Nutraceutical Regulatory Challenges with Luca Bucchini of Hylobates Consulting

Episode Overview

Episode Topic: In this episode of NutraPreneur, we discuss the complexities of Nutraceutical Regulatory Challenges with Luca Bucchini, the Managing Director at Hylobates Consulting. As it is a vital area affecting businesses in the nutraceutical industry, our discussion navigates through the intricate web of regulations, compliance strategies, and the importance of staying updated with the ever-evolving legislative landscape. Whether you’re a startup or an established company in the nutraceutical sector, understanding these regulatory hurdles is crucial for your product’s market success and consumer safety.

Lessons You’ll Learn: Listeners will gain invaluable insights into navigating Nutraceutical Regulatory Challenges, including practical tips for ensuring compliance with food safety standards and labeling requirements. The episode highlights the significance of regulatory advice in the development and marketing of dietary supplements and health products. Luca Bucchini’s expertise sheds light on the importance of education in understanding and applying nutraceutical regulations effectively.

About Our Guest: Luca Bucchini, the Managing Director at Hylobates Consulting, brings a wealth of knowledge and experience in addressing Nutraceutical Regulatory Challenges. With a distinguished career spanning two decades, Luca has established himself as a leading authority in food risk assessment, regulatory consulting, and labeling. His role as chair of the European Specialist Sports Nutrition Alliance (ESSNA) further amplifies his deep understanding of the sports nutrition sector and its regulatory environment.

Topics Covered: Including the evolution of dietary supplement regulations, strategies for compliant labeling and advertising, and the impact of technological advancements on regulatory consulting, this episode covers a range of critical topics related to Nutraceutical Regulatory Challenges. There will be exploration of the importance of novel food legislation, and the role of sustainability in product development. Through Luca Bucchini’s expert lens, we discuss how companies can stay ahead of regulatory changes and position their nutraceutical products for success in a competitive market.

Our Guest: Luca Bucchini- Steering the Nutraceutical Industry Through Regulatory Challenges

Episode Transcript:

Luca Bucchini: Very often companies are unhappy because there are mistakes, even grammar mistakes, or sometimes it has happened that a company stays in front of a pack with no caffeine. And when there is caffeine in the ingredient list, which is obviously quite bad. So those are other mistakes that you need to process. And many companies do not have a process for that, even relatively large companies.

Bethany Jolley: Welcome to NutraPreneur. The Neutral Industry podcast. I’m your host, food scientist, and nutraceuticals consultant, Bethany Jolley. Each episode will 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 to NutraPreneur, your gateway to the latest innovations and trends in the nutraceutical industry. I’m your host, Bethany. In this episode, we’re honored to have Luca Bucchini, Managing Director at Hylobates Consulting, as our guest. Luca is also chair of the European Specialist Sports Nutrition Alliance, also known as ESSNA, with expertise in food risk assessment, regulatory consulting, and labeling, Luca’s insights are invaluable for anyone navigating the complex world of food and nutraceutical regulations. Hylobates Consulting is based out of Rome, and they’ve been a cornerstone in the sector since 2003, offering specialized services and food safety, labeling, health claims, and more. Welcome, Luca. It’s so great to have you today. 

Luca Bucchini: Thank you. Good to be with you on this call.

Bethany Jolley: First off, it’d be great if you could tell us about the genesis of Hylobates Consulting and your journey to becoming its managing director.

Luca Bucchini: Yeah, about 20 years ago, I had worked in academia, in the United States, working in risk assessment for foods particularly, and we decided with my current business partner to start a company to do in the private sector what we had done in the academia. And we started off with risk assessment with the safety side. We worked on that side, but we soon found that there was a lot of interest in addressing the regulatory matters concerning food supplements and food. So we started to work with companies and we grew with the business, actually. We learned from them and we work with regulators. We, of course, started regulations and the company has grown all the time. We have now 23 people and we work across the globe.

Bethany Jolley: Wow, That’s fantastic. And yes, I’m sure 20 years ago there was definitely a demand for this type of consulting. And then even now, there are still so many people that need assistance with regulations because they can be a bit vague and difficult to understand. And of course, they’re always changing as well.

Luca Bucchini: Yeah. No, that’s true. There are a lot of consumers, rightly so, want to be healthy, want to continue to be healthy as they age. And so there is a demand for products, for food products, for food supplements, for nutraceuticals that would help them. And the industry is responding with innovation. And at the same time, regulators across the world are trying to figure out the best way or they’re trying sometimes to fail, but they are trying at least to define regulation. And so companies that want to bring products to market need good regulatory advice so they don’t have problems and they don’t or the other side do waste time and doing the wrong thing or making things more complicated than they are. So yes, there is a lot of demand and with larger companies getting into the sector, new companies, new ideas, new products, there is a lot of work and it remains a very interesting job for us, very fascinating in understanding regulations and understanding products, the ideas, understand the science and then working with the companies and seeing them succeed with their products and ideas.

