Scientific Substantiation Of Health Claims Research Articles

An Evaluation of the Nutri-Score System along the Reasoning for Scientific Substantiation of Health Claims in the EU-A Narrative Review.

In this narrative review, the scientific evidence in support of the front-of-pack label (FOPL) Nutri-Score system is evaluated along with the reasoning for scientific substantiation of health claims in the EU. A health claim could be phrased as ‘Nutri-Score as an FOPL system results in an increased purchase of healthier foods by consumers’. Peer-reviewed scientific literature as found in Pubmed under search terms ”NutriScore” and “Nutri-Score” that investigate the effects of the Nutri-Score on food purchases were evaluated. In total, eight papers were identified. Only three studies were conducted in real-life settings, and five were on online purchases. In the EU, health claims are evaluated by the European Food Safety Authority (EFSA). Considering the three basic questions that EFSA uses to evaluate scientific substantiation of health claims, it appears that the (i) food/constituent (the Nutri-Score system) is sufficiently defined/characterised, and (ii) the evidence is sufficient to appraise the system as ‘beneficial to human health’. However, the scientific evidence for a (iii) cause-and-effect relationship is contradictory and limited. In conclusion, based on the EFSA approach for substantiation of health claims, there is insufficient evidence to support a health claim based on the Nutri-Score system, since a cause-and-effect relationship could not be established.

The essentiality of nutrients: a challenge to methodological monism in the scientific substantiation of health claims

This paper analyzes the way in which the EFSA has addressed the limitations that the essentiality of nutrients presents to the requirement of obtaining evidence from RCTs for the scientific substantiation of health claims. By redefining the requirements to affirm causality in the case of essentiality of nutrients, the EFSA has constrained the debate on the relevance of different methodologies in the field of nutrition research. However, avoiding this methodological debate does not settle the controversy as to whether the EFSA's evidentiary hierarchy is the best for both investigating causal relationships in nutrition and for achieving social objectives such as fostering innovation and public health.

Next Generation Health Claims Based on Resilience: The Example of Whole-Grain Wheat.

Health claims on foods are a way of informing consumers about the health benefits of a food product. Traditionally, these claims are based on scientific evaluation of markers originating from a pharmacological view on health. About a decade ago, the definition of health has been rephrased to ‘the ability to adapt’ that opened up the possibility for a next generation of health claims based on a new way of quantifying health by evaluating resilience. Here, we would like to introduce an opportunity for future scientific substantiation of health claims on food products by using whole-grain wheat as an example. Characterization of the individual whole wheat grain food product or whole wheat flour would probably be considered as sufficiently characterized by the European Food Safety Authority, while the food category whole grain is not specific enough. Meta-analysis provides the scientific evidence that long-term whole-grain wheat consumption is beneficial for health, although results from single ‘gold standard’ efficacy studies are not always straight forward based on classic measurement methods. Future studies may want to underpin the scientific argumentation that long-term whole grain wheat consumption improves resilience, by evaluating the disruption and rate of a selected panel of blood markers in response to a standardized oral protein glucose lipid tolerance test and aggregated into biomarkers with substantiated physiological benefits, to make a next-generation health claim for whole-grain wheat achievable in the near future.

Single Probiotic versus Multiple Probiotics - A Debate On Current Scenario for Alleviating Health Benefits.

Strain, dose, duration, validated clinical trial studies and scientific substantiation of health claims are needed in order to define a successful probiotic. In particular, the potency of probiotic differs from strain to strain. In this view, we aimed to know whether the single strain or multi-strain construct is more beneficial. We found that the studies were still under debate and mechanisms remain sometimes unclear. No conclusion can be made based on the strain experimentation. Safety data and significant statistical results for efficacy via well-controlled clinical trials are needed.

Guidance on the scientific requirements for health claims related to muscle function and physical performance: (Revision 1).

EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.

GP/EFSA/NUTRI/2014/01 Scientific substantiation of health claims made on food: collection, collation and critical analysis of information in relation to claimed effects, outcome variables and methods of measurement

GP/EFSA/NUTRI/2014/01 Scientific substantiation of health claims made on food: collection, collation and critical analysis of information in relation to claimed effects, outcome variables and methods of measurement

Grading health claims by weight of evidence would make for a better-informed public.

