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Regulations and protection for functional food products in the United States
Abstract
In line with increasing concern and attention to health, functional foods and dietary supplements have been gaining popularity and prominence for their role in disease risk reduction and benefit to health in the recent past. Development of these food products has become a hot research area in the academia and the industry. As in the biotechnological and pharmaceutical industries, research and development of health food products are often risky and require enormous resources. In this article, the current governmental regulations and patent protection, two prime factors for paving the way for developing and marketing functional foods and dietary supplements in the United States, have been discussed. The newly reformed requirements of patenting natural matters in view of Supreme Court rulings such as Mayo, Myriad and Alice are highlighted, and we provide suggestions and advice for a better intellectual property protection for these products.
... Accordingly, a pre-market approval is mandatory only if the food contains a non-GRAS substance or a food additive. Notably, the FDA is not responsible for validating the GRAS status [63]. Instead, the agency establishes a voluntary GRAS notification program such that the food producer may claim the added substance is GRAS and supplement information supporting the GRAS assertion [29]. ...
... Consumers can raise inquires and complaints about the validity of claims for foods to the FDA. The agency will take action to ensure the validity of claims and works with the Federal Trade Commission (FTC) in the case of advertising [63]. ...
... To be entitled a patent, the invention must be a statutory patenteligible subject matter that is useful, novel and non-obvious. The invention must be fully described and enabled by the specification [63]. Generally patent is eligible for compositions, products (articles of manufacture), methods (processes) and machines, while natural laws and abstract ideas are excluded. ...
Food is a basic and personal necessity to human. Safety of food is a prime factor to consider apart from nutrition, quality and cost. Genetically modified (GM) foods first came on the market in 1994. Yet safety, transparency and traceability of GM foods are still under hot debate. Nonetheless, the market of GM foods is huge and attractive. Regulatory affairs and intellectual property (IP) are two critical factors affecting the development and commercial success of a food product. This article will take a look at the GM food technology and regulatory framework for GM foods in China and the United States. This article will also discuss the unique patent issues and non-patent IP tools for safeguarding the technology in these two countries.
... Critics argue that consumers may be exposed to products with questionable health benefits or potential risks without more stringent regulations [23]. ...
... The absence of a specific regulatory category for functional foods within the FDA has resulted in uncertainties for manufacturers and consumers alike [8,10]. While the current categorization of conventional foods allows for faster market entry, it raises concerns about misleading marketing and unsupported health claims [23]. Striking the right balance between streamlining the approval process and ensuring consumer protection remains a delicate task [20,22]. ...
The increasing demand for functional foods, stemming from the growing health consciousness among consumers and their preference for products that provide more than just basic nutrition, presents both opportunities and challenges for regulatory agencies, notably the U.S. Food and Drug Administration (FDA). Functional foods lack a specific regulatory category, leading to uncertainties for manufacturers and consumers. Collaboration between the FDA and the Functional Food Center (FFC) is proposed as a solution to enhance functional food regulation. The FFC's expertise in biomedical sciences and its 17-step process for defining functional foods can contribute valuable scientific research and aid the FDA's evaluation process. By fostering collaboration, both organizations can ensure consumer protection and promote public health while meeting the growing demand for functional foods. Keywords:Functional foods, health claims, regulation, functional food definition, consumer demand, collaboration
... It has become increasingly important for businesses that want to succeed in developing novel functional foods to learn and adapt to legal practices, legislations, and procedures that are essential to a product's introduction and success in FIGURE 14.1 (A) A graph of the number of publications available in PubMed over the last 2 decades using the search term "functional foods"; (B) A graph of the number of publications available in PubMed over the last 2 decades using the search term "function foods" filtered by "clinical trial" and "randomized Control trial". the market (Wong et al., 2015). This includes procuring intellectual property protection and seeking guidance on compositional specifications, safety laws, labeling laws, etc., at a national and international level. ...
... In this scenario, it would be the responsibility of the manufacturer to conduct such studies which may stifle innovation in the functional foods space if finances are tied up in funding clinical trials (Chopra et al., 2022). Further and more detailed information on legislation and monitoring practices of the FDA can be found in the following references Wong et al. (2015) and Bagchi (2014). ...
In this chapter, we discuss the advancements in functional foods development and their impact globally. The food industry has expanded into multiple fields including dietary supplements, nutraceuticals, food ingredients, cosmetics, and of course functional foods. Functional foods play an important role in economic activities, including the valorization of food industry by-products that otherwise may become waste. The functional foods industry is expected to continue its growth for decades to come. Consequently, proper legislation and protection for the consumer are also warranted. Functional food products targeting inflammation and cardiovascular diseases (CVD) and health are particularly popular considering CVD is the world's leading cause of mortality as discussed in this book. In this chapter, we discuss the origin of functional foods and the growth of their consumption ever since. We discuss the increased interest in researching functional foods. We also discuss the wider implications of functional foods development with regard to legislation and monitoring by the FDA and EFSA. In summary, the functional foods market is booming and is expected to continue to grow and evolve over the next decade. Further support for the functional foods industry with adequate monitoring and protection for the consumer will be important to sustain market growth and prevent the scourge of noncommunicable diseases such as CVD.
... The horizontal innovation across industry boundaries is still a challenge to manage, both in literature and in practice (Hahn 2015;Gassmann, Enkel, and Chesbrough 2010). Especially in the rapidly growing functional food market, active companies have to cope with technology, market and regulatory challenges (Bröring 2005;Wong, Lai, and Chan 2015). Multifaceted definitions of convergence can be found in the literature. ...
... The time frame was restricted to the period from September 2005 to August 2015, covering the last 10 years as ten years show an appropriate time frame to industry developments. In addition, this time frame is characterised by an increasing importance of the functional food sector (Siró et al. 2008;Wong, Lai, and Chan 2015). ...
Convergence processes are based on the activity of distinct industry sectors showing crossindustry
collaborations. The aim of this paper is to analyze cross-industry collaborations between
the food and pharmaceutical sectors in the convergence area of functional foods. Selected
companies from food (Nestlé/Danone) and pharmaceutical (Martek/Bayer HealthCare) sectors
are analyzed using the determinants of motivation and industrial scope. The analysis shows that
food companies are more active in cross-industry collaborations than pharmaceutical companies.