Bethany Jolley: Yeah, and in this constantly evolving regulatory environment, how does Hylobates ensure its clients stay compliant, especially in the area of food supplements and dietetic products?

Luca Bucchini: We need to understand the product so we work with our customers or we see the composition of products. We ask them, of course, what’s part of the compliance review, what is the composition. We look at the labels, we see the advertising material, and we warn them whenever there is a change of regulations or scientific evidence may affect them. So we have a lot of respect for business decisions. So we don’t try to replace their decision-making. But our aim is to be precise and informative in what we do. So we want to keep our customers updated at any time on what is happening and what is going to happen but may affect them. And so that helps them stay compliant all the time, or choose what they want to do in a very informed way, but protects consumers and informs them correctly.

Bethany Jolley: Yeah. And you bring up a good point. There are businesses that are quite receptive to regulatory feedback. And then there are others, of course, that just want to go along with their business decisions. There’s going to be a little bit of a conflict of interest there, but I think it’s great that you’re keeping them informed and providing advice to make sure their products are as compliant as possible. 

Luca Bucchini: Yeah, that’s a very valid point. And for many companies, it’s a matter of not knowing the regulations. Of course, there are some very bad companies out there, but. They don’t care about regulation or even the safety of the consumers. But most companies try to do their best. Sometimes they take their risks, especially on the claims side. But when you look at the non-compliance and also with, as you have mentioned, me being a chair of ESSNA, we have a compliance program also to tackle non-compliance in the sports industry sector. And many companies just don’t know. So very often companies have problems with retailers or problems with authorities because they don’t know. It’s not a choice. So we try to help them maximize compliance but I think it’s really unfortunate to be non-compliant because you don’t know what you’re doing.

Bethany Jolley: Right. I think that’s important to not only just correcting what might be non-compliant, but also educating them along the way. 

Luca Bucchini: Absolutely. And one of our main points, or things that we explained to our junior consultants that they need to explain the regulations and the facts of regulations to customers, because educating them, is not just providing information, but really making them understand why the regulation dictates this or that action. So education is key and it’s part of the competitive advantage. If you don’t understand the regulations, you’ll face problems or maybe you want those things that are allowed because you don’t know. So I think education is key for the industry.

Bethany Jolley: And I’m sure you’ve worked with a lot of different businesses and teams over the last 20 years. And so could you share with us an instance where your team navigated a challenging regulatory scenario and really highlight your approach and the outcome?

Luca Bucchini: Yeah, that’s a very good question. Over 20 years, we witnessed many things. For example, the emergence of e-commerce for food supplements and dietary supplements. It’s been a great change. But part of that we work across the world, particularly in Europe, in the EU. And what really changed about ten years ago was that companies that used to sell in their own country, or maybe they went to another country in Europe, but always through distributors with different labels. So what happened with the internet is that companies started to market the same product, the same pack to different countries, and that was a big challenge because regulations are different companies. Then Amazon came up and again the same issue. So it was difficult. Products were blocked. There were many issues.

So companies were looking desperately for consultants able to help them. And we were there and we had expertise. We built further expertise really to help companies comply, change their labels, or make labels that could fit in the package and still be compliant. Do all the notifications registration required in all the countries with our expert but with deep knowledge of each country. So I think we were instrumental to help companies market the same product across Europe. And what was a big change? It really was a sea change for companies for which companies emerged. And I’m happy to say that we enabled that change, and it was through dedication and expertise, building expertise. But that’s really the key in this sector.

Bethany Jolley: Yeah. That’s fantastic. And that’s another thing that just comes from a lack of knowledge. A lot of businesses don’t realize just how different the regulations are from country to country, and certain ingredients aren’t allowed in some countries, or they’re more of a medicinal product rather than a supplement. And you have to register. There’s all those different scenarios. And so being able to help people take their brands internationally is huge.

Luca Bucchini: Yeah, it’s been a good thing really. Companies did not understand. They saw the problems. They still see the problems in different countries. But many companies succeeded in having the same product. And now I would say not all, but many if not most of our food supplement customers in Europe have a multi-content strategy. They try to bring the same product at the same time, and eat at least 3 or 4 of the main European countries. So yeah, this is change completely and I think it has benefited consumers in terms of more products and better prices and better quality as well. So you mentioned it’s evolving all the time. France is bringing in a new approach. I can’t say a better approach, but a new approach. So it changes all the time. And we are still trying to figure out the best way for companies to label in a compliant way.

