How to Start a Supplement Company & Formulation: Operators Build (E3)

Welcome back to episode three of Operators Build, where we go through the pain of launching a new brand, document the entire thing in public, so hopefully you, our listener or watchers, can actually learn something from us. That's the hope. Today we're going to be covering what it takes to nail an effective product formulation. We're starting a supplement company after all. We're going to be answering questions like: Do you build the formula yourself, or do you go with something off of a shelf? This is sort of the custom formulation argument, right? Or are you basically just taking a private label of something else. And we're going to tell you why Winx isn't private label, why we went custom. So who are you actually making this for? It's another great question. Target audience. We're marketers here. You're going to hear us talk a lot about this in every episode. And then back to the product, like what does the formula need to say about your brand? I think formulation and how much work you put into it, just like any product, is a big part of your brand identity. And then finally, in this first segment, How do you actually decide what goes in it? Do you do market research or do you just, you know, go do ingredient research or you just make it up? We put a lot of work into this product, so you're gonna kind of hear us pick it all apart. Let's get into it.

Todd, nice to meet you. I'm Sean. I'm the CEO of Ridge. I, I do the podcast with Matt and Mike, and we're doing this new brand with Curtis. I think you might get involved in it, so.

Yeah. And, I just want to frame this up, Todd. A, number one, would love to hear your background or you can share with the boys. And then, also let's talk about the formulation, the ingredients, what we've done, why we've done it, what your perspective is on it, even sharing your perspective in the market from a sleep perspective. You have a lot of insights and some of it might be repetitive for myself and Matt, but overall, I think your insights, your background, as well as we can talk about even the current samples, like the sediment and how do we— what does that look like for the iterations? And the last thing, I think, maybe talk about the ingredients on the— how we pick specifically 3 trademarked ingredients and why that's advantageous in the claims that we can make, essentially. I think that's most of it. Mike, Sean, Matt, do you have anything else?

And there's just, there's a ton of talk about entrepreneurship and building businesses, but there's very little behind the scenes. And so we thought, man, what would be better than to give people actually a picture of the inception, the conversations, how you make decisions? This is a perfect example that we're in the product phase of what we're going to go to market with. This is really an episode about what's in the product, the efficacy of the product. Um, one of the things like I'd love to hear more about, obviously you can talk us through all the different ingredients that we've picked. Some examples of ways this conversation could go, hey, are there some ingredients that are on the line? They're expensive, they help some, they're not necessarily critical. Do we want to include those? Things like that are the type of decisions that you have to make to win in the market of understanding how you're going to position yourself, what the messaging's going to be. So anyway, excited to have you on the pod and to talk about all these different things.

Yeah, yeah, no, thanks for having me. And kudos to you guys because you're right. I mean, you guys all hit the same head Right nail on the head is that there's all these people who want to open do their own businesses and be self-employed, but they're like, "I don't know where to start. I don't know how to compete." You know, there's it's just the hyper saturated market. For example, like supplements, like what we're talking about, right? And so for you all to be really successful, I think it's a good kind of like altruistic pay it forward, helping people, helping people not take it in shorts and go on to Shark Tank, right? And just have to raise a bunch of money, but they basically have to give their whole company away. You know, which it's devastating. So I think you guys are doing a great thing. And Curtis mentioned, you know, kind of debriefed me on the platform and the idea behind it. And so, you know, I think when he invited me to come on, I was like, yeah, I think it's a great idea because it can just help that more people. Plus Curtis and I, I mean, Matt's been CC'd. I don't know how much he is able to catch the strings of emails, right? So it's a lot of back and forth, a lot of figuring things out. So how do you get this great product? Yeah, from idea Inception to what we have now. And, it's always a work in progress. But honestly, to kind of Curtis's part in the beginning is that, so I've been in patient care clinical practice for 15 years. So, I'm a naturopathic doctor and certified nutrition specialist. And, I've been heavily involved in the supplement industry for 13 years on basically the industry side of it, mostly healthcare practitioner channel. But working with a lot, I do a lot of advising and consulting to mostly startups, direct-to-consumer, e-commerce, some, a couple retail brands. And as you guys know, retail is very difficult, particularly in the supplement world, right? You walk into Whole Foods or Sprouts, it's like, oh my God, I mean, it's all the same. Who's the what? What's differentiation? So, a lot of experience. Most of the supplements on the market are garbage. It's just I don't want to be denigrating, but they are poorly bioavailable ingredients. You know, the wrong form of the botanical. You know, like it's not even the right species. One of the biggest culprits is an inefficacious amount to actually do anything. So you get these formulas with lots of window dressing or pixie dust, right? It's like, oh, there's 10 milligrams of alpha lipoic acid, and now you're making blood sugar claims. First of all, that's illegal. It's not even regulatory compliant. Second, it's not going to do anything. That doesn't mean you can't get like these synergy antioxidant formulas to play on each other, but that's not what we were going for. And that's not what Matt and Curtis asked me to do, right, with their idea. So, I kind of understand I'm a unique entity somewhat in the industry, and then I'm a practicing physician. So, I know what happens when you put something into someone versus a lot of translational research, right? Someone reads a document, they read a research study, they're like, oh, bacopa this, let's do that. They don't know necessarily what's gonna happen when you start putting formulas together and also making things that work for, say, a particular condition, whether it's IBS or sleep. So that the sleep formula, well, that was the idea, right? There's a lot of different types of sleep dysfunction, right? There's sleep onset insomnia, There's sleep maintenance insomnia. So sleep onset, people who have trouble falling asleep. Sleep maintenance insomnia, people who have difficulty staying asleep. Then you have early morning insomnia, or they call it early waking. These are people that wake, like they sleep, maybe sleep all night, but 3 or 4 in the morning, they're like, I'm up, this sucks, you know, and I gotta go to work. I gotta, I could sleep 2 more hours, but, you know, and they toss and they toss and turn. And then now, you know, they're exhausted by 10:00 AM. So the point of this formula was to make something that essentially would address all stages of sleep dysfunction and insomnia, given the fact that most people have mixed type insomnia, right? They have trouble falling asleep, they have trouble staying asleep. So we kind of whittled it down. Okay, now you know what you want it to do. So when I look at product development in the nutraceutical space and I consult And advise currently 10 different brands, and again they're all different channels. And then I have my private practice, and then I'm a key opinion leader for a lab company, and then I'm consultant advisor to a medical group as well. So you know, kind of a lot of hands and a lot of cookie jars, but it gives me a lot of experience. And I always like I like startups especially because people there's a lot of skin in the game. Usually get a lot of really creative people. People want things to succeed versus me getting brought into a legacy brand. And then it's just like, oh my God, dude, to get you guys to change and fix what's not working is brutal, right? Because you're just— there's so much resistance. You get, you know, people like, well, why are you doing it this way? I'm trying to understand. You want me to come in and clean house and write and, uh, you know, optimize your systems or whatever? What's working and what's not working? You get a couple people like, well, we've always done it this way. Well, okay, is it working? No. Why are you doing it this way? Right? That kind of thing. Curtis is laughing because he knows that he and I were involved in a company. It's like, you know, we got to clean house and fix some things because it's just an inefficient system and you're bleeding money essentially. And so we kind of came up with that. So once when I approach people or they approach me, you know, it's always referrals. So I don't promote, you know, out there. Uh, except LinkedIn, I think I, I have like, um, hired Open to Work, um, Nutraceuticals or something. I, I have something done, but it's all referred. And, uh, so usually what ends up happening is I'm like, okay, so some, some, you know, someone has like an idea, right? Like a lot of CEOs and founders, they got ideas. And that's why I think you guys are a little ahead of that curve that you have ideas, but you know how to make it happen and then make things something successful. Most founders just have an idea and now they need a high-functioning team to implement their wisdom, right? Their creativity.

