Clinical Research of Natural Products with Sarah Burden

Sarah Burden: 0:00

We kept being asked about this main competitor product that made some really bold claims around inflammation and one night at the hotel we’re having dinner, he pulls up his computer and starts clicking around and really looking into their research. And he was like Sarah the only study showing that it helps fight inflammation was on seven obese cats and we, like, laid our heads down on the table. Yeah, just imagine, like Garfield or something right, just because it works for Garfield does not mean it’s going to work for my body.

Tina Smith: 0:31

Welcome to the Natural Products Marketer podcast. I’m Tina.

Amanda Ballard: 0:35

And I’m Amanda and we’re here to make marketing easier for natural products businesses so you can reach more people and change more lives, can reach more people and change more lives. Hey guys, welcome back to Natural Products Marketer. We are so glad to be joined today by Sarah Burden. I have known Sarah for quite some time now. I actually have a vivid memory of meeting Sarah. It was at Expo West gosh six plus years ago and I remember walking up to the booth that she was working at and my colleagues were already there and they were just nerding out everything that Sarah had to say and I was like who is this lady? So then I joined the party and I realized I was like this woman is a genius and she’s hilarious. And I was like why woman is a genius and she’s hilarious? And I was like why can’t more people be like Sarah? So, sarah, thank you so much for being here today.

Sarah Burden: 1:32

What a great intro. I love it so much. Thank you. I do feel like I deliver edutainment right. We’ve got the facts, but also the razzle dazzle, so thank you for picking up on that.

Tina Smith: 1:45

It was instantaneous, so and as fellow nerds, we appreciate the nerd part and we are also, like, fans of the office and parks and recreation. So we are here for the fun.

Sarah Burden: 1:59

Excellent, excellent. We got to have that balance in life, right.

Amanda Ballard: 2:03

Yep, yeah. So, sarah, tell us a little bit about who you are and where you’re at now, and how you got into this industry in the first place.

Sarah Burden: 2:12

Well, wonderful. Thanks again so much for inviting me to your podcast. I’m thrilled to be here with you both. So I’ve been working in supplements since 2002, which feels bonkers to say that so much of my life has been in this industry. But I had been working in cosmetics and skincare, working at department stores, and a couple people I worked with had started to question some of the ingredients in the formulas we sold at 21, 22,. Never crossed my mind.

Sarah Burden: 2:42

But one day I was selling a really expensive cream to a customer and she leaned across the counter and she said you know that it’s more about what you put into your body than what you put on your body, right? And that was a pivotal moment for me because it had not occurred to me before that I was a typical young 20-something eating garbage food, right, and staying up late, never hydrating, no bottles of water ever. And it was showing up in my skin. So she said there’s a health food store down the street. You should go check it out.

Sarah Burden: 3:13

So I wandered into my first health food store mind blown the grind, your own peanut butter machine and bottles of herbs I’d never heard of. And it just became my new passion. So I got the big, famous bulge book of natural remedies and I just started reading it all the time, learning as much as I could, and I eventually got hired there in that department and started to be able to interact with customers, where I learned so much from the customers, from my coworkers, from the different reps who came around, and I went to every training that anyone would let me attend. I would go off the clock if I needed to, just to try to soak up as much as I could. So I’ve been in the natural product industry since then.

Amanda Ballard: 4:04

Awesome. It’s funny. We talk a lot about how sometimes your best hires are your customers. Yes, and so you’re definitely a testament to that.

Sarah Burden: 4:13

I was that person, for sure. I wandered in like a babe in the woods like what is all this stuff, and never heard the pronunciation of most of these herbs. But I wanted to know.

Tina Smith: 4:26

Well, sarah, I’m so excited for you to tell us more about your company, because I was doing a little background. Look into what’s going on, and it’s something I have a passion for, which is the testing of these products. So tell us everything. How did it start, what made you get into that business and get that started, and what do you do?