Bethany Jolley: Yeah, and the nutraceutical industry is also witnessing rapid technological advancements. So how does Hylobates integrate these technologies in risk assessment and regulatory consulting?

Luca Bucchini: Well, we realized some time ago, many years ago actually, but we implemented a better use of IT. Of course, we are constantly updated with science. We have a process to follow, our all regulatory changes to anticipate it, and also in the scientific area. But we are integrating that but in our IT system. So in a way that we can bring all changes, all the new ideas rapidly to bear on what regulatory advice we give. And I think there are some very advanced things and that we are coming up, and we have been happy to provide advice on those as well like you have been cultured mate. Not exactly, but we have been working on that as well. So we are. And that means not only understanding the regulations that exist today but try to predict the regulation that will come up. So that’s very challenging and interesting. But on an everyday level, I think, but we are bringing more and more IT in our process, including artificial intelligence, but in a way that can interact well with the human consultants because that’s really what is needed, the interaction of the machine with the human.

Bethany Jolley: This episode is brought to you by nutrapayments.com. If your business needs credit card processing, that fully integrates with most major neutral software platforms, offers the lowest industry prices, and has built-in features like recurring billing, zero-dollar trials, and chargeback prevention. And visit us at nutrapayments.com for a free online quote. And, you know, the label I think is such a critical aspect of a product. And there are a lot of regulations about labeling, and they’re also crucial for consumer trust. That’s usually the first thing that the consumer is looking at. So what strategies does Hylobates employ to assist clients in these areas, ensuring that their labels are accurate and they’re following all regulations?

Luca Bucchini: So we have multiple steps. So the first thing they’re, you know, even with artificial intelligence and what have you today in terms of IT, people tend to forget is that first, you need to understand what is in the product. And some companies are separating the labeling from R&D and from production. You need to know what is in the product and what the name, the correct name, and the correct warnings on the application for the safety of the ingredient. And if you are not very careful about that, you will get all the labels wrong. So you need to understand the composition of the product in full. But that’s where we tend to focus most of the time because the consultants need to understand that and the companies need to understand that. And that’s a reason mistakes are made at that level. So we get the information on the composition, on the specific ingredients, and then we work with the customer to define the label. So we have an automated process to put together the labeling information in different languages. So that’s another part. So we propose we check the text. We have always at least two people checking all texts. When that text goes to the company we get the artworks back. We check the artworks again. The mix of automation and humans as many times as required to get a label which is compliant and is compliant, understandable for consumers and consistent with the philosophy and marketing of the company.

Bethany Jolley: Yeah, and from your experience, what are the most common hurdles for companies in the realm of food safety and labeling, and how does your firm help overcome those challenges?

Luca Bucchini: Well, for many companies, a large and very large issue is “Lack of staff with sufficient experience” because they have other things to do. And there are very few professionals out there that are qualified. So they make mistakes because the staff doesn’t have the skills, doesn’t have the time. So that review to understand the regulations, so that’s the big issue. And that’s the lack of automated systems, the lack of software. That software leads to mistakes. And the worst mistake is well there are many bad mistakes. But I think from the consumer’s point of view, so also our point of view is that when allergens are missed or ingredients are missed because that’s really a safety issue. So that’s for us the first concern and those mistakes do happen, do happen.

So that’s the first issue that we focus on. And yeah. So we’re really, that’s the first one, really not having the staff not having the time and not having the resources to do it. So you get a wrong label and it can be a safety issue. So it probably needs to be recalled. And very often companies are unhappy because there are mistakes, even grammar mistakes, or sometimes it has happened. But a company stays in front of the pack with no caffeine. And when there is caffeine in the ingredient list, which is obviously quite bad. So those are other mistakes. And You need a process. And many companies do not have a process for that, even relatively large companies. So we specialize in this. We don’t specialize in manufacturing. We don’t specialize in selling products. But with what brands do we specialize in this?

Bethany Jolley: Yeah. There are so many components to a label. And if you’re trying to do everything manually and you might not understand the regulations, it can be easy to miss something. Or like you said, with allergens, sometimes there’s ingredients in the product that you might not realize contain an allergen, but they do or even the various countries have different allergens that need to be cleaned. So that probably also is another mistake that gets made.

