Nutraceutical Legal Compliance 101, with Lee Gray of Rubicon Bridge Ltd.

Episode Overview

Episode Topic: In this episode of NutraPreneur, we dive deep into the intersection of regulatory compliance and technology in the nutraceutical industry. Joining us is Lee Gray, Business Development Director at Rubicon Bridge Ltd, a leading authority in this field. We’ll explore how cutting-edge technology is transforming the landscape of regulatory compliance, making it more accessible and efficient for businesses in the nutraceutical sector.

Lessons You’ll Learn: During this episode, you’ll gain insights into the vital role of regulatory compliance in the nutraceutical industry, the influence of Lee Gray’s extensive experience in retail and e-commerce on compliance strategies, and how Rubicon Bridge’s innovative solutions empower brands to expand into new markets seamlessly while meeting regulatory requirements. Discover the real-world success stories and challenges faced by businesses when scaling internationally with food supplements and how technology is shaping the industry’s future.

About Our Guest: Lee Gray, the Business Development Director at Rubicon Bridge Ltd, brings over a decade of expertise in food and food supplement product development, regulatory compliance, and technology. His experience with major industry players like Tesco and Amazon uniquely positions him to share invaluable insights into the dynamic landscape of regulatory compliance and technology-driven solutions.

Topics Covered: In our conversation with Lee Gray, we’ll explore his journey and role as Business Development Director at Rubicon Bridge Ltd. We’ll discuss retail and e-commerce’s impact on regulatory compliance, Rubicon Bridge’s technology-driven approach, real-world success stories, key challenges in scaling with food supplements, future trends in compliance technology, and Rubicon Bridge’s upcoming goals for the nutraceutical industry. Don’t miss this enlightening discussion with Lee Gray.

Our Guest: Nutraceutical Industry Insights from Lee Gray’s Role at Rubicon Bridge

Episode Transcript:

Lee Gray: Often when I speak to an American brand, for example, for the first time, and I ask them why they’re not currently selling in the UK, the answer is just the regulations. The basic premise of the tool is to take away that hard work. You’re not relying on a third party and paying them thousands and thousands to perform checks and waiting months. You just upload your product information, select the countries that you’re looking to launch into, and then the tool will automatically check it against all of the regulatory requirements from each of those countries. So then that gives you a really simple readout of whether that product is viable in those markets or not.

Bethany Jolley: Welcome to NutraPreneur, The Neutral Industry podcast. I’m your host, food scientist, and nutraceuticals consultant, Bethany Jolley. Each episode we’ll be exploring what it takes to thrive in the nutraceutical industry. From conversations with successful nutraceutical entrepreneurs to venture capitalists to tech executives whose innovations are reshaping the nutraceuticals industry. We explore the innovations and trends that are shaping the next generation of nutraceutical businesses.
 
Welcome back to NutraPreneur, your window into the world of pioneering innovations in the nutraceutical industry. I’m your host, Bethany. Today, we have the honor of speaking with Lee Gray, a visionary with over a decade of experience in developing food and food supplement products for the UK and EU markets. As the Business Development Director for Rubicon Bridge Limited, he’s been at the forefront of developing regulatory compliance technology. With a background as the technical manager for Tesco’s health and wellness category and the food safety manager for Amazon’s nutrition category. Lee’s insights are invaluable. So thank you for joining us today. Lee, it’s great to have you.

Lee Gray: No problem. Thank you for having me.

Bethany Jolley: With your extensive experience in both product development and regulatory compliance, could you share with us your journey and how it led to your role as the Business Development Director for Rubicon Bridge?

Lee Gray: So I studied food and nutrition at university. And I think when you’re younger, you think the idea of product development is really sexy and exciting. And don’t get me wrong, I’ve had some really fun jobs and I’ve got to launch some really exciting products. But what is often overlooked, as in a lot of ways the most important factor is regulatory compliance. Like, if you spoke to me when I was at university and you told me that I was going to have a career in regulatory compliance, I would have said, that sounds like the most boring career you could possibly have. And it’s true that there’s a lot of ill feeling towards regulatory compliance, but it’s important to remember that the reason why we have it in the first place, everything always comes back to customer safety. No brand, no retailer, nobody that I’ve ever come into contact with wants to hurt customers. So they want their products to be safe. And as a side effect of that, it means complying with the regulatory requirements. But as I said, it’s not the most fun. It’s not the most sexy topic. And actually, throughout my career, I’ve been really fortunate to do all sorts of different roles. I have done product development roles, I’ve done technical manager roles, which in the UK means that you’re responsible for regulatory compliance and food safety.
 
