Probiotics are one of the most popular functional ingredients to add to food and beverage products today.###Different strains of the good-for-you bacteria have been shown to help digestive function, bolster immunity and improve organ function — and the market for probiotics continues to grow. BCC Research projects the global probiotics market will hit $50 billion by 2020.###Various probiotics have been added to different food and drink for years, conferring added benefits to consumers without impacting taste and texture. One particular strain, GanedenBC30, has led the way as a functional ingredient. The spore-forming bacteria, developed in 1997, is protected and can remain effective in many food and drink products. It can be found in a wide variety of items, from baking mixes to protein powders.###Food Dive visited Ganeden’s corporate offices in Mayfield Heights, Ohio, last month. In a conference room lined with shelves of food products that include GanedenBC30, President and CEO Michael Bush — who is also president of the International Probiotics Association — discussed the science, strategy and outlook for probiotics and GanedenBC30.###The following transcript of the conversation has been lightly edited for continuity.###Food Dive: How has the probiotics business been developing in the last couple of years?###Bush: Insanely busy. Launches have gone up. It’s been a magnitude of increases. This year, we’ve launched … over 200 SKUs into the market. Things have been going very, very well. Ganeden as a company has been doubling in size every couple years and we see that when it comes to SKU counts, at least that.###It’s great. 800 products in over 60 countries and lots of launches occurring. A lot of the products that are launching are sticking. They’re resonating with consumers. Consumers like them. It’s really fun for all of us to be able to walk through a grocery store and see BC30 logos in virtually every aisle. Compared to years ago, we would all do a field trip to see one bar on a shelf. It’s been great.###The industry itself keeps growing. Eight-plus percent per year. We just don’t see any slowdown in sight.###Food Dive: When did things start changing for probiotics? I remember for most of my life, you could just get yogurt that had probiotics.###Bush: I’d say that 2011 and 2012 were really the tipping point … Rather than just having yogurt and supplements as their options [for probiotics], [consumers] began seeing and really grabbing a hold of the non-yogurt, non-supplement items.###Now it’s this whole new category. When they report on probiotics numbers, they have fermented foods, fermented dairy, and then you have supplements. Now there’s this new category that’s a $1 billion to $2 billion category that is … in the middle there. Itferrous gluconate medscape keeps resonating with consumers. Consumers love it.###Food Dive: I would assume that GanedenBC30 definitely made an impact on that.###Bush: Yeah. We basically invented this market space. We have done a lot of work. We were the first one into baking mixes and probiotic waters and juices and protein powders. We have so many firsts, it’s hard to name them.###… The founder of the company discovered this family of bacteria through selective isolation techniques. He found strains that grew at various temperatures and had various metabolic properties. BC30 … was specifically chosen for its ability to grow below human body temperature and it has the stability that you require, as well as the immune and digestive benefits that we knew would occur when consumers took it.###… Ganeden started launching finished products on the supplement side of things in 2003, and then we got into the food business, with our first launch being in 2008. Then we sold off that supplement business in 2011.###Food Dive: What made it take off in food so much?###Bush: I think it was [that] we decided to focus on it. We started the ingredient business at Ganeden in 2006. It took … over a year to do the regulatory work that we needed to do to get FDA GRAS [generally recognized as safe] and self-affirmed GRAS and then subsequent to that, it just became the more horsepower we threw behind it regarding clinicals and things. In 2009, we started publishing our studies. Ganeden has 27 published, peer-reviewed studies available now. It takes time.###It’s one of those things that if you put all your efforts toward it, it still takes a good deal of time because you just have regulatory periods you have to wait through. And then you have the food development process, which ranges anywhere from pretty quickly with entrepreneurial companies to … five years from inception to product launch with the big CPG companies.###… We continue to do clinical work now. We’ve got studies running right now and studies that are starting soon. We’re going to keep working on it to figure out what kind of claims we can support and what kind of benefits we can provide to consumers. We’re always looking for new areas that are interesting to us.###Food Dive: What are some of the functional benefits of probiotics and GanedenBC30?###Bush: … When it comes to probiotics, everything is related to the strain. … We can support “probiotic” and “supports immune” claims at 500 million CFU [colony-forming units] per day. Then at one billion CFU per day, we can support those two claims plus “supports digestive health” and “supports protein utilization.” … It’s a spore form, so it just obviously is going to survive gastric acidity, shelf life, and things like that much more effectively than a vegetative cell.###Food Dive: Is there anything that’s newer that’s come out about efficacy of BC30 or anything that’s pending?