In the European Regulation 1924/2006 and especially its first recital, the evaluation of health claims (HC) by European Food Safety Agency (EFSA) was introduced so as "to ensure a high level of consumer protection, [and] give the consumer the necessary information to make choices in full knowledge of the facts…". Now, with 10 years of hindsight since the Regulation was adopted, it can be asked whether EFSA HC process of evaluation that led to a marginal number of accepted claims is consistent with this objective, not just for protecting consumers but for allowing them to decide freely and make informed choices. The aim of this paper was to demonstrate that the inclusion of a ranking of the weight of evidence in the assessment of EFSA's scientific substantiation of HC would allow consumers to benefit from the very high standard of scientific evaluation performed by EFSA. The definition of standards of proof is a generalized practice and rests on the principle that evaluations of health practices should be understood in terms of descriptions ranging from formal proof from high-power double-blind placebo-controlled studies to rankings based on the consensus views of experts or even agreement among professionals. Grading of weight of evidence - not of scientific expertise - is pervasive in all the recommendations or consensus meetings of health authorities or learned societies. This approach would stimulate research and product innovation as industrials would see a positive return on investment.

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.

The role of epistemic policies in regulatory science: scientific substantiation of health claims in the European Union

This paper presents an analysis of the concept of scientific substantiation in European health claims regulation. It focuses on the controversies about the demand for the establishment of cause-and-effect relationships between food consumption and health outcomes in claim substantiation. Our analysis, on the basis of regulatory and scientific documents, identifies two opposing views about the aims of health claims regulation. Each of these two stances links certain regulatory objectives with specific epistemic policies, that is particular sets of scientific methodology, criteria, and procedure. The regulators, in selecting a demanding evidentiary approach based on a hierarchy of methodologies that requires causal data for substantiation of claims, give priority to preventing the authorization of false claims. The opposing view, espoused by the critics of this approach, opts for less demanding requirements for substantiation, implying the market availability of a wider range of products with health claims that may provide individual as well as public health benefits. We argue that one of the objectives that underlie the European regulators’ demand for causal data is to protect their own credibility, by trying to isolate them from value-laden debates about the limitations of scientific methodologies, as well as the societal and policy implications of regulatory decision-making.

Stakeholders’ perception of the nutrition and health claim regulation

In 2007, the Nutrition and Health Claim Regulation (NHCR) entered into force, which required scientific substantiation of health claims. In the field of antioxidants, most proposed claims were negatively assessed by the European Food Safety Authority (EFSA). This study reviews the perception of the NHCR of 14 Dutch stakeholders to unravel the grounds for disproving the putative health claims. Most claims are shown to be refused based on the quality of scientific substantiation, due to usage of scientific methods on which no consensus has been reached and the differences in expectations and requirements. Three themes exemplify the need for improvement in applying the NHCR: (i) enforcement; (ii) methodology; and (iii) perceived impact of the NHCR. With highly diverging perceptions of stakeholders, the current effectiveness of the NHCR can be questioned. The views of different stakeholders on these themes help to focus the discussion on the NCHR in capturing health effects.

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Stimulus-based inferences about the scientific substantiation of health claims on food

Purpose – This paper aims to examine the effects of qualifying language, functional ingredient, ingredient familiarity and inferences of manipulative intent (IMI) on the likelihood that consumers make stimulus-based inferences about the level of scientific support for health claims on food. Design/methodology/approach – An advertisement copy test for a fictitious product bearing a caries risk-reduction claim has been conducted. The test design comprises three claim conditions, each corresponding to one of the sufficient levels of support for nutrient-health relations within the World Health Organization (WHO)-framework. Findings – The claim conditions have affected the likelihood of making stimulus-based inferences, which is lower for high-level-of-support claims as opposed to low-level-of-support and moderate-level-of-support claims. No effect of ingredient familiarity has been observed. The effect of the functional ingredient featured is significant at the 10 per cent-level. IMI has a negative effect on the likelihood of making a stimulus-based inference. Research limitations/implications – The survey relies on a demographically homogeneous sample. Practical implications – Examining the likelihood of stimulus-based inferences about health claim substantiation is essential for assessing the effectiveness of claim formulations and for addressing resulting miscommunication. Originality/value – The current paper addresses the research gap on consumer ability to identify the level of support for health claims within the European context.

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to cytidine 5′‐diphosphocholine and maintenance of normal vision pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Supporting PublicationsVolume 11, Issue 5 597E Technical reportOpen Access Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to cytidine 5′-diphosphocholine and maintenance of normal vision pursuant to Article 13(5) of Regulation (EC) No 1924/2006 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 21 May 2014 https://doi.org/10.2903/sp.efsa.2014.EN-597 Published date: 21 May 2014 Question number: EFSA-Q-2014-00309 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Reference Morreale Bubella R, Carità S, Badalamenti R and Morreale Bubella D, 2011 (claimed as proprietary by the applicant). Neuroprotezione del paziente con glaucoma cronico ad angolo aperto: ruolo della citicolina in soluzione orale. Ottica fisiopatologica, 3, 1– 7. Ottobelli L, Manni GL, Centofanti M, Iester M, Allevena F and Rossetti L, 2013 (claimed as proprietary by the applicant). Citicoline oral solution in glaucoma: is there a role in slowing disease progression? Ophthalmologica, 229, 219– 226. Volume11, Issue5May 2014597E ReferencesRelatedInformation

