Health claims play a central role in communicating the health benefits of foods to consumers. As health and wellness continue to grow in importance, health claims offer companies a significant competitive advantage by attracting consumers and building product credibility. In the most countries, health claims are strictly regulated to ensure consumer protection and fair competition.
In this blog we look at the development, regulation and current trends of health claims both within the EU and globally. We also explore how research and health claims can be used step by step, even before an official health claim application is submitted.
What are health claims?
Health claims are statements made by food companies suggesting that consumption of a particular food or ingredient has a positive effect on health. A typical example is the claim: ” Calcium is needed for the maintenance of normal bones“. The definition and terminology of health claims can vary slightly from country to country. In general, health claims fall into two categories: functional claims and disease risk reduction claims, which often require different levels of scientific evidence.
In addition to verbal claims, images, symbols or graphic elements that indicate a health benefit are often considered health claims and subject to regulation.
Most countries provide lists of pre-approved health claims that companies can use without having to submit their own applications. In the EU and the UK, for example, there are over 200 approved claims available to food companies. However, new health claims usually require prior approval from regulatory authorities. In the US, on the other hand, companies can use structure/function claims based on their own assessment without prior approval.
What are not considered health claims?
The regulations on health claims apply specifically to the commercial communication of foods, such as marketing materials intended for consumers. Therefore, information or advice provided by public health authorities is not considered a health claim. Similarly, scientific publications, non-commercial communications or advice given to patients in healthcare settings are not considered health claims. Communication between companies is also generally outside the scope of health claim regulation.
Free webinar: How to get health claims approved in the EU
Do you want to stand out from the competition of food products with your own, brand new health claims? In this webinar we’ll provide an overview of the health claim approval process and the related requirements in the EU. Practical examples will also be showcased.
A brief history of health claims in the EU
Our Senior Regulatory Affairs Expert, Pia Karjalainen, has extensive experience with health claims and has followed the development of EU health claims legislation from the very beginning. Here we present key milestones in the history of health claims in the EU.
Before 2000, health claims were regulated inconsistently across the EU, with each Member State having its own rules and practices. This fragmented regulation created market imbalances and confusion for consumers. In 2006, a major step towards harmonisation was taken with the adoption of the Nutrition and Health Claims Regulation (EC) No 1924/2006. This Regulation introduced consistent rules for the use of health claims across the EU.
An ambitious goal was set to have a centralised EU register of all approved health claims by 2010, allowing companies to use only scientifically validated and reliable claims in their marketing.
In the initial phase of the Regulation, the Commission received over 44 000 health claim applications, many from companies, via the Member States. These claims were screened and consolidated, resulting in 4 637 health claims being submitted to the European Food Safety Authority (EFSA) for scientific evaluation. In addition, companies were able to submit their own health claim applications for evaluation.
In 2009, the Commission approved the first health claims based on companies’ own applications. A major milestone followed in 2012, when more than 200 claims submitted by Member States were approved. Most of these claims related to vitamins and minerals, but claims for ingredients such as oat fibre, live yoghurt cultures, fish and meat were also approved.
Examples of approved claims are:
- “Iron contributes to normal cognitive function”
- “Vitamin D contributes to the normal function of the immune system”
- “Plant sterols/stanols contribute to the maintenance of normal blood cholesterol levels”.
The list of approved and rejected claims is available on the European Commission’s website and is continuously updated as new health claims are evaluated.
Challenges in the assessment of botanical health claims
The complexity of the EU health claims process is well illustrated by the ongoing evaluation of botanical claims, some of which have been under review for over 10 years. The so-called list of botanical health claims contains 1548 general functional claims for botanical substances. While their final status remains uncertain, companies can continue to use these claims in their marketing for the time being.
Caffeine: Proven benefits, lingering safety concerns
The different roles and responsibilities of the European Commission and EFSA are evident in the case of caffeine claims. While EFSA has issued positive scientific opinions on some caffeine-related claims – such as its ability to improve concentration, alertness and endurance – the approval process at the Commission has stalled due to safety concerns. Discussions on these claims have been ongoing for more than a decade.
Health claim applications: challenging but achievable
Since 2008, companies have been submitting their own health claim applications to EFSA, particularly for disease risk reduction claims and those seeking data protection. Initially, the guidance for these applications was limited, although EFSA began to issue more detailed guidance in the following years. These guidelines have clarified the scientific evidence required for authorisation and helped companies to better prepare their applications.
However, many applications have been rejected due to insufficient scientific evidence or poor study design. Common problems include inadequate product characterisation or the use of studies with participants who were too sick to be representative of the general population. This highlights the importance of robust study design and clear product definition from the outset.
Competitive advantage through health claims and clinical studies in consumer and B2B markets
The regulation of health claims is now an established part of EU legislation. The list of authorised claims is constantly updated and new applications are regularly evaluated by EFSA. Recently, we have seen a growing interest in health claims and it is likely that the number of applications will increase in the near future.
Research plays a critical role as companies seek to use approved health claims to differentiate themselves from competitors and deliver value to consumers. A growing trend is the focus on global markets, which requires companies to be meticulous in the design of their health claims.
