Regulatory Framework of Fortified Foods and Dietary Supplements for Athletes: An Interpretive Approach.

A varied and well-planned diet can meet the nutritional needs of an athlete; however, in certain cases, it could be advisable to increase the intake of some vitamins, minerals or other components through the controlled intake of fortified foods or dietary supplements. In the European Union, a high number of sport foods and supplements are marketed; athletes could at times consume them indiscriminately or even choose products that have not been evaluated and approved by scientific evidence. In this sense, it is necessary to know and interpret the specific regulations for these products in order to make adequate use of them. The aim of this manuscript is to describe the current status of the European regulatory framework, focusing on: (1) regulation of the marketing and labelling of both fortified foods and supplements; (2) regulation of the use of substances used as ingredients in fortified foods; and (3) regulation of nutritional claims and/or health properties associated with nutrients, ingredients and other related substances. This review can facilitate knowledgeable decision making by sports nutrition professionals in order to counsel or manage adequate food choices as well as help consumers make better-informed food decisions. Other experts, such as producers who ensure food safety, might also be interested in this review.

A Graded Approach for Evaluating Health Claims about Plant-Based Food Supplements: Application of a Case Study Methodology.

The implementation of REGULATION (EC) No 1924/2006 has led to the formation of a list of health claims that can be used in food supplements (EU 432/2012). However, such supplements are often composed of plant preparations with claims omitted from this list. The peculiarity of plants is related to their long history of use, that could allow claims based on traditionally recognized health effects. In addition, the scientific literature has been enriched over the years through clinical studies that have assessed the bioavailability and efficacy of bioactive components, and investigated their mechanisms of action. Based on existing recognized models which aim to classify research according to the level of scientific evidence, Synadiet developed a three-grade model (A, B or C) for assessing plants health claims. In this paper, the applicability of the model is illustrated through an example for which a Grade B health claim attesting the possible contribution of red clover isoflavones to the improvement of blood lipid levels in postmenopausal women has been attributed. The model appears able to be easily extrapolated to claims pertaining to other plants. If adopted by consensus at European level, this model could initiate the implementation of a positive list of health claims on plant preparations.

Health-related claims in food supplements endorsements: a content analysis from the perspective of EU regulation.

OBJECTIVES: Based on the legal framework regulating the advertisement of food supplements in the EU, the aim of this article is to analyse the relationship between the presence of endorsers, the different types of health-related claims (H-RCs) and product content information. STUDY DESIGN: We applied a quantitative approach based on the content analysis of all radio spots broadcast throughout 2017 on full-service radio stations in Spain. METHODS: A corpus of 10,556 radio spots was obtained of the three radio stations with the highest audience levels (165 without repetitions). We incorporated data on the accumulated broadcast frequencies to supplement the content analysis specific to each radio spot with its weight in relation to the overall advertising discourse. We developed a coding scheme to assess the type of endorser, the types of H-RCs, and the product content information. RESULTS: Results show that European directives are breached in different ways. Healthcare experts prevail in disease claims, although they are prohibited. Celebrities are the most widely used endorsers (25%) in the function and reduction of disease risk claims. In addition, although these types of claims require substantiation by authorised ingredient, 73% of H-RCs lack this information. CONCLUSIONS: The high presence of illicit H-RCs and endorsers, such as physicians, and the omission of compulsory product information suggest that public administrations must apply stricter monitoring and sanctioning mechanisms to dissuade advertisers from further breaches of the law and to protect consumers. Implications for public health policy are made.

Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.

Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y (n = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.

Predicting obesity reduction after implementing warning labels in Mexico: A modeling study.

