Probiotics, Prebiotics, Postbiotics — Oh My! 

Postbiotics have gained significant attention in recent years, but despite growing interest in these ingredients, regulatory acceptance in Canada remains uncertain. 

In Canada, any product making a health claim must be supported by robust scientific evidence. The Natural and Non-prescription Health Products Directorate (NNHPD) is responsible for evaluating the safety, efficacy, and quality of such products. However, postbiotics are not yet formally recognized as a distinct ingredient category within the Natural Health Products Ingredient Database (NHPID). 

As a result, attempts to register products containing postbiotics are often met with regulatory ambiguity. 

Pro vs. Pre vs. Postbiotics 

What’s the difference between all these “-biotics”? 

Prebiotics, unlike probiotics and postbiotics, are not microorganisms. Instead, they serve as “food” for beneficial bacteria in the gut, helping to foster a healthy gut microflora. 

Probiotics are live microorganisms that are widely known for their beneficial impact on digestive and immune health. 

Postbiotics, by contrast, are non-viable (i.e., inactivated or killed) microbial cells or their components. In simpler terms, they are the metabolic byproducts of lysed probiotics – no longer alive, but potentially still beneficial. They can be thought of as the inactivated cousins of probiotics: biologically inactive, yet functionally relevant. 

What are the Benefits of Postbiotics? 

There are many benefits to the use of inactivated microorganisms rather than the live version. Probiotics are microorganisms that can multiply and colonize the gut to promote the existence of health gut microflora. Where this can be beneficial in most cases, probiotics may be harmful to immunocompromised individuals. Postbiotics do not directly impact the gut microflora and are considered a safer alternative. Inactivated microorganisms are more shelf-stable, making them easier to package and transport 

What Regulatory Challenges Exist? 

As noted, the NNHPD’s position on postbiotics remains unclear. While the ingredient itself isn’t explicitly prohibited, it currently lacks a defined regulatory pathway. The Probiotic Monograph clearly states that inactivated microorganisms are not covered, meaning any submission involving postbiotics must go through a Class III application with substantial supporting evidence. 

Like all Class III NHP submissions, NNHPD expects high-quality evidence to support the safety and efficacy of any novel ingredient. For postbiotics, this presents an added challenge: any clinical data must come from studies that use the same microorganism and strain, prepared using the same method of inactivation. Given the limited amount of available research meeting these exacting criteria, building a compliant application can be a significant challenge. 

Postbiotics Currently Available in Canada 

As of now, only eight licensed NHPs in Canada include the term “postbiotic” in the brand name. While the term has been accepted in product names, its use in health claims is not currently permitted. None of these licenses include claims specifically referencing postbiotics, and NNHPD has confirmed via email correspondence that the term “postbiotic” will not be permitted at this time. 

What’s Next? 

Globally, interest in postbiotics continues to grow, with countries such as Japan and select European Union jurisdictions taking early steps toward formal recognition. In Canada, however, there has been no indication that NNHPD will change their current stance based on the currently available evidence. 

There is a clear need for more proactive engagement from Health Canada on postbiotics, and any other emerging ingredient categories. Specifically, it would be helpful to see: 

• Interim guidance on acceptable use and positioning of postbiotic ingredients. 

• Inclusion of clearly defined postbiotic terms and ingredients within the NHPID. 

• More transparency when it comes to what evidence will be accepted for a more novel ingredient 

Closing Thoughts 

Postbiotics represent a compelling advancement in microbiome science. However, like many innovations in the natural health space, they are caught in the transitional phase between emerging research and regulatory recognition. 

Until more clarity or flexibility is provided, companies seeking to introduce postbiotic-containing products in Canada should proceed with caution. Engaging experienced regulatory professionals, building a comprehensive evidence dossier, and using conservative, compliant language on labels and in marketing materials will be essential. If you’re interested in submitting an NHP application for a postbiotic product, or other novel product, contact one of our experts to ensure a smoother submission. 

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