Regulations impacting probiotic ingredients and finished products vary across geos and categories, but IPA is on the case.

Probiotics continue to draw attention worldwide, with an estimated one in four adults consuming probiotics in the last six months, according to a new survey conducted by Kerry. In fact, the online survey results showed nearly half (49%) of respondents in China had used such a product, followed by 42% of respondents in Mexico. And just as usage rates differ, the way these products are regulated varies by market. The International Probiotics Association (IPA) aims to promote the safe and efficacious use of probiotics throughout the world, and is recognized as the unified ‘Global Voice of Probiotics.’ Its executive director, George Paraskevakos, speaks globally around the opportunities for the sector, including connecting directly with regulators around the world to ensure these products have clear paths to market. IPA recently released the Global Regulatory Manuscript, detailing how probiotics are currently regulated, and potential changes ahead.

Tune in to hear more about:

• How regulations impacting probiotics differ across geos and countries.
• IPA’s commitment to providing timely insights on changes to regs that impact the industry.
• Surprising shifts for probiotic regulations in GEO
• Tips to support IPA—and your business—and boost consumer confidence in probiotics.

Guest: George Paraskevakos, executive director, International Probiotics Association (IPA).

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Welcome to the Vitafoods Insights Podcast. Join us as we explore the latest science innovation, helping the global health and nutrition industry connect, develop and progress. Today's host is Heather Granato, Vice President of content.

Probiotics are on everyone's minds, and in everyone shopping carts these days. New research from Kerry found one in four consumers worldwide consumed a product with probiotics in the last six months. And those numbers only went up when looking at geos like China, Mexico and the United States. But just as usage rates differ, the regulations surrounding these live organisms also vary from Market to Market. Understanding the regs can be a challenge. And it's something that George Paraskevakos, Executive Director of the International Probiotics Association (IPA), focuses on every day. It's a priority for IPA member companies to understand the lay of the land. And the association just released a regulatory manuscript with the latest on global probiotic regulations. I spoke with George recently and started with what should be a very basic question: are probiotics regulated? his takes shouldn't surprise you.

You're so correct. This is such an unrelenting question when it's, I believe, one of the biggest misconceptions that people have about probiotic supplements, even probiotic foods. This question comes up over and over again. I hear it from media sources. I hear it from, you know, healthcare professional sources. It's a question that, I believe, is unfounded. So, the short answer to that is yes, they are; they are very regulated. Let us put it into perspective. The state that even the probiotic market around the world is unregulated market, it's pretty bold statement; means that whoever says things like this does not examine the nuances of regulating a live biological product, you know, with a multifaceted purpose profile. There's a variety of approaches, at a worldwide level, to regulate probiotics. At the minimum, they all have good manufacturing, or GMP requirements, to ensure consistency of batches, and hence the quality and safety of probiotics, which applies to probiotics as part of the category in which they fit into based on their intended use. So, yes, they are very regulated.

I'm glad that I had that one right. Obviously, you know, we've got probiotics, they are regulated. But how do the regulations differ across different geographies and countries?

So, this is something that IPA has taken on. I mean, after looking at the different probiotic regulations that exist, which I can safely say that they've been based on the WHO, FAO probiotic definition, which was put together by an expert group back in 2001, 2002; was the definition that wasn't law. And countries have taken it and basically have interpreted it and created regulations around that definition. So, what's happened is a regulatory divergence basically has grown across the world. A sort of confusion, because, as the definition was interpreted, then that particular countries regulated created regulations, or legislation on how to look at probiotics that want to be commercialised in these regions. So, depending on the country, probiotics can be qualified either as foods, or supplements, or medical devices, and even in some countries have to be registered as drugs. Then, in different regions and countries, you can report their benefits as being very generic, like supporting digestive health, or you're allowed to be more specific and even therapeutic. So, the commercialised route to market in these different regions and countries around the world vary as well. So, there's a pre licencing, or preapproval process in some countries. There's a notification and others, self-determination, or even post policing. So what happens is this confusions constitutes a medley of very different, and sometimes, very complex requirements that companies need to basically navigate around.