Sarah Burden: 4:48

Yeah, no great question. So I think there’s a number of different tracks you can take when you stay in the industry for a long time and you learn more. Maybe you want to get more into the storytelling art within the industry, Maybe you want to get into the formulation part, and so I was kind of dabbling looking at all of these different areas and I came back to the same place you did, Tina, that if we can’t prove that the products are effective, here’s part of it. We just had our block party. I’ve got a great block, we have a wonderful community, and when I say I work in the natural products industry, I can feel that thing that happens where people either are afraid I’m going to try to enlist them in a multi-level marketing scheme or they think everything we do is snakeern.

Sarah Burden: 5:31

And she shared that her mom was having blood sugar issues and I said you know, there’s some really good evidence for cinnamon, something as simple as cinnamon. This was before Jim Nima was kind of the go-to and she said, oh, I would really need to see some research before I’d ever be willing to recommend that to my mom. And at the time I thought, gosh, it’s got 2000 years of traditional use in India and Ayurvedic medicine, but she needed research, and so that’s one of those other kind of pivotal moments of shaping your worldview right. Someone in the medical community is going to need to see a published human clinical trial, randomized, controlled gold standard clinical trial. So that’s what radical science provides. So most clinical trials are run through organizations that can either accommodate pharmaceuticals or they’ll take on dietary supplement clinical trials as well. But the format was really built for the pharma model that you can take a small sample size 12 to 48 people is sort of the average for a pharmaceutical trial and because of the drug-like effect of a pharmaceutical you can kind of capture that change in some health metric quickly in a small population.

Sarah Burden: 6:56

Dietary supplements don’t work like drugs. That’s the definition. That’s why we can sell them over the counter, and so it does take a larger population to really get a good idea. And because we are all so different in the way that we respond, they don’t have a drug-like effect, they have a food-like effect, a botanical effect, and so Radical created a platform where dietary supplement brands or ingredient suppliers can get human clinical evidence here in the US from a diverse group of people to really find the true effects of the supplement and during the R&D process, to really finesse a formula so that it works for the demographic that you’re looking to target.

Amanda Ballard: 7:38

Wow, that’s so fascinating. Yeah, I love that.

Tina Smith: 7:40

I know, and I think there’s so much research that can be done in this industry that has yet to be done and some of the trials that are out there. I have a lot of questions around what form of this are they using? Is it pure? Because you get varying feedback from some of these trials where you’re like I feel like there’s more evidence that is should come our way, that this thing will work, and, at the same time, what are they using? So how do we know that this is the right thing and the right formulation? And so it’s nice to hear that there’s someone with your background that’s getting into this work to help test, because we do know that there are different kinds of products on the market, some that have very effective formulations and some that don’t even contain what they say are on the bottles.

Sarah Burden: 8:35

Right? No, it’s absolutely true. And yeah, it was only in 2022 that the FTC issued some clarification on their guidance that if you, as a supplement company, are making a bold claim on your product, there needs to be human clinical research to back that up and it needs to be on a like population. I’ll never forget this was probably close to 10 years ago, but a good colleague of mine and I, who had done a lot of trainings across the country, we kept being asked about this main competitor product that made some really bold claims around inflammation. And one night at the hotel we’re having dinner, he pulls up his computer and starts clicking around and really looking into the research and he was like Sarah. The only study showing that it helps fight inflammation was on seven obese cats and we, like, laid our heads down on the table.

Sarah Burden: 9:25

Yeah, just imagine, like Garfield or something right, because it works for Garfield does not mean it’s going to work for my body. So you’re so right, tina, that the standard of what counts as evidence. It’s been a little shoddy sometimes within the industry, so the FTC has sort of tightened that guidance like, hey, it needs to be people. If you’re selling to an American audience, it needs to be Americans. Because if a study is done in India primarily vegetarian diet, tons of D3, lots of body movement is that going to have the same effect on the Americans eating a standard American diet? It may not. Maybe it does, but we need to be able to prove that it does.

Amanda Ballard: 10:03

So if a manufacturer were to go through the clinical trial phase with radical science, what does that look like for them? And then, what do they kind of get as far as being able to, like you know, come to find out their products? Fantastic, Um, all of these great things. How can they then use that in their marketing material to? To tell that story.

