Health Claims Regulation Research Articles

Health claim regulations on foods: impacts on life expectancy in Canada and the United States.

Chronic disease accounts for 70% of deaths globally and causes substantial economic burdens. Research indicates diet can significantly reduce the risk of many chronic diseases. Governments regulate health claims that can inform consumers of foods' health attributes and encourage them to consume healthy diets. This paper evaluates how the health status of North Americans has changed over time and after the approval of health claims in Canada and the United States. Data were obtained from the OECD Health Statistics database. A logarithmic health status function with country fixed-effects for Canada and the USA is used to evaluate changes in life expectancies over time. The findings indicate the health claims significantly affected female but not male life expectancies. However, both female (0.303%/year) and male (0.611%/year) life expectancies improved over the period, suggesting they are responsive to external health information. This paper provides insights and discusses policy options regarding the efficacy of specific health claims in Canada and the USA at nudging consumers to improve health outcomes.

Have health claims affected demand for fats and meats in Canada?

AbstractChronic illness is a global epidemic and places significant economic and social burdens on societies. Research has shown that a healthy diet can be used to mitigate or significantly reduce the risk of many chronic illnesses. Health authorities around the world have begun regulating health claims on foods to encourage the consumption of healthy foods. However, the “ex post” efficacy of health claims regulations on consumers demand for healthy foods has not been assessed. The demand for fats and meats in Canada is estimated using a linear‐approximate almost ideal demand system. The results indicate health claims decreased unhealthy food demand between 1.41% and 7.10% and increased healthy food demand between 1.95% and 8.50%.

Public Communication of Science through healthy food labelling in the US and Europe

A theoretical analysis of the American and European Health claims regulations. Following the studies on public communication and understanding of science, I identify the underlying regulatory strategies for the regulations on the presentation of this kind of information on food labelling. Based on empirical studies on perception and purchase intention, I assess the extent to which their communicative approaches contribute to achieving the regulatory objectives. Results: Both regulations follow different approaches depending on their different political objectives; The available studies point to the failure of these objectives in both cases; This seems to be due to underlying classical conceptions about science communication and enculturation.

Identifying labelling and marketing advantages of nutrients in minced beef meat: A case study

In 2006, the European Commission approved nutrition and health claim regulations of foods to stimulate healthier choices. To document how commercial, minced beef meat complied with regulations, meat samples from 72 carcasses were analysed. These samples were a source of niacin (B3), pyridoxine (B6), phosphorus and iron (cow meat only), and a rich source of protein, monounsaturated fat, vitamin B12 and zinc. A potential exists for establishing beef meat as a source of vitamin K, iron and selenium. The meat's nutrient relevance for young women when ingesting 150 g of raw beef mince/day was estimated. Increased levels of riboflavin (B2), pantothenic acid (B5), iron and selenium beyond presently observed, would better support this group's recommended nutrient intake. If the bioactivity of 25-OH-vitamin D3 could be used in calculations, vitamin D3 in the minced meat would add positively to the intake of vitamin D3 that was 49% of the recommended intake.

Understanding How Consumers Categorise Health Related Claims on Foods: A Consumer-Derived Typology of Health-Related Claims.

The Nutrition and Health Claims Regulation (NHCR) EC No 1924/2006 aims to provide an appropriate level of consumer protection whilst supporting future innovation and fair competition within the EU food industry. However, consumers’ interpretation of health claims is less well understood. There is a lack of evidence on the extent to which consumers are able to understand claims defined by this regulatory framework. Utilising the Multiple Sort Procedure (MSP), a study was performed (N = 100 participants across five countries: Germany, the Netherlands, Slovenia, Spain and the United Kingdom) to facilitate development of a framework of health-related claims encompassing dimensions derived from consumers. Our results provide useful insight into how consumers make sense of these claims and how claims may be optimised to enhance appropriate consumer understanding. They suggest consumers may not consciously differentiate between a nutrition claim and a health claim in the way that regulatory experts do and provide insight into where this might occur. A consumer-derived typology of health-related claims based on three key dimensions is proposed: (1) Familiarity with the nutrient, substance or food stated in the claim; (2) statement type in terms of simplicity/complexity; (3) relevance of the claim, either personally or for a stated population group.

A qualitative analysis of the enforcement of the regulation of nutrition and health claims made for foods and its implications for health.