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So I'm like, all right, you got an idea. Like, this just happened 2 weeks ago. So I was— there's a new startup they have, they don't know anything about the health industry. They're all tech guys, but they have a family that's got— everybody's got GI issues, so they want to have some gut products. Okay, well, what do you want them to do? Like, we want them to treat IBS. You guys know what IBS is? I mean, I'm not— oh yeah, yeah, yeah. And that's what I say to them. I'm like, well, do you know what IBS is? There's different types of IBS. What homework have you done? And that's how we led down the road, and they don't know And then they just send me all this stuff that they collated from ChatGPT. And then I was like, well, that's cool. It's a start, right? But, you know, you want me to go through this document at my rate and clean it all up? Or do you want me to just— it's faster, honestly, for me just to go from scratch. Not that I want to throw out your ideas. So they were like, oh yeah, we don't know anything. They thought literally they were going to have a product and have it launched in October. And I'm like, dude, you guys, This is how it actually works. And they were like, oh, anything from the regulatory side and the formulation side, pricing to MOQs, right? Everything we've already dealt with. And then I was like, well, what kind of format do you want it? And they're like, I don't know. So we kind of walked them through that. So with this great 40 Winks formula, which I'm quite pleased with, you know, by Winks now, by the way, Winks. I love the 40 Winks though. Play on that. That was brilliant. I was like, you guys trademarked that? Simplified it.

Winks.

Yeah. So, but then my one thought was, I was like, what if you guys have like other products? You're going to call them all 40 Winks? So I guess that's why you—

One product, one word, one syllable.

Yeah, one word. So we kind of had a lot of— so it was great. So the first couple times Matt and Curtis and I met, we were like, okay, so now we have an idea what we wanted to do. Now when it comes to sleep, I always ask people the same thing. I'm like, what kind of formula? You want something just to knock someone out, or do you want something to like gently let people go to sleep? Do you want, you know, how do we want it? And Matt and Kurt were like, we don't want to just knock people out. We want stuff for families. We want stuff for kids. You know, we want the whole— they already kind of had it pretty well laid out, which made my job a whole lot easier.

And then— Melatonin-free, as an example.

Yeah. Yep. And they were like, well, let's avoid melatonin because not everybody needs melatonin. And there's also shortcomings to, to the use of, of non-sustained-release melatonin. And some people get the, you know, the nightmares and the grogginess. Plus there's theoretical safety, long-term safety concerns in children because of how it augments the endocrine system. So we're like, all right, well, let's choose something to help people calm down, go to sleep, similar to a competitor that has, you know, A very robust kitchen sink formula, but our formula isn't so much because kitchen sink formulas have a lot of ingredients and not in a therapeutic dose. This does. So, and there's certain strategies to formulations. One is what, you know, is colloquially called a hero ingredient. So, your hero ingredient is one that's usually a brand ingredient, has lots of human studies, and you build most of your claims around that. But this is a high-end Cadillac premium Rolls-Royce sleep formula. So that's where the branded ingredients came in. One, because of quality purity, also because of the level of studies behind it. And so that's how kind of the inception. Then we wanted as a powder, which then has its own hurdles, right? Because when you get into powders and liquids and chewables, taste, smell, mouthfeel is a big part of that experience versus someone just popping a capsule and going about their day. So hopefully that was a good 10,000-foot, 10-minute ramble on all that.