As consumer awareness grows, there is an increasing demand for concrete information and transparency about the health benefits of products. Often the aim of the health claim application process is to have an approved health claim displayed on the product packaging. While product names cannot currently be used in applications, detailed product characterisation can prevent competing products from using the same approved claim. Where possible, companies also seek to take advantage of the five-year data protection granted with health claims.
Health claims can also be an integral part of a multi-channel marketing strategy. Companies can use approved health claims across different channels, such as social media, websites, in-store campaigns and physical marketing materials. For example, companies can create nutrition and health-related content for their websites that explains how a product’s ingredients support health in line with approved claims. This not only improves search engine visibility, but also provides additional information to help consumers make purchasing decisions. Social media can be used to target health-conscious consumers more effectively.
In B2B markets, increasing sophistication and competition have raised expectations for scientific evidence to support the efficacy of a product or ingredient. Many companies start with research that can be used in business-to-business communications. The advantage is that individual studies can often be used in B2B marketing without the need for full health claim approval.
Protecting your claim
In the context of an EU health claim application, data protection refers to the protection of scientific data and the granting of exclusive rights to the applicant to use certain scientific findings and research results. This protection applies to certain parts of the application, such as clinical trials, and prevents others from using this information in their own applications for a certain period of time (five years). This exclusivity gives the applicant a competitive advantage as competitors cannot rely on the same studies to make a similar health claim within the period of protection.
Global markets and health claims outside the EU
Today, the general strategy is to target global markets from the outset, including, for example, the EU, the US and the UK. Ideally, research to support a health claim is designed so that the results are applicable to all target markets.
It is crucial to define the expectations of the research and ensure that the endpoints are in line with the desired health claim during the study planning phase.
The US system, which includes three categories of claims, enables companies to utilise various types of research and, if desired, gradually progress from structure/function claims to full health claims.
A carefully designed study plan and accurate product characterisation are key to success
EFSA’s assessment criteria are stringent and many applications have been rejected due to insufficient scientific evidence or weak study design. A common problem is inadequate product characterisation – failure to define precisely which ingredient or combination is responsible for the claimed health benefit.
Investing in a well-designed study plan is essential. Identifying the key variables of the study and their relationship to the desired health claim is critical. For example, a health claim related to blood pressure management is unlikely to be approved if the primary variable measured is unrelated to blood pressure. Including systolic and diastolic blood pressure as primary endpoints and indicators of effects on the renin-angiotensin system can provide a sound basis for the mechanism of action of the claim. If the study includes reasonably healthy participants, has an appropriate sample size and is conducted rigorously, the application will be much closer to success. It should also be emphasised that EFSA places considerable weight on human studies and a single study is rarely sufficient.
Product characterisation, as mentioned above, is another critical factor. Applications need to demonstrate exactly which compound or mixture is supporting the health claim. For example, while many studies on cranberries have shown promising results, many have been conducted on different cranberry products without adequate characterisation, or the products were too diverse in composition.
With a robust study plan and a well-characterised product, the same clinical trial can often be used in global markets. While the EU and UK may require more comprehensive applications and evidence, the research data can be used for B2B marketing or structure/function claims in the US.
Medfiles: your partner for health claim strategies
Medfiles’ experienced team has extensive expertise in both leveraging approved claims and navigating the application process for new claims. We are ready to help you develop a health claim strategy tailored to your specific needs and objectives.
Author: Anne Kivimäki, Ph.D., Regulatory Affairs Expert, Food
Anne joined Medfiles in 2021 and has been involved in several client projects since then. Her diverse and interdisciplinary experience in food and biomedicine brings a broad perspective and innovative problem-solving skills to various projects. In her current role, Anne can benefit from her diverse education, which includes a PhD in biomedical sciences, a Master’s degree in food chemistry with a specialisation in food safety, and an Bachelor of engineering degree in bio- and food technology.
Anne has a solid 20 years of scientific research experience in medical nutrition physiology, pharmacology, and oral health. In her PhD research, Anne studied the effects of Nordic berries on cardiovascular function, which illustrates her interest in the health effects of food. During her scientific career, Anne has been involved in several national and international pre-clinical and clinical research projects, and coordinated the operations of a research laboratory. As a result, she has excellent project management and coordination skills and a wealth of experience in scientific writing.
With a degree in Bio- and Food Engineering, Anne has solid expertise in food processing techniques and technologies. Prior to her university career, Anne gained valuable experience in the food industry, working as a health inspector and in food production.
Author: Pia Karjalainen, Team leader, Health claims and Nutrition // Senior Regulatory Affairs Expert, Food, feed and cosmetics
Pia Karjalainen has advised companies on various topics within food regulatory and scientific affairs throughout the past 15 years. She has gained wide regulatory expertise for a vast range of food categories, such as food supplements, foods for special medical purposes, food additives, novel foods and conventional foods. In recent years, Pia has expanded her areas of expertise to include animal feed and cosmetics.
Since the beginning of her regulatory career, Pia has focused on health claims, which has become her key competence area. She also has in-depth expertise in designing regulatory strategies for innovative ingredients. Her ability to understand the bigger regulatory picture and work with a solution-oriented attitude has led her to leading and handling many complex projects related to different product categories and borderline products.
Pia has earned a master’s degree in health sciences (nutrition) from the University of Eastern Finland. Prior to joining Medfiles in 2014, she worked with food regulatory affairs and as a registered dietitian in healthcare.