And I’ve also done pure food safety roles and pure compliance roles as well. And one thing that I’ve learned throughout that process is that it’s it really shouldn’t be as bad as it is. So often you’ll have a fantastic idea for a product, you’ll be super excited about bringing it to market. And then it comes to the practicalities of actually bringing it to market and what that means. And for most products, that means you have to create the packaging, but you have to work backwards before that process. And what you don’t realise is that any time you buy a consumable product, 90 to 95% of the copy that’s actually on that packaging has been checked for regulatory compliance. It’s not marketing copy. The marketing copy is big and shiny on the front of the pack, but it’s all the words on the back of the pack that you need to get right. And when you work for companies like Tesco and Amazon, you can’t afford to get it wrong. Because if the authorities are looking at anyone, they’re looking at you. And if they can make an example out of you, they will. So it really does need to be right. But my experience has been that you have all this excitement for a project to launch these exciting and amazing products, and then it comes to the regulatory compliance bit, and particularly when you’re looking at launching internationally, that is, to date, an incredibly laborious manual process.
 
Most big companies like your Tesco’s and your Amazon’s, they will rely on third parties to advise them on regulatory compliance for their products. And unfortunately, what that means is that you’re relying on manual assessments of products which in multiple countries and multiple languages, which can take months and months, and there’s nothing fun about that process. So actually, the reason why I was really excited to join Rubicon was because they’re the first company to create technology that removes that need for manual intervention. So for me, it was like this pain point that I’ve suffered through my entire career, the laborious regulatory process and the approval loops and projects being delayed and all of that. So to meet some people and to be involved in a project that actually completely removes that for brands, it is. Yeah, it was just too exciting to say no to. So yeah, that’s how I’ve got to where I am now and why I’m here, and why I’m really passionate about helping people get to market quicker and showing that there’s a better way to do it.

Bethany Jolley: Yeah. That’s incredible. And a lot of companies try to find shortcuts because like you said, it does take so long to really do things the correct way and follow all of the regulations. And so helping these places have a more efficient route is really important.

Lee Gray: As well as like it being a more efficient, a quicker way. You do have to realize that there are limitations of any manual process in terms of accuracy. You’re not going to get more accurate than our technology. People come and go and they leave companies and you get new joiners and you see service levels slip. That doesn’t happen with technology.

Bethany Jolley: Right. And you’ve mentioned that you’ve worked with major players like Tesco and Amazon. How has your background in retail and e-commerce influenced your approach to regulatory compliance and technology development for the nutraceutical industry?

Lee Gray: So I have been very lucky to work for those companies, but those are two companies that probably take quite different approaches to regulatory compliance. And when I was at Tesco, it was during a period where everything was manual, kind of everywhere. It was just how we did things and there was some introductions of they were called product life management tools, but essentially they were just blank databases that then had to be manually checked anyway, so there wasn’t really anything overly innovative happening there. When I joined Amazon, I was sold on the cool aid that they did things differently and that was what I found. Okay, just as much as Tesco do about having safe and compliant products, but their business model, they don’t hire hundreds of people, they hire a few people and they build like technology solutions. When people talk about Amazon, they often neglect to talk about AWS which is one of the best, biggest, most powerful tech companies in the world as well. So they’ve got that behind them. So the biggest kind of learning for me was adjusting to the fact that actually not everything has to be checked manually, and there is usually some kind of tech solution to every issue.

Bethany Jolley: Yeah. You know how technology has come so far where you don’t have to do all of those manual checks? It’s great. So Bridge really specializes in helping brands enter new markets and understand regulations. So can you provide some more insights into how your platform empowers brands to navigate the complex landscape of regulatory requirements, especially for food supplements, whenever they’re entering these new markets?

Lee Gray: Sure, it’s not a secret that European regulations are pretty complex. And often when I speak to an American brand, for example, for the first time, and I ask them why they’re not currently selling in the UK, even though it’s a bigger market than, say, Amazon Canada. Often the answer is just the regulations, like it’s just too much hard work. So the kind of basic premise of the tool is to take away that hard work. You’re not relying on a third party and paying them thousands and thousands to perform checks and waiting months. The really simple concept of the tool is that you just upload your product information, select the countries that you’re looking to launch into, and then the tool will automatically check it against all of the regulatory requirements from each of those countries.

