August 18, 2022

Healty

Slick Healthy

Personalized nutrition | RAPS

Feature ArticlesFeature Articles

| 28 July 2022 | By Nard Clabbers, MSc, Judith van der Horst-Graat, MSc, PhD 

| ©


2751


Personalized nutrition is founded in evidence-based science and draws on individual-specific information to help consumers promote positive, sustainable dietary behavioral change resulting in measurable benefits in health improvement and maintenance, or disease-specific benefits. This article provides a comprehensive definition of personalized nutrition and examines its regulation globally and in the EU in regard to data protection, product qualification, and claims.
 
Keywords – datahub, health claims, linked ecosystem, nutrition claims, personalized nutrition
 

Introduction

The personalized nutrition market is growing rapidly.1 Current trends – including the need for better health in the wake of Covid-19 and the search for a sustainable food system – create opportunities for a strong personalized nutrition industry. These opportunities also present challenges in this immature and evolving market. It could be argued that personalized nutrition as an industry started in 2006 with the launch of the UK-based direct-to consumer nutrigenetic company Sciona. The industry continued to grow slowly until 2012, when more genetic and blood marker testing companies entered the space. By 2015, the industry had expanded into several segments that included smart eating, devices, trackers, DNA and blood biomarker tests, personalized nutrition supplements, and meals.
 
Following publication of several landmark papers on personalized nutirition2 and general public interest in the topic, the microbiome segment became exceedingly popular. Novel insights into how diet, the microbiome, and health are interconnected could support the development of solutions for chronic diseases, prevent or postpone the occurrence of such diseases, and make personalized nutrition for better health a reality.3 By 2018, the industry had expanded to 200 companies that provided a combination of products and services. Despite the challenges presented by the pandemic, the industry has expanded further and currently comprises more than 350 companies offering a range of solutions.
 
The evolution of the personalized nutrition market is distinguished by three phases, beginning with a focus on DNA analysis. This phase evolved into a second phase with a systems approach and more holistic advice enabled by advances in technology and artificial intelligence. This phase is currently evolving into a third phase, with recommendations being underpinned by behavior change techniques to ensure clients can develop lasting healthier eating habits.

 
Modern personalized nutrition approaches require interaction and reciprocity between the company and the consumer, unlike previously, when consumer consumers were required to submit only health and lifestyle data to receive personalized advice. Consumer feedback on the effectiveness and utility of the advice is important for future success of personalized nutrition. This on-going consumer feedback is an integral part of data needed to improve underlying algorithms for continuously providing tailor-made advice. Ecosystems of companies need to work together to add true value for the individual consumer by providing advice, tools, and products necessary to facilitate behavior changes that support the user’s health, wellness, and even sustainability goals.
 
Figure 1. Timeline of personalized nutritio 
 
 Source: Foodvalley
 

Ecosystem-aligned definition of personalized nutrition

Clarity about what personalized nutrition is and is not, is a prerequisite for discussing the topic and establishing important steps in the shift toward a mature market. Personalized nutrition is, or should be, more than just the best evidence-based nutritional advice – behavioral change is also necessary. Thus, the definition should at least contain two pillars: the physiological and the psychosocial.
 
One of the more recent definitions states that personalized nutrition “uses individual-specific information, founded in evidence-based science, to promote dietary behavior change that may result in measurable health benefits.”4 The present authors agree this definition is suitable for the description of personalized nutrition, but suggest further clarification is needed for marketplace and/or healthcare application. They therefore propose the following definition:
 
Personalized nutrition could be a service or a product. It uses individual-specific information, is founded in evidence-based science, and its goal is to empower consumers to achieve positive, sustainable dietary behavioral change. That may result in measurable benefits for personal goals, such as health improvement and maintenance, or disease-specific benefits.
 

Finding business success in personalized nutrition

There are few examples of personalized nutrition the profitability, despite its seeming potential for success. There are as many opportunities as pitfalls in this space, necessitating a cautious approach. This section will provide an overview of successful and unsuccessful business cases, the factors driving success, and the outlook for overcoming barriers to sustained growth.
 
