CHPA Chat - Probiotic Supplements and Quality Guidelines

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Join Duffy MacKay, Senior Vice President of Dietary Supplements at CHPA, and George Paraskevakos, Executive Director of the International Probiotics Association to explore the science behind probiotics, why gut health is so important, and what’s next for this growing category.

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Episode Transcript

Anita Brikman: Up next on CHPA Chat. Are you being good to your gut? Seriously, gut or digestive health matters a lot and probiotics can be a powerful tool in keeping our guts healthy. The science says so, and we're going to be talking about it coming up.

Speaker 1: Welcome to CHPA Chat, conversations in the consumer healthcare industry with Anita Brikman.

Anita Brikman: So, did you know that gut health is so important to our overall physical and even mental health? Seriously. And a great way to support what's happening in your gut, probiotics, which are a growing category within the dietary supplement space. And we're seeing increasingly positive studies showing just how important gut health and probiotics are in our everyday lives. I am super excited to chat with my cohost, CHPA Senior Vice President of Dietary Supplements, Duffy MacKay, and George Paraskevakos, Executive Director of the International Probiotics Association to explore the science behind probiotics and what the future may look like. Duffy, George, I have a gut feeling we're in for a good episode here. Okay. I'm sorry. I had to put that in there. Hi, guys. Welcome.

Duffy MacKay: Hi, Anita. Thanks for hosting.

Anita Brikman: All right. George-

George Paraskevakos: Anita.

Anita Brikman: ... let's get started with what IPA is. What is the International Probiotics Association? What do you do? And then, of course, I'll turn this more over to Duffy to drive this conversation, but trust me, I am super interested in this space, so I will be jumping in. Tell us about your organization, George.

George Paraskevakos: Awesome. Thank you for having me and inviting me, Anita and Duffy. Pleasure to be here. So the International Probiotics Association, the kind of work we do, what we are, who we are, in one phrase, we are the global voice of probiotics. We're an international nonprofit organization and we represent the probiotic industry at the global level. Our mission, we want to promote the safe and efficacious use of probiotics through the world and that's based on basically four strategic pillars. Championing the standards development for probiotics, we want to be the go-to association for all government regulators around the world when it comes to probiotics, we want to increase the education outreach awareness of probiotics and foster interactions among all the stakeholder groups.

If I can talk a little bit about how our work is supported, the heavy lifting is basically from our 300-plus member company representative volunteers within our nine committees and task forces, all the work we put out, all the publications, the standards, whatever comes out of the association is supported from our member representative companies. Lastly, and I think this is an important one, we also have observer status at the WHO FAO Codex Alimentarius. It's an important part of the work we are doing for the category as we propose an initiative to help harmonize probiotic standards globally through the Codex mechanism.

Duffy MacKay: That's pretty interesting, George. Now, the probiotics market it encompasses more than just supplements. My understanding we use probiotics in dairy products, it's in fermented products, but how big is the market and how much of it do you think is made of dietary supplements?

George Paraskevakos: It is an interesting question, pretty loaded, depending on the data sources, but IP works with a few data partners, and if I can bring it to the floor through two different perspectives. We know from the data we collected in 2021, the bricks-and-mortar, the retail market closed about $48 billion US. If we want to break that out, 80 to 82% of that was yogurts, fermented milks, fermented drinks. Four percent of that was foods fortified with probiotics, and 14% was dietary supplements, which makes a dietary supplement market from a retail perspective almost $7 billion US.

Duffy MacKay: Wow.

George Paraskevakos: I'd like to bring to the listeners' attention, the US is the biggest probiotic supplement market at around $2.3 billion US.

Duffy MacKay: That's interesting. Why do you think the US is the biggest market?

George Paraskevakos: I mean, supplements have always been something North America or the US has been interested in. Supplementation has been something of an uptake when it came to consumers incorporating additional to what they take in from their everyday foods. And it's interesting because there's no other market that comes close to when it comes to supplements. China's running a not so much close second, they're not even at a billion US dollars right now, and considering the size of that country, the numbers aren't that big when it comes to what the US has done from the supplement side.