That's great.

So one question I have right off the bat is how far along are we in the science of understanding what really impacts sleep? It feels like to me, like I'm a supplement guy, that actually we've come quite a long way in the last maybe 10 years or so. in terms of understanding clinically with like documented studies that you can really rely on that replicate, hey, here are things that really work and are really effective to do different things. Can you describe like how far have we come in the last 10 years? Like, is this an area where our understanding has increased significantly?

Yeah.

I mean, sleep medicine is huge, right? I mean, one of the number one reasons why people see their GP in industrialized nations, right, is is sleep. They can't sleep. Um, that's like in the top 5. And so— Holy shit.

Wow.

Yeah, it's, it's big. I mean, everybody, you go to your GP, the, the 5 complaints, some kind of GI issue, sleep, fatigue, and then, you know, cardiovascular disease. But that's an un— that's like the silent killer because you don't know you have it. But that's the typical complaint someone goes in their GP. We're not talking about acute care, like, you know, you get injured and you go into your GP, you're like, I sprained my ankle. You know, or I twisted, or I fell, you know, or my back hurts because I lifted my giant kid. So yeah, those are in up there. And now we're in— and sleep dysfunction has gotten worse, right? And we're living in the world of it's the rat race, constant bombardment from information. People aren't sleeping, they're on their phone. So sleep medicine specialists, right, they're booming, and they run all the fancy tests. And whether it's going to be an overnight you know, tests for them to assess your sleep and do, you know, sleep studies. Or they're going to do now telemedicine, right? Even things you can do remotely with devices. Telehealth is different. Telemedicine is the actual use virtually of medical devices. And you can actually now— which is better for normal sleep versus putting someone in a room and then having like a rat, and then you're getting watched all night.

That—

it's hard to get regular normal sleep. So you can do a lot of this at home now. But it's very, very well understood. And I've spoken at conferences, you know, right alongside sleep experts where I'm like the functional medicine naturopathic take, you know, insight. So the pharmaceutical side, right? And I'm not against pharmaceuticals, I prescribe them, but you know, it's very reductionistic. We're going to give you zolpidem, right? Which is Ambien, a hypnotic. We're going to give you, you know, trazodone. And there's even guidelines of position statements of different organizations versus family practice versus internal medicine. I'm like, which ones you use first? The problem with a lot of those meds is, one, you build tolerance to them, so then you need more over time. Second is that many of them interrupt sleep architecture. So like, they may knock you out, but you're not actually getting through the normal circadian sleep cycles, maybe not even staying in stage 4 deep sleep long enough, the restorative sleep. So there's these new medications like what, maybe just a couple years ago, the orexin, um, drugs, agonist drugs that work on different mechanisms that are supposed to be safer, less tolerance, uh, less of the, you know, um, dependence on them. I would still say, generally speaking, again I'm biased, is that natural medicines still have a far larger role to play because of the fact that you can hit so many mechanisms and work More naturally with the body's rhythms. And yeah, to Mike's question is that tons of data, and I hear this all the time from conventional colleagues, you know, biomedic medical conference speaking, or even naturopathic colleagues, functional medicine, natural medicines don't work. Oh, they sure as hell work. Number one, you got to use the good stuff, which is what we're using in our product. That's why it's more expensive because it's been tested potency, purity, identity, heavy metals, micro. And you also have to use it at a therapeutic dose, right? So if someone is trying to get sleep from their passionflower, which is a great herb, and they're taking 50 milligrams, there's a reason why it didn't help you sleep. It's not enough. So we're at all those therapeutic levels. But yeah, I would say understanding mechanisms of sleep, why we sleep, how much we sleep, how much sleep do we need, and then what's causing sleep dysfunction. So that's where I look at it. Most people in the United States anyway, North America, They don't sleep well because they're just too much in sympathetic overdrive and their cortisol is too high, which you can measure in blood and serum. So, people lie, labs don't usually lie, right? Objective data. So, you can see that people have elevated cortisol and cortisol is the main hormone that helps you wake up in the morning. So, when people have these cortisol surges in the middle of the night and they wake up and then cortisol then stimulates physiologically to your adrenal gland. It's a signal to release adrenaline and pre-adrenaline, which then amps you up more. So, um, there's a lot of things around sleep architecture and understanding mechanisms and cascades, and that's why I think something like this product is going to work better than the medications for most people.

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You know, and I'm, I'm, you're talking to one of the best sleepers on earth, man. Look at, look at my OneSleep, my sleep score. 100% last night. Let's go to the night before, 95%. I'm out here killing it, man. So, Yeah.

Well, I'm one of the opposite people. I'm not a great sleeper. So, insomnia is near and dear to my heart to try to help fix it.

Yeah, awesome. Hey, Todd, do you want to go into the ingredients a little bit more? And, you talk about the ingredients. Well, you just talked about the architecture and the difference between the pharmaceuticals and the organic or natural supplements that are out there and how you look at all the ingredients within the WINKS formula that we've created, both the branded ones and the unbranded ingredients. And yeah, if you go through line by line if you know them.