Successful and unsuccessful business models
The dominant business model for personalized nutrition companies is business-to-consumer (B2C), although some use the business-to-business or even business-to-business-to-consumer models. Companies in the personalized nutrition value chain offer solutions ranging from personalized dietary recommendation services to personalized products, such as meal kits or supplements (including vitamins, probiotics, etc.) based on different levels of specificity. Other incumbent models also help customers with “at-home” or “on-the-go” healthy eating.
 
Business models that cater to high-interest consumers, especially targeting supplements, are successful, but still niche. These business models seem to resonate with strategies given the ease of scalability. It also underscores that the cost, convenience, and deliverance of clear consumer benefits are current drivers in the personalized supplement space.
 
B2C products and services that are combined in a clear, easy-to-understand way and targeted at a specific consumer base seem to have achieved a reasonable degree of success on the personalized dietary recommendation front.
 
Crucial factors in profitable business models
Successful business models are likely to embody science- and evidence-based products and services that offer a good balance between perceived effort and experience gains. This approach entails having a clear target group and value proposition to organize the right distribution channels with a scalable and sustainable cost model. Profitable personalized nutrition business models should provide an affordable route to the market for consumers and a profitable path to market for investors. As personalized nutrition solutions continue to evolve, it is desirable to reduce the cost burden to consumers while delivering increased benefit and value, especially for solutions with more personalization.
 
In addition, convenience will continue to be an essential factor for a profitable business model. Solutions with a good value proposition that provide actionable insights and rapid attainment of measurable health benefits and that blend with consumer lifestyle tend to retain consumer engagement, striking a balance between effort and gains. The gap between personalization and convenience is narrowing, and this will eventually play a crucial role in shaping the future of personalized nutrition.
 
One simple way to narrow the gap between personalization and convenience is to offer a product or service that target groups can use routinely, which results in increased engagement and retention. A short feedback loop of goal-related parameters and the smart use of behavioral change techniques may also add to this. As the user becomes more engaged, services can be expanded.
 
Removing barriers, expanding innovation
Industry investment and collaboration is essential for taking personalized nutrition to the next level. Promoting joint innovation and fostering partnerships is crucial for addressing value chain challenges and driving growth in personalized nutrition. Industry players from various value chain points (including tech and diagnostic companies, food producers and retailers, as well as dieticians and health insurance and health care groups), should be involved to foster a connected ecosystem. The concept of “food as medicine” will gain momentum if local governments are supportive in creating space for developing such solutions.
 
Personalized nutrition solutions will evolve to become a multifaceted model, allowing users to self-select what goods and/or services best meet their needs. This, in turn, will enhance user retention for subscription-based programmes and compliance with prescribed dietary regimens. Reduced costs of testing (e.g., DNA sequencing, microbiome) and consumer tests to create the right value proposition will reduce out-of-pocket costs for users. Companies will monetize data on the back-end, for instance, with newfound information on nutrition-health relationships, thereby adding revenue streams to further reduce consumer-facing price points.
 

The ecosystem of personalized nutrition

Personalized nutrition can be seen as an ecosystem with a broad reach that goes from seed developers to food retailers, and from tech and data companies to the hospitality industry, always with the consumer in the driver’s seat and connected through, and driven by, data (Figure 2). A prerequisite to this ecosystem is a foundation of trust and transparency. Apart from businesses, the personalized ecosystem also includes governmental and nongovernmental bodies, knowledge institutes, and educational institutes.
 
A flourishing personalized nutrition ecosystem linking all contributing parties will empower consumers to change their behavior to healthier and preferably more sustainable dietary practices. A linked system will deliver products and services that are attractive, simple to use, affordable, convenient, and available together so that the consumer can make fully informed choices. Such an ecosystem is the best way to deliver targeted products and services be provided that will truly empower and change consumer behavior on a meaningful scale, although some niche, one-on-one solutions may still be relevant and profitable.
 
It is evident that more data-driven connections and joint innovations are needed to enable the growth of the personalized nutrition market.
 