The latter are more active at the front-end of the value chain focusing on research and
development, and delivering their ingredients to food companies that due to their higher
expertise in consumer marketing launch the products. While the first cross-industry
collaborations were based on an exploration motivation, those that follow focus on exploitation.
Acquisitions and licensing agreements are dominant in inside-out and outside-in processes,
whereas strategic alliances and joint ventures are based on a coupled process between the food
and pharmaceutical sectors.
... The concept gained international attention following a 1993 article, "Japan explores the boundary between food and medicine," marking the first use of functional foods and highlighting the sector's rapid growth in the US [179]. In the United States of America (U.S.A), functional foods are regulated under the Federal Food, Drug, and Cosmetic (FD&C) Act and the Dietary Supplement Health and Education Act (DSHEA), overseen by the Food and Drug Administration (FDA) [180,181]. These products are categorized as nutraceuticals, dietary supplements, or conventional foods but not as medicines [182]. ...
Aging is a complex and inevitable biological process characterized by a gradual decline in physiological function, including increased oxidative stress, chronic inflammation, and mitochondrial dysfunction. While aging is a natural part of life, it is often accompanied by various disorders collectively known as age-related diseases (ARDs) or aging disorders. These include neurodegenerative diseases like Parkinson’s (PD), cardiovascular diseases, diabetes, osteoporosis, and frailty, among others. As the global population ages, the prevalence of ARDs such as PD and frailty is rising, necessitating innovative approaches to enhance healthy aging. Nutraceuticals are natural bioactive compounds in foods that offer health benefits beyond essential nutrition, which is pivotal in preventing and managing aging-related disorders. Nutraceuticals, with their antioxidant, anti-inflammatory, and neuroprotective properties, offer promising strategies to counteract these processes and promote healthy aging. This review highlights the potential of nutraceuticals as valuable adjuncts in managing PD and frailty, two conditions intricately linked to ARD. By examining the differential impacts of these bioactive compounds on the underlying mechanisms of each condition, this study underscores the promise of nutraceuticals in promoting healthy aging. The review aims to inform future research and clinical strategies by advocating for developing novel bioactive compounds, using advanced delivery technologies, and integrating personalized approaches based on genetic and epigenetic profiles. These efforts will pave the way for more precise, effective, and individualized interventions, ultimately extending health span and preventing ARD.
... The oil of walnut has several constituents that are α-linolenic acids, triacylglycerols (980 g/kg), linoleic acids, oleic acid, monounsaturated fatty acids, and polyunsaturated fatty acids. The word "nutraceutical" is usually used to determine food nutritional supplement that states a medical or health benefit to provide proper nourishment (Wong et al., 2015). They contain useful nutrients which are famous as a good remedy for chronic diseases (Luciano, 2014); their leaves, bark and nuts are ethnobotanically used for the cleansing of teeth (Irfan et al., 2018a, b), leaves are used for intestinal infection and eczema (Irfan et al., 2018c, d), bark is used in cleaning of teeth, toothache and in diabetes (Irfan et al., 2018e); fruits are rich in proteins used for cleaning of teeth and throat infections (Ahmad et al., 2016), bark is used in dry cough, decoction of leaves given for eczema and intestinal worms (Irfan et al., 2017a, b). ...
Juglans regia L. are nutritious fruit bearing plants mostly found in Northern areas of Pakistan. The population of walnuts was explored from district Dir and Swat Khyber Pakhtunkhwa, Pakistan for their geographical, climatic and chemical divergence. The geographical differences such as altitude, latitude and longitude whereas climatic
differences viz. soil EC, soil pH, precipitations, intensity of light, temperature and soil temperature. In both districts TPC ranged from 211.2±0.6 to 227.8±0.4 mg/100g, RSA ranged from 43.32±1.5% to 52.18±0.4%, conductivity ranged from 296.43±0.6 to 312.22±0.3 S/m and elemental composition such as iron, copper, calcium, zinc and magnesium in Dir differs from 0.312±0.032, 0.209±0.13, 20.0±0.313, 0.406±0.10 and 10.2±0.030 mg/L to 0.543±0.65, 0.698±0.82, 28.7±0.234, 0.685±0.15 and 17.6±0.015 mg/L respectively. Altitude and temperature showed a correlation with total phenolics contents and radical scavenging activity while soil pH, precipitations, soil temperature, soil Ec and light intensity indicated a weak correlation with chemical traits of walnuts. Further studies of walnuts are needed to explore their therapeutically important phytochemicals to succeed naturally pharmaceutical nutrients of the maximum significance for the health of human beings.
... The oil of walnut has several constituents that are α-linolenic acids, triacylglycerols (980 g/kg), linoleic acids, oleic acid, monounsaturated fatty acids, and polyunsaturated fatty acids. The word "nutraceutical" is usually used to determine food nutritional supplement that states a medical or health benefit to provide proper nourishment (Wong et al., 2015). They contain useful nutrients which are famous as a good remedy for chronic diseases (Luciano, 2014); their leaves, bark and nuts are ethnobotanically used for the cleansing of teeth (Irfan et al., 2018a, b), leaves are used for intestinal infection and eczema (Irfan et al., 2018c, d), bark is used in cleaning of teeth, toothache and in diabetes (Irfan et al., 2018e); fruits are rich in proteins used for cleaning of teeth and throat infections (Ahmad et al., 2016), bark is used in dry cough, decoction of leaves given for eczema and intestinal worms (Irfan et al., 2017a, b). ...
Juglans regia L. are nutritious fruit bearing plants mostly found in Northern areas of Pakistan. The population of walnuts was explored from district Dir and Swat Khyber Pakhtunkhwa, Pakistan for their geographical, climatic and chemical divergence. The geographical differences such as altitude, latitude and longitude whereas climatic
differences viz. soil EC, soil pH, precipitations, intensity of light, temperature and soil temperature. In both districts TPC ranged from 211.2±0.6 to 227.8±0.4 mg/100g, RSA ranged from 43.32±1.5% to 52.18±0.4%, conductivity ranged from 296.43±0.6 to 312.22±0.3 S/m and elemental composition such as iron, copper, calcium, zinc and magnesium in Dir differs from 0.312±0.032, 0.209±0.13, 20.0±0.313, 0.406±0.10 and 10.2±0.030 mg/L to 0.543±0.65, 0.698±0.82, 28.7±0.234, 0.685±0.15 and 17.6±0.015 mg/L respectively. Altitude and temperature showed a correlation with total phenolics contents and radical scavenging activity while soil pH, precipitations, soil temperature, soil Ec and light intensity indicated a weak correlation with chemical traits of walnuts. Further studies of walnuts are needed to explore their therapeutically important phytochemicals to succeed naturally pharmaceutical nutrients of the maximum significance for the health of human beings.