BACKGROUND: In October 2019, Mexico approved a law to establish that nonalcoholic beverages and packaged foods that exceed a threshold for added calories, sugars, fats, trans fat, or sodium should have an "excess of" warning label. We aimed to estimate the expected reduction in the obesity prevalence and obesity costs in Mexico by introducing warning labels, over 5 years, among adults under 60 years of age. METHODS AND FINDINGS: Baseline intakes of beverages and snacks were obtained from the 2016 Mexican National Health and Nutrition Survey. The expected impact of labels on caloric intake was obtained from an experimental study, with a 10.5% caloric reduction for beverages and 3.0% caloric reduction for snacks. The caloric reduction was introduced into a dynamic model to estimate weight change. The model output was then used to estimate the expected changes in the prevalence of obesity and overweight. To predict obesity costs, we used the Health Ministry report of the impact of overweight and obesity in Mexico 1999-2023. We estimated a mean caloric reduction of 36.8 kcal/day/person (23.2 kcal/day from beverages and 13.6 kcal/day from snacks). Five years after implementation, this caloric reduction could reduce 1.68 kg and 4.98 percentage points (pp) in obesity (14.7%, with respect to baseline), which translates into a reduction of 1.3 million cases of obesity and a reduction of US$1.8 billion in direct and indirect costs. Our estimate is based on experimental evidence derived from warning labels as proposed in Canada, which include a single label and less restrictive limits to sugar, sodium, and saturated fats. Our estimates depend on various assumptions, such as the transportability of effect estimates from the experimental study to the Mexican population and that other factors that could influence weight and food and beverage consumption remain unchanged. Our results will need to be corroborated by future observational studies through the analysis of changes in sales, consumption, and body weight. CONCLUSIONS: In this study, we estimated that warning labels may effectively reduce obesity and obesity-related costs. Mexico is following Chile, Peru, and Uruguay in implementing warning labels to processed foods, but other countries could benefit from this intervention.

Intake of Non-Nutritive Sweeteners in Chilean Children after Enforcement of a New Food Labeling Law that Regulates Added Sugar Content in Processed Foods.

After enforcement of a new food labeling law in 2016, Chile exhibits a greater offer to reduced sugar products with addition of non-nutritive sweeteners (NNS). Many of these products are consumed by children, who are at greater risk of reaching the acceptable daily intake (ADI) of these food additives. The objective of this study was to evaluate the intake levels of NNS in Chilean schoolchildren after the enactment of the aforementioned law. A total of 250 Chilean children 6-12 years old were surveyed. NNS intake was assessed through a food frequency questionnaire. All children evaluated consumed at least one NNS during the previous month. Sucralose had the highest consumption frequency reaching 99.2%, followed by acesulfame-K (92.8%), stevia (86.0%), and aspartame (85.2%). Aspartame showed the highest median intake, which came mainly from beverages (96%). No children exceeded the ADI of any NNS. Smaller children exhibited a higher body weight-adjusted intake of sucralose, acesulfame-K, stevia, and aspartame (p < 0.05). In Chile, a wide range of processed foods with NNSs is available and all schoolchildren evaluated consumed at least one product containing NNS. However, this consumption does not exceed defined ADIs for any of the six sweeteners authorized for food use in Chile.

Potential Nutrition and Health Claims in Deastringed Persimmon Fruits (Diospyros kaki L.), Variety 'Rojo Brillante', PDO 'Ribera del Xúquer'.

In Europe, nutrition and health claims made on food must be based on scientific evidence, which means a comprehensive evaluation by the European Food Safety Authority (EFSA) prior to authorisation. Processed foods are subject to numerous claims derived from the presence of bioactive compounds; however, natural food products, often the original sources of those compounds, are not habitually the subject of these claims. Although the consumption of persimmon fruit has important health benefits, up to date no specific health claims are authorised for this fruit. In this work, 'Rojo Brillante' persimmon fruits (Diospyros kaki L.), Protected Designation of Origin (PDO) 'Ribera del Xúquer' were characterized regarding the presence of fiber (soluble and insoluble), vitamin C (ascorbic and dehydroascorbic acids), carotenoids (neoxanthin, violaxanthin, ß-cryptoxanthin, lycopene, ß- carotene) and mineral elements (Fe, Cu, Zn, Mn, Ca, Mg, Na, K). Different fruit batches harvested in different seasons were analyzed by standardized analytical methods (Association of Official Analytical Chemists, AOAC), high-performance liquid chromatography with ultraviolet detection (HPLC-UV) and atomic absorption spectroscopy. Based on the results, Persimon® is potentially able to show two nutrition claims "Source of fiber" and "Sodium-free/salt-free". This work could set the ground for future studies and to start considering natural food products as candidates for the use of approved claims.