Duffy MacKay: So, for probiotic companies, the US market is a real focus. Are there also drugs derived from probiotics that are used to treat diseases?

George Paraskevakos: Sure. Before I go into that, I'd like to talk a little bit about that, but let's look at the market from an online sales perspective because I just talked to you a little bit about retail and bricks-and-mortar. Online is becoming so important and significant, in 2021 it was reported close to a global $1.7 billion US figure when it comes to probiotic supplements. This is not foods, this is not yogurts, this is just supplements alone. And that doubled in the last two years from the last time they looked at the online sales in 2019.

So that's pretty significant growth. Mind you, probably driven from everybody staying at home and shopping online, but from within the online sales, Amazon is a big, big player in that group, where 70% of the probiotic sales are coming through Amazon, and Amazon reported probiotics as the number one VMS category growing at about 50% annually. So pretty significant stuff when it comes to online sales as well, and to consider when any company that wants to jump into that space.

Duffy MacKay: You mentioned the online sales are really a growth driver right now. Are these the legacy brands expanding online, or are we seeing new players enter the marketplace online?

George Paraskevakos: I love this question because if I recall, it was the top 10, three were just online companies. Not the legacy brands that we were used to seeing on the shelf and in bricks-and-mortar stores. These are out of the blue created companies that all they did was online sales, and these are top three. In the top three out of the top 10. That's pretty interesting if you think about it.

Duffy MacKay: Real market disruption right there. And when we see that in other categories where we have legacy dietary supplement brands that are well established, well established relationships whether it be with the natural channel or the food, drug and mass channel. And then out of nowhere you have an online company that really is an expert in pushing things out online, and it's a totally different kind of marketing strategy, and they really do take some of the market share.

George Paraskevakos: Oh, they've nipped away at the heels at some of these bigger legacy brands. And I'm telling you, they're feeling it. The legacy brand, and number one is a Legacy brand that's out there, but number two, and I think four, are these online companies. Real disruptors.

Duffy MacKay: So what's interesting about that, I'm going to jump ahead and maybe we can get back to the drug question because one of the things that strikes me is if the online sales are really increasing, that means there's a lot of warehouses. There's a lot of shipping on trucks. And one of the questions I had planned to ask you is about, what are some of the unique attributes of probiotics that might require an organization like yours to set aside some special quality standards or labeling standards? Because I know that one of the reasons you guys exist is because probiotics are a bit different than other ingredients we use in dietary supplements.

George Paraskevakos: Yeah, that's exactly right. We are a very unique ingredient category that requires certain considerations when manipulating it, when manufacturing it, when doing anything with it. So if I can go one step back, the WHO recognized and respected definition for a probiotic is a live organism when administered in adequate amounts confers a health benefit to the host, right? So, from a measurement perspective, they're measured in CFUs or colony-forming units, versus milligrams as every other ingredient, other than enzymes in the VMS category. So this measurement provides something meaningful to the consumer about the quantity of viable organisms in a product.

If you want to go and dig a little into the weeds, what does this mean? It quantifies how many bacteria in a probiotic are capable of dividing and forming colonies, so that means that if they are dividing and forming colonies, they are live, hence back into the definition. So again, it's an ingredient category that is unique. So once use, you know, look at manufacturing of it, so that takes care of labeling and CFUs, and I can come back to what we did or hopefully ask the FDA to change some of the regulations because on the supplement facts panel everything is supposed to be recorded in milligrams. We actually had a citizen's petition that we went out to the FDA to try and change that which now they allow for CFUs to be reported, so that was a bit of a victory, but at the same time they also want milligrams.

