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Most of the requests of authorisation to the use of health claims pursuant to Regulation EC 1924/2006 related to the gastrointestinal (GI) tract have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of an insufficient substantiation of the claimed effect (CE). The present manuscript refers to the collection, collation and critical analysis of outcome variables (OVs) and methods of measurement (MMs) related to the GI tract compliant with Regulation 1924/2006. The critical evaluation of OVs and MMs was based on the literature review, with the final aim of defining their appropriateness in the context of a specific CE. The results obtained are relevant for the choice of the best OVs and MMs to be used in randomised controlled trials aimed to substantiate the claims on the GI tract. Moreover, the results can be used by EFSA for updating the guidance for the scientific requirements of such health claims.

Currently, nutraceuticals do not have a specific definition distinct from those of other food-derived categories, such as food supplements, herbal products, pre- and probiotics, functional foods, and fortified foods. Many studies have led to an understanding of the potential mechanisms of action of pharmaceutically active components contained in food that may improve health and reduce the risk of pathological conditions while enhancing overall well-being. Nevertheless, there is a lack of clear information and, often, the claimed health benefits may not be properly substantiated by safety and efficacy information or in vitro and in vivo data, which can induce false expectations and miss the target for a product to be effective, as claimed. An officially shared and accepted definition of nutraceuticals is still missing, as nutraceuticals are mostly referred to as pharma-foods, a powerful toolbox to be used beyond the diet but before the drugs to prevent and treat pathological conditions, such as in subjects who may not yet be eligible for conventional pharmaceutical therapy. Hence, it is of utmost importance to have a proper and unequivocal definition of nutraceuticals and shared regulations. It also seems wise to assess the safety, mechanism of action and efficacy of nutraceuticals with clinical data. A growing demand exists for nutraceuticals, which seem to reside in the grey area between pharmaceuticals and food. Nonetheless, given specific legislation from different countries, nutraceuticals are experiencing challenges with safety and health claim substantiation., (© 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

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., Competing Interests: The authors declare no conflict of interest.

The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids., Competing Interests: The authors declare no conflict of interest.

Qualified health claims (QHCs) are found on food and dietary supplement labels and aim to communicate the quality and strength of scientific evidence for a diet-disease relationship. Since the evidence varies for diet-disease relationships, the language to describe the evidence also varies. However, research indicates that consumers misinterpret QHCs as a whole product evaluation. The FDA is reviewing the evidence ranking system for QHCs and the current study aims to inform future consumer research. A content analysis examined the language used to convey scientific evidence in 53 QHCs and organized them into an intrinsic scale of evidence. Results revealed 36 formats to present the evidence in 53 QHCs. Seventy-seven percent (n = 41) demonstrate a reading level above 9th grade. Most claims describe the quality of evidence (n = 51, 96%) ("very weak") and/or reference its consistency (n = 41, 77%), while a quarter (n = 13) also quantify the evidence ("two studies"). Twenty-five claims (47%) present the evidence before stating the diet-disease relationship. There is an absence of a systematic description of evidence among QHCs that may contribute to the misleading, albeit unintentional, nature of these claims. Policymakers might consider reforming QHC regulations so that a hierarchy of evidence for diet-disease relationships is clearly communicated to consumers.

Food supplements are classified as foods. They are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect. Their purpose is to supplement the normal diet. Food supplements have to comply with the applicable legal provisions of the food law. In order to ensure the health protection of consumers, food supplements that will be put on the market must be safe. For food supplements, regulations exist at the EU level as well as at the national level. Specific requirements are regulated in the Ordinance on Food Supplements, with which the European Directive on Food Supplements was transposed into German law. The European and German legal provisions applicable to food supplements are outlined. Important aspects regarding the delimitation between food supplements and medicinal products are addressed. These borderline issues are of special importance to food supplements which are marketed in dose forms such as capsules, tablets etc., the typical forms of medicinal products. Problems resulting from the lack of harmonized rules are described. The European harmonization of the rules is still incomplete for substances with a nutritional or physiological effect other than vitamins and minerals for use in food supplements. The setting of maximum amounts of vitamins and minerals present in food supplements as envisaged in the Directive on Food Supplements has not yet been implemented.