[Evaluation of Safety Information of the Foods with Function Claims Based on Adverse Event Reports in Information System on Safety and Effectiveness for Health Foods Database].

Foods with Function Claims are allowed to label health claims based on scientific evidence evaluated by the manufacturers. To prevent health problems caused by inadequate use, the manufacturers should label proper safety information. To evaluate whether safety information is sufficiently provided, we conducted the adverse event review focused on popular functional ingredients using the database; Information system on safety and effectiveness for health food. The data suggested that causal factor of adverse events related to products containing soy isoflavone, ginkgo biloba extract and docosahexaenoic acid/eicosapentaenoic acid were overdose intake, concomitant use with certain medicines, and use by whom with an allergic predisposition. However, the safety information on the label was insufficient to prevent adverse events on each products' label. It is important not only to encourage food manufacturers to provide sufficient information based on safety review, but also to inform consumers about adverse events.

Uncured-Labeled Meat Products Produced Using Plant-Derived Nitrates and Nitrites: Chemistry, Safety, and Regulatory Considerations.

Consumers often malign conventional curing agents while concomitantly accepting the natural forms of the same constituents in numerous food products. This paradox ostensibly exceeds all other food-related controversies to date and likely contributes to the rapid expansion of meat products that utilize natural nitrate derivatives. While there is high demand for these products, a fundamental lack of understanding regarding the safety and chemical implications of curing agents, whether derived from synthetic or natural sources, continues to persist. This manuscript elucidates the variations among curing preparations with particular emphasis pertaining to the associated safety, chemical, and regulatory ramifications encompassing these product categories.

Análise do perfil de cloreto de sódio em salsichas tipo hot dog: comparação com a descrição na rotulagem / Analysis of sodium chloride profile in hot dog sausages: comparison with description in labeling

As salsichas são alimentos que contém grande quantidade de sódio, uma unidade corresponde cerca de 20% do valor recomendado diário desse micronutriente. O objetivo desse estudo foi quantificar o teor de NaCl em diferentes lotes de salsichas tipo hot dog, que utilizam em seus rótulos o termo “30% menos sódio”, verificar se atendem ao que preconizam as legislações e se as informações nos rótulos estão de acordo com os resultados obtidos. Todas as análises foram realizadas seguindo a metodologia oficial. As comparações entre os resultados e os rótulos atuais mostraram que os lotes de salsichas analisados estão de acordo com legislação, porém, em desacordo com seus rótulos. Conclui-se que o processo de fabricação dos lotes das salsichas analisadas, possui falhas em sua padronização, uma vez que, constatou-se uma grande variabilidade entre as porcentagens determinadas nas análises laboratoriais e as declaradas em seus rótulos.

A Systematic Narrative Review of the Evidence for Labeling of Natural Health Products and Dietary Supplements.

Background: It is not clear what information is needed on labels of natural health products and dietary supplements to support informed consumer choice and use of these products. Aim: The purpose of this review was to explore if/how label information impacts consumer decision-making about food, over-the-counter drugs, and natural health products/dietary supplements and to make recommendations about how this evidence may be applied to natural health products/dietary supplements. Method: A narrative analysis of a systematic review was performed. Medline and Embase databases were systematically searched to identify relevant studies from 1985 to February 2018 for all available English-language articles. This was supplemented with hand searches of the reference lists of review articles. Results: One hundred and fifty-one studies met the inclusion criteria, and after excluding review articles, 127 were included in the analysis. The findings from the studies were categorized into three main themes: (1) impact of labeling on consumer behavior (the majority of studies found that changes in label format or information had little to no effect on consumer behavior such as purchasing); (2) consumer comprehension of label information (significant proportions of consumers were unable to accurately interpret information found on natural health product/dietary supplement, over-the-counter medication, or food labels); and (3) label formatting/design, including standardization of information in fact tables (standardization, front-of-pack, and contrasting color panels were preferred and best attracted consumer attention). Conclusions: Many consumers did not regularly read product labels, nor understand the information they read on those labels. There was evidence that consistency of information was preferred by many consumers. Font size clearly impacted consumers' ability to read and understand the information on labels and this needed to be balanced with the amount of information required on labels. There was evidence that symbols that are simple and used sparingly are helpful in providing direction to consumers. Finally, regardless of what information was on the label, changing labels alone was unlikely to have a significant impact on consumer behavior.

