Nutrasource Blog

A Regulatory Recipe for Adding Prebiotics and Novel Strains to Your Probiotic Line

Posted by Nutrasource on Wed, Jun 26, 2019

It’s no secret that probiotics are dominating the supplement market, and the consumer demand for foods and supplements that contain beneficial bacteria is increasing exponentially. In fact, the probiotics market is predicted to be worth $69.3 billion by the year 2023.

Market saturation is driving companies to use novel strains with unique therapeutic applications to differentiate themselves and gain market share.

Prebiotics, novel strains, and synbiotics are at the forefront of product development conversations and have the potential to inject new life into product lines. While this may be a viable route to stand out from the crowd, it’s important to understand the long-term strategy required to be successful in this product category.


Gaining Market Access

The first step in accessing Canadian and U.S. markets is to ensure safety with a robust and comprehensive safety review of your product. In the United States, safety must be shown down to the strain level for novel probiotics to be added into foods and dietary supplements.

Product combinations and strains in their infancy stage may not have adequate safety data published. This is the first regulatory hurdle that can be tackled by executing a well-designed randomized controlled trial (RCT).

RCT’s are a necessary investment when looking to stay ahead of the product development curve. A strong study design with a long-term strategy can serve multiple functions beyond safety, including substantiating various marketing claims that can increase the impact of your marketing.

As with most health products, the regulations regarding foods and dietary supplements containing live microorganisms differ from Canada to the United States. Below, we’ll explore the key regulatory requirements for each country to help you successfully launch your novel probiotic.


All supplements (referred to as natural health products) in Canada require pre-market approval before hitting the shelves. This can be done by filing a Product License Application (PLA), Class I, II, or III, to the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada.

Novel strains or unconventional bacteria products will most likely require a Class III filing—which has the lowest levels of certainty, require well-designed RCT’s, and is subject to Health Canada’s 210 calendar day performance standard for licensing. In other words, it could take 6+ months for them to decide on your application.

These up-and-coming products will unlikely fall under the probiotic monograph that makes market access easier and faster for conventional probiotics. Companies can refer to the Quality of Natural Health Products Guide, as it outlines general finished product specifications for products containing live microorganisms.

The United States

Novel probiotics must be evaluated down to the strain and shown to be safe for the intended use in foods or dietary supplements via a Generally Recognized As Safe (GRAS) conclusion or New Dietary Ingredient Notification (NDIN). Read more about GRAS and NDIN in this previous blog post.

Adequate substantiation must be in file to demonstrate the structure/function claim for the probiotic is truthful and not misleading. Depending on how novel the strain or combination may be, accessing the U.S. market may require primary research through a RCT.

Additionally, all substances used in culture media and as cryoprotectants or carriers must be food grade and permitted for use in food. For further guidance, the FDA has issued draft guidance on the labelling of probiotics in dietary supplements.


How Can Companies Ensure A Safe and Effective Market Entry?

Evidently the list of probiotic product regulations that companies must consider is extensive. So how can these companies differentiate their probiotic line in a way that allows for optimal marketing, while considering mandatory safety measures?

Those seeking the path of least resistance should consider working with a global contract research organization (CRO) that has a wealth of international regulatory expertise. The involvement of a CRO, such as Nutrasource, will be valuable across multiple domains to develop a global market strategy while handling the regulatory hurdles along the way.

Contact Nutrasource today to learn how we can assist with your regulatory, clinical, and testing needs, from culture to claim.

Topics: Regulatory, Concept to Claim, Probiotics, Dietary Supplements/Natural Health Products