So then that gives you a really simple readout of whether that product is viable in those markets or not. And that’s the first piece of the puzzle, just finding out whether your products are actually going to be viable. The second issue that a lot of brands have is specifically when it comes to creating that mandatory copy that I was talking about before for the packaging. 90, 95% of the information that will be on your product is mandatory information. The complexity of that and the complexity of the UK and the EU, and the relationship of individual nations within the EU is that there is this overall idea of harmonization. But when it comes into practically speaking, it doesn’t really quite work like that.

So there are European wide rules and regulations that you have to apply with. And then there are individual country rules as well that you have to comply with. And alongside that there are each nation may well have their own list of things like mandatory warning statements. So it’s not the case that when if you’re currently, for example, say you’re an American brand and you’ve got packaging that’s fully compliant for the US market and it is written in English, like we might disagree on the odd spelling or the odd word, but if you sold it in England, people would understand it. It actually still needs to be translated into the regulatory text of English or otherwise it is not compliant. And so you’ve got that text in English. It’s not as straightforward as just putting it in a tool like Google Translate for the other European countries, because they’ve got their own specific rules, and because strictly speaking, it’s not a translation. It’s actually you need to write things in the way that they appear in the regulation. So what our tool does is it also creates what we call an international copy, but it’s essentially all of the copy that you need for each of the countries that you want to launch in. And we always say it translates it, but truly speaking, it’s not translating it. It’s sourcing the local regulatory texts and pulling together one file for you to create your packaging.

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That sounds like this tool could be game-changing for a lot of brands. I know a lot of brands feel restricted because they just don’t understand all of the different regulations for all of the different countries. And so this could be a way to really help them expand internationally. 

Lee Gray: Yeah, exactly. It is a game changer. There’s nothing like that on the market.

Bethany Jolley: Yeah. It’s incredible. Could you share with us some real-world examples or success stories, where Rubicon Bridge has been instrumental in helping brands expand into new markets and achieve compliance seamlessly, particularly in collaboration with Amazon sellers in Europe?

Lee Gray: Yeah. So one of our first customers actually had a business model that basically they wanted to utilize Amazon’s, which is their European fulfillment network. And it’s a fantastic service that Amazon provide because it means that you can deliver into your local FC. And then from there, Amazon will ship and handle everything into each of their European countries. But the challenge from a product perspective is that means that the product itself fundamentally and compositionally has to be compliant with each of those countries because they’ll all have their own limits and rules that you have to abide by. It also means that you need product packaging that is compliant in all of those countries as well. So the first customer that we worked with that we actually worked with them.

Our first kind of touch point with them is that in the EU, in certain countries there’s this requirement that’s called pre-market notification, but basically means that you need to provide documentation about any product to an authority before you launch it. And unfortunately, we spoke to that brand a bit too late in their journey. And what we found was that of their think they had about 57 products or something like that, and only 20 of them were actually viable, even though they had supposedly done all the all of those checks and supposedly translated and created like compliant copy and packaging for those countries, they were, in fact, completely unviable.

The really interesting fact that they shared with us at the time was that because they were pretty upset, you can imagine they thought they had all of these products. They’d been through this painful process, but at least they were like finally at the end of it, and they were finally going to be able to launch them. The statistic that they told me that I always remember was that it actually took them over 50 weeks to get to that point. So just to check that their products were compliant and then to produce what they thought was compliant, copy took them 50 weeks. So we actually did a trial with them just on a small handful of products. And that 50 weeks we were able to reduce down to about five minutes. Wow. Which is you said it before, it’s like game-changing because not only is that saving you time, but it also means that you can launch your products nearly a year earlier, which means that you benefit from nearly an extra year of revenue. So it’s huge. And I had that number. I think it was four minutes and 27 seconds or something was on average. I had that number in my head for years. And then I was actually in Salt Lake City earlier this year, and I was doing a presentation.

It was one of our partners, Patton. They have an amazing conference that they put on every year, and I had to follow Jessica Alba and Michael Phelps, and so did my best. And I’m talking about regulatory compliance. And I’m also so I know that, like, maybe my sense of humor isn’t going to quite translate as well. So these sales are a bit nervous and thought, what I need to do is show them the tool. So I have this video produced just showing the process end to end, and I thought it would be really powerful to just have a timer going to just it’s real-time. So the video just shows somebody uploading their product information. They check it for compliance, they enter their packaging information, and then they produce the compliant copy. What was really odd about that video, but it really struck me at the time, because I had this four-minute 27 in my head for so long was it took exactly a minute. So we’ve managed to refine the process that much just since I’ve joined, which has only been a year. So that now it’s actually completely possible to do your compliance check, produce that compliant copy in only a minute. Products compared to 50 weeks is huge.