Sarah Burden: 10:28

That’s a great question. So we feel like all data that we can get for you is good data. And we’ve had some brilliant brand partners who have even shared from the stage at supply side West when they had a product that did not beat placebo in terms of achieving statistical significance and they went back and reformulated and I love that kind of transparency, right, and I know that there are major retailers who also love that kind of transparency that the brand invested in science, saw what the outcome was and then made changes to bring the most effective product to the marketplace. That’s going to ensure customer satisfaction, loyalty, trust to not only that brand but then all of the retailers who feature that brand and our industry as a whole. Then I won’t have my neighbors at the barbecue saying that stuff’s a bunch of hogwash. So we love being able to provide the data and insights.

Sarah Burden: 11:23

Even in a pharmaceutical trial, only about 20% of drugs that would go through a trial end up achieving statistical significance against placebo. So it is an uphill battle to achieve that. So all data we say is good data because then you’ll know more, you’ll be able to see how your stuff is really affecting your customers. But sometimes we find things like hey, maybe overall, maybe it didn’t achieve statistical significance, but for women over 40, this thing was a home run. Well, now maybe that company can reposition this formula as a women over 40 sleep aid or whatever, right? So now you have a demographic who does respond to it, right? So there are a number of things you can do. If the product ends up being super successful, then the study can help substantiate the claims that you want to make helps customers get a good night’s sleep.

Sarah Burden: 12:14

We’ve had brands who share the statistics on their website 87% of participants in a human randomized controlled trial saw better sleep quality within six weeks. So there are a number of different claims you can make with the outcome of your trial. But you can tinker, you can improve, you can shift your demographics, you can get more ROI on your marketing, because you’re going to be just talking to the people who have the highest likelihood of really feeling the effect of the formula. And if manufacturers, brands, come to us during that R&D phase, we can really help optimize their cost of goods. We’ve had a brand partner who came pre-market to us and tested their formulation at 25 milligrams, 50 milligrams, 75 milligrams. They were all effective, but with the same degree of efficacy. Well, you can just manufacture the 25 milligram because everyone felt the same. So there are a lot of options of how brands and ingredient manufacturers can utilize the data, which turn into more credibility for retailers, more satisfaction for the end consumer.

Tina Smith: 13:22

So here’s a thing that I’m really interested in, because you’re talking about helps with sleep over age 40 or 45 for women, what Deshae is always on everyone’s minds. So what are the things that you can do with clinical trials and the data that you get, and what are some things that maybe you cannot do still, yeah, that’s a great question, and this year in October will be the 30th anniversary of the Deshaies Act passing.

Sarah Burden: 13:49

I just got to be in Salt Lake City for the Deshaies Summit celebrating 30 years and get to hear from folks who are in the room you know when that was enacted and the hard work that went into place in order to keep the industry safe no-transcript health condition, and so this is one of the reasons I wanted to come work at Radical.

Sarah Burden: 14:41

Two of the brands I’d worked for in the past invested in clinical research. So, like stage one is, I want more brands to invest in clinical research, but asterisk clinical research that’s being guided by people who understand Deshaies, understand the regulatory landscape of the dietary supplement industry, because especially one brand I worked for did not understand regulations, did not understand Deshaies spent a huge amount of money on a study to prove that the product could have an effect on cholesterol, not realizing they were not going to be able to say this lowers cholesterol, even if they proved it. So that was unfortunately not a great spend. So I think if a brand is thinking about clinical research, partner with a platform, with an organization who is focused on the dietary supplement space, so that you don’t accidentally blow five years worth of research funds on something that you can never share externally. Right, it was such a heartbreaker to see. So when I saw Radical’s model it was almost like if you take a kid bumper bowling like, you’re not going to accidentally wind up with a non-compliant claim here.

Tina Smith: 15:47

We’re not going to accidentally wind up with a non-compliant claim here. Yes, that sounds like huge.

Amanda Ballard: 15:51

Yeah, such a needed service. Yeah, we think yeah, very, very cool. So I’m curious, just because I like to know these types of things what are some of the things behind the scenes that happen in a clinical trial that maybe people don’t know about?