Technical meeting on the reporting of human studies submitted for the scientific substantiation of health claims

Technical meeting on the reporting of human studies submitted for the scientific substantiation of health claims

Implementation of the nutrition and health claim regulation – The case of antioxidants

This article analyses the consequences of the implementation of the nutrition and health claim regulation in the field of food products containing antioxidants or food products claiming antioxidant activity. To this end, it first examines the origin and creation of the regulation and the involvement of EFSA in assessing scientific substantiation of health claims. Three criteria are regarded as critical in EFSA’s opinions on the scientific substantiation of a health claim: the claimed effect (i) is well defined; (ii) is a clear beneficial physiological effect; and (iii) shows a cause effect relationship with the consumption of the food or functional ingredient. These criteria have implications for the research requested to substantiate health claims, although these implications do not all seem to fit nutrition research as it is currently executed. Looking at antioxidants, the complexity of the mechanisms and actions of antioxidants is not recognised by the criteria used to evaluate proposed health claims, nor by the methodologies used to assess the effects of antioxidants. These criteria should be adjusted with novel scientific insights after consulting stakeholders.

Use of published research in paediatric nutrition for the scientific substantiation of health claims referring to children's development and health

The European Food Safety Authority (EFSA) provides policy makers with scientific and technical advice in relation to food safety and human nutrition in an independent and transparent way, and communicates such advice to the general public. Requirements for the scientific substantiation of health claims referring to children's development and health are the same as for other health claims. However, children (particularly infants) have peculiarities which should be taken into account, because these may impair the extrapolation of results to other groups. Health claims used in commercial communications should be authorized only after a scientific assessment of the highest possible standard by EFSA. EFSA's negative opinions on rejected claims should not be read as a criticism to research studies published in paediatric nutrition but rather highlight their limitations in relation to the substantiation of specific health claims made on foods.

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to Slendesta® Potato Extract and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to Slendesta® Potato Extract and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL‐cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL‐cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Scientific substantiation of health claims in the EU

EU legislation on nutrition and health claims made on foods (Regulation (EC) No. 1924/2006) specifies that health claims should be only authorised for use in the Community after a scientific assessment of the highest possible standard is carried out by the European Food Safety Authority (EFSA). This paper focuses on the scientific substantiation of health claims within the context of the EU Regulation. The evaluation of the substantiation of health claims is carried out by the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA). The EFSA has published extensive guidance to assist applicants in the preparation of applications for authorisations of health claims. This guidance summarises the general principles applied by the NDA Panel in the evaluation of health claims, including the scientific criteria for substantiation, as well as the scientific requirements for the substantiation of specific health claims. To date, the EFSA NDA Panel has concluded that a wide range of health claims has been substantiated. These include claims for many well-established functions of nutrients, as well as beneficial effects of foods and food constituents on a range of body functions. In addition, claims have been substantiated on the role of nutrients in growth and development of children and on the effects of nutrients and food constituents on reduction of risk factors for disease. EFSA evaluations and guidance have made an important contribution to the understanding of the scientific substantiation of health claims which will help to set new directions for research and will guide future innovation.

Impact of a new European regulations on functional food market – an overview

Functional foods are defined as foods that provide health benefits in addition to their basic nutritional value. These additional health benefits form the basis for producers’ health claims on foods. Legislation demands that health claims should be based on and substantiated by generally accepted scientific evidence. The main topic of this presentation will be how the European Food Safety Authority (EFSA) approaches the issue of scientific substantiation of health claims on foods. Health claims can be categorized in different ways, but basically they will be of two types, namely those relating to maintaining or improving a biological function (‘function claims’), and those relating to reduction of a disease risk factor (‘risk reduction claims’). Disease itself can not be used as the formal end point, and claims on treatment or cure of disease can not be made. The target population of the health claim must be specified, and essential criteria are that the claim must be sufficiently specific to allow evaluation, the claim must represent a beneficial physiological effect, the food/food component for which the claim is made must be sufficiently well characterised, and last but not least there must be sufficient scientific evidence to substantiate the claim. All the criteria must be met. Scientific evidence is evaluated according to standard criteria for good science. The ongoing work in EFSA, with evaluation of some 4000 health claims, is an important step to secure that health claims on products in the marketplace are based on by sound, convincing scientific evidence, and that the claims will not soon have to be re-evaluated in light of new scientific data. Securing that claims are truthful, accurate and not misleading is expected over time to increase consumers’ trust in health claims on foods, and thereby supposedly also the use of products bearing health claims.