So, to me, there's still some education to be made at the government level there. But coming to the manufacturing considerations, the handling considerations, the storing considerations, when you're doing all these things it has to be looked at from a perspective of specific temperature, specific humidity levels, even lighting. So anything that you consider to do with it, and any type of formulation that you put these live organisms in, you have to consider what you're going to blend it with. Even types of probiotics together, you have to know and have to have studies to understand how they react. And then the non-medicinal, or if you will, the carrier, whether it's a maltodextrin or a potato starch, these are also things that have to be considered and levels of humidity.

How much of it and where they're going to be finished in a product format, whether it's a bottle, a blister, a sachet. Do you nitrogen flush it? These are all very, very specific considerations that we at the IPA have looked at and created manufacturing guidelines for this. The one thing though that's interesting, and we'd like to reach out and work a little bit more with these online retailers which have these areas in these warehouses and these trucks, we'd like to maybe educate them a little further on how or what is required when it comes to distributing and putting these products into the supply chain.

Anita Brikman: Duffy, George, can I interrupt with a layperson's question?

Duffy MacKay: Of course.

Anita Brikman: So you mentioned probiotics being live, and I think I've seen people being confused in the store. If I'm buying this with a yogurt in there, are there live organisms in there?

George Paraskevakos: Yes. I mean, you need two bacteria to actually help create a yogurt, a streptococcus and a bulgaricus, these are two organisms that you need to help ferment the probiotic. And then when you are buying a yogurt with probiotics in it, or has been fortified, whether it's a yogurt, a food or a supplement, on your label, whatever is marked as a live number or a CFU, that should be there at the expiry dating.

Anita Brikman: That is such good information. Thank you.

Duffy MacKay: That is a really important question. And George does this every day, but his long explanation there was essentially, yes, these are live organisms and you have to treat them as such. Just like when you have flowers delivered and you have special considerations so they don't show up at the recipient's doorstep dead, you need to be treating probiotics from the moment you start manufacturing, encapsulating, labeling, and getting it to the consumer. And so a lot of what the IPA's done is really raised awareness around this. And so the manufacturer can do all sorts of wonderful stuff to make sure their probiotics are going to be alive and then it goes into a hot UPS truck and all that work is done.

And so, so much education throughout the supply chain to make sure that people are cooperating and so the consumers are getting the probiotics with, like he said, the full amount of the live microorganisms at the end of shelf life, and they get the benefit, because the last thing we want is the consumers to be consuming the probiotic and not realizing the benefit because it was exposed to heat or something along the way. Now, I think it's fair to say, since this product category has evolved so much, there are probiotics that are shelf-stable or packaging that really can extend the resilience of the live microorganisms. And so innovation is helping this category a ton meet the consumer needs of an active lifestyle and need an inability to refrigerate all the time and things like that.

George Paraskevakos: What I wanted to say to what Duffy said regarding probiotics which are shelf-stable, there are, there's considerations as well in that particular domain. But again, to a degree. Shelf stability means, what are room temperatures? It's like 20, 25 Celsius, maybe 30 max. But past that, once you start pushing the envelope then you get into these what we call zone four, like really tropical environments. The shelf life tends to shorten quite a lot. So, yeah.

Duffy MacKay: So I know there's a lot of reasons we use probiotics as supplements, maintaining healthy gut and preventing occasional diarrhea and keeping our skin healthy. But I asked the question earlier, I know that probiotics are health promoting enough that in some cases they're therapeutic and actually used as drugs. Are there probiotic drugs here in the US?

George Paraskevakos: Not that I can speak to currently. I do know, though, there's ongoing trials or investigation on new drugs being researched right now in the pipeline with a few companies, at least 15 that I can think of right now. And their development that'll take longer than what a supplement will, and there are in areas as applications of gut health or GI and gut intestinal health in areas of upper respiratory tract infections and allergy. So these are the areas that I've heard of that are being worked on in the US from a drug perspective.