To be placed on the market legally, food supplements have to meet national and European food law regulations. This is true for all substances used as well as for the labeling on the packaging of and the advertising for food supplements. The food business operator is responsible for its compliance with all regulations. Therefore, in this article, a concise step-by-step assessment is presented, covering all necessary legal requirements to market food supplements. Additionally, all steps are visualized in a flow chart. All vitamins, minerals and other substances used have to meet the legal conditions. Food business operators have to make sure that their products do not contain medicinal ingredients based on their pharmacologic effect. It is prohibited to place medicinal products as food supplements on the market. Furthermore, food business operators have to make sure that their products are not non-authorized novel foods according to the novel food regulation (EC) no. 258/97. Also, food supplements have to meet the requirements of article 14 of Regulation (EC) No. 178/2002 concerning the safety of foodstuff. Food shall not be placed on the market if it is unsafe. For food supplements that fail the German food-related legal standards but are legally manufactured in another EU member state or are legally put into circulation, the importer requires the so-called general disposition, which must be applied for at the BVL according to § 54 of the German Food and Feed Act. Another possibility for food which fails to meet German food law is to apply for a certificate of exemption according to § 68 of the Food and Feed Act. The food business operator has to meet the harmonized regulations concerning maximum and minimum levels of additives, flavors and enzymes. The packaging has to meet the compulsory labeling as well the voluntary labeling, like health claims. The BVL is also the relevant authority for other tasks concerning food supplements. A figure shows all notifications since 2005 of food supplements in Germany at the BVL. Additionally, an overview for notifications in the rapid alert system for food and feed concerning food supplements is given as well as a brief introduction into the survey of food supplements marketed on the internet.

Because of the growing healthcare market and the increasing health consciousness of the population, more and more food supplements are being placed on the market in addition to medicinal products. Concerning the demarcation of medicinal products to food supplements, not only is the intended purpose of the product critical, but the mode of action of the respective preparation also plays an important role. Following the legal definition, a drug has a pharmacological effect, without it being further defined. Therefore, many courts have already tried to interpret the term pharmacological effect, including the terms metabolic or immunologic effect, and try to describe this in more detail.It should be noted that the pharmacological effect, which means an interaction of the substance of a medicinal product with cellular constituent of the human body - unlike the effect of a foodstuff - must significantly affect the physiological functions and must therefore exert targeted effects on the human body and its functions, more than with the consumption of a conventional quantity of a food would be possible. These modifying physiological functions of the body must be addressed positively, which means beneficial to human health. Products which are consumed only for euphoria purposes, or even have a harmful effect, shall not be classified as medicinal products, despite their pharmacological mechanism of action.

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.

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

Background: Dietary supplements have been widely used among the United States of America (USA) and the European Union (EU) population not only as a form of nutrition but also for medicinal purposes. Still, the legislation regulating these supplements remains unclear due to the fact that they can be considered as foodstuffs and/or medicinal products depending on various factors., Methods: The present review article intends to provide information concerning the variations on the definition of dietary supplements, the allowable substances on it, as well as the marketing and labelling requirements among the USA and the EU legislation., Results/conclusions: In fact, several discrepancies can be found between regulations in the USA (mainly regulated by the Food and Drugs Administration) and in the EU (principally regulated by the Food Supplements Directive or by the Directive 2001/83/EC), and even between the different Member States of the EU, with the main differences observed in new products marketing requirements., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

The Food and Drug Administration (FDA or we) is issuing a final rule to define a single-serving container; require dual-column labeling for certain containers; update, modify, and establish several reference amounts customarily consumed (RACCs); amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. We are taking this action to provide consumers with more accurate and up-to-date information on serving sizes.

The Food and Drug Administration (FDA or we) is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases, health-related conditions, physiological endpoints, and/or maintaining a healthy dietary pattern that reflects current public health conditions in the United States, and corresponds to new information on consumer understanding and consumption patterns. The final rule updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the Nutrition Facts label.