In common with local government organisations across the world, local authorities in the UK have responsibility for promoting health. A key part of this function is the frontline enforcement activities of officers responsible for compliance with health and nutrition claims. This study identifies attitudes, values and practices of enforcers: namely trading standards and environmental health officers, when faced with the problem of non-compliance with the Regulation. Semi-structured interviews with frontline enforcers from local authority regulatory services to investigate challenges with the enforcement of Regulation (EC) 1924/2006. Twenty participants were interviewed; sixteen were based in North West England and two in the North and two in the South of England. The participants were selected for their specialist knowledge and experience of enforcement of nutrition and health claims. Regulation (EC) No. 1924/2006 on nutrition and health claims presents particular challenges for enforcers seeking to apply an optimal strategy to flawed regulatory design. As with other regulations, when faced with non-compliance, enforcers, specifically trading standards and environmental health officers have a wide discretion to determine their response: ranging from the deterrent or accommodative styles of enforcement. The participants reported using advice rather than action and by doing so confronting their bifurcating identity of prosecutor and advisor. Enforcers used advice as a regulatory tool in enforcing the law relating to nutrition and health claims.

The history of food reformulation

The history of food reformulation

Challenges and opportunities in the use of low‐energy sugar replacers

Challenges and opportunities in the use of low‐energy sugar replacers

Health Claims and Methodological Controversy in Nutrition Science.

This article analyzes the debate about data acquisition and assessment in health claims regulation by identifying the underlying controversies on methodological choice. Regulation in the European Union imposes the need for a scientific substantiation of all health claims (claims about a relationship between consumption of certain food ingredients and positive health effects). Randomized controlled trials (RCTs) are the method that generally is considered to provide the highest quality data for decision making in claims regulation because they allow for establishing cause-effect relationships. The latter are demanded in European regulatory practice for authorization of a claim. This requirement has contributed to a debate about the advantages and limitations of the RCT methodology in nutrition research and regulation. Our analysis identifies five types of tensions that underlie the controversy, with respect to evidence, cognitive values, standards of proof, future lines of research, as well as expert judgment. We conclude that there is a direct and mutual interaction between methodological decisions in nutrition science, and different strategies in health claims regulation. The latter have social and public health consequences because not only may they affect the European market for functional foods, as well as concomitant consumption patterns, but also the generation of future regulation-relevant evidence in nutrition.

The EU health claims regulation: implications for innovation in the EU food sector

Purpose One of the objectives of the Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) is protection and promotion of innovation in the food industry. The purpose of this paper is to explore the impact of the NHCR on both innovation and the sourcing of external knowledge in the European Union (EU) food sector. Design/methodology/approach An online survey was conducted which resulted in a sample of 105 EU companies for the study. Structural equation modelling was used to examine the nature of relationships that existed among the challenges related to the implementation of the NHCR, external sources of knowledge and innovation. Findings Challenges related to the NHCR are currently found to have a negative direct impact on product innovation. However, they have a positive indirect effect on product innovation, especially in the case of small and medium-sized enterprises. They also seem to positively affect external knowledge sourcing. Additionally, sources of external knowledge are found to have a positive effect on product and process innovations. Practical implications This study provides insights to different stakeholders in the food industry who might wish to work jointly and address the various issues related to the requirements of the NHCR and facilitate compliance with the regulation. Originality/value Understanding the impact of the NHCR on innovation seems pivotal because innovation plays an important role in the EU food sector. To this purpose, the paper delivers insights into some main compliance challenges and their effect on innovation.

Health and nutrition content claims on Australian fast-food websites.

To determine the extent that Australian fast-food websites contain nutrition content and health claims, and whether these claims are compliant with the new provisions of the Australia New Zealand Food Standards Code ('the Code'). Systematic content analysis of all web pages to identify nutrition content and health claims. Nutrition information panels were used to determine whether products with claims met Nutrient Profiling Scoring Criteria (NPSC) and qualifying criteria, and to compare them with the Code to determine compliance. Australian websites of forty-four fast-food chains including meals, bakery, ice cream, beverage and salad chains. Any products marketed on the websites using health or nutrition content claims. Of the forty-four fast-food websites, twenty (45 %) had at least one claim. A total of 2094 claims were identified on 371 products, including 1515 nutrition content (72 %) and 579 health claims (28 %). Five fast-food products with health (5 %) and 157 products with nutrition content claims (43 %) did not meet the requirements of the Code to allow them to carry such claims. New provisions in the Code came into effect in January 2016 after a 3-year transition. Food regulatory agencies should review fast-food websites to ensure compliance with the qualifying criteria for nutrition content and health claim regulations. This would prevent consumers from viewing unhealthy foods as healthier choices. Healthy choices could be facilitated by applying NPSC to nutrition content claims. Fast-food chains should be educated on the requirements of the Code regarding claims.