Duffy MacKay: That's incredible to have a live microorganism to help with things like asthma. That's such a nice evolution of these products. So we talked a little bit about probiotics being live and them having to be handled in certain ways. And so you guys have done a lot of work in the area of quality guidelines. And my understanding, you've recently partnered with an organization that CHPA does work with, GRMA. So I'd like you to just talk a little bit about what your aspirations are with the GRMA, who is just a third party who's really working on setting publicly available quality standards so that the retailers and manufacturers can all be reading from the same standard book and really creating GMP standards and testing standards that are transparent, fit for purpose, and really benefiting everyone in the supply chain. So a little bit curious about what work you plan to do with the GRMA.

George Paraskevakos: It goes back to the harmonization initiative at Codex across the world. It's the same thing. The thinking behind in what we did back in, I don't remember, one of our member companies was complaining regarding some of the products we were seeing on the shelf that weren't quality that could affect our industry. So we said, "Okay, what can we do?" We formed a manufacturing committee. It took about two years and we created the International Probiotics Association Manufacturing Best Practices or Guidelines. Basically it wasn't reinventing the wheel. It was taking what was out there from GMPs, what the FDA requires, and then taking the probiotic ingredient and fitting the guidelines to address what I discussed earlier, what it takes and what is required to manufacture these unique organisms.

And it's from the moment a manufacturer takes on basic an ingredient blend, or an ingredient culture, all the way to bringing it to market into a finished product. These guidelines look at what is required and they were formed with experts from the association from our membership that do this. That's their every day. And basically, we looked at it. It took two years because our committees are always consensus-based. It's not one way or the other way. Everybody has to agree on a way forward, because we're always about making the right decisions for what the industry has to put out for consumers to increase the credibility and the integrity and to deliver safe products and products that work.

So after two years, we put that on hold for a while, until we knew what was the right fit. And then we started discussing with GRMA who you all know has the ANSI 455-2 standard, which is a publicly accepted standard. We started talking to them on how the guidelines can fit within the standard. So from here, the work has begun where collaboratively we'll look at our guidelines together with the GRMA, see if there's gaps, create a paper and then submit it for approval. And then once we get that green light, they become an addendum, that IP manufacturing guidelines become an addendum hopefully to the GRMA for the 455 ANSI standard.

Duffy MacKay: The challenge with retailers, the retailers really want to making sure that the products that they're selling, specifically responsible retailers, they'll set up their own quality programs and they'll ask for certain certifications and they'll ask for certain testing, which is a really positive thing, but the challenge is, the retailers don't work together on this and they're all asking for different third party standards and different sets of tests, and really puts a stress on our members because they're being just bombarded with these, "Hey, can you have this auditor in on Monday?" And this completely different auditor doing the same exact thing on Thursday. We call it audit tourism. And so the 455-2 standard that George mentioned is a GMP standard, a publicly available ANSI standard.

Duffy MacKay: It's been accredited so that now we're hoping all retailers will say, when they're asking for an audit, they ask for this audit. And not only that, this audit is very robust, the auditors have to be accredited to conduct the audit. So what we're trying to do is create a level playing field. And what George is trying to do is now marry in the unique attributes of a probiotic into this publicly available standard so that now the unique attributes of a probiotic will be accounted for in the 455-2 publicly available standard. So, really, we're starting to see a harmonization amongst quality standards so the winner really is the consumer. We know that our members are winners because they'll have less audits per year and they'll have one robust audit, but really the winner is the consumers.

Anita Brikman: I would agree with that, and as a consumer, and I am very interested in digestive health and have really researched this area, but I do feel that I am bombarded with choices. And that's one thing from the consumer standpoint, are there basic things that people should be looking for when they're shopping for probiotics? This harmonization makes sense, like you said, for our members, for consumers, and honestly for the retailers, too, to just have one standard out there. But are there things that, George, you tell people they should be looking for? Or that your members would hope people look for when they're shopping for a probiotic?