I can remember most of them, but you may have to share a screen. But yeah, so part of the trick of this formula is that a lot of botanicals and ingredients we were not— I'm not able to use because it's a powder and there's nothing you can do to mask these, like valerian, for example. You just cannot mask the taste. So I had— or skullcap, Scutellaria lateriflora. There's 2 kinds of skullcaps. These are great for sleep. Don't lend them well to powders. They're very bitter. You could put all the natural bitter maskers and taste blockers you want in there and all the flavoring agents, and it's still going to not be pleasant. So that kind of limited us to some of them. And, the other aspect was where we wanted the recovery phase. I mean, just by someone sleeping better, they're going to be more recovered, but we also wanted things to help people feel kind of this longevity movement, better healthspan. And, that's why the tart cherry is in there. So, Montmorency cherry, the tart cherries have great data for sleep because it contains natural melatonin. not synthetic melatonin. It also works as a little bit of a melatonin agonist, makes your body produce a little bit more. And then, um, its ability for sports recovery and enhancement, muscle recovery, is pretty solid. I mean, it's even accepted in like the Olympics, right? Because it's not a banned substance. So that's in there for Sleep Architecture, and we're using all organic ingredients. Uh, we used a branded form of— it's the most studied saffron.

Right.

Saffron is the most expensive spice in the world, and you can get generic saffrons, and they're that's fine. But a lot of the the studies were done on this particular saffron, and this saffron also this this it's called Afron. I have no affiliation to own my Gencor. They standardize it to a patented form of a constituent. I think they're called the pyramides from saffron. So it has the normal constituents the generics would have, but they have their own patent. On an extract that they do with this constituent, what has been shown to improve mood. So we want sleep, mood, memory, right? This whole recovery thing saffron does that. It's very well studied in ADHD and depression and you know everything insomnia safe in kids. The whole form is safe in kids. Magnesium we used the form magnesium we used bisglycinate. So again, using a highly bioavailable form. Very GI tolerable, and one that is is more calming than some of the other ones. There's different forms of magnesium, right? So we use the bisglycinate. It has a glycine molecule which can help people calm down. What are some of the other ingredients in it? Lithium is in there. So some people, even healthcare providers, they're like, "Oh God, why'd you put lithium in there? They don't have bipolar." Well, first of all. It's lithium orotate. Lithium chloride is what's used in mostly bipolar disorder, and this is in 500 micrograms. So it's, you know, the starting dose in bipolar usually is 600 micrograms. This has 500 micrograms. So like, what is that, 1/1,200th the amount? And that's more for that calming, quiet the mind, help with the ruminating thoughts. Um, also lithium, the, the populations in the world that have the highest lithium levels in their drinking water, it's a naturally occurring element, have the lowest rates of Alzheimer's disease.

No way.

Yeah, and there, there's a big correlation because lithium is neuroprotective. So it's in there for multiple purposes. Um, and that, in that smaller amount, again, makes it very safe. You don't have to monitor people's thyroid like you would with, um, lithium and You know, 600 to 1,200 milligram doses for bipolar. What, what else is in there?

We got L-theanine, ashwagandha, right?

So we used the branded form of ashwagandha. So real famous, you know, herb, like everybody knows about it, right? It's an Ayurvedic herb. It's been used for thousands of years as an adaptogen. And the definition of adaptogen is it helps your body adapt to physical, mental, and emotional stressors. But this form is a hot water extract of the root and leaf. And its studies are for anxiety and lowering cortisol, thus improving sleep at a much lower dose than you would need. And ashwagandha can be a not-so-palatable herb in higher doses. So this is nice because then you only have to put, you know, 125 to 250 milligrams in there. So, and ashwagandha being an adaptogen also helps with recovery. Uh, the theanine. So there's theanine is an amino acid from Green tea, and theanine, right? Is a lot of people use it in the generic form because it's cheap, and I get it. But we didn't want the cheap stuff. We want, and also the manufacturing processes—they use some weird solvents in some of these lower-end suppliers. So we use the form of L-theanine that is a fermented form, doesn't have all those nasty solvents, and also has three human studies showing the calming effects. So we want people to, again, kind of slowly calm down and go into a gentle sleep without just being knocked out and then they're all groggy and, you know, and then the kids can't really take it, uh, because you're worried that they're gonna basically be ODing on it.

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Cool, man. No, I'm super excited. I drank it, thought it was good, thought it tastes good, but I'm already such a perfect sleeper. So like, you know, how can I, how can I figure out if it's good or not? So I trust you guys on that.

Yeah, we need to do more for like the taste and the mouthfeel because taste is so subjective, right? And Americans tend to have a little bit more of that sweet tooth. So I always defer to other samplers because for me, I'm like, this is plenty sweet, you know, but Americans like it sweeter. 10, so maybe 10% on the sweetness. So with this one, and that's just the way powders are, you got to go through a number of iterations and these benchtop samples These are literally made with a hand mixer versus the scale-up when there's giant Bosch machines, for example, that are really going to blend them into a fine powder. And minerals tend to leave some sediment, calcium, magnesium. So, one of the things I did was guide the manufacturer to be like, look, if we can't get it— because people are not going to want a bunch of sediment in their mouth, they're not going to want sediment in their cup. So, If that's still an issue, then I recommended them to a supplier that actually makes minerals that are more dissolvable in liquids versus the ones that they were using. So they believe that upon scale up, it shouldn't be an issue. But let's see what happens. So yeah, it's taste is always an issue. Taste, mouthfeel, smell, the look. You know, I thought it was, you know, a good amount of grape, but needs to be more because it's kind of like, well, there's a little bit of grape. Maybe you want kids to take it. You know, you want it to be a little bit more grapey.