###Bush: Yeah. There’s always something new coming out. Our last study was related to the cell wall, so it’s a new ingredient called Staimune, and that’s the inactivated cells of BC30. We just got clinical data back the other day. We can’t discuss it yet because it’s out for publication, but some really neat areas that we’re looking at outside of the areas we’ve already discussed. Stay tuned, but there’s some pretty neat news coming down the pipe as soon as we get the paper written up.###Food Dive: What does it take to develop a good functional probiotic strain?###Bush: It involves lots of screening. … Known probiotic or known bacterial strains are deposited into a bacterial repository. In the case of BC30, it’s at the ATCC, which is the American Type Culture Collection. What folks are doing is they’re going through the ATCC and they’re looking at strains that are non-proprietary, but characterized strains. … The first thing you always look for is: is it safe?###You do that work. … The initial screening can be done genetically, where you can run a sequence or take an existing sequence and look for things that could be potential problems. … Then you do the initial safety work because if it’s not safe, you can’t … go into effectiveness.###Then you pick your end points and you pick what claims you’d ultimately like to support with this strain, and you just start running clinicals. The IPA [International Probiotics Association] and CRN [Council for Responsible Nutrition] came out with voluntary guidelines last year that discusses … the proper way to label a probiotic. It goes into labeling and identification. We’re moving everything to strain specificity, so that rather than just listing “lactobacillus acidophilus” or “bacillus coagulans” or whatever on your [ingredient] label, you have to list the actual strain names.###In our case, it’s “bacillus coagulans GBI-30 6086.” Because there’s no data that suggests that you can say, “Bacillus coagulans does this,” because many strains of bacillus coagulans grow above body temperature and are used industrially for things like lactic acid production. … It necessarily wouldn’t affect human health. We as consumers need to know what strain it is and what data is there supporting what that specific strain does.###Food Dive: What are some unique challenges of probiotics?###Bush: [For] probiotics in general, the unique challenges are all related to formulation. If you’re using a traditional lactobacillus or bifidobacteria and you want to put it into, for example, a food product, there is lots of food science involved in trying to pick the right food product, [and] find an environment that allows it to remain viable throughout the shelf life and at time of consumption. How do you get it into the food product? How do you make sure that it’s stable?###The challenges are all related to formulation, which is why BC30 has allowed us to get beyond the formulation challenges. Of course, we still have formulation challenges of our own. We can’t go into shelf-stable beverages. We can’t go into retort [or] aseptic-type products. If it’s a sterile product or if it’s a shelf-stable beverage, it just doesn’t work.###… At least as it comes to BC30, we can pretty much tell how the organism is going to do in a product very quickly. Somebody could say, “I’m thinking about doing this product,” and we’ve done so much testing over the yearferrous fumarate 456 mgs that we’ll say, “That will work,” “That won’t work,” or, “Let’s give it a shot.”###Food Dive: If a manufacturer wants to put BC30 in something, do you work with them? Do their food scientists take it on? How does partnership work?###Bush: [It depends on] however the company happens to be structured. Typically, what will happen is … we’ll send some samples. [Their company R&D will] formulate it. They’ll send it here for testing. We’ll say, “100% survived or 50% survived or 92%” — whatever the number is. If it’s low, we’ll help them figure out what we need to do to either improve viability, so that their overages aren’t massive. If it’s high, we’ll work with them and make sure that they get it down, so they’re not putting too much overage in so that it’s a cost factor for them.###Once we pin down the formula and thcyanocobalamin ferrous fumarate and folic acid capsules uses in kannadae use, how they’re applying it and things like that, then there’s an outside validated lab that can do their third-party testing and validation for them. It’s a very simple process as far as we’re concerned. You send them a sample, they send us samples. If we have something on Monday, we have results back to them Wednesday, Thursday with … no charge for them.###We also check for things like contamination. Are there other bacteria in there that shouldn’t be there? All that kind of stuff we do just as a standard test.###Food Dive: You said that you work with them if it’s low. What is low? For a product, do you shoot for 100% survival?###Bush: … What we have is we have the specifications, so … let’s say that the goal is to support the digestive claim. We need a billion CFU per day. If they’re shooting for a billion, we always gauge off of the specification. A billion is the spec. We’ll count the bacteria in it. … If it’s lower than 60%, we’ll work with them to figure it out. Is there a way we can optimize that in their current process so that they’re not having to put incyanocobalamin ferrous fumarate and folic acid capsules price large amounts of overage? We typically will see overages in the range of 10% or so. That’s what we’re shooting for. We always make sure that we’re above the specification. For us, it’s very black and white. There’s no “below is OK.” … We always make sure that we get the inclusion rate right so that they’re always able to support their claim. Then it’s up to them to make sure they do that on an ongoing basis.