George Paraskevakos: I always like to revert back to the labeling standard that we published. Basically, apart from the guidelines with the standard creating something of a harmonization, this way it'll allow manufacturers to work on formulations of quality and that are safe and are efficacious for the consumer. So, like Duffy said, they win, which if the consumer look for when he goes to the store and he's faced with these hundreds of choices in front of him, look at the CFU on the bottle, make sure that there's an expiry dating and it says so many CFU guaranteed at the expiry date. That's important. That means the manufacturer has done his stability testing to make sure that's what they will find.

Next, I'd like to, the labeling guidelines, talk about, make sure that on the supplement fact panel you have listed your probiotic, your specie, lactobacillus or bifidobacterium, your genus, whether it's a rhamnosus or an acidophilus. And then the strain. The strain always links back to who actually produced the probiotic, the fermented organism. Who actually was the producer of that organism. So look for the organism to be named, genus, specie, strain. Some labels actually talk about the input of the strain in the formulation, so many CFU per strain. Look for if there's any evidence linked to the strain. Always look to find a probiotic or the strains in the formulation that have been studied or researched against what is on the label.

Yeah. Yeah. And then also look at storage parameters because there are manufacturers that actually put storage parameters. Duffy said, they're shelf-stable probiotics and those are formulated to be shelf-stable. Personally, I put them in the fridge all day long. It just increases the life and you get more legs out of your product.

Anita Brikman: Great tip. Love that.

Duffy MacKay: You know, Anita, I think one thing that's not well recognized, IPA really took the lead on developing the labeling guidelines. I was back at another association. I worked with George on part of that project, but a lot of other organizations saw the wisdom in this and lo and behold, CHPA put its own guidelines together. So we have guidelines that really reflect a lot of what IPA's put together, and they talk about these things. And for your question about what should consumers look for, to simplify it, there's certain things in the guidelines that most responsible manufacturers are paying attention to, and they're the things that George listened to.

So it's kind of a checklist. If you see that it's in CFUs, if you see that the strain is there and you see they've listed storage instruction, you know that it's a manufacturer who's paying attention, who's part of the tribe, who knows that these are important things, and so they've done these things to the label. It's not a guarantee, but it's a real good marker that this is a company that knows what they're doing, they know how to work with this ingredient, and they're following the instructions of the industry about how to label it correctly. And so, again, it's just real clear that way.

Anita Brikman: That's awesome. No, it really is, because there are so many choices out there, and I think I mentioned my daughter a lot on these podcasts because her shopping behaviors are radically different than mine. Very much focused on what influencers are talking about, what they describe as being kind to their gut, et cetera. She is very clued in on that. But I often ask her, "But how do you know you're getting a quality product, especially if you're going with a company mom has never heard of?" Because mom knows everything.

Duffy MacKay: Right, right, right. And there's other trusted sources. I mean, I know that the NIH office of dietary supplements has a nice summary of probiotics and it goes into talking about what some of the organisms are intended. Some are for this and some are for that. And so good authoritative. Probiotics, the science is so strong that we've seen academic institutions, the NIH do nice summaries that are objective. They're not driven by industry, and they really tell consumers, this is how you can use these products safely for your own wellness.

And then, of course, if you have a condition like irritable bowel or inflammatory bowel disease, that's when you want to be talking to your doctor because probiotics can be very good integrative care for ulcerative colitis and asthma. But you want to be going to a doctor, some doctor that knows some of this, because it is specific strains that have been researched to be effective in these conditions. So, if you have a medical condition, you just don't want to go run blindly to the probiotic aisle. You want to get the one that's right for you.

George Paraskevakos: Exactly.

Anita Brikman: So you did mention the science and as we get close to wrapping up, it sounds like a lot that's been done. There's a lot that's coming. What does this industry look like in the next five years? George, Duffy, what do you think? Because it is exciting and the science is there to back it up, but where are we going in the future?

Duffy MacKay: I mean, I think because these are bacteria, there's a lot of opportunity to modify them. And so I think in the future, we're going to see a lot of bacteria, whether it be through crossing strains and making things, or genetically modified, that will be very powerful in both the health promoting as is the medical treatment arena.