Yeah, I think, I think the only thing was like, for me, it was, it was very much more like a fruit punch, like very, very mild. Um, so I think we'll do a little bit of, of, of flavor testing. But though, look, I like premium. I like the whole, the whole idea is like we're selling these to, you know, upscale Midwest moms or whatever, right? So I like premium. I like it's safe for the whole family. I like that we're focused on efficiency. Case studies really help in ads. Dude, it's gonna be great. Super excited. For us, it's really just timeline. Like, we have to get the branding down, we have to get that stuff down. I think, think we're getting really close, and then, you know, trying to launch in Q1 next year.

Before we go any further, I want to do a quick intro to the next section that you're going to hear. This is all about what does it take to turn a formula into a supplement company? Who's going to make it once we have our formula? This is about the contract manufacturer, or comands is what they might be called. How do you make sure that every batch is what it says it is? Quality control, good manufacturing processes. How much do you invest in that upfront? That's a great question to answer. How much do you have to commit to before you've sold a single unit? This is the minimum order quantity thing again, very important to get right. And then what does it actually cost to get the product made? What's left over after it's sold? So Pricing, startup costs, profit margins, gross margins, shipped margins, all of that good stuff. We gotta answer that. And then finally, how do you turn one formula into a whole product line? Should we actually be building a supplement line? What are the marketing strategies around single SKU versus multi-SKU? We're gonna go into all of that in the next segment.

Yeah. And there's still, you know, for amount of work, you know, like for example, Things need to be written in structure-function compliant language. So you can't say insomnia, you can talk about occasional sleeplessness. The trademark licensing agreements will need to be coordinated with the branded ingredients like Sensoril and the Afron and the Alpha Wave theanine because that's part of their compliance is that you review their trademark license agreement, you abide by them, and then they'll give you the high-resolution logos and the verbiage that needs to go on the packaging. Then there's also considerations of whether you guys want this to be listed as proprietary blend. The FDA doesn't love it, but they haven't banned it yet as far as proprietary blend, you know. So, uh, I, I've worked with brands, what they'll do is, um, they'll list maybe half the formula out and then the other half is proprietary blend. And, you know, most customers that if they really want to know, and you can kind of tease out whether it's a mole from another company trying to steal your formula, but, you know, if they're that lame, then they got their own problems. Then you can, you know, divulge, oh, there's this many milligrams of passionflower or whatever it is. But almost all the ingredients are organic and they're, um, certainly high level. No artificial flavorings, colorings, additives, even the bitter blockers of Tastemasters. are all natural, so no synthetics are in here.

One of the most interesting things I think that's been true of the world, and I think it even applies here, is that it's really easier than ever before to go out and copy something. This is certainly true. Like, I make— I sell water bottles, so it's very easy for somebody if they want to create a water bottle that looks very similar to one of the ones we sell and source it for a similar cost. I think in the consumable world, this is Pretty true also, and it really like the the magic is in the marketing and the distribution of the thing. So it's probably less important than ever before that you have to be super secretive about a formula. I'm sure there's groups out there that could deconstruct almost any formula fairly rapidly. It's you know like we're coming from a generation where Coca-Cola wouldn't allow all the people that knew the formula to be on the same plane at the same time because if it went down, nobody knew how to make Coke. And I just don't think we live in that world anymore because I think, I think that the, the making of the product is becoming more commoditized. It's a judgment of what you put in the product and how you distribute it and how you market it, which is where the magic is.

Yeah, yeah. The, the world that we live in, um, you can't patent a natural substance. You just can't do that. So that's where these branded ingredients come out because you can patent an extraction method. You can patent a particular constituent profile that you do. Those can all be patentable, and then you do your studies. So it is certainly still illegal. Say you guys just put everything on the label and it's fair game, and then you come across something that's similar or even the exact. Of course, you can definitely sue them because you're like, "Look, this this is our release date. This is your release date." So the FDA, now that it's being somewhat not not being it's currently it's dismantled. Enforcement, who knows, right? As far as, and they've never come down with an official statement upon proprietary blend. They just don't like it. You just do your due diligence and right, it comes down to marketing. And then the product speaks for itself because it's going to work, you know, and there's no tolerance. There's no dependency on it. You know, that's again one of my, they say strengths and advantages that I've used all these ingredients on patients for 15 years, not necessarily together because I put this formula together, but I know what they'll do. I know what, how they'll react. Of course, you'll have some outliers that someone's like, oh, and it's a scoop, which is nice because then you can titrate it. Like, that's too much for me. I'm gonna do half a scoop. I could use a double scoop. So I went through and made sure, um, from, you know, part of my role is to protect the company from, you know, lawsuits, litigation, FDA. So they're all safe even if someone wanted to do 2 scoops. Uh, um, you know, it's still very, very safe. There's no like toxicity doses. They could drink the whole bag and the most thing that would happen is they vomit all over the place. But, um, that's also a regulatory thing. If someone goes to the hospital, say they go to the ER, you know, and they have an adverse, serious adverse event, which is different than adverse event, then technically that has to be filed with the FDA via MedWatch. But if you're suggesting, if someone takes more than your suggested use, The onus is on the consumer. We didn't tell you to take that much. That's your fault. You know, so, but even if someone wanted to just take a bunch, it's still very, very safe. And it's not like someone would go into renal failure because they took it or their dog just got into the bag, you know, and just ate a whole bunch of it. The worst that's going to happen is a bunch of GI distress and some will be very, very sleepy.

Yeah. Well, Todd, you're gonna crush in ads, man. We're gonna get you some good—

He usually wears glasses too. He usually has glasses on.