Sarah Burden: 16:15

Oh, it’s a good question. So one thing that is trickier than anyone ever expects is getting your placebo manufactured. So especially so many brands work with co-manufacturers. They have their schedule planned so far in advance and then you need to run 500 bottles of a placebo. That can be tricky. So starting the process earlier than you think is a really good idea. If you think you’re going to want to pursue clinical research because you have to get scheduled into the line, it’s not a moneymaker for the co-manufacturer, so you’re going to get relegated to the very last possible moment. So kind of building that into the schedule and just the kind of cleverness and creativity that needs to go into sometimes building a placebo.

Sarah Burden: 16:57

What if I have a client who makes a greens powder? What’s the placebo going to be? It can’t be anything botanical because it has to have no effect, right? So there’s no herb or green that I can give them. It’s going to have zero effect. So we’re going to have no effect, right? So there’s no herb or green that I can give them, that’s going to have zero effect. So we’re going to have to get kind of crafty with that. If it’s a tincture, same kind of thing, right, it has to match and be undetectably different from the active. So I think that’s one of the kind of interesting light bulb moments that most people have when they start thinking about a true gold standard clinical trial versus an open label consumer impression study. So a consumer impression study can be great for market research, but it can’t substantiate a claim because there’s no control against something that looks identical so that we can account statistically for that placebo effect, which in our industry is really strong.

Tina Smith: 17:48

Yeah, well, this is amazing and I it makes me think of I’ve been reading this book, how not to age by Dr Greger. Yeah, at the very beginning he talks about how many of the supplements don’t have what they say are in the supplement. So, tell us a little bit more about how can just a consumer know that they’re getting what they think they’re getting? What should they be looking for and what kind of certifications should they see? Or what are the labeling practices that have to be done that do protect the consumer?

Sarah Burden: 18:23

Yeah Well, I heard a piece of advice a couple years back, during the height of the pandemic, when we’re all trying to figure out what we could possibly take for our immune system and trying to do things remotely, and someone told me don’t put anything on your body or into your body that you bought from Amazon, which I thought was pretty startling advice to hear. But then, more as more and more trickles out and we’ve got industry leaders like Now Foods who will do a big sweep and order a bunch of things online from Amazon and then test it and it doesn’t turn out to be authentic. It doesn’t have the recommended label amount or the declared label amount. So I think that’s one thing that unfortunately, there is a lot of counterfeiting that happens and it’s in the most popular categories, right? So if you’re Googling or searching turmeric creatine, the most popular supplement ingredients are the ones that are getting counterfeited.

Sarah Burden: 19:18

So working with a brand or a retailer who you trust and who has established credibility, I think is a great place to start I look for personally as a shopper, I look for CGMP status of the manufacturer to make sure that they’re following those standard good manufacturing processes. Nsf certification is certainly a great third party that I like to see on the supplements I consume and that I give to my family too. So I think some of those third party certifications are really smart to have and I think also, just as consumers, we always want to keep, you know, our little spidey sense going that if this deal seems too good to be true, right, if this supplement is a fraction of the cost of all the rest of the pack. You know, when it comes to pricing on this supplement, I have to ask myself why.

Tina Smith: 20:17

Yeah, 100%, and it just makes me think the reason that you’re calling these things out and scrape for them to be on the label and I know that it costs some of the manufacturers more money to make sure that they’re certified or that they’ve got some other transparency happening and that they’re acting in good faith and that they are actually producing the product that they’re saying they are producing and doing things like that protects the consumer and protects them as a manufacturer.

Tina Smith: 20:46

So I love seeing these practices put into place and we know that there are bad actors that are out there and unfortunately, it feels like a tax. You know that we have to do all of these things and do disclosures and have certifications and at the same time, it’s nice to hear and I think that we should be the ones that are trumpeting this on behalf of these manufacturers and telling people this is who you can trust, because there are people that are out there You’re right making counterfeit substances on Amazon, and we are not in favor of consumers wasting money on something that’s not going to have efficacy, and so that’s why we want to be the champions of the manufacturers who are getting this right.