Bethany Jolley: That is so huge. And there’s so many challenges along the way that we’ve discussed when you’re trying to launch a new brand. And so in your experience, what are the key challenges that brands typically face when trying to scale internationally with food supplements? And how does Rubicon bridges the Regtech tool address these challenges?

Lee Gray: So a big thing is not understanding the requirements of the e-commerce platform that you’re going onto. I can speak on Amazon’s behalf because this is public information, but they treat food supplements as a restricted product category. That means that you need to provide evidence of compliance before you can go to market. So a big thing that we see is that actually, brands aren’t aware of that. So the first thing they speak to us is when they’ve tried to launch a product and it’s been removed from sale because they’re unable to provide that documentation. So one of the good things about Rubicon and the Rubicon Group is that we are very familiar with Amazon’s requirements. So we usually anytime we meet a brand for the first time, we make them aware of them, because often that’s the first thing that they have to work on. The other thing that brands get wrong too often is that they wait until they’ve produced a product, and in some instances, even manufactured a product before they seek expert third-party advice is not a sensible way to do it, because too often, and like with the example that I shared before, you can find out that actually your product isn’t viable in those markets. And in the worst instances, there’s absolutely nothing you can do. You have to reformulate it. So my big takeaway for any brands that are looking to launch an Internationalise is to make sure that you’ve done that compliance check upfront before you get too far down the line. And then the third thing is those mandatory warnings that are specific to each country. Because if you don’t know, you just don’t know. And if you don’t know, it’s perfectly reasonable to think you can use a tool like Google Translate, but you can’t. You need to be aware of them and particular countries like France, for example, they will actually check your premarket notification incredibly thoroughly. And if you’ve got anything like that missing from your packaging, they will just reject it. And then you’re back to the drawing board and you’ve got to create a new artwork. Those would be my main points.

Bethany Jolley: I think that Rubicon is sounds like a great resource for any startup brands, just to make sure that they’re doing things correctly before going into production, like you said, or wasting time trying to gather documents for Amazon and not truly understanding what Amazon needs. I’ve seen that happen many times, where brands are just going back and forth with Amazon getting frustrated because they don’t know what the requirements are or they don’t know what specific document they’re looking for. So I think having Rubicon there to really help them and guide them and like we said, make the process more efficient is really important.

Lee Gray: Yeah. And like we are a tech company, that’s the focus of our business, but also with people. And we’re more than happy to jump on a call and talk them through any of the requirements or any of the questions that they have. It’s just it’s really important that you try to have those conversations up front and early in a project, and you need to know what you’re kind of what you’re facing with a launch like that if you’re new to it and you haven’t done it before. There’s an awful lot that goes into it. And if you’re not using, I would say, a solution like ours, but there truly isn’t another solution like ours. If you’re not using our technology, you’re looking at a very, very painful process. And what I will say as well is that I think we’re quite unique in understanding e-commerce platforms like Amazon’s requirements and the fact that you’re a small brand, it doesn’t matter. Everybody needs to comply.

Bethany Jolley: Right and of course, e-commerce is huge. There are so many people that are buying their supplements online now rather than at storefronts.

 Lee Gray: It’s massive. And the UK, Germany, Italy for example. They are big marketplaces for food supplements in particular. 

Bethany Jolley: Yes.and the regulations. There’s so many things. There’s always new regulations popping up and trying to understand all of the different countries’ regulations. It can just be very confusing and overwhelming. And so I think that’s why regulatory technology is really a rapidly evolving field. And what trends and innovations do you foresee in the realm of regulatory compliance technology, and how is Rubicon Bridge planning to stay ahead of the curve?