Well, no, I got— when you guys pull up your screen, I got my old man reading glasses. I'm like, wait, what is that? Yeah. Like, this is safe. I promise. I endorse it.

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I'm curious, how about that? Like, you know, take us through your perspective from a doctor. You, you know, you mentioned, um, you know, top 5 biggest pain, pain or problems that, that people face. Um, you also, you know, we know the market, we know the— as Mike asked the question about, you know, the studies around sleep, the interest around sleep, the We understand sleep better than ever because of things like Oura and Whoop. And, look at Shawn, he's a superhero on sleep. Most people aren't. And, as we evaluated the market and the opportunity, although there's sleep supplements out there, a lot of brands have a line of magnesium or have a line of recovery, there hasn't been many brands, if any, that have actually built a brand around sleep. And, our concept and thought was, There's a gap in the market. There's a gap in the market from our belief that people have built regular morning hygiene. So, our parents grew up and they didn't even go to the gym. They had a coffee, read the newspaper, went to work. Our generation grew up where we had supplements and protein shakes and went to the gym. And now, the future generation, they aren't even drinking. They're focused more on sleep hygiene more than ever. And so, there's a huge opportunity, I think, that we understand sleep more than ever, but most of the sleeping aids out there are either pharmaceuticals or they're the over-the-counter NyQuils or they're just strictly magnesium. So, from a doctor perspective, obviously, you helped formulate the current formula, but how do you see this speaking to doctors and family physicians and you name it, families, kids, you name it? We believe that it's very marketable, but how do you see the landscape of sleep supplements How do you see the landscape of what do you get recommended? How do you recommend, you know, to families and kids that are having sleep issues? Like, you're not telling them, you know, to put a concoction like this together. And now if this is available, like, you know, yeah, we feel like this is a go-to, but, you know, what's your perspective on the overall competitive landscape?

Those are good questions, good points you bring up, because even what do most people when they go to the doctor? Yeah, a lot of times they write a script, but they'll just say take Benadryl. The main ingredient of Benadryl is diphenhydramine, right? It's an H1 receptor antagonist, so it makes people sleep. The problem with Benadryl or any of these diphenhydramine products, which is the main ingredient in Tylenol PM and Advil PM and all those PMs, is that one, you get tolerance and addiction potential, but also the longer you take a diphenhydramine and the more potent it is and the higher the amount, the more likely you have increased rates of dementia. So if you look at the studies, any retreat, honestly, it's about 10 to 83% increased risk of getting dementia. I don't know about you, but if I have something that's going to give me an 80% increased risk of being demented later in life, I'm sure as hell going to stop it. So patients will come in and they're usually on these and they're like, I've been on this for 25 years and I, I mean, I can't take it. I'm like, do you want me to get you off of it? And that has to be tapered. And they're like, yeah. So, and I see a lot of these formulas, these sleep formulas that you mentioned, they're either not enough to really do anything or they cheat. They have like window dressings of the herbs, a little bit of poorly absorbed magnesium, and then they just throw in a whole bunch of melatonin. And I'm like, well, that's kind of, for me, that's misleading the consumer and also not doing any good. You're just charging a lot for melatonin with some pixie dust in there. And then you're going to throw in some 5-HTP. And then, which is a precursor to serotonin, and you don't know what meds they're on. I just don't. I have concerns with safety and the medications. Again, the the people that are seeing me, they're the non-responders typically, right? These are people who don't respond well to the meds. They don't tolerate the meds, or they're like the meds work, but man, I cannot. I feel so nonfunctional until about noon the next day.

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You know, I can't, you know, this is, it's just not working for me, or I have really bad nightmares, but it's like, would I rather not sleep or I want some nightmares? So I feel that a formula like this is it's because of its safety profile, the efficacy. Um, and we could always, you know, we've discussed this internally, Curtis and Matt and I, um, that let's just wait for some customer feedback. Do people want it stronger? Do a line extension. You can easily make this stronger, um, by, um, different ingredients or even just increasing some of the more sedative herbs in there, the botanicals like passionflower, without it being really nasty tasting. So when people come in to see me, children, you know, adolescents— my practice is 70% United States, 30% global. I have 2-week-olds, 1-day-olds, all the way to 100-year-olds, and they talk to me about their insomnia. It's like, okay, so how long has it been going on? You know, situational sleep hygiene, are you eating? You know, all these things, because I'll one of the first questions I ask people is, uh, when do you eat dinner? Especially people who say they wake up at like 2 or 3 in the morning and they have trouble going back to sleep. And they'll say, oh, especially now that keto is so popular, intermittent fasting, they'll say, oh, I like 6 o'clock. And I'm like, well, that's why. The reason you wake up at 3 is you basically, your body went into a fasting state for 9 hours. And when you, your body, as far as like, say the advent of electricity, right? What, maybe 200, 150 years we've had light.

Yeah.

We used to go to sleep when the sun went down and we came up when it got up. So, people are staying up really late, they got their phones, they're not eating, and they're just basically— their circadian rhythm is all messed up.

Yeah.

So, this formula, um, is to help— is that not just the quick fix or the Band-Aid to help people sleep, it's actually more long-term with the cortisol regulation. And that's where the phosphatidylserine is in there. And I put sunflowers so you get a hypoallergenic claim versus soy. So phosphatidylserine protects the brain. It also competes with cortisol binding, so it will lower your cortisol slowly over time overnight, so it'll last longer. And then again, it's a non-GMO sunflower source. So I think that, in my opinion, knowing for 15 years of practice and then formulating for the dietary supplement industry for the last 13 years, I don't really know of anything quite like this that say is robust, um, kind of all-encompassing without just, hey, let's throw 50 ingredients in there and let's hope for the best, right? It's very purposeful, very methodical. And I think it's a great thing to talk around parents because usually, especially we all have young kids, you know, kids not sleeping, mom and dad aren't sleeping. That's just the nature of the beast.