... Dukungan pemerintah dapat dilakukan, salah satunya melalui kegiatan standardisasi (Larasati, 2002). Aspek standardisasi yang sebaiknya dilakukan pertama kali adalah pengembangan Standar Nasional Indonesia (SNI) terkait istilah dan definisi pangan fungsional ( Susanto et al., 2019) Wong, Lai, & Chan, 2015). Sedangkan Jepang mendefinisikan pangan fungsional sebagai produk makanan yang diperkaya dengan konstituen khusus yang memiliki efek fisiologis menguntungkan (Martirosyan & Singh, 2015). ...
p>Definisi pangan fungsional diartikan berbeda-beda di setiap komunitas bahkan pada setiap negara, sehingga menimbulkan kebingungan di kalangan para ahli dan non-ahli. Indonesia juga tidak memiliki definisi yang formal tentang pangan fungsional, yang menyebabkan terhalangnya pengembangan teknologi, inovasi, komersialisasi dan hilirisasi serta perdagangan produk pangan fungsional. Tujuan dari penelitian ini adalah mengembangkan definisi pangan fungsional sebagai rekomendasi penyusunan Standar Nasional Indonesia (SNI) istilah dan definisi pangan fungsional. Penelitian ini menggunakan metode Framework for Analysis, Comparison, and Testing of Standards /FACTS. Penelitian ini dilakukan pada tahun 2018 dengan melibatkan 109 responden yang terdiri dari pemerintah, lembaga penelitian, asosiasi, konsumen, pelaku usaha, akademisi dan praktisi. Hasil penelitian ini menunjukkan bahwa 97% responden menyetujui usulan definisi pangan fungsional yang diusulkan dari hasil FGD dalam penelitian ini . Definisi pangan fungsional yang disetujui yaitu pangan segar dan/atau olahan yang mengandung komponen yang bermanfaat untuk meningkatkan fungsi fisiologis tertentu, dan/atau mengurangi risiko sakit yang dibuktikan berdasarkan kajian ilmiah, harus menunjukkan manfaatnya dengan jumlah yang biasa dikonsumsi sebagai bagian dari pola makan sehari-hari, yang harus tetap dalam bentuk pangan, bukan dalam bentuk pil atau kapsul. Hal-hal yang perlu ditinjau lebih jauh dalam definisi pangan fungsional meliputi jenis pangan, kajian dan bukti ilmiah dan jumlah konsumsi.
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... As per Alice Yuen-Ting Wong et al. [1], FDA's regulation is essential for safety and labeling of functional foods and dietary supplements. Health claims and misleading labeling are significant issues. ...
Because of increasing concern and attention to health, functional foods and dietary supplements have been gaining popularity and prominence for their role in disease risk reduction and benefit to health in the recent past. This development has become a hot research area in academia and the industry. As in the biotechnological and pharmaceutical industries, research and development of health food products are often risky and require enormous resources. So, it’s very important to develop nutraceuticals and obtain more patents.
... However, big pharmaceutical companies were not successful in marketing and distributing functional foods and other related products as the material properties of the carriers (e.g., yoghurt and spread) were associated more with the image of food than with drugs (Jauho & Niva, 2013;Lu, 2015). The limited reference to food in the object of pharma's activity (contradiction between instrument [image] and objective), as well as the absence of a concrete regulatory regime usually associated with drugs (Wong, Lai, & Chan, 2015; new contradiction between objective and rules), blared the image of these "pharmaceutical" products, and contributed to their failure. ...
In this paper, we introduce activity‐based analysis (ABA) for explaining and learning about sociotechnical system change at the societal function level. The analysis is based on a novel conceptualization of sociotechnical systems as activity systems, and change as result of the resolution of contradictions that develop within and between activities carried out for the fulfilment of societal functions. We develop ABA for the specific domain and employ it in the construction of a narrative explanation of the evolution of the food/nutrition sociotechnical system from the institutionalization of processed food to the emergence of medical nutrition.
... The first is connected with consumer demand for sustainable products (34,35), reflected in the increasing market of sustainable food marketed as regional and local foods (36), or animal welfare and fair trade products (37,38). Secondly, consumers are more and more focusing on a healthy diet (39)(40)(41) which can be seen for example in the increasing market of functional foods supposed to deliver a health benefit beyond the nutritional value (25,41). Food products incorporate several credence attributes relying on connections to health benefits, organic production, fairness of production and trade, sustainability, etc. (42). ...
Current discussions about the concept of nutritional sustainability show a high complexity of this topic leading to many different definitions. Regarding communication issues of nutritional sustainability between actors of food chains this complexity should be reduced. One opportunity to tackle these challenges of reducing complexity might be the concept of ingredient branding. Therefore, the aim of this mini-review is the identification of conditions for ingredient branding application as a communication strategy for nutritional sustainability which might overcome challenges in communicating the complexity between the different stakeholders of supply chains. In doing so, the specific case of agrifood chains is discussed based on the selected characteristics of globalization, increasing consumer demands, foods incorporating credence attributes and price. Along the agrifood chain, a sourcing strategy reflecting nutritional and sustainable aspects might lead to an ingredient branding strategy implying a brand policy for a special ingredient within the final product which is an important component but cannot be clearly recognized by the user. A “nutritional sustainability inside” strategy should reflect the multifaceted information along the agrifood chain and should be based on standardized criteria for nutritional sustainability.
