• Claims must remain cosmetic – In Canada, cosmetic claims are regulated under the Food and Drugs Act and the Cosmetic Regulations. While products may claim to moisturize, improve the appearance of skin or enhance radiance, claims suggesting tissue regeneration, stimulation of collagen production or cellular repair may imply a therapeutic purpose and could shift a product into the drug and natural heath product category, depending on the overall presentation.

• Scientific evidence matters – Many marketing materials reference in-vitro studies or clinical research involving injectable PDRN. Companies should ensure that any efficacy claims made for topical cosmetic products are supported by evidence relevant to the finished formulation and intended route of application. Extrapolating results from injectable products to cosmetics may not be considered appropriate substantiation.

• Ingredient sourcing and transparency – Since PDRN is commonly derived from salmon DNA, manufacturers should maintain appropriate documentation regarding ingredient identity, purity, manufacturing controls and supplier quality.

• Cross-border compliance – PDRN products originating from international markets may require claim adjustments before entering the Canadian market. Marketing language that is acceptable in one jurisdiction may trigger different regulatory classifications elsewhere, particularly when references are made to regeneration or DNA repair.

PDRN represents both an exciting innovation and a reminder that emerging ingredients require careful regulatory review. Companies introducing these products should evaluate ingredient documentation, product classification, claim substantiation, and advertising language early in the development process to support compliance while minimizing regulatory risk. If you wish to have your cosmetic ingredients or claims reviewed prior to market entry, please contact us.

The post PDRN – The New Popular Cosmetic Ingredient appeared first on Focal Point.

Inspectors reviewed 96 cosmetic products, including 41 imported products, through both online and in-person inspections. The findings underscore the importance of regulatory compliance:

• 35 products were found to be compliant
• 31 products required companies to commit to corrective actions
• 30 products were subject to stop distribution measures due to non-compliance

The most common deficiencies involved labeling non-compliance, while several products also failed to meet Cosmetic Notification requirements. These findings reinforce that Health Canada continues to prioritize accurate product labeling and ingredient disclosure, particularly for ingredients with specific conditions of use such as eucalyptus oil.

For cosmetic manufacturers, importers, and brand owners, this report serves as an important reminder that compliance extends beyond formulation. Companies should ensure that products meet the requirements of the Food and Drugs Act, the Cosmetic Regulations, and the Cosmetic Ingredient Hotlist, including:

• Accurate bilingual labeling and mandatory label information
• Timely submission of Cosmetic Notifications
• Compliance with ingredient-specific restrictions and cautionary statements
• Regular reviews of imported products to ensure Canadian regulatory requirements are met before market entry

Although HC notes that Compliance Verification Projects target products considered more likely to be non-compliant and therefore do not represent the overall Canadian marketplace, the results demonstrate that deficiencies can result in significant business impact, including stop-sale and stop-distribution actions. For companies operating in Canada’s cosmetics market, proactive label reviews and regulatory audits remain one of the most effective ways to reduce compliance risk.

Give us a call to ensure your product’s compliance.

The post Key Takeaways from Health Canada’s Cosmetic Compliance Verification Project appeared first on Focal Point.

Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes. 

If you wish to understand how these changes might affect your business, please reach out to us.

The post Health Canada updates guidance on nitrosamine impurities in medications appeared first on Focal Point.

Phase 1 reporting remains mandatory. Producers of packaging, electronics and electrical equipment, and single-use plastics destined for the residential waste stream must continue to submit required data.

Additionally, ECCC has announced plans to introduce a new reporting notice for 2027-2029 and is seeking stakeholder input.

For more information, contact us.

The post Federal Plastics Registry: Reporting Deadlines Updated appeared first on Focal Point.

For more information, reach out to us.

The post CARB launches 2025 Technical Assessment for Personal Fragrance Products VOC Compliance appeared first on Focal Point.

To ensure your products remain compliant, please reach out to us.

The post New Jersey enacts PFAS ban impacting cosmetics 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.

For more information, reach out to us.

The post Health Canada updates Acceptable Intake limits for Nitrosamine impurities appeared first on Focal Point.

Should you identify these two ingredients in your formulations and would like further information on next steps, please contact us.

The post New SNAc provisions added for two substances on Canada’s DSL appeared first on Focal Point.

For applications received on or after December 15, 2025, priority will be based on the application’s date of receipt, as attestation questions are now integrated directly into the PLA form. This process aligns with the NHP Management of Applications Policy and ensures a fair, transparent, and consistent review process while managing high application volumes. Applicants must ensure that all attestations in the PLA form are accurate, complete, and meet eligibility requirements.

Give us a call to understand more about NNHPD operations.

The post NNHPD clarifies review prioritization for NHP licence applications appeared first on Focal Point.