Lee Gray: In the context of almost any industry at the moment? Everybody’s looking at AI. That’s something that we’re looking at as well, because we treat our technology as self-serve, and it is so we can set up a brand, and it’s really straightforward for them to just input their product information. But it does rely on some basic understanding of the product. Like you have to know what a capsule is versus a tablet, for example. So I’d be lying if I said I fully understood what that is going to do for us, but it is something that we’re exploring. The other thing that we’re doing. So we work with a third party. They’ve got an API into our tool, which they have incredible technology, by the way. T=0, that’s what they’re called. But basically we’ve solved about a third of the problem because we’ve made the red checks and creating the copy super simple. With our partner T=0 (timeequals0), we’ve sold another third of the problem, because often what we’d see is even if you get that international copy, like completely correct when it comes to creating the packaging artwork, again, if you’re relying on a human, there’s some room for human error there. So what their technology does is really cool. They have essentially like blank blueprint of a label that’s ready to receive our international copy, which means that when you get to the end of our process, instead of downloading that international copy and creating the artwork yourself, or sending them to a third party to create for you manually, you can fire that file over to T=0 and their platform, and then use their platform to produce a label or an artwork for their label. 

Lee Gray: And that’s all that’s like minutes we’re talking. So that’s a big game changer. I think the next step so I’d mentioned that’s two-thirds of the issue solved. The missing piece of the puzzle is going direct to print. So that’s something that we’re interested in in the future. We have a card company I guess you’d say in the UK it’s called Moonpig. It’s a really fun name, but it’s basically you can create your own birthday cards, Christmas cards, whatever it is, you can upload photos of your family, you can change the text, all of that stuff, and you order it and it gets delivered it in a couple of days. I don’t see why there’s any reason why we can’t get to that point with packaging. Because like, say, we’ve solved two-thirds of that. So it’s only the final third that we need to solve. So that’s where another point of innovation that I see being a priority for us. And the final thing is that we focus on food supplements because it’s our bread and butter, and also because it is an incredibly challenging, complex regulatory product area. But there’s no reason why we can’t apply what we do on food supplements to other product categories like food, like cosmetics, like medicines, medical devices, etcetera. So those areas are interesting to us as well.

Bethany Jolley: Yeah, that’d be great to expand into those areas as. And given your expertise in food safety and nutrition, how do you envision the intersection of data technology and compliance shaping the future of the nutraceutical industry, particularly for food supplement sellers that are looking to expand globally?

Lee Gray: I think there needs to be some integration of regulatory checking in a way earlier in the process. So broadly speaking, what the process looks like, say you’ve got an amazing idea for a food supplement brand and you’ve met a manufacturer. You ask them to manufacture a product for you, then you get it red-checked. So it’s still happening. Too late. Really. In an ideal world, those brands, well, they do now have that information at their fingertips before they’ve actually signed off on the recipe or the formulation for a new product. I see them utilizing technology like ours just earlier in the process, just to make it more seamless.

Bethany Jolley:  Absolutely and looking ahead, what are the key goals and projects on the horizon for Rubicon Bridge, and how do you plan to continue making regulatory compliance more accessible and efficient for businesses across the nutraceutical sector?

Lee Gray: Yeah, we like to think that we’ve democratized regulatory compliance, but truly speaking, we’ve only done that for food supplements in Europe. So we’ve got ambitious growth strategy. And when I say Europe, that’s actually only the six major Amazon marketplaces, which is the UK, Germany, France, Italy, Spain. So there’s room even for us to grow within Europe. There’s other countries, other regions, Latam, the Middle East, Africa, other countries that are of interest that we can. There’s no reason why we can’t develop them into our tool. And then like I mentioned before, these other product categories where you have the kind of the similar kind of process and headaches with the existing process. Those are the areas that excite us the most because they’ve got the biggest problems to solve. 

Bethany Jolley: Yes, absolutely, and like you said, all of those markets are just continuing to grow. I’m hearing more and more about Latin America introducing new supplements into their regions and the Middle East as well. And more and more brands are trying to get the appropriate certifications to be able to sell in those regions. And so I think the market’s really expanding there. 

Lee Gray: Definitely.

Bethany Jolley: As we conclude this insightful conversation, we’ve delved into the world of regulatory compliance and technology with Lee Gray, Business Development Director for Rubicon Bridge Limited. His expertise is truly transformational for our listeners interested in exploring Rubicon Bridge’s innovative solutions for regulatory, compliance, and international market expansion will provide the necessary links in the show notes. Don’t forget to subscribe, share your thoughts, and join us in celebrating the ever-evolving world of nutraceutical innovations on social media. Until our next episode, stay informed, compliant, and inspired. Thanks for tuning in to this episode of NutraPreneur. If you enjoy the show, please subscribe and better yet, leave us a review as it really helps us grow the show.