In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

The Dietary Supplement Health and Education Act of 1994 (DSHEA), which arbitrarily classified herbals and other medicinal products as dietary supplements, obscured fundamental differences between two classes of products. Authentic supplements to the diet, such as multivitamins or calcium, have nutritional value and are safe. Herbals are used worldwide as medicines, they do not supplement the diet, they may cause severe adverse events, and they should be regulated as medicines. DSHEA also prevented the Food and Drug Administration (FDA) from effectively regulating herbal supplements as medicines. One consequence of weak FDA regulatory oversight is the poor quality of herbals. FDA inspections of manufacturing facilities have revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications. Moreover, many "all natural" herbals marketed for weight loss, enhancement of sexual health and improving sports performance are adulterated with prescription and over-the-counter medications that have caused adverse cardiovascular events. New procedures to authenticate the identity of plants used in herbals will neither detect adulteration by medications nor provide assurance of appropriate pharmacological activity or safety. Nonvitamin, nonmineral "supplements" should be regulated as medicines, but revision or repeal of DSHEA faces strong opposition in Congress. The marketing of botanical supplements is based on unfounded claims that they are safe and effective. Health professionals need to inform patients and the public that there is no reason to take herbal medicines whose composition and benefits are unknown, and whose risks are evident., (Copyright © 2015 John Wiley & Sons, Ltd.)

Despite increasing use of dietary supplements by millions of consumers, regulation of these products has not kept pace with changes and risks in the market. A major reason for this policy gridlock is the inability of different parties to come to an agreement on a path forward. The purpose of this paper is to set out a new framework for regulation in which consumers, industry, and regulators can all find common ground. This framework is based on a conceptual shift from 'benefit versus risk', the model for prescription drugs, to 'access with safety'. Steps should include registration of all dietary supplements to permit easier enforcement against rogue products, a stronger disclaimer explaining the limited role of FDA in evaluating structure/function product claims, the establishment of standard laboratory techniques for characterization of products, and more clear authority for the agency when safety concerns arise. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

This review examines the emergence of dietary supplements and how the Food and Drug Administration (FDA) attempted to regulate these, beginning with the arrival of vitamins and how these were managed under the 1906 Food and Drugs Act, and ending with the seismic influence of the 1994 Dietary Supplement Health and Education Act (DSHEA). Included are the impact of major laws, key court decisions, and the construction of the FDA's supplement actions and rules from the 1920s to the 1990s for products that were neither drugs nor typical foods. Stiff resistance to the regulations by supplement manufacturers, trade associations, politicians, and especially the public at large is an important part of this story. The paper closes with the passage of DSHEA and how it literally changed the definition and parameters of control of dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

Federal regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act of 1994. The law has been criticized as weak and ineffective. Alarming research has emerged demonstrating that supplements may be mislabelled, contaminated, adulterated with dangerous or unknown compounds, or sold at toxic doses. As a result, the health community has raised concerns about the safety and quality of dietary supplements. Increased federal oversight is an important avenue for improving supplement safety; however, states and local governments may also pursue strategies to strengthen the overall regulatory control of dietary supplements. States and local governments have substantial experience in regulating other products that pose a risk to public health, such as tobacco. Additionally, much has been learned about the tactics the tobacco industry has employed to protect its interests. Lessons learned may be applied to new regulatory efforts aimed at improving the safety of dietary supplements at the state and local levels. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

This is a summary from a workshop convened as part of the 13(th) annual meeting of the International Scientific Association for Probiotics and Prebiotics. A group of 24 stakeholders, including clinical experts, researchers, federal government officials, funding agencies, lawyers and industry experts met to review the challenges of the current regulatory approach to human research on probiotics in the USA and to discuss ways to move research forward. There was agreement that some of the current regulatory requirements imposed on probiotic research in the United States hindered research progress and increased cost without improving study subject safety. Many situations were outlined by clinical investigators demonstrating the impact of regulatory delays on research progress. Additionally, research is compromised when study designs and outcomes require manipulation so as to invoke less burdensome regulatory requirements. These responses by investigators to regulatory requirements have placed United States' researchers at a disadvantage. The public ultimately suffer when research to clarify the role of these products on health is stalled. Workshop participants concurred that regulatory oversight should balance study subject vulnerability with documented safety for the intended use for the probiotic strain, and that human research on foods and supplements should not be be regulated as drug research. Challenges and potential improvement strategies are discussed.