Figure 2. The personalized nutrition ecosystem
  
 Source: Foodvalley
 

Data and IT infrastructure

Modern personalized nutrition approaches require interaction and reciprocity between parties. Consumer feedback on the effectiveness and utility of the advice is important for future success. This continuous feedback is an integral part of data that need continuously improvement and adaptation. The underlying algorithms to continuously provide tailormade advice. It will put the consumer in control on its nutritional advice.
 
Figure 3. Customer journey of personalized nutrition
  
 Source: Foodvalley
 
Personal information is required for the development of targeted nutritional advice, products, and services. The input can include:
 

  • Medical data (diagnoses, medication, allergies, intolerances),
  • Genetic, microbiome, and physiological data,
  • Behavioral data (diet, physical activity, sleep),
  • Information about routines,
  • Fitness and weight goals,
  • Personal, social, and cultural preferences, and
  • Purchase habits and other environmental data.  

Such data are extremely sensitive and require special security and handling protocols. Personalized nutrition data can be static (e.g., having an allergy), change over time (e.g., body weight), or measured at a continuous rate (e.g., physical activity, glucose level) and can differ in quality. The type and sensitivity of personalized nutrition data entail some particular requirements for the underlying IT infrastructure so that clients can be reassured their data are protected in the immediate term and for posterity.
 
Requirements
Working with personal data, real-time components, artificial intelligence algorithms, and the “internet of things” requires a robust IT infrastructure. Continuous innovation in personalized nutrition demands a platform that is flexible, but at the same time governable, secure, scalable, and cost effective. A datahub setup can be the start for long-term success. A datahub typically consists of five main components:
 

  • Management and control – Covers security settings, which have to be certified (conform with applicable regulations); all authorizations, logging, backup policies, retentions etc. for the datahub.
  • Data-ingestion – Data in all kinds of formats and different speeds (batch or streaming) and volumes can land on the platform.
  • Data storage – Data can be stored in tables, databases, or files; it can be archived when not used.
  • Processing – Algorithms can be deployed to “learn,” put into production; data can be combined, transformed, etc.
  • Serving layer – Transformed data can be made available to applications, used in visualization, or downloaded.

 Trust and transparency should be the foundation of the personalized nutrition platform, both to comply with regulations and remove consumer doubt about data sharing. Best practice includes clear communication about the risks and benefits of using the platform, how to opt in and out of using the platform, the approach and evidence (nutrition guidelines) used in the platform, and which data are stored and what is done with collected data.
 
To conclude, the end user of the personalized nutrition platform should be kept in mind when designing a data platform. Data and platform requirements are determined by the use case, considering the option to grow and extend the use case. The consumer should be free to choose what fits their needs, able to rely on data safety, and have the right to opt out at will.
 

Science of personalized nutrition

People differ greatly in their response to food. Personalized nutrition solutions should consider inter- and intra-individual differences in response to food. Given these individual differences, it is important to scientifically substantiate the effectiveness of a personalized nutrition approach. For personalized nutrition solutions, two levels of substantiation can be considered:
 

  • Personalized nutrition approaches that make use of substantiated food-health relations and incorporate those in decision algorithms or models; and
  • Substantiation for the effectiveness of the personalized nutrition solution in its totality in improving dietary behavior and inducing health benefits.

 
For the first level of substantiation, physiological inter-individual differences are used as a starting point in a personalized nutrition algorithm and linked to existing evidence-based food-health relations. For instance, for individuals with elevated triglyceride levels, the European Food Safety Authority’s (EFSA’s) health claim on the beneficial effect of omega-3 fatty acids in lowering triglyceride levels could be incorporated into a personalized recommendation.
 
In addition to taking account of existing food-health relations, personalized nutrition approaches can also use data-driven strategies in discovering new diet-health relations and personal dietary responses. Underlying models should be based on large, representative, inclusive datasets that contain information on long-term outcomes and are based on physiological and/or psychosocial principles. Public health guidelines, either global or national, should form the basis of personalized nutrition solutions.
 