... Penelitian lain juga telah memberikan bukti dari ekstrak alga laut (MAE) yang dapat meningkatkan anti-osteoporosis dan menginduksi pembentukan tulang menggunakan model tikus dan sel induk sumsum tulang. Kemampuan MAE untuk menipiskan osteoporosis telah dilakukan oleh Wong et al (2015). ...
p>Kekurangan asupan kalsium akan memberikan resiko penyakit osteoporosis yang seringkali ditandai dengan berkurangnya massa tulang dan adanya perubahan mikroarsitektur jaringan tulang yang berakibat menurunnya kekuatan tulang dan meningkatnya kerapuhan tulang serta risiko terjadinya patah tulang. Pengembangan pangan fungsional di Indonesia sangat prospektif dan memiliki peluang dalam perdagangan ekspor, antara lain ke Jepang, Eropa, dan Amerika. Banyaknya penelitian dan pengembangan pangan fungsional yang terbukti dapat membantu penyerapan kalsium yang harus didukung dengan keberadaan SNI sehingga akan memberikan peluang pasar yang lebih besar dan stabil. Hambatan pada saat perumusan standar sering dihadapi pada tahap awal prosesnya karena kurangnya informasi tentang kebutuhan pemangku kepentingan dari perspektif yang berbeda yang dapat menyebabkan standar yang dirumuskan tidak diterima oleh konsensus. Jadi penting untuk mengetahui semua kebutuhan pemangku kepentingan dan mencari kesepakatan bersama untuk masing-masing pemangku kepentingan. Penelitian ini menggunakan metode FACTS ( Framework for Analysis, comparison, and Testing of Standards ). Metode ini menyediakan sarana untuk menganalisis, membandingkan dan menguji standar yang akan dikembangkan. Penelitian ini menghasilkan kerangka kerja yang dapat digunakan sebagai acuan pada saat penyusunan standar terkait pangan fungsional. Penelitian ini merekomendasikan penyusunan SNI istilah - definisi pangan fungsional dan SNI formula pangan fungsional untuk membantu penyerapan kalsium, yang didalamnya mengatur tentang tata cara klaim pangan fungsional.</p
... Danish, Finnish and American consumer's perceptions toward the healthiness of FF are explained by different factors, including the values pertaining to man's manipulation of nature, the use of different health claims, processing methods, enrichments and product types (Bech-Larsen and Grunert, 2003;Loebnitz and Bröring, 2015;Bimbo et al., 2017;Shan et al., 2017). A number of studies had been conducted for consumer knowledge and behavior regarding FF in various regions around the world, including, mainly, Europe (Verbeke, 2005;Landtro †m et al., 2007;Urala and Lähteenmäki, 2007;Annunziata and Vecchio, 2011;Bornkessel et al., 2014), USA (Childs, 1997;Wong et al., 2015) and Asia (Büyükkaragöz et al., 2014;Siegrist et al., 2015), but NFS very few were conducted in developing nations, (Seechurn et al., 2009;Salleh et al., 2015) and there is specially a paucity of data in the Middle Eastern and North African (MENA) region (Kaur and Singh, 2017). Accordingly, the need to know further about the MENA consumers' attitudes is crucial. ...
Purpose
The development and commerce of functional foods (FF) is complex, expensive and risky. Besides technological obstacles and legislative aspects, consumer demands also need to be considered. The purpose of this study is to assess the Lebanese consumer’s knowledge, attitudes and acceptance of FF and functional ingredients.
Design/methodology/approach
A cross-sectional study recruited a convenience sample of adults living in Mount Lebanon in 2015. An interviewer-based questionnaire assessed socio-demographic factors, medical status, consumption and knowledge of FF and FI ingredients. The data were analyzed using statistical package for social sciences.
Findings
Out of 251 respondents, 40.6 and 32.0 per cent were knowledgeable about FF and FI, respectively, and 67.3 per cent consumed them. Calcium (48.0 per cent) and omega-3 (38.6 per cent) were identified as the most important FI. The consumption of FF was mainly owing to their nutritional benefits beyond basic nutrition (44.2 per cent); however, fearing artificial additives and their side effects (33.4 per cent) were reasons for rejecting them. FF knowledge was higher among young (p = 0.005) and single individuals (p = 0.002) and those going to the gym (p = 0.001), whereas willingness to learn about them was only associated with higher education (p < 0.001). Prebiotic yogurt consumption was higher among gym visitors (p = 0.017) and knowers of FF (p < 0.001). The consumption of protein bars and shakes was higher among males and those going to the gym (p < 0.001). The consumption of cereal bars was higher among young individuals, single, with high income, going to the gym and knowledgeable about FF (p < 0.05).
Originality/value
The findings are useful for market orientation, development and successfully negotiating new market opportunities of FF for both food industries and policymakers.
... Nowadays, when designing new functional products it is important to consider if it meets specific characteristics regarding consumers' needs, which means if it has the expected functionality (nutritional value and health benefits) and if it possesses the sensory acceptance (Villegas et al., 2010;Beristain et al., 2006). Therefore, functional foods are included in this new market segment (Khan et al., 2013), thus they can be defined as: "food products that provide extra benefits to one's health in addition to basic nutritional values" (Yuen-Ting Wong et al., 2015;Beristain et al., 2006). ...
New trends in product development are based in the incorporation of prebiotics, however their use must be linked to consumer acceptability. This study compares in vitro prebiotic index (PI) and sensory consumer analysis of five different ready-to-eat pork Sous Vide marinade prototypes. Sole ingredients used in the marinade (MI) formulations and each prototype was evaluated for their PI, also: MI added with additives and, MI added with additives and prebiotics. Prebiotics were: nopal fiber (Opuntia ficus-indica), corn fiber and, chicory inulin (Chicorium intybus). Consumer acceptance (n= 205) was evaluated by: landscape segmentation analysis (LSA), just about right (JAR) test and, penalty analysis (PA). Results show that ingredients with good PI (above 1) were obtained with: chipotle (Capsicum annuum), garlic (Allium sativum) and, rosemary (Rosmarinus officinalis). Prebiotic prototypes: nopal fiber (Opuntia ficus-indica), corn fiber and, chicory inulin (Chicorium intybus), showed a prebiotic index of 1.20, 1.83 and, 1.62 respectively. LSA showed that the prototype, which contained chicory inulin as a prebiotic was located nearer to optimal regions, which is in accordance to results obtained by JAR and PA. Results reveal that chicory inulin-marinated Sous Vide pork meat possesses an accepted in vitro PI and the best sensory characteristics. © 2017, Universidad Autonoma Metropolitana Iztapalapa. All rights reserved.
... Added to this, microalgae production is not only limited to the possibility to obtain biofuels in a near future. Some microalgae strains, Spirulina and other green genera like Chlorella, Dunaliella or Haematoccocus, are industrially cultivated for being used as protein and nutritional supplement (Enzing, et al., 2014), or additive sources for substances like antioxidants such as ß-carotene, astaxanthin, polyphenols, vitamins or polyunsaturated fatty acids(Rasul Suleria, et al., 2015), included in the group of functional foods and nutraceuticals, those that taken in a regular basis contribute to reduce disease risks beyond the concept of conventional foods (Wong, et al., 2015;Gouveia, et al., 2010). ...
