“No winter lasts forever; no spring skips its turn.”
– Hal Borland
February offers a calm midpoint in the winter season and a timely opportunity to reflect on recent industry developments. Across all divisions, our team has continued to advance regulatory, creative, and clinical initiatives that position our clients for a strong year ahead. In this edition, we highlight key insights, updates, and important articles from Q4 of 2025 to help inform your planning and support your strategic objectives. We invite you to settle in and explore what's new.
HEALTH CANADA OPENS CONSULTAION ON DRAFT GUIDANCE FOR DECENTRALIZED CLINICAL TRIALS
Health Canada has released a draft guidance on decentralized clinical trials, now opening a public consultation that runs until February 21, 2026. This update represents a key milestone in Canada’s ongoing clinical trials modernization initiative and provides long-awaited regulatory clarity for sponsors and investigators planning decentralized or hybrid trial designs.
» More about the consultation and how to participate
HOW PHARMACOKINETICS AND PHARMACODYNAMICS GUIDE DOSE SELECTION FOR CLINICAL TRIALS
Understanding how a health product behaves in the body, and how the body responds in return, is central to developing safe, effective, and scientifically justified therapies. Pharmacokinetics (PK) and pharmacodynamics (PD) are the disciplines that define this relationship.
» Learn more about PK/PD in clinical research
HEALTH CANADA TEMPORARILY PAUSES COST RECOVERY FOR NHPs
The natural health products (NHP) sector in Canada continues to evolve as Health Canada progresses toward a modernized, risk-based regulatory framework. Many industry stakeholders have been monitoring the proposed cost recovery initiative with a tentative target implementation date of December 1, 2025. In a recent updated, Health Canada confirmed that this implementation date will not be moving forward at this time, offering important clarity for manufacturers, importers, distributors, and Canadian product licence holders.
FRONT-OF-PACK NUTRITION LABELLING IN CANADA IS NOW IN EFFECT
Front-of-package (FOP) nutrition labelling is a major regulatory initiative introduced by Health Canada to support healthier food choices among Canadians. This labelling requirement mandates a standardized nutrition symbol on prepackaged foods that are high in saturated fat, sugars, or sodium, which are nutrients commonly linked to chronic illnesses such as heart disease, obesity, and type 2 diabetes. The FOP symbol is designed to provide consumers with immediate, accessible information about the health profile of a product, allowing for quick comparisons between similar items without needing to review the full Nutrition Facts table
» Learn more on how to ensure compliance of your food products
HEALTH CANADA PERMITS CAFFEINE IN SUPPLEMENTED CANDIES
On November 25, 2025, Health Canada published a Notice of Modification updating the List of Permitted Supplemental Ingredients to expand the permitted use of caffeine and introduce a new mandatory cautionary statement for certain high-caffeine solid supplemented foods.
If you manufacture, import, or private label functional gummies, caffeinated candies, or other solid supplemented foods, this change has direct implications for both formulation and label compliance.
» Learn more about the permitted caffeine amounts and what to keep in mind
MDL AND MDEL FOR RED-LIGHT THERAPY DEVICES SOLD IN CANADA
Did you know that obtaining a Medical Device Licence (MDL) is only half the requirement for bringing a red-light therapy device into Canada? Many manufacturers are surprised to learn that the Canadian importer must also hold a valid Medical Device Establishment Licence (MDEL), which authorizes the activities of importing and selling the device.
This authorization is distinct from the device licence itself and cannot be substituted by the foreign manufacturer’s regulatory credentials. Any company importing these products must maintain an active MDEL and comply with quality system expectations established by Health Canada, including documented procedures for complaint handling, recalls, and distribution record management.
» Learn more about MDEL requirements for red-light devices
AAFCO PET FOOD STANDARDS AND THEIR ROLE IN U.S., CANADA, and EUROPE
Pet food labels are dense with nutrition claims, life-stage statements, and references to Association of American Feed Control Officials (AAFCO), yet the meaning behind those references is often unclear. Misunderstandings around AAFCO’s role are common, particularly when its name is associated with concepts such as approval, certification, or regulatory oversight that it does not provide.
» Learn about the role of AAFCO in pet foods
EU COSMETIC LABELLING REGULATIONS: WHAT ARE THEY AND HOW TO COMPLY
Entering the European Union (EU) cosmetics market requires more than a strong formulation. It demands precise alignment with the EU’s labelling framework, where compliance expectations are centralized, highly technical, and actively enforced. Regulation (EC) No. 1223/2009 establishes harmonized requirements to protect consumers, support product traceability, and ensure transparent, consistent communication across all EU Member States.
» Entering EU? This article is a perfect start!
CREATIVE DESIGN FOR REGULATED PRODUCTS IS UNLIKE ANY OTHER
If you have ever worked on a regulated product launch and assumed that packaging would be a relatively straightforward final step, the complexity likely became apparent very quickly. In regulated prepackaged consumer product categories, packaging is not a decorative layer added at the end of development. It is a regulated deliverable that directly affects product market access, approval timelines, and ongoing compliance.
Creative design for regulated products therefore differs fundamentally from standard branding or packaging work. It is a controlled, evidence-based process in which regulatory requirements, safety considerations, and design decisions must be integrated from the outset.
» Here's what to keep in mind for your next product launch
SNI is gearing up for a busy season of tradeshows and reconnecting with familiar faces. If your team will be attending and would like to schedule a meeting, we would be happy to connect.
Our next stops include:
- CHFA West in Vancouver - Feb 20 - 22, 2026
- Expo West in Anaheim - March 3 - 6, 2026
- Alimentaria in Barcelona - March 23-26, 2026
CONTACT US
SNI knows the ins and outs of the regulations for all consumer products. Contact us today (info@sourcenutra.com) and let us help you make the regulations work for your products.
Whatever your regulatory, packaging and/or clinical research needs are- contact SNI today to learn how we can help you achieve brand success and market penetration in 2026 (info@sourcenutra.com).
SNI is your “one-stop-solution” for strategic consulting, regulatory compliance, clinical trials, graphic design, bilingual labelling and importation and fulfillment services for foods, natural health products, cosmetics, medical devices and pharmaceutical products.
Contact us today to learn more about how we can help you get your products to market quickly, compliantly and cost effectively.