Unlocking the Energy of the Amazon? the Need for a Food Fraud Policy Approach to the Regulation of Anti-Ageing Health Claims on Superfood Labelling

The prevention and control of ‘food fraud’, including false or misleading statements made about a product for economic gain, is now emerging as an important and discrete policy goal for governments and regulators in the interface between food and public health. The control and prevention of food fraud complements regulation to ensure microbial food safety. This article uses a case study of anti-ageing claims made in the labelling and advertising of açai berry superfood products to argue that Australia's new regulatory system for nutrient content and health claims on food (Australia and New Zealand Food Standards Code Standard 1.2.7) inadequately addresses ‘food fraud’. This article argues that the over-reaching claims on açai product labelling will potentially mislead consumers and subvert public health messages in a context of ‘gastro-anomy’ (confusion over appropriate norms for eating) and ‘healthism’ (individual responsibility for making healthy choices). This conduct can usefully be conceptualised as food fraud. Second, the article argues that although the substance of Standard 1.2.7 is well designed to avoid food fraud, the fact that the standard allows food businesses to self-substantiate evidence when making some health claims undermines the protection offered. Australian food regulators need to articulate a more strategic and proactive approach to the prevention and control of food fraud.

The Nutrition and Health Claims Regulation Applies to Commercial Communications Addressed to Health Professionals

Case C-19/15 Verband Sozialer Wettbewerb eV v Innova Vital GmbH (ECJ, 14 July 2016)On 14 July 2016, the Court of Justice delivered its judgment on a request for a preliminary ruling concerning the interpretation of Article 1(2) of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. The Court ruled for the first time that the Regulation applies to nutrition and health claims made in commercial communications exclusively addressed to health professionals. This represents a major breakthrough as – in a climate of uncertainty – the established industry practice was to interpret Article 1(2) in the sense that the Regulation only applied to commercial communications addressed to final consumers. From now on, food business operators will need to take further precautionary steps to ensure that any information they communicate to health professionals either qualifies as non-commercial or complies with the Regulation. The following case note analyses the content of the judgment and its main implications (authors' summary).

Exploring the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What is the impact on innovation in the EU food sector?

Literature suggests that despite its positive aim of promoting innovation, the Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) may bring along several compliance challenges, which might affect innovation in the EU food sector. This study investigates the challenges faced by companies to comply with the NHCR (specifically Article 13.1) and their impact on innovation. To this end, we conducted an online survey with 105 companies involved in the EU food sector. Results indicate that companies perceive wording of claims, missing transparency and limited financial resources as major challenges to comply with the NHCR (Article 13.1). Companies reported not to have increased their R&D expenditure or innovation activities after the NHCR (Article 13.1) was implemented. Thus, this study highlights specific compliance challenges related to the NHCR (Article 13.1) and indicates that currently, the regulation does not seem to have fostered innovation in the EU food sector.

Reviewing the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What do we know about its challenges and potential impact on innovation?

Health claims potentially represent an opportunity for firms to engage in product differentiation and thereby induce investment into R&D and innovation in the food sector. The Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) aims at protecting and promoting innovation as one of its objectives. However, existing studies indicate that this regulation may create several challenges for innovation in the food sector. To this end, we review the challenges related to the NHCR (Article 13.1) and its impact on innovation. Extant literature suggests that companies face challenges related to changing list of ingredients, missing transparency, wording of claims, limited financial resources, limited R&D resources, switching product categories and abandoning the functional foods sector. Moreover, current studies imply that so far the NHCR (in specific Article 13.1) does not seem to encourage innovation in the EU food sector.

Perception and understanding of health claims on milk powder for children: A focus group study among mothers in Indonesia, Singapore and Thailand

Health claim regulations and guidelines on food products have been established in some Southeast Asia (SEA) countries. Health claims on food products aim to help consumers make informed food choices to achieve a healthy diet. This study aimed to investigate the perception and understanding of health claims and the associated regulatory frameworks of SEA mothers using semi-structured focus groups conducted in Indonesia, Singapore and Thailand. Milk powder for children for three years and above was used as product focus. The mothers recognised and recalled some specific nutrients and food constituents by name but lacked full understanding of their function. The findings indicated that the mothers in all three countries trusted health claims made on the products which was, in part, explained by their trust in their governments and the international brand manufacturers. Their understanding of health claims was influenced by several factors such as their familiarity of the nutrient, previous knowledge of the nutrients, the perceived relevance of the nutrient, the use of scientific terms, the choice of words, and also the phrasing and length of the claims. Consumer education efforts via Public, Private Partnerships could be an approach to educate SEA consumers and help them to better understand health claims. The findings of this study may be relevant to different stakeholders such as local regulatory bodies, policy makers, food industry, academia and non-profit organisations that aim to effectively communicate health claims.