Sustainable diets are defined as those that present low impacts both on the environment and the biodiversity, contributing to food and nutrition security and to a healthy life for present and future generations. Algae (macroalgae and microalgae, including cyanobacteria) have recently taken an increased interest as valuable products, being used as ingredients or condiments in the modern diversifying occidental cuisine. Moreover, nutritional research has confirmed algae as rich sources of potentially valuable, health-promoting compounds in a scenario where consumers are increasingly aware of the relationship between diet, health and disease prevention. Combining both ideas, nutritional needs vs. health promotion and disease risk reduction, algae are shown as a very interesting source of functional ingredients for being considered as a component of our day-to-day diet and related food products. Sustainability contribution of cultivation systems and techniques to biomass increasing in quality, security and control, so reducing effects on the environment and biodiversity, makes algae production a promising activity to be included in future developments toward a responsible and healthy way of living.
Coming back to FAO statistics(FAO, 2016), microalgae contribution to worldwide aquaculture numbers is poorly reflected and restricted to data for the cyanobacteria Spirulina (common name for most Arthrospira species), basically due to that only a few countries are able to report real biomass production values. Opposite to those occurring with macroalgae, the use of microalgae as food in the traditional cuisine is insignificant and its consumption have been mainly restricted to genera such as Spirulina and Chlorella in the form of dried powders and capsules for the dietetics market. However, as far as we increase our knowledge on the biodiversity, cultivation and processing possibilities for a higher number of species and their nutritional properties, biomass availability and new ideas to incorporate microalgae concentrated paste, fresh, powder or freeze-dried in dishes designed by star chefs is nowadays an authentic reality. As an example for mass media in Spain, Chef Angel León (the chef of the sea) from the restaurant Aponiente, in a research-development collaboration with the company Fitoplancton Marino (www.fitoplanctonmarino.com), creates an interesting variety of dishes phytoplankton-enriched (concentrated microalgae paste) with a great success. As a first important step, the cited company has obtained the European certification as “novel food” for the photobioreactor produced green microalgae Tetraselmis chuii that probably will open new opportunities for other alternative strains.
... Act of 1990 and recent modifications [62][63][64] mandate the labeling of nutritional ...
For nutrition and its associated disciplines, ethical considerations related to research are often complicated by factors that range from the use of experimental research designs that are overly holistic to inextricable links between nutrition research and marketing. As a consequence, there is the need for constant vigilance to assess and deal with apparent conflicts of interest. Also, there are few scientific disciplines that are defined by cultural, religious, or political codifications as is nutrition. Accordingly, examples of historical, cultural, and political events are described that have influenced ethical approaches related to nutrition research. Further, nutrition research questions are often multi-faceted and require dealing with complex variables. In this regard, ethical principles and perspectives are highlighted that have relevance to data acquisition, the publication and translation of nutrition research, and the marketing of nutritional products and concepts.
... ETs and EA-containing food products such as pomegrante juice have been acknolwedged as potential functional foods due to their health benefits beyond their nutritional values (Shahidi & Ambigaipalan, 2015;Wong, Lai, & Chan, 2015). However, this must be scientifically proven (González-Sarrías, Larrosa, García-Conesa, Tomás- . ...
... In the last decades, consumers have become increasingly concerned with the effect of food components on physiological function and their health (Lalor, Madden, McKenzie, & Wall, 2011). In this regard, functional foods that provide special nutrients for humans or prevent nutrition-related diseases have been gaining popularity and prominence (Vo & Kim, 2013;Wong, Lai, & Chan, 2015). Beef can be considered a functional food because it contains numerous compounds thought to be functional (Dalle Zotte & Szendro, 2011;Khan et al., 2011). ...
One of the most pressing challenges facing society today is the rising prevalence of physical and cognitive frailty. This geriatric condition makes older adults more vulnerable to disability, illness, and a heightened risk of mortality. In this scenario, Parkinson’s disease (PD) and geriatric frailty, which share several common characteristics, are becoming increasingly prevalent worldwide, underscoring the urgent need for innovative strategies. Nutraceuticals are naturally occurring bioactive compounds contained in foods, offering health benefits over and above essential nutrition. By examining the literature from the past decade, this review highlights how nutraceuticals can act as complementary therapies, addressing key processes, such as oxidative stress, inflammation, and neuroprotection. Notably, the antioxidant action of nutraceuticals appears particularly beneficial in regard to PD and geriatric frailty. For instance, antioxidant-rich nutraceuticals may mitigate the oxidative damage linked to levodopa therapy in PD, potentially reducing the side effects and enhancing treatment sustainability. Similarly, the antioxidant effects of nutraceuticals may amplify the benefits of physical activity, enhancing muscle function, cognitive health, and resilience, thereby reducing the risk of frailty. This review proposes a holistic approach integrating nutraceuticals with exercise, pharmacotherapy, and lifestyle adjustments. It promises to transform the management of ARD, prolong life, and improve the quality of life and well-being of older people.
The importance of environmental sustainability, together with its economic and social pillar, and circular economy issues permeates more and more any aspect of our daily life through proactive initiatives, tending towards zero-waste and zero-pollutant production processes to the ongoing ecological transition. Hence, there is a need for some industries, such as the nutraceutical, pharmaceutical, and cosmetic industries, to innovate their production processes from a circular perspective, trying to ensure the minimum environmental impact, a high level of quality throughout the life cycle assessment (LCA) of its products and services and the maximum expression of the hi-tech–hi-green performance combination. This chapter aims to demonstrate how internationally shared sustainability objectives can guide and bring actual benefits through companies that embrace a circular bioeconomy approach and how this, in turn, can be the basis of a multi-output production process related to markets and bioeconomy sectors. To this end, a case was studied concerning a pilot project dedicated to research and development activities applied to the nutraceutical, cosmetic, pharmaceutical, and green agriculture sectors, allowing the export of sustainable production models to places other than Sicily.
As a result of their unique physical properties, biological membrane mimetics such as biopolymers are used in a broad range of scientific and technological applications. This comprehensive book covers new applications of biopolymers in the research and development of industrial scale nutraceutical and functional food grade products. All the major food biopolymers are included, from plant, animal and marine sources. Coverage also includes biopolymer-based drug delivery mechanisms intended for biological applications such as bio-detection of pathogens, fluorescent biological labels, and drug and gene delivery.
