Claims do matter, but this isn’t the whole picture. The formulation and how the product works are also important. A key consideration is how the product is represented to consumers…it’s overall representation. An ingredient commonly used in cosmetics does not automatically mean that a finished product will be classified as a cosmetic. There can be an important regulatory distinction between claims such as ‘brightens skin’ and ‘helps skin look brighter’. Classification is not simply a matter of changing a few words on a label. Health Canada can consider the overall representation of the product, including its name, packaging design, images and symbols used on the label, directions of use, implied claims, information on websites and social media posts.

The best strategy is to address classification early on during product development, rather than after the formula, packaging and marketing materials have been finalized.

Companies should consider:

• Reviewing the formulation
• Assessing the product’s intended mode of action
• Evaluating implied claims across all marketing channels
• Documenting the scientific and regulatory rationale for the proposed classification
• Engaging with Health Canada where the classification remains uncertain

Our team can help assess your product and develop the right regulatory strategy for you. Reach out to us to learn more.

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If you need assistance assessing affected products in your portfolio and potential website disclosure obligations, please contact us.

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Although litigation could affect certain provisions, it does not currently pause SB 54 implementation. Companies should continue preparing for potential packaging compliance requirements and associated costs while monitoring regulatory and legal developments. For more such updates, follow us.

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To stay updated, please contact us.

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Distributed manufacturing is a decentralized manufacturing approach in which equivalent manufacturing units operate at different locations under the oversight of a single quality system. Under the proposed “hub-and-spoke” model, a central hub provides quality oversight, while multiple equivalent manufacturing units or “spokes” manufacture the same drug at different locations.

Currently, each manufacturing unit located at a different physical location generally requires a separate establishment registration. The proposal would allow qualifying distributed manufacturing networks to register as a single establishment, with a streamlined process for adding, relocating, or removing manufacturing units. Advance notification to FDA would be required for relocation or closure of a unit.

The proposal would also clarify that certain foreign establishments manufacturing drugs or APIs that ultimately enter the US market through another foreign establishment must register with FDA and submit applicable drug listing information. This is intended to improve FDA visibility into upstream drug supply chains.

If finalized, the changes could reduce duplicative registration requirements for qualifying distributed manufacturers while increasing supply-chain visibility and registration obligations for certain foreign establishments. The proposal is not currently effective. Follow us for more such updates.

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This change aims to align inspection transparency practices across the affected programs while ensuring that publicly available information reflects completed regulatory assessments. To ensure you are inspection ready, reach out to us.

The post Health Canada to discontinue public posting of initial inspection deficiencies appeared first on Focal Point.

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.

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.

Health Canada typically sends renewal packages early in August. Manufacturers or their regulatory correspondents who have not yet received their package should contact Health Canada. Following renewal, invoices are generally issued in December and are payable within 30 days. Failure to renew by the November 1 deadline may result in cancellation of the MDL, meaning the device can no longer be offered for sale in Canada.

If you require assistance with renewals so you don’t miss this deadline, call us.

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