###Food Dive: What are some of the less conventional or more surprising things that probiotics are found in nowadays?###Bush: Now? The beverage industry has really adopted probiotics as a delivery system. Some of the things that because of just the uniqueness of our organism are things like these little microwave muffins. Who would have ever thought to put that there? Some of the trail mixes that are available are doing quite well. Kale chips. You just look around the room and you go, “Well, that’s an interesting place to put a probiotic.”###What we try to do is we try to not focus on things that may be inherently unhealthy products. … Although it would be delicious, we don’t want to have probiotic Swedish Fish swimming around in the candy store. … 95% of the time, the companies we’re working with, they’re working on a healthy or a better-for-you product versus, “Let’s put in some junky product.”###Food Dive: Do manufacturers ever come to you or you ever talk to them about developing a product that is for a specific population?###Bush: Oh, yeah. We have kids’ products on the market. We have products for athletes. We have products for seniors. We have products for people who have food allergies. … People will come to us and specifically say, “This is a millennial focused and targeted product,” or, “This is a children’s focused product,” or everything in-between. … This one is geared towards moms. We have a product … [that] was geared towards pregnant and nursing women. We never know what target population somebody would be interested in. Typically, if it’s a smaller company and they have a very targeted population, it’s usually something that affects them personally. We do get a kick out of some of those things we see.###Food Dive: Where do you see the market heading?###Bush: Honestly, beyond the general population, we see the probiotic market in general going into a more condition-specific type of environment. There are probiotics on the market now that are geared specifically toward heart health. There are probiotics on the market that are specifically geared towards kidney health. Things like that.###We think that, especially as the microbiome is more fleshed out, … as we do more research looking at the gut-brain axis, we’ll start seeing things that are more stress or mood related, potentially neurotransmitter related. It will be interesting. The more we learn about the microbiome, the more we see opportunities to help people through microbiome management.###Food Dive: Are there different strains that are better for heart and kidney health?###Bush: Oh, yeah. There’s a strain that is very specific for kidney health and there’s a strain that’s very specific for heart health. There are strains that affect cholesterol, for example. Yeah. You have to screen the strains, and then you have to do the clinical work to say, “Yes. This strain in fact does these things.”###Food Dive: Are most of these strains as resilient as BC30?###Bush: No. The ones off the top of my head are both vegetative cells, but they would typically be sold in supplement form, where you can [do] more [to] control your environment. I think that when it comes to supplements … you’re going to start seeing more target market or condition-specific probiotic supplements. It’s good, though, because it allows consumers to go, “I have this situation going on and I’m going to supplement using this particular probiotic supplement,” rather than having to guess, “I wonder if this one will help?”###Food Dive: Probiotics are pretty ubiquitous now. Do you think that that’s going to continue?###Bush: We believe so. Through the work we’re doing at the International Probiotics Association, we just got some statistics the other day that over 1,500 studies have been published over the last several years — let’s call it the last five to 10 years — specially looking at probiotics.###There was just an article the other day in one of the magazines that said, “Probiotics haven’t been fleshed out as being effective yet.” I’m thinking, “1,500 studies, many of which showed positive statistical significance and outcomes. I don’t know how you can say there’s no data around it.” Typically, when somebody writes that, you point them in the direction of PubMed, and they write back and say, “Oops. I missed [those] 1,500 studies,” or whatever.###There’s lots of clinical work being done. There’s some players in the probiotic industry who are spending literally millions and millions and millions of dollars trying to determine how we can benefit consumers. We don’t see any slowdown in the marketplace.###Food Dive: What do you think is coming next to move probiotics forward into the next thing?###Bush: I think it’s more information around the microbiome. I think, just like the human genome, it piqued people’s interest in personalized medicine. It hasn’t gotten there yet, but it piqued interest and it made people aware of the fact that it exists and it could exist in the future.###I think personalized nutrition will come out of some of the microbiome work that’s being done now. There was just an article that somebody published this morning about how how much iron is in 324 mg of ferrous gluconateyour choice of diet directly affects the makeup of your microbiome. … I think the next evolution will be driven by the microbiome and strain-specific data relating to individual end points and supported claims.
Q&A: Ganeden CEO Michael Bush on where probiotics are headed — and the unexpected places they're found