This is the first interdisciplinary book to address this area specifically and is essential reading for those who produce the functional biopolymer materials as well as those who seek to incorporate them into appropriate nutraceutical, food and drug delivery products.
With dietary supplements usage growing exponentially, it is crucial to have a clear grasp of such products. This extensive review article aims to provide comprehensive information about dietary supplements from multidisciplinary perspectives from clinical to dosage form production and official regulations. It provides a crucial background of various topics relating to dietary supplements along with the corresponding key issues. The review article consists of four main sections. The first section gives the general background along with the usage and safety of dietary supplements. Here the article looks at the topic through a clinical lens. The second section focuses on the manufacturing aspect of dietary supplements. This section of the article is practical and provides an in-depth discussion of the issues revolving around dietary supplements, which range from extraction of active ingredients to stability and more. The third section provides comprehensive information with regards to the regulation of dietary supplements, which remains a crucial and evolving topic of discussion. The article goes into details about health claims, product labels and more. Finally, the fourth section brings forth the awareness of the global market trend of dietary supplements.
The status of chocolate as functional food is still questionable for some other people as chocolate can also give some adverse effect due to its high fat and sugar content. To overcome this issue, some attempts have made by food scientist to produce chocolate with high potential health benefits and minimum adverse effects such as by fat reduction, sugar replacement and probiotic supplementation. Some of sugar replacer are providentially identified as prebiotic substances. This review, therefore, deeply discuss the potential use of probiotics and sugar replacer in chocolate. The health benefit as well as the effect on the consumer acceptance are also covered as chocolate reformulation may result in the alteration on the chocolate characteristic. Moreover, the regulation in chocolate manufacturing and functional food from different regulatory boards are covered in this review as the guidelines to answer challenges and opportunities in developing functional chocolate. This review also clearly shows a possible direction of designing probiotic chocolate in the future that has not been fully explored until to date.
There have been seven qualified health claims (QHCs) in the marketplace about the relationship between the consumption of green tea and the reduced risk of breast and/or prostate cancers that were written by three stakeholders (the U.S. Food and Drug Administration (FDA), Fleminger, Inc. (tea company), and the Federal Court). This paper evaluates assertions about the effects of these claims on consumers, which were contested in a federal lawsuit. Using a 2 × 7 experimental design, 1,335 Americans 55 years and older were randomized to view one QHC about green tea and cancer, or an identical QHC about a novel diet-disease relationship; yukichi fruit juice and gastrocoridalis. The results show that differing stakeholder descriptions of the same evidence significantly affected consumer perceptions. For example, QHCs written by Fleminger, Inc. were rated as providing greater evidence for the green tea-cancer claim. An FDA summary statement implied mandatory (vs. voluntary) labelling and greater effectiveness, and qualitative descriptions suggested that greater evidence existed for the claims (vs. quantitative descriptions). Greater evidence was also inferred for familiar claims (green tea and cancer).
Background
The convergence of formerly distinct industries has been observed across a number of sectors including telecommunications, biopharma or nutrition. Its transformative character challenges incumbent market and industry structures by changing the way customers perceive products and technologies, forcing companies to restructure their offerings or even reshaping entire industry landscapes. Yet while the earlier stages, namely science and technology convergence, have received much attention, the later stages of convergence remain under-researched.
Methods
This study investigates the process of convergence at the market level. Building on the recent introduction of start-up formation at the transition from applied research to application within a technology life cycle, it explores the role of start-ups in the field of probiotics, spanning the convergent sectors of Nutrition, Pharmaceuticals and Cosmetics. The “LexisNexis” database is used to conduct a search of press releases on start-up formation, product launches and collaborations in the field of probiotics.
Results
Firstly, a classification of probiotic products originating from start-ups is developed. Secondly, a framework of collaborations in convergence is applied and extended to take account of collaboration forms present in start-ups distinguishing collaborations of different intensity and orientation.
Conclusions
The study expands the literature on convergence by offering an extension of the framework of collaborations in convergence. It further informs practitioners of the relevant markets occupied by start-ups in the probiotic field. Lastly, it offers guidance to practitioners on how to close technology and market competence gaps through collaborations with start-ups possessing respective complementary competences.
This study aimed to develop a salty type appetizer and evaluate its physicochemical, sensorial and instrumental characteristics and the resistance of the lactic acid bacteria (LAB) to the gastrointestinal tract (GIT) simulated in vitro. Five formulations were prepared after desorbed of kefir: F0: kefir, salt, garlic and herbs (control); F1: F0 and Lactobacillus acidophilus; F2: F1 and green banana flour; F3: F1 and passion fruit albedo flour; F4: F1 and orange peel flour. The formulations were stored refrigerated for 28 days and realized analyzes. Resistance of the LAB to GIT conditions was done for F0 and F4 at 0, 14 and 28 days. The formulations didn't differ (p > 0.05) for pH, acidity and texture at zero time, however, F3 presented greater firmness and gumminess at 28 days. The formulations were safe for consumption and F0 and F1 were the most acceptable. The addition of fruit flour didn't influence the viability of the bacteria. In the in vitro GIT test, at 28 days, > 8.5 Log CFU/g of LAB was available to promote consumer benefits. There are no any negative impact using of these by-products is environmental friendly and will help to avoid production of food industry nus-products in great extent.
The bioactive compounds in foods are diverse and they are present in plants, animals, and other organisms in small quantities as secondary metabolites, alkaloids, growth factors, phenolic compounds, lignans, salicylates, stanols, sterols, and glycosinolates, among others. These bioactives have been tested either for health benefits or as potential factors for the prevention of pathological processes. This chapter highlights the crucial role of these natural products, emphasizing their beneficial effects. It brings to the readers an overview of bioactive compounds, how they are related to health, and how they work on chronic disorders as well as in degenerative diseases, by reporting some in vitro tests, experiments in animal models, and in clinical studies. Moreover, a brief description of claims and regulations about functional food worldwide is presented. This section intends to foster the consumption either of foods with bioactive compounds or functional foods.