Yeah.

So it's like, you know, even if you're Shawn and you're a great sleeper, My wife and, you know, my 3 brothers and my dad, nothing wakes them. My oldest is like that. He's 10 and you could drop a brick on him and he's just like, oh, but he didn't sleep for the first 8 years of his life. So now I think he's making up for it. But it's like giving kids anything you can to help 'em sleep. So you even like a family routine. Everybody has their little drink mix before they go to bed.

Exactly.

You know, I, I, I just love that idea when you guys brought that to me. You're like, we want something. The family can take. And I was like, oh, that's sweet. And then powder. And that's where we started the ball rolling, getting the creative juices flowing. So yeah, I think to your point, when patients come in, I'm like, all right, what are you doing sleep hygiene? What kind of sleep dysfunction do you have? Who else in the house is not sleeping? You know, um, all of these things. So you got to do the foundational things, which is, I'm sure, is part of education that Winks will be doing. It's not just here to take something. Here's all that— this podcast is part of that, right? You know, here's education around, you know, sleep routine, um, and getting people to sleep. We're really good when our kids are young about being militant, draconian about sleep, right? Sleep routine, gotta go to bed at 8.

Yeah.

But then as adults, we're all over the place. We haven't— you know, we still need to get sleep routine too. So, um, I think that this will be just a great thing, and it's an easily counselable product because it's not overly complicated where it's got some bizarre items.

With the formula as it is now, does it— I— something you said made me think of this, but is it something that, uh, I guess compounds? So like, you know, the first night you take it won't have the same as good of an effect as maybe like the 15th night that you take it? So like, does it need to kind of build up in the system? Is it like creatine or Like where it, like you need it to like build, or is this sort of a, you're gonna start to see it on day 1?

You'll, that, that's a good question. So the, the way the rationale, the formula, this is, comes from a, a marketing standpoint, right? Uh, yeah. A consumer standpoint.

I just wanna know how to sell it.

Yeah. So consumers, right? I don't think you'll have a problem with it. Repeat, and you won't have a problem with repeat. So consumers, they want, they think everything should work like a drug, right? They want it to be fixed yesterday, even though they've been sick for 30 years. They want it fixed yesterday. So, I wanted to formulate something that will work within 30 minutes. You're going to feel it, you're going to start feeling the effects. But also, over time, you will have that compounded reaction where you're like, wow, I'm not feeling as amped up like I used to. This cortisol dysregulation, it's classic.

Got it.

People are waking in the morning, they get going around 11 or 12, 2 or 3, they get a dip, and then they start waking back up at 8. That's an inverse cortisol Cortisol should be high around 5:00 AM at its highest and then slowly go down. You'll see people and you can do salivary testing. You know, it's also subjective just asking them. But yeah, the more you take it, the more it's gonna work over time where you're like, I'm getting better sleep. I forgot to even take it last night. This is great. And, but it will work on the first night and then subsequent nights. Yeah, you'll definitely get more of a, of a compounded effect over time.

That's great, Sean. That's a pretty good bit of info.

Oh dude, this is gonna crush on ads. It's gonna be awesome. I'm very excited.

That's, that makes me very excited. Uh, retention especially, like that's gonna be great.

And then, you know, everybody's got their devices now, the Oura Rings and this and that. And, um, so they can get their own data. Yeah. I mean, you guys will have no problem. People can even like give you testimonials even on your own you know, your own, um, employees that you're like, we tried it ourselves and look what we got. These are our results over the past 15 days. Here's day— Sean would be a terrible, um, sample size, but the rest of the people who don't sleep well, right? They're like, I was at a 50, day 15 I'm at an 80, right? Um, so—

Sean doesn't have kids.

Yeah, I was gonna say, if he's like, I sleep great, but he's got that big, uh, bear behind him.

Yeah, I have a nephew and he really likes it.

So he doesn't sleep when the nephew comes into town.

No, and the nephew's gonna be here for 3 weeks. Working on having kids. But dude, I mean, no, my sleep score, that's gonna be one of the hooks for the ads. I'm just gonna scroll through my sleep score. People are gonna be like, damn, how do I be like that guy? I'm gonna be like, gotta take Winks.

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Yep. Yeah. And You know, and we can, as we go along, right? Again, part of my role is protection of the company, is when we start talking about what you can and cannot say in marketing and influencers and all that to protect you. And then what's out of my league, I have regulatory people we can consult, and all the way up to an FDA attorney if we're really wondering. What ends up happening mostly in the United States is that the FDA isn't your biggest fear unless you're flagrant, like we're gonna spike this with Ambien, right? Yeah, that's not the problem. Most of the time you guys are doing your due diligence, everything's fine. You get a warning letter from the FDA, it's a, you know, 483 that says you have 15 days to either substantiate this claim or to check this, because even the co-man we're using is all GMP, NSF, blah blah blah. It's the plaintiff attorneys, right? They just troll the internet all day looking for this kind of crap to to sue people on, and they do it. This is what they do for a living. So you would avoid things like that if— and that's easy, right? You just avoid disease claims, things that are unsubstantiated. That's easy, right, to protect you. It's worth your $300 to have a regulatory person quickly review an ad you wanna go out, right, versus paying the fines later.

