Requirements: Clearer details on the types of GMP evidence accepted (e.g., inspection reports from recognized regulatory authorities, on-site audits, etc.)
• Risk-Based Approach: Emphasis on using a risk-based approach for accessing compliance evidence, especially where mutual recognition agreements (MRAs) don’t exist.
• Foreign Building Annex (FBA) Guidance: Updated instructions on how to complete and submit the FBA as part of the Drug Establishment Licence (DEL) application or amendment.
• Inspection Validity Periods: New timelines on the acceptable age of GMP inspection reports “(e.g., generally not older than 3 years at the time of DEL application).
• Clarified Expectations for MRA vs Non-MRA Jurisdiction: Differentiated guidance based on whether the foreign authority ahs an MRA with Health Canada.
• Additional Scenarios Included: More examples and clarifications for contract testing labs, repackagers/relabelers, and virtual manufacturers using foreign sites.

A pre-recorded webinar highlighting the key changes will be announced soon through an upcoming DEL bulletin.

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This guidance explains how to report information to the FDA if you register under section 510 of the FD&C Act with regard to a listed drug. Listed drugs subject to reporting includes human drug products (including non-exempt biological products) marketed under an approved application, animal drug products marketed under an approved application, medical gases, homeopathic products, OTC drugs, animal drugs not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.

If reports for calendar year 2023 were already submitted using the previous version, no resubmission is required. For those who haven’t submitted their 2023 report, the deadline is July 31, 2024.

Uncertain about where to begin? Allow us to assist you with the Drug Reporting process!

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While there is no published list of chemicals that meet the definition of PFAF, the statute requires any chemical containing at least one fully fluorinated carbon atom (a carbon atom on which all the hydrogen substituents have been replaced by fluorine) that is intentionally added to a product to be reported to the Department. Provided is a webpage of chemicals considered PFAS by the FDA, which, while not exhaustive, provides some clarity on what compounds are considered within the definition of PFAS.

Manufacturers impacted by this new legislation may request an extension if the presence of PFAS in their products is unknown and/or if they cannot provide sufficient information to meet the reporting requirements in Maine law by the reporting deadline.

Don’t hesitate to contact us if you have any questions about this update or would like our assistance determining if this new legislation could impact your products.

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