Pomegranate Juice Can Do THAT? Navigating the Jurisdictional Landscape of Food Health Claim Regulation in a Post-POM Wonderful World

Pomegranate Juice Can Do THAT? Navigating the Jurisdictional Landscape of Food Health Claim Regulation in a Post-POM Wonderful World

¿Bueno para la salud? Un análisis de los requisitos de sustanciación científica en la regulación europea de las declaraciones de salud

To identify the various types of evidence, as well as their relative importance in European health claims regulation, in order to analyze the consequences for consumer protection of the requirements for scientific substantiation in this regulation. Qualitative analysis of various documents relevant to the regulatory process, particularly as to the implications of the standards of proof for the functional food market, as well as consumer behavior. European regulation defines a hierarchy of evidence that turns randomized controlled trials into a necessary and sufficient condition for health claim authorizations. Consumer protection can be interpreted in different manners. High standards of proof protect consumers from false information about the health outcomes of functional foods, while lower standards lead to more, albeit less accurate information about such outcomes being available to consumers.

Active ingredients leading in health claims on functional foods

Defining and characterising the active ingredient is the first criterion in reviewing scientific substantiation of health claims by the European Food Safety Authority under the Nutrition and Health Claim Regulation. This study analyses three health claim dossiers where the active ingredient is directly connected to the food item containing the bioactive. Since this bioactive itself is held responsible for the effect, the association of the food item and the bioactive is not always justifiable. This association is shown to be influenced by both the type of claim and the substantiating evidence. We argue that it would be preferable to more precisely chemically define the active ingredients. Claims could then be based on a bioactive constituent without the necessity to connect the claim to a specific matrix, becoming more transparent and relevant to both the industry and consumers. Characterisation and defining the bioactive should therefore be central in the health claim.

Navigating the Nutrition and Health Claims Regulation

An aspect of many of the papers in this issue of Nutrition Bulletin is the requirement for robust evidence if claims are to be made linking a nutrient, food or ingredient of a food with a particular beneficial effect. Examples include papers on fluoride (Ruxton & Bond 2015), vitamin D (Buttriss 2015a), fibre (Buttriss 2015b), plant bioactives (Kay 2015) and, in particular, a paper that describes an EC-funded project (REDICLAIM) that aims to understand the impact of European Regulation on the substantiation and use of new general claims and ‘reduction of disease risk’ claims in foods and drinks (Raats et al. 2015). REDICLAIM is seeking to understand the impact the Regulation is having on use of ‘reduction of disease risk’ claims, the main issues and hurdles regarding substantiation and use of these claims, and the level of awareness of legal obligations with regard to the use of claims, amongst relevant stakeholders. A modelling exercise will also be conducted to estimate the possible health and economic impacts in the general population of a ‘reduction of disease risk’ claim. In the September issue (Buttriss 2015c), we summarised the claims process and reported on some of the ongoing challenges being faced in the implementation of the Nutrition and Health Claims Regulation [Regulation (EC) No 1924/2006], even in situations where a positive opinion on the underpinning science has been given by the European Food Safety Authority (EFSA), the wording of a claim has been approved by the European Commission (EC) and the claim has been incorporated into the official list of approved claims. The Regulation harmonises the provisions related to nutrition and health claims and establishes rules governing the European Community authorisation of health claims made on foods and drinks. To help those considering submitting applications for new claims under the Regulation, EFSA has been consulting on an updated draft of the General Scientific Guidance for Stakeholders on Health Claim Applications; the consultation ended on 11 September 2015. Guidance documents have been available since 2007 (www.efsa.europa.eu/en/nda/ndaclaims.htm). Before the adoption of the new guidance document, account will be taken of the responses received during the public consultation. Once adopted, the new guidance will supersede the guidance published in 2011 (www.efsa.europa.euenefsajournalpub2135.htm) and the pre-submission guidance published in 2007. The draft guidance draws on experience gained during EFSA's evaluation of health claims and takes into account the outcomes of public consultations conducted previously that identified issues such as general principles, and administrative and procedural aspects related to the evaluation process that needed further clarification in order to assist applicants in preparing and submitting their applications for the scientific evaluation of health claims. Another source of information for would-be applicants, specifically written with the needs of small- and medium-sized enterprises (SMEs) in mind, has been developed within the EC-funded BACCHUS project (FP7-312090). The BACCHUS project focuses on developing rigorous science to support potential health claims in relation to a range of bioactives and cardiovascular health. The BACCHUS Best Practice Guide for Nutrition and Health Claims can be found at http://bit.ly/1MUm1YR. In addition to including guidance on the application process, the guide also summarises some work conducted within the BACCHUS project on the experiences of SMEs with the health claims process.