Qualified Health Claim Language affects Purchase Intentions for Green Tea Products in the United States.

Qualified health claims (QHC) describe diet-disease relationships and summarize the quality and strength of evidence for a claim. Companies assert that QHCs increase sales and take legal action to ensure claims reflect their interests. Yet, there is no empirical evidence that QHCs influence consumers. Using green tea as a case study, this study investigated the effects of QHCs on purchase intentions among adults 55 years and older living in the US. An online survey using a between-subjects design examined QHCs about the relationship between green tea and the reduced risk of breast and/or prostate cancer or yukichi fruit juice and the reduced risk of gastrocoridalis, a fictitious relationship. QHCs written by a green tea company generated greater perceptions of evidence for the relationship, greater confidence in green tea and cancer, and increased purchase intentions for green tea than other QHCs. Factors that mitigated the claim's effects on purchase intentions are: Race/ethnicity; age; importance of health claims; supplement use; health; worry about health/becoming sick with cancer; worry that led to dietary change; green tea consumption; and familiarity with the green tea-cancer. Consumers who made health-related dietary change in the past year and consider health claims important indicated greater purchase intentions than others.

How effective is food industry self-substantiation of food-health relationships underpinning health claims on food labels in Australia?

OBJECTIVE: The Food Standards Code regulates health claims on Australian food labels. General-level health claims highlight food-health relationships, e.g. 'contains calcium for strong bones'. Food companies making claims must notify Food Standards Australia New Zealand (FSANZ) and certify that a systematic literature review (SLR) substantiating the food-health relationship has been conducted. There is no pre- or post-notification assessment of the SLR, potentially enabling the food industry to make claims based on poor-quality research. The present study assessed the rigour of self-substantiation. DESIGN: Food-health relationships notified to FSANZ were monitored monthly between 2013 and 2017. These relationships were assessed by scoping published literature. Where evidence was equivocal/insufficient, the relevant government food regulatory agency was asked to investigate. If not investigated, or the response was unsatisfactory, the project team conducted an independent SLR which was provided to the government agency. SETTING: Australia.ParticipantsSelf-substantiated food-health relationships. RESULTS: There were sixty-seven relationships notified by thirty-eight food companies. Of these, thirty-three relationships (52 %) from twenty companies were deemed to have sufficient published evidence. Four were excluded as they originated in New Zealand. Three relationships were removed before investigations were initiated. The project initiated twenty-seven food-health relationship investigations. Another six relationships were withdrawn, and three relationships were awaiting government assessment. CONCLUSIONS: To ensure that SLR underpinning food-health relationships are rigorous and reduce regulatory enforcement burden, pre-market approval of food-health relationships should be introduced. This will increase consumer and public health confidence in the regulatory process and prevent potentially misleading general-level health claims on food labels.

Perspective: Structure-Function Claims on Infant Formula.

In the context of a food product label, the term "claim" refers to information that attributes value to the product. The term extends to many different types of information, from product identity, descriptors of intended use, and identification of characteristic properties to the physiologic effects in the body of substances in the food, including the reduction of risk of disease. Food labeling, which includes claims, provides information that consumers want and use to improve their diets. Consumers prefer short statements on the front label claims to longer, more detailed information, including ingredients statements and a nutrition panel. Three types of claims are permitted in the United States. Nutrient content claims describe the level of the nutrient in the food relative to an established daily value, e.g., "Excellent source of choline," and are subject to composition limits for other nutrients, such as total fat, saturated fat, and cholesterol. Health claims describe the relation between a food substance and the risk of disease, e.g., "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis." They must undergo a premarket evaluation by the FDA to ensure that there is significant scientific agreement about the relation in question. The third type of claim, structure-function (SF) claims, has recently come under scrutiny, particularly regarding their use on infant formula. Such claims represent a food's effect on the structure or function of the body for maintenance of good health and nutrition. These claims must be truthful and not misleading, but are not subject to premarket approval before use. The purpose of this perspective is to describe the origins and unique niche of SF claims, and to comment on recent proposals to further regulate such claims on infant formula.