Dedicated trials are required for assessing the effectiveness of the personalized nutrition approach in achieving behavior change and health benefits. This brings us to the second level of substantiation. The required level of evidence may vary depending on the novelty and complexity of the approach and differences in legislation between countries. Novel, data-driven approaches may require more extensive validation compared with approaches focusing on dietary preferences. Traditionally, food-health relations are investigated using randomized controlled trials and population averages. In personalized nutrition, study designs focusing on individual responses, such as n-of-1 case studies, modelling, or segmented analyses may be more suitable. In n-of-1 studies, an individual’s response to various dietary interventions can be investigated over time.
 
In personalized nutrition studies, not only health effects should be considered, but also the clinical relevance and added value thereof in relation to the burden of frequent or invasive measurements for customers. Lastly, for scalability of personalized nutrition approaches, it is important to consider which populations were studied and the possible ethical implications thereof.
 
To conclude, transparency on the personalized nutrition algorithms used, the rationale behind resulting recommendations, the level of scientific evidence and associated ethical issues are key to establishing a sound a scientific foundation for personalized nutrition.
 

The regulatory framework of personalized nutrition

From a legal perspective, the personalization of nutrition raises many questions about the applicability of existing law to personalization, including which legal framework is applicable based on type of claims made and the functioning and effects of the product. There are three main legal challenges from an EU law perspective – processing personal data, product qualification, and nutrition and health claims. (Although this contribution has been based on the EU regulatory framework, comparable legal questions also arise in other regions and countries globally.)
 
Processing personal data
The essence of personalized nutrition is that it targets individuals, including their phenotypic and/or genotype information and specific lifestyle and/or dietary requirements. To target a personalized nutrition product or solution in this way, a supplier will have to process personal data and especially, data concerning health. It is therefore crucial that a supplier processes personal data based on a valid legal basis, such as consent (see Article 6, EU Regulation 2016/679, aka, General Data Protection Regulation, or GDPR5). Processing health data is, in principle, prohibited unless specific conditions have been met.5
 
Suppliers of personalized nutrition products and/or solutions should be able to demonstrate that conditions of articles 6 and 9 of the GDPR5 (such as consent) have been met, for example, by documentation of written consent forms.
 
Product qualification
As personalized nutrition has been defined in this article, “measurable benefits” may imply a certain health intervention at an individual level. The way in which these health benefits are communicated plays an important role in the qualification of the product being offered. For example, such a product could qualify as a medicinal product, rather than as a food product, both by way of function and of presentation.
 
Personalized nutrition products could also qualify as a medical device or an in vitro medical device. Medical devices are any device, software, or other article intended for use for specific medical purposes, such as the diagnosis, prevention, monitoring, or treatment of a disease (see Article 2, EU Regulation 2017/745, aka, Medical Device Regulation, or MDR6). The key question for the MDR’s applicability is therefore whether the article or software concerned has a medical purpose or is merely lifestyle or well-being related.
 
How a personalized nutrition product or service is qualified determines the applicable regulatory framework and has a significant impact on the legal requirements. Entrepreneurs should be open to a thorough product qualification analysis before market entry.
 
Nutrition and health claims
Even if personalized nutrition qualifies as a food product, rather than a medicinal product or medical device, claims about its health benefits have to be substantiated and fall within a legal framework. In fact, there is a strict legal framework that applies here, both for mandatory and voluntary food information. Any statement that describes, suggests, or implies that a food product has certain beneficial nutritional characteristics (nutrition claim) or that its consumption will result in certain health benefits (health claims) is regulated within the EU (see Regulation (EC) No 1924/20067).
 
Only pre-authorized claims substantiated by scientific evidence, as assessed by the EFSA, can be used on foods. Health claims can be used to address health benefits of foods, and no suggestions or implications can be made that consuming a food may result in treating, curing or alleviating symptoms of a disease.7 Health benefits of personalised nutrition products can be put forward only they are supported by pre-authorised claims and the product meets the conditions of use for this claim. For example, it is currently uncertain whether referring to genetic predispositions in claims would be considered a medicinal or health claim. Also, it is unknown whether health claims, currently mainly targeting the general population, could be directed to specific target groups that might benefit from these personalised or tailored products.8
 
Overall, personalized nutrition is subject to extensive regulation under existing EU legislation. From a birds-eye view of legal frameworks applicable globally, data protection, product qualification, and the regulation of voluntary food information comprise similar concepts although the detailed rules differ. Awareness of the different regulatory frameworks is critical before market entry.
 