My biggest question is like, how do we, on the evidence side, kind of get the most bang for our buck? You know, like, I know you can do sleep studies, Sean's going to be leading up the marketing effort. Obviously, having you and testimonial from you with your expertise is going to be huge. We'll, I'm sure, pull in some UGC, user-generated testimonials. But also, the more that we can be clinically proven, scientifically backed to help you sleep better, the better. So, how do we do that as inexpensively as possible, I think is my question.

So, for now, what you can do is it's just fancy wordsmithing. So, right now, you cannot say that the formula is clinically studied or clinically validated because that means you've studied the formula. But the ingredients that have been clinically validated, which all of them have, you could say clinically validated ingredients, doctor-formulated product. You can use— one of the reasons I like to use branded ingredients is because it's not borrowed science. So you can actually leverage their own statistics. You could say in this study, you know, it's arbitrary, right? 53% of people had improved sleep with blah blah blah. You can totally say all those things, and then you just have to reference them. And then why this is, I don't know, but from the United States regulatory standpoint, you just have to leave the title of the, of the article. So you have the author, the journal, you know, when it was published, but no title. And part of the rationale for that is, I mean, that's what you have to do legally, is that If the— in the title, they compare the natural ingredient to a drug, the way the FDA sees that is that you are now making a drug claim. So, you just leave that off there.

And, just for context, we have 3 branded ingredients, so we can leverage all of those studies on those 3 branded ingredients, correct?

Yep, yep. And then, just how you word them. Same with magnesium. And so, the way it works from a structure-function compliant way is that you can legally make claims that are not in human double-blind randomized placebo-controlled trials if they're mechanism claims. So you could talk about how— even though this isn't a therapeutic dose, say you just want to talk about how magnesium works, you can totally say that. But if you want to start getting into structure-function, like how it actually helps people sleep, you could say that. And then, you know, this is how it does it, this is how it does it. And I can supply all those studies and the wording and, you know, all of that. But yeah, really when you get into this like FTC compliant structure function language, it really is an art, right? To be able to wordsmith it legally, but also the consumer understands it, right? And it is a, fortunately for us, right? The wording that you can have lies in a big gray area with the FTC. It's a very large gray area you can operate. So it always depends how risk-averse you are or aren't. If you're like, no, we actually— Matt's like, yep, I feel comfortable leaning to the right of being less conservative and making some bold claims because we can still substantiate. And again, the worst the FDA does is send you a letter and all you got to do is like, here's the studies. They'll tell you what they want for you to— or they'll say remove it. They don't do anything.

I'm very comfortable in the gray.

Yeah, yeah. One foot in jail, one foot out.

Okay. Yeah. Versus some companies too. Yeah. And some companies I've worked with, they, they're so far conservative, the way they want things written. I'm like, this doesn't even make any sense because now it's so constipated that you're like, what? I don't even know what that means. I mean, what is it? What does this product even do now? Because it's so overly conservative. So yeah, from a marketing standpoint, and plus, You guys are, I think you're gonna get a, like a sachet or pouch, which gives you much more real estate to write things on there without it being jumbled and cumbersome. And then the website can go more into depth. Your ads, right? Those get more terse and succinct. And so I'm not the most creative.

Oh no, we got that on this. Yeah, we got that on this. So we're good. Yeah. Yeah. You put your brains behind it and then we'll, Yeah, you know, I'm excited.

I think this is going to do really well for a lot of people. I think you guys will do really well and it'll be sweet.

Awesome. Well, we know you got to jump, Todd. Thanks for, uh, obviously joining today, but also all the work that you've been doing. Um, you know, great to introduce you to the rest of the guys. And, and, uh, you know, uh, we're looking forward to obviously getting— Frank is sending out that 3rd round of samples hopefully next week. He had to get a couple more ingredients. And so, we should have the 3rd sample of the grape coming out next week, which we can give feedback on and, yeah, kind of go from there.

Yeah. And, if that gets approved, they are 12 to 14-week lead time. But then, that's for them to make it, then it has to be tested. So, that's going to be 3 weeks. So, in theory, I mean, this could still launch at the end of the year, but you guys could always build the momentum and be like, dude, it's right, you know, pre-orders, blah, whatever, you know, you guys are the market experts. So, um, if— what I would just hate is it comes back and it's crap, and now we're like, dude, now we got to go to iteration 4.0 and 5.0, and, and then it starts to just kind of go in— in my experience, it starts to go in circles where you're like, well, now we're actually back to like how bad it was the first time, and it gets irritating. So yeah, but no, we should rock it. I appreciate the invite, guys, and pleasure meeting you at least virtually, and we'll catch up soon.

Thank you, Todd. Appreciate your time. Thanks, guys.

Have a good weekend.

Okay, that's a wrap on episode 3 of Operators Build. You heard us talk about what makes a real supplement company and not just a good idea, not just another private label product. And look, one of the things, right, that's important if you're gonna go into building a supplement company is you need to understand what the FDA is. What does it function in this whole business? What is the DSHEA, the Dietary Supplement Health and Education Act? And really compliance, this idea of compliance when you're starting a supplement company, it is as important as the formula itself because everything you do to go to market with a supplement hinges on you understanding what you can and cannot say.

That's it for today.

Hope you enjoyed the episode. As always, if you liked it, please subscribe, follow, comment, ask us any questions. We are so happy to help. See you next time.

See you next time.