Tina Smith: 21:32

And there are some lovely manufacturers who are very transparent, honest, do the research, have things tested and they make sure that what they claim on their label is what’s in that product.

Sarah Burden: 21:43

Absolutely Part of the Dachet Summit. I was just at involved the current leader of the Office of Dietary Supplements from the FDA speaking on the panel. I always think she’s brave for showing up because there’s going to be grumbles in the audience full of folks working in the dietary supplement industry right about some of the decisions or the way that things get run. So I always respect her for showing up at these events. But it’s clear just from patterns over the years that office is really underfunded. They don’t have the amount of resources or staff to be investigating as many manufacturers as there are now. The size of that office hasn’t kept up with the growth of our industry and so there are trade associations within the natural products industry CRN comes to mind that really do advocate for that sort of self-policing. You know, like how, how can we put some best practices into place, that a standard we can all rise to, and then the FDA can say oh, check, look, they’re doing. They’re doing all of these things that we would like to see.

Amanda Ballard: 22:43

Yeah. So, sarah, if, if anyone wanted to learn more about radical science how to go through, you know, a clinical trial for themselves and their brand how could they do that and ways that they could get in touch?

Sarah Burden: 22:58

Yeah, anyone can reach out to us through the radical science website, and we’re radical spelled CLE instead ofL. The radical is the first root of a plant that grows underground. So we feel like we’re breaking new ground with our model. We’re kind of doing things in a radical way, but with that organic growth happening in a new territory, so they can reach out to us to find out more. Clinical trials are what we do, but because of our unique model our completely virtual model we actually are able to gather quite a bit of market research for brands as well. So, in addition to the data that will help substantiate claims, we gather a lot of data that people go elsewhere for for consumer research, and so that’s all built into our trial model trial models. So folks in marketing teams, salespeople, r&d folks all really benefit from the kinds of data that we’re able to generate around an ingredient, a formulation in your innovation pipeline or an established legacy product.

Tina Smith: 24:00

Tell me a little bit more about these market research pieces. How do you get started with that? What are you learning? Who are you asking Like, how does that work?

Sarah Burden: 24:11

Yeah, so the participants who agree to be a part of a radical trial. We have 500 participants per study every time, so 250 will receive the active product, 250 receive the placebo. We also can offer multi-arm studies. So we have sometimes a thousand folks in a study. I think we’ve got one in the queue that’s going to have 2000 people in the study. So that’s a ton of data that we’ll be able to generate through six weeks of interacting with all those participants.

Sarah Burden: 24:39

Some of the questions that they’re getting specifically deal with whatever kind of study that they’re in. If it’s a sleep product, right, they’re getting questions all throughout about how many hours did you sleep last night, over the last week, would you say, the quality of your sleep improved, declined, right? So they’re reporting back on their feelings, their fatigue, their energy levels, their cognition, and so we’re collecting all that data to help with the outcome of the study. But, in addition, if a brand, say, delivers their supplement by a sachet, like a stick pack sachet, and maybe this is in the innovation pipeline, this is still in the R&D phase Well, we’re collecting all that data about the health outcomes.

Sarah Burden: 25:21

But we could also be asking questions like how easily did this dissolve in your liquid? Did you use hot or cold water? Did you like the flavor? Would you have liked it? An easier tear stick pack, right? So we can be collecting all kinds of that real-time data as well, and that’s incredibly valuable, as you can imagine, to anyone developing a product. You don’t want to get it all the way rolled out and find out everyone hates the mode of delivery, or no one likes the flavor, except for the three people who were on your R&D team delivery, or no one likes the flavor except for the three people who were on your R&D team, right. We’ve all been at brands that have seen that happen over time, so it’s a great way to kind of avoid those kinds of lost financial gains.

Tina Smith: 25:59

Yeah, and you know, there’s something that we talk about a lot in marketing is using the words of your customers. They feel like you’re reading their minds. So it sounds like, especially if it’s open-ended questions, that they’re giving you a lot of keywords really that people like them would use. So if they’re a fan of the product, in the end and you use those same words to attract other people, it will attract other people like them. Yeah, so that sounds great. That sounds like a really amazing report If you could have all the details behind it. And then, man, I bet you’d also know what people would search online to find the product and different language that you could use to talk about the benefits or why it’s different than another product.