Future recommendations

Future development is forecasted in the following areas of personalized nutrition:

 

  • Joint and multidisciplinary innovation for the growing market and ecosystems of personalised nutrition;
  • Structured and demand-driven investment, from public and private sources;
  • Policy and legislation to support this growing field; and
  • Training the broad range of personalised nutrition professionals of the future.  

There are two possible scenarios for personalised nutrition:
 

  • One in which niched, highly specialised players will interact in one-on-one with their well-informed clients, as is the case in existing business models; or
  • One in which larger consortia will build dynamic digital platforms where the mass market consumers can find the information and motivation that fits their momentary personal goals. It is believed that the bulk of personalised nutrition growth will be in this segment.  

Irrespective of which scenario plays out, joint innovation and a uniform vision for personalised nutrition service providers and related services for the future for the industry will be required.
 
Acronyms and abbreviations
B2C, business-to-consumer; EFSA, European Food Safety Authority; MDR, Medical Device Regulation.
 
About the authors
Nard Clabbers, MSc, is chief science officer at Happ. He has worked for the food industry for more than a decade as the liaison between marketing and science. In 2011, he joined Dutch applied research organization TNO to lead the nutrition and health business line. While at TNO, he also set up the world’s largest public-private research consortium on personalized nutrition and health with Wageningen University. Clabbers has a master of science degree in human nutrition from Wageningen University in the Netherlands. He can be reached at [email protected]
 
Judith van der Horst–Graat, MSc, PhD, is the innovation lead, food & health, at Foodvalley NL. She has a master’s degree in biological health sciences from Maastricht University and a PhD in human nutrition and epidemiology from Wageningen University. She can be reached at [email protected]
 
Acknowledgment This article is an edit of a personalized nutrition position paper published by Foodvalley NL in 2021. The full citation for the paper is: 
Clabbers N, van der Horst–Graat J, et al. Personalized nutrition position paper. Foodvalley. Published 2021. https://www.foodvalley.nl/wp-content/uploads/2021/10/Personalized-Nutrition-Position-Paper-final.pdf
 
Citation Clabbers N, van der Horst–Graat J. Personalized nutrition. Regulatory Focus. Published online 27 July 2022. https://www.raps.org//news-and-articles/news-articles/2022/7/personalized-nutrition
 
References
All references were accessed and/or verified on 30 June 2022.

  1. Miller R. Personalized nutrition: An exciting category with challenges ahead. Published 30 June 2021. https://www.foodvalley.nl/news/personalized-nutrition-an-exciting-category-with-challenges-ahead/
  2. Zeevi D, et al. Personalized nutrition by prediction of glycemic responses. Cell. 2015;163:1079-94. https://www.cell.com/cell/pdf/S0092-86741501481-6.pdf
  3. D’Hondt K, et al. Personalized nutrition for better health: Targeting the human microbiome.  Regulatory Focus. July 2019. https://www.raps.org/news-and-articles/news-articles/2019/6/personalized-nutrition-for-better-health-targetin
  4. Adams SH, et al. Perspective: Guiding principles for the implementation of personalized nutrition approaches that benefit health and function. Advances in Nutrition. 2020;11(1):25-34. https://academic.oup.com/advances/article/11/1/25/5556010
  5. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679
  6. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
  7. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:404:0009:0025:En:PDF
  8. Braakhuis A, Monnard CR. Consensus report of the Academy of Nutrition and Dietetics: Incorporating genetic testing into nutrition care. J Acad Nutr Diet. Published online March 2021. https://pubmed.ncbi.nlm.nih.gov/32624395/

© 2022 Regulatory Affairs Professionals Society.