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006.

Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function.

Development of functional agricultural products utilizing the new health claim labeling system in Japan.

In April 2015, Consumer Affairs Agency of Japan launched a new food labeling system known as "Foods with Function Claims (FFC)." Under this system, the food industry independently evaluates scientific evidence on foods and describes their functional properties. As of May 23, 2017, 1023 FFC containing 8 fresh foods have been launched. Meanwhile, to clarify the health-promoting effects of agricultural products, National Agriculture and Food Research Organization (NARO) implemented the "Research Project on Development of Agricultural Products" and demonstrated the risk reduction of osteoporosis of ß-cryptoxanthin rich Satsuma mandarins and the anti-allergic effect of the O-methylated catechin rich tea cultivar Benifuuki. These foods were subsequently released as FFC. Moreover, NARO elucidated the health-promoting effects of various functional agricultural products (ß-glucan rich barley, ß-conglycinin rich soybean, quercetin rich onion, etc.) and a healthy boxed lunch. This review focuses on new food labeling system or research examining functional aspects of agricultural products.

Why Americans Need Information on Dietary Supplements.

Until a decade ago, no dietary supplement (DS) databases with open access for public use existed in the United States. They were needed by researchers, since half of American adults use dietary DSs and, without information on supplement use and composition, exposures could not be estimated. These articles on Challenges and Future Directions for Dietary Supplement Databases describe subsequent progress. They begin by describing why information on DSs is needed by the government and how it is used to ensure the health of the public. Current developments include: application of DS information to meet public health needs; research efforts on DS quality, efficacy, and safety (as conducted by the Office of Dietary Supplements and other federal agencies); enhanced regulatory activities implemented by the FDA Office of Dietary Supplement Programs, the FDA Office of Enforcement, and the Federal Trade Commission; and initiatives for broader development and dissemination of DS databases for commercial and public use. Other contributions in this journal supplement describe the challenges of working with DSs and the progress that has been made. Additional articles describe surveys of DS use among the general US population and also among special groups such as high supplement users, illustrating why there is a need in the United States for information on supplements. Likely directions for the future of DS science are summarized.

Characteristics and Challenges of Dietary Supplement Databases Derived from Label Information.

Launched in 2008, the Dietary Supplement Label Database (DSLD) permits the search of any term that appears anywhere on product labels. Since then, the database's search and download features have been periodically improved to enhance use for researchers and consumers. In this review, we describe how to customize searches and identify products and ingredients of interest to users in the DSLD, and provide the limitations of working with information derived from dietary supplement product labels. This article describes how data derived from information printed on product labels are entered and organized in the DSLD. Among the challenges are determining the chemical forms, types of extract, and amounts of dietary ingredients, especially when these are components of proprietary blends. The FDA announced new dietary supplement labeling regulations in May 2016. The 2017 DSLD has been updated to reflect them. These new regulations and examples cited in this article refer to this redesigned version of the DSLD. Search selection characteristics such as for product type and intended user group are as described in FDA guidance and regulations for dietary supplements. For this reason, some age groups (such as teens and seniors) and marketing recommendations for use (e.g., weight loss, performance, and other disease- or condition-specific claims) are not included in the search selections. The DSLD user interface features will be revised periodically to reflect regulatory and technologic developments to enhance user experience. A comprehensive database derived from analytically verified data on composition would be preferable to label data, but is not feasible for technical, logistic, and financial reasons. Therefore, a database derived from information printed on product labels is the only practical option at present for researchers, clinicians, and consumers interested in the composition of these products.