That's a lot of things for a company to have to tackle anything from, what type of product is it to, what can I say about it? But IPA just published a regulatory book, I believe, addressing a lot of these issues. Why did you do that?

Yeah, that's exactly right what you said, you know, how do you come under this wave of regulation? So, we stepped back and we thought about this and said, this divergence reigns at the global level, how can we facilitate the understanding? So I've been approached over and over and over by IPA members, even non members, for help with this regulatory confusion and the environment that exists. So because of that divergence, we decided to take a look at all of this and step back and say, how can we bring everything onto the same page? So we started working on this, it began as a book, we call it a manuscript. So after close to two years of work, we created, I like to call it the IPA regulatory advice tool. Strategically, we looked to analyse, we chose 28 countries to start with coming from all continents around the globe, literally. And we looked at their probiotic food and supplement regulations, and designed this tool which allows our members to compare the same items when looking at different regulations around the world. So what we wanted to do was, even though there's divergence, we wanted to put everything on the same page and sort of create this apples to apples comparison of these countries regulations that we decided to analyse to begin with, and using the same category across all these regions.

Excellent. So, what is the plan then to keep this information up to date? Are there going to be regular updates to the tool?

Because this tool is dynamic, it'll evolve with time. We plan to update it annually. So currently, the book has been copy written and we're looking to add 10 more countries to this tool. We are working on it, and should be done with 10 additional countries, hopefully by the end of this year. And at the same time, we'll also be looking at the countries we've already analysed. So, if there's been any changes, update those as well. So, you'll have something at your fingertips that will help facilitate commercialising probiotic products if you're an international player, or if you want to open new countries. Now, it doesn't eliminate the aspect of having a regulatory affairs department, but we're hoping it'll facilitate the work of our members.

So, can you give me a little peek inside the book? maybe give me a little something, a tidbit that our audience might not be aware of that they would discover if they were utilising this resource.

What we decided to do was, we broke down, I would say, subcategories or segments of each country's analysis. So, to bring everything under kind of the same umbrella we looked at, first off, when it comes to probiotics: product classification, what does the actual probiotics classified? So each section of country has these subcategories. So product classification, definitions within the country (if they exist), permitted probiotic microorganisms, or are there safe lists of organisms in these countries? conditions of use/you know, labelling requirements- are there any? Some countries have them and some don't. You know, are you allowed to make claims? Are there standards you have to abide by or looked at when you're manufacturing? The types of market entry- do you have to pre apply? Can you, you know, notify, etc? And then the proper regulatory authorities, organisations over looking provided in those countries, and then the references that these regulations are based on. So, all these subcategories of what we've done is, we've analysed each country, and they're not all the same. And we basically have defined each country under these subcategories. So at least, when you're leafing through the book, you can pinpoint and compare from one country to the next, what's allowed and what is not.

I think that would be hugely helpful, certainly for, not only the regulatory affairs department, but even something like marketing, to be able to look at if I've already got a product in market in Germany, how does that compare to what I might be able to put out in France or in the United States?

100% that's something that could become even a strategic approach to opening new countries or not. So yeah, absolutely. It's not only for regulations, but other departments within companies or member companies as well.

Right. So, the big question, then, how do I get my hands on a copy of this George?

I love that question. You have to be an IPA member. Right now as it stands, the IPA's regulatory book is only available to IPA members. You know, we produce so many things at the IPA from blogs and we're involved in webinars and events, but this is another, you know, piece of value that your membership can get you as an international probiotic Association member. You can reach out to me at george@internationalprobiotics.org or consult our website and give you more information on membership and getting your hands on this, I think very valuable book.

Fantastic. Well, great information as always and certainly, we'll be hoping to connect with you at some of our upcoming events, whether those are virtual or in person and, as always appreciate all the work that you and IPA do to bring safe efficacious products to consumers, to really deliver the value of probiotics.

Looking very forward to it. And thank you so much again Heather.

Thanks, George. Have a great day.

And you.