Luca Bucchini: Yeah, yeah. No, that’s true. That’s another issue. And then the warnings are also important. Sometimes regulatory issues. Sometimes it’s a safety issue because you know consumers need to be aware. But what is the proper use of the product? And it can be serious. For example, let’s say the product is saved when you take one tablet per day, is by mistake, you suggest four tablets per day. Then there could be a serious issue. So there are many things that you need to check and multiple levels. So yeah, and as you said, people read the labels, and rely on the labels to support proper use. And they also need to be clear because otherwise. Consumers do not read them in full and that can be an issue. So yeah, it’s a small part of the entire industry, but it’s significant nonetheless.

Bethany Jolley: Yes. And you have extensive experience in nutrient and health claims. And so what trends do you foresee in the regulatory landscape of the nutraceutical industry?

Luca Bucchini: Well, I imagined this before. I think people, rightly so, have a desire to keep healthy and even as they age, to keep doing things, to even young people, to just want to be healthy and prepare for living a healthy life even at a young age. So this is the underlying trend, but in a prosperous society is going to continue. And so you will get more products. I think we will there might be, say, small trends related to acute intakes like caffeine or focus, immediate focus. Yes, I think they might be important for a while, but I think the main things will be related to mental health and mental well-being as you age. Muscle fitness, but not so much in the sense of bodybuilding and light. Yes, this will continue as poor performance, but people will want to continue to be able to have good muscle mass as they age. So I see that and I work a lot with sports nutrition.

And what we have seen, and this is going to continue, is that if you are an elite athlete or you are very physically active, the main thing is that you need to be in good health to exercise. And so we are seeing and we will continue to see more products to help the physically active, to keep in shape, to avoid respiratory infections, and to avoid injuries. So claims related to those will be in the legislation on claims in Europe is very complicated. So it may be the way of communicating the benefits will not be through the health claims regulation, but those are there as well. I expect more innovation and more need to provide advice. And the other big trend is sustainability, and we’ll see more of that. There might be some moments in which things seem to go backward. But yeah, sustainability will be a big trend. And so substantiating sustainability, substances that are sustainable, that would be another big trend in the coming years.

Bethany Jolley: Yeah, absolutely. And how does Hylobates Consulting prepare for the upcoming changes in regulations, especially concerning novel foods and sports nutrition as you mentioned? 

Luca Bucchini: Of course, part of our work is reactive in the sense that there is a new regulation is published and we study it. And we interpret it in a way that’s useful, that can be applied to the products we deal with. But we try to do more than that. We read the proposed regulations so we understand what things are. And even before that, we read the scientific, the science, the scientific opinions and views that are going to shape regulation. So in a way that we help our customers to prepare for regulatory change. And so that reading scientific literature, attending scientific conferences, attending regulatory conferences. So we anticipate in that sense what is going to happen. Of course, then we follow case law because case law in the member states, in the EU, but also at the European level is also shaping what has to be done in the regulatory field.

Bethany Jolley: Yes. And looking ahead, what are Hylobates Consulting’s goals and visions, particularly in contributing to the evolution of the global regulatory framework?

Luca Bucchini: Yeah, look, what we see is that as our industry, the sports nutrition industry, and the food supply industry continue to grow. And because of consumer demand, we see that regulators are failing more than in the past. They failed in the past and are still failing. They were a complex political reasons or for complex reasons. They are not keeping track. And it’s not very often the fault of individuals, but it’s the lack of attention, a mix of things. So we have to contend with this situation. And the only good response from the industry has to be that the industry is reliable in the sense that they have best practices, they apply the regulations, they interpret them in a good way. So the response we have the industry in that sense. So as we have many customers, we work with so many products and we have different standards on how the industry complies. So but our contribution really is to make sense of that sometimes the regulatory mess out there.

So that in the end, that part of that uncertainty, part of that interaction of regulation becomes coherent. Our vision is really to provide that type of excellent understanding of regulations, putting them together. So the output is not only good compliance, reliability of products from a compliance point of view. So in that sense, I think we are helping the industry. We are helping consumers to be compliant, safe, and responsible even in the face of a fragmented regulatory landscape. So our vision is to continue to do that and always in a better way by having very good consultants, excellent consultants, because people matter and we want to have more and more great consultants and with systems, with systems that take human error out of the way and help put everything together in an effective way. So that’s our vision.

Bethany Jolley: Well, once again, thank you, Luca, for sharing your profound insights and the impactful work of Hylobates Consulting. For those looking to delve deeper into the world of regulatory consulting and food safety, we will provide links to Hylobates Consulting. Remember to subscribe and share your thoughts on today’s discussion. Stay tuned for more empowering conversations right here on NutraPreneur, where we explore the cutting edge of nutraceutical innovations.

Luca Bucchini: Thank you very much.

Bethany Jolley: 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.