Sarah Burden: 26:47

And it’s my hope that eventually we’ll be able to capture user-generated video, maybe all through the process right, we’re not there yet but to be able to do that for folks who are participating in the trial, so that over the six weeks we’re collecting that data and then at the end, what they think about it, once they’re unblinded, and find out you know what kinds of ingredients they were taking. So we do make it possible for brands too, if and participants are open to it, at the end of the trial to receive brand marketing so that they and a lot of times they are clamoring to find out like this really helped me with my sleep, what was I taking, you know. So we give permission, if the participant agrees, for the brand to reach out to them and say surprise, you were taking this right and now you have a raving fan. That’s very cool.

Tina Smith: 27:35

Yeah, you know what else this makes me think, though. I’m like hey, how do I get on that list, so I can try new products?

Sarah Burden: 27:42

You can do that at radicalsciencecom as well, so you can reach out in a kind of sales capacity If you’re thinking you’re a company, brand or retail and you’d like to learn more about how you could work with us, and if you’re interested in being a participant in the trial, the trials that are actively recruiting are listed and you can click and be added. So that’s one of the other things. Amanda, when you asked what are some things behind the scenes that people might not expect, the screening process is one that I think not everyone thinks about, because if you’re taking any medications that would potentially have contraindications, safety things like that we have a primary investigator, dr Emily Pauly, who works for Radical Science, and she is meticulous. Nothing is more important to her than the protection of the participants’ health and identity protection in terms of anonymity throughout the study, but then also protecting their health data at the end. She is so scrupulous about that, so we feel really lucky to have her on board Very cool.

Tina Smith: 28:44

Yeah, that’s very interesting. It sounds like a good pairing that dovetails right into what you guys are doing over there. So the testing is that a requirement that they have to have? They have to show that what’s in their product is in what they say is in their product is actually there, sorry as well, wherever that’s been manufactured.

Sarah Burden: 29:18

And then we quarantine everything product and placebo and do a second run of all of those QA QC steps with a third party lab that we contract with, just because the health and safety of all of our participants is our primary, you know, objective. So we do that second run as well.

Tina Smith: 29:34

Amazing. Yeah, all right. Well, I’m definitely going to the website because I to see, like, what trials are out there and one of the reasons why, of course, I’m going to sign up and be like can I participate? But one of the things I think everyone could do is go look and it’ll give you some idea of new products that might be coming to your area soon. So some of our retailers might get some ideas around what might be popular that’s coming in the door and what maybe they can get before other places could get them.

Sarah Burden: 30:08

That’s a great idea. Yeah, I love when I’m at Expo West Supply Side West I know what’s kind of coming around the bend in terms of industry trends and especially on the supplier side. I start thinking like, oh, I’m going to start seeing some of these kinds of formulas come onto the marketplace soon, so I think that’s a great strategy.

Amanda Ballard: 30:27

Well, thank you so much for spending some time with us today, Sarah. You’ve been a just absolute pleasure to speak with and super excited to see just all of the success that you’ve had throughout your years in the industry and look forward to just seeing what’s next with Sarah. It’s always something exciting and you’re just great everywhere you go. So thank you again for spending time with us.

Sarah Burden: 30:53

Oh, I appreciate that, amanda, thank you so much. It was a pleasure to be here with you both. It was a great conversation. Thanks for having me.

Tina Smith: 30:59

Yeah, it was great to meet you. I’m excited about getting to see you at the shows in the future.

Amanda Ballard: 31:04

Yeah, thanks so much for listening to the Natural Products Marketer Podcast. We hope you found this episode to be super helpful. Make sure you check out the show notes for any of those valuable resources that we mentioned on today’s episode.

Tina Smith: 31:17

And, before you go, we would love for you to give us a review. Follow, like and subscribe on Apple Podcasts, Spotify, YouTube or wherever you’re listening today, and make sure you join us for our next episode, where we give you more marketing tips so that you can reach more people and change more lives.