George Paraskevakos: To build on that, just to come back to the science aspect, one time, I don't remember, somebody told me, "Oh, they're not researched." So I said, "Oh, yeah?" So we got an independent scientist to do it, just a quick overview. He looked at just two databases, the NIH database, ClinicalTrials.gov, and the database from the WHO, and we pulled out, I don't remember, 1,650 studies in applications of research, probiotics and humans. Different areas of outcomes, different applications from GI to you name it, to immune, to gut health, bring gut to... There's a lot out there of what Duffy discussed. So, I mean, crystal ball, five years down the road, I say, if we look back, five years ago I said, "We need to harmonize. We need to raise the bar. We need to get quality labels, such..." This happened. It's in the process of happening. I'm very happy for it.

But going forward, I think, the harmonization process at the global level has to continue. I think what COVID and this pandemic has done has brought to the fore top-of-mind wellness and maintenance. So consumers are so taken up with reducing vulnerability to being sick and diseased. So they're taking ownership. So what this, I think, will create is a sort of personalized probiotic application where somebody might be able to analyze, let's say, their stool on the spot. And then it gives them a report through some AI application that, "Hey, you're missing some diversity. You'll need maybe some bacteria in this realm." Another area where I think what Duffy alluded to was, yeah, when you ferment a probiotic, and a probiotic is a live organism, like a person, so when we eat different foods, we react differently.

It's the same thing when we're fermenting bacteria. When you're actually giving it different types of proteins and sugars and yeasts and whatever else we are feeding those bacteria to grow and to multiple, you can, I don't want to use the word manipulate because it has a negative connotation, but you can have the bacteria produce different compounds and metabolites that will actually have them address specific areas that might be something in GI health, or might be something in immune support or resilience of the gut. So, yeah, from a food-type perspective, I think we're going to see that happen, or a supplement perspective, and then from a drug perspective, I think, there'll be acceptance to actually manipulating the genes within the probiotic to actually address certain disease states.

I think that will become more widely accepted as technology and evolution advances down the road. And then one last thing, we're working on a dietary microbes project. So we're looking at different countries around the world that have higher intake of fermented foods and we're doing an exercise where we're going to see disease states in these populations. So this will form the basis of our dietary microbes intake, where one day, hopefully, we might have a specific recommendation of the amount of microbes that you need to intake to support health if you're not getting it from your food, and it'll become like a food guideline recommendation.

Like an RDA for bugs. Like a RDA for bugs. Right? Should be on a global-

Anita Brikman: I love how you describe them as these little kind of mini organisms in people. The one phrase I wanted to bring up before we close, gut buddies. Are they our buddies?

George Paraskevakos: Gut buddies?

Anita Brikman: Yeah. Like, they're good for our guts. They help us. I've heard that's several times.

Duffy MacKay: Anita, this is serious science. That is just too cutesy-cutesy. Come on now.

George Paraskevakos: Anita, we are not... I don't remember. It changes all the time with the science. We're 90% bugs. They're on us, in us. They're all over us. Just in our GI, we have anywhere between two and four pounds of bacteria in there. Just the gut alone.

Duffy MacKay: They say more bugs in your body than cells in your body.

George Paraskevakos: Human cells. Exactly.

Anita Brikman: Wow.

George Paraskevakos: So, yeah.

Anita Brikman: Okay. Well, let's keep those bugs friendly. Gentlemen, Duffy, George, thanks for joining me, for entertaining some of my more basic questions. This was a great CHPA Chat.

Speaker 1: Thank you for joining us here at CHPA Chat. For more information and to hear our entire catalog of shows, please visit chpa.org.

Guests

Duffy MacKay Headshot
Senior Vice President, Dietary Supplements
George Paraskevakos Headshot
Executive Director, International Probiotics Association (IPA)
 

The views expressed in this podcast are solely those of the speaker and do not necessarily represent the opinions of the Consumer Healthcare Products Association.


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