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

The objectives of this work were to evaluate current legislation on dietary supplements in the United States, the European Union and Brazil, and the profile of adulterated and/or irregular products on these markets. Due to a less restrictive legal framework, a supplement product that is freely available in the US may be considered a drug or even be proscribed in the EU and Brazil, thus giving rise to a clandestine market based on smuggling. From 2007 to 2014, the United States Food and Drug Administration reported 572 cases of supplement adulterations in the country, mainly products for sexual enhancement (41.6%). Data from the European Union Rapid Alert System for Food and Feed showed 929 adulterations during the same period, over 40% due to unauthorized ingredients or undeclared medicines. From 2007 to 2013, the Brazilian Federal Police Department seized 5470 supplement products, 92.2% with an American-declared origin. Qualitative chemical analyses performed on 2898 products found 180 adulterations, 41.1% due to undeclared drugs, mainly anabolic steroids, anorectics and products for erectile dysfunction, all considered medicines in Brazil. Educating the public regarding the potential risks they are taking when consuming adulterated or irregular products is necessary to protect the health of consumers., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting., (© 2015 American Society for Nutrition.)

The article discusses various aspects of the regional (the European Union) and national (European countries) regulation related to food supplements. The use of botanicals and minor bioactive substances in food supplements, and their labelling are studied. The EU principle of mutual recognition is described in the context of current challenges that exist in the regulatory harmonisation between the EU member states. The concept of novel foods and novel ingredients is also presented, and the procedure of their pre-market approval is described in detail. Basic principles of using claims for food supplements are also outlined.

Herbs are used in Europe as medicinal products, food, food supplements, and related products. This paper will discuss the concepts of Traditional Herbal Medicines and Traditional Plant Food Supplements, defined in European legislation under differing legal frameworks, regarding Traditional Plant Food Supplements (including Claims Regulation) and the role of the European Food Safety Authority in health claims.

The evidence sufficient to establish the expectation of safety for new ingredients in dietary supplements is an area of considerable controversy. Recently, the U.S. Food and Drug Administration (FDA) proposed a sound scientific framework for evaluating the safety of new ingredients. The level of evidence the FDA requires (i.e., in vitro, animal or human testing) hinges on three key factors: (1) documented history of use; (2) the dose and formulation of the new ingredient compared with the historically used ingredient; and (3) the supplement's recommended use (i.e., daily or as needed). Despite its strengths, the framework requires four key modifications to ensure the expectation of safety: (1) historical use should rarely, if ever, be sufficient to replace experimental data; (2) entirely novel ingredients should undergo, at a minimum, a 90-day human testing; (3) manufacturers should be required to submit to the FDA all available data regarding new ingredients, both favorable and unfavorable; and (4) before assuming that consumers follow instructions on supplement labels, this assumption should be empirically confirmed. In the absence of significant modifications, the FDA's guidance may have the effect of providing a false sense of security to consumers seeking safe dietary supplements.

The Dietary Supplement and Health and Education Act of 1994 gives the U.S. Food and Drug Administration (FDA) responsibility for oversight of the dietary supplement industry. Recent draft guidelines proposed by the FDA to insure the safety of new dietary ingredients would significantly alter the ability of manufacturers to bring new dietary ingredients to market, and may cause many products introduced since 1994 to be discontinued. These changes will have an impact on health care, but with limited research on dietary supplements and how their use affects the health care system, there is no way to predict what their overall effect on health will be. Since the natural raw materials for dietary supplements are often inexpensive and generally cannot be patented, manufactures have little incentive to conduct the research which might otherwise be warranted. Appropriate clinical trials that evaluate the use and efficacy of various supplements may be critical for our health care system. If inexpensive dietary supplements are found to be safe and effective, such research could yield significant cost savings as well as health benefits.

Manufacturers wish to communicate the benefits of probiotics in advertising and labeling with lawful and adequately substantiated claims. Regulatory and substantiation requirements differ for products intended to cure, treat, prevent, or mitigate a disease; to reduce a healthy individual's risk of developing a disease; or to affect the structure or function of the body. Food labeling is regulated by the US Food and Drug Administration, and advertising is regulated by the Federal Trade Commission; the standards and methods used by these agencies differ. Food manufacturers must design their claims regarding the benefits of probiotics with the regulatory environment in mind and must develop their research plans to provide evidence that satisfies the agencies' substantiation requirements. This article offers an overview of the applicable laws and regulations, what they mandate regarding legitimate claims