ABSTRAK Indonesia yang kaya akan sumber alam, memiliki kandungan bioaktif yang potensial yang dapat dikembangkan menjadi sumber pangan fungsional. Inovasi pangan fugngsional di Indonesia sangat prospektif dan memiliki peluang dalam perdagangan ekspor, antara lain ke Jepang, Eropa, dan Amerika. Hasil inovasi pangan yang telah dilakukan oleh peneliti dan industri sebaiknya didukung dengan adanya proses standardisasi dan sertifikasi. Hal ini dimaksudkan untuk mempermudah produk hasil inovasi masuk ke pasar. Dengan adanya proses standardisasi dan sertifikasi, maka akan mempermudah konsumen untuk mengenali kualitas produk yang beredar di pasar. Keberadaan Standar Nasional Indoensia (SNI) dimaksudkan memberikan peluang pasar yang lebih besar dan stabil bagi produk hasil inovasi pangan. Kajian mengenai metode perumusan SNI untuk dapat menghasilkan SNI yang dapat diterapkan oleh stakeholder sangat perlu dilakukan. Hambatan pada saat perumusan standar sering dihadapi pada tahap awal prosesnya karena kurangnya informasi tentang kebutuhan pemangku kepentingan dari perspektif yang berbeda yang dapat menyebabkan standar yang dirumuskan tidak diterima oleh konsensus. Jadi penting untuk mengetahui semua kebutuhan pemangku kepentingan dan mencari kesepakatan bersama untuk masing-masing pemangku kepentingan. Penelitian ini menggunakan metode FACTS (Framework for Analysis, comparison, and Testing of Standards). Metode ini menyediakan sarana untuk menganalisis, membandingkan dan menguji standar yang akan dikembangkan. Hasil penelitian menunjukkan terdapat 5 produk hasil inovasi telah mencapai tahapan demonstrasi prototipe sistem dalam lingkungan sebenarnya. Terdapat 1 produk yaitu produk yang masuk ke dalam kategori flake seasoning yang telah mencapai tingkat pengoperasian dan telah siap diedarkan di pasar. Produk tersebut sejenis abon tabor sampai saat ini belum ada SNInya, pengusulan pengembangan standar untuk produk ini dapat memperhatikan parameter kualitas yaitu: harus bubuk kering bersih dan sehat, komposisi, bau dan rasa, kadar air, kadar minyak volatile, ekstrak larut dalam air dingin, abu tidak larut dalam asam, serat kasar, BTP, cemaran mikroba, dan cemaran logam. Kata kunci: FACTS, pangan fungsional, inovasi, standardisasi, SNI ABSTRACT Indonesia is rich in natural resources, has a potential bioactive content that can be developed into a functional food source. Functional food innovation in Indonesia is very prospective and has opportunities in export trade, including Japan, Europe and America. The results of food innovations that have been carried out by researchers and industry should be supported by the process of standardization and certification. This is intended to make it easier for innovation products to enter the market. Standardization and certification process will be easier for consumers to recognize the quality of products in the market. The existence of the Indonesian
Purpose
After the introduction of functional food term in 1980s, production and marketing of functional food in Japan, USA and European markets has developed rapidly. Compared to these developed countries, the market size of the functional food in Turkey is very limited. The purpose of this study is to explore reasons of limited development and marketing strategies regarding the size of expenditure, governmental legislation and consumer preferences and highlight the type of functional food products available at large retail chains of important suppliers in Turkey.
Design/methodology/approach
Description and exploration of market size and expenditure were determined by using Euromonitor International (2017). The factors influencing consumption and attitudes toward functional food purchasing were evaluated by studying literature research. The number and types of functional foods in the most important supermarket chains were determined to show the growth rate in Turkey. Products in the markets were determined based on the direct observation available, and functional foods sold in the markets were noted at the visits and tabulated. The type of functional food product, its category, the main benefit offer to the consumer and the brand and status of the food processing industry (national or not) were identified. Government legislation on special health claims for functional foods was stated.
Findings
Market size of Turkey per capita expenditure was approximately US86.7m and 100.2m, respectively, in 2017. The variety of functional food products was at a very low level, and functional food market share was limited compared to powerful countries like Turkey. International companies had a higher market share than national companies. Danone with dairy functional foods was the biggest company in Turkey market. Literature studies showed that Turkish people have less knowledge about functional foods and need education. According to reviews, socio-demographic characteristics such as age, education, income levels, gender and prices were important indicators influence consumer awareness and consumption of functional foods. Consumer’s knowledge must be increased with their health benefits by education. Reviews showed that nearly 60 per cent of people did not have any information about functional food and women were more aware and the most active user group. Dairy products were the most preferred functional foods in Turkey. Because of limited awareness, there is a need for elucidating studies that are targeting potential consumers. Turkey did not have labeling system to claim foods functionality on packages and did not permit foods that contribute to health maintenance and/or recovery from disease, but Republic of Turkey Ministry of Food, Agriculture and Livestock applies some laws and regulations.
Originality/value
This study provides market study and detailed research about marketing strategies and legislation of functional foods in Turkey. People have high demand to consume and there are big potentials of functional food marketing and opportunities for food industries. But to increase consumption and marketing size, it needs education of consumer, advertising and some adjustment of legislation by government.
Walnut, Juglans regia (L.) is an economically significant plant for its
immense nutritive and economic value. The breeding character of walnut has
lent it a wide diversity in genetic characteristics. The principal vegetative and
common traditional agronomic traits together with biochemical characterization
i.e., karyotyping and isoenzyme expression have been the early research
methods. However, these techniques are time-consuming and susceptible to
the environmental variations. Literature is meager in the distribution, applied
applications in general and the use of agriculture biotechnology in particular in
case of walnut plants. The bio-techniques like molecular markers are adequate
in number and there is little or no diversity in the method employed for
research on walnuts. Despite basic research method, the organization of information,
its retrieval and presentation structures, form elaboration experienced
immense advancement via molecular markers such as RFLP, ISSR, RAPD AFLP,
SSR and SNP. This appraisal in its first part provides detailed information
regarding the present scenario of data on biogeographical distribution, health
benefits of walnut worldwide and current applications in the agroforestry management,
biochemical evaluations and applied uses of a walnut tree which is
relevant for both basic and applied research. The review in its second part
sheds light on the application of sophisticated agricultural biotechnology techniques
such as use of molecular markers to evaluate, realize the full potential
of walnut for increasing its quality, quantity and for its sustainable production
which cannot be obtained through usual breeding techniques to meet the
demands of a projected world population.
This chapter contains sections titled:
Introduction
Common Antioxidants in Foodstuff
Antioxidants for Bioactive or Preservative Purposes
Analysis of Antioxidants in Foods
Conclusion
Background:
Nowadays, the functional foods represent one the most promising, interesting and innovative areas in the food industry. Various components are being added to foods in order to render them functional.
Methods:
One example of these components are plant naturally occurring phenolic compounds, which are associated with a high antioxidant capacity and thus with benefits in relation to human health.
Results:
However, despite the huge number of scientific studies and patents on this topic and their natural presence in foods, namely in the ones from plant origin, there are still few marketable products enriched with these compounds. The commercialization of this type of functional products needs to go through various regulations, proving that they are safe and present the ascribed health benefits, conquering the target audience. In this review the growing interest of industry and consumers' appetence for functional foods and nutraceuticals is highlighted, focusing especially on phenolic compounds.
Conclusion:
Although several published works show the multitude of bioactive properties of these compounds, ensuring their use as bioactive ingredients in food, they present inherent stability issues needing to be solved. However, considerable research is presently ongoing to overcome this problem, making viable the development of new products to be launched in the market.
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.
At a time when Americans spend over $30 billion on functional foods and dietary supplements, the Food and Drug Administration (FDA) is doing little to ensure that all the safe and efficacious products that could come to the market are allowed to do so. FDA has only responded slowly and reluctantly to Congressional action and to mandates from the Courts to implement the law. Additionally, FDA had set the bar too high for Health Claims and was forced by the Courts to implement a more reasonable standard, but the response, Qualified Health Claims, has failed to gain the confidence of the public because of the confusing wording of the claims demanded by FDA. FDA demands that efficacy data be published destroys any hope of return on investment as "copy-cat" products proliferate-if the same principle of disclosure of efficacy data were applied to the drug side of FDA, would we have many new drugs today? Congressional efforts to assure consumer access to dietary supplements have been met with similar resistance from FDA with impossibly high safety testing requirements and a 70% rejection rate of New Dietary Ingredient Notifications. FDA's zealousness to protect consumers from unsafe or ineffective products with artificially high barriers to market entry will have the paradoxical outcome of manufacturers calculating that it is cheaper to come to market without testing or FDA involvement - the result will be the proliferation of unsafe and ineffective products - the very circumstance FDA hoped to avoid. Included herein also is a description of a pathway for FDA to bring safe and effective products to market, but it will require a conservative and sometimes intransigent agency to exercise some flexibility. Inasmuch as FDA has a duty to protect the public from unsafe substances and fraud, it also has an obligation to take affirmative steps to improve public health by working with manufacturers to bring beneficial substances to market.
Extracts and compounds of natural products have potential as alternatives to current Western medicines. However, these products may not be patentable under the statutory requirements because of their naturally-occurring nature. This article analyzes the current patenting practices for natural products in the United States, particularly in light of the recent Supreme Court ruling in Myriad, and suggests an advantageous strategy for patenting these products. Briefly, isolated natural products per se are not patentable in the United States. Therefore, patenting focus should be placed on the modification, formulation, manufacture, and application of natural products. A detailed description of each invention is highly recommended for stronger support and broader coverage of the claims.
Under the US laws that FDA enforces, food label claims generally fall into three categories: nutrient content claims, health claims and structure/function claims. Nutrient content claims are statements that characterize the level of a nutrient in a food. Nutrient content claims on food labels must be used in accordance with FDA authorizing regulations. Health claims describe a relationship of a food, food component or dietary supplement in reducing the risk of a disease or health-related condition. Health claims must be evaluated and authorized prior to their use in food labeling. There are three ways by which FDA exercises its oversight in determining which health claims may be used in food labeling. One way is the issuance of authorizing regulations based on FDA's conclusion that there is significant scientific agreement that the available scientific evidence supports the relationship. A second way is through a notification to FDA of a health claim based on authoritative statements from a scientific body of the US government or the National Academy of Sciences that ensues from that scientific body's deliberative review of scientific evidence on the substance/disease relationship. The third way provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. Structure/function claims are food label statements that describe the role of a nutrient or dietary supplement ingredient to affect normal structure or function in humans. Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements. However, the Dietary Supplement Health and Education Act of 1994 established special regulatory procedures for the use of such statements on dietary supplement labels.
Market entry requirements for nutraceuticals, functional foods and supplements vary from country to country. While most essential vitamins and minerals have achieved widespread acceptance, the regulatory acceptability of other bioactive ingredients and botanicals varies and in many cases is tied to a local country or regional positive and/or negative lists. Most of the finished products are regulated as a category of food, and as such, the market entry requirements tend to fall under one of three categories: registration, notification or no entry requirements. There are benefits and drawbacks to all three approaches, although a notification-based approach provides the proper balance between allowing consumer access and choice and protecting public health.
Because the Federal Food, Drug, and Cosmetic Act (FFDCA) does not provide a statutory definition of functional foods, the Food and Drug Administration has no authority to establish a formal regulatory category for such foods. The primary determinant of the regulatory status of a food is its intended use, which is determined largely by the label and labeling information accompanying the product. This information includes nutrient information, nutrient content claims, and various types of health claims. In marketing these foods, manufacturers may come under one of several existing regulatory options. The first decision manufacturers will make that will help determine their product's regulatory status is whether the product is a food or a drug. Thus, manufacturers and retailers have a range of legal and regulatory categories in which their products may be classified. This article describes the definitions provided in the FFDCA for a drug and a food, the safety and labeling requirements of various food categories, and types of possible claims for dietary supplements.
An analysis of US Federal Circuit decisions shows strategies for designing around patents.
Health claims in the United States have been a topic of intense controversy since the mid-1980s. Three categories of claims can currently be used on food and dietary supplement labels in the United States: 1) health claims, 2) nutrient content claims, and 3) structure/function claims. Structure/function claims were authorized under the Dietary Supplement Health and Education Act and describe the effect of a dietary supplement on the structure or function of the body. Nutrient content claims are used to describe the percentage of a nutrient in a product relative to the daily value. Health claims describe a relation between a food, food component, or dietary supplement ingredient and reducing risk of a disease or health-related condition. Health claims are based on a very high standard of scientific evidence and significant scientific agreement. Are U.S. health claims really benefitting public health? Recent evidence suggests that this mode of communication has had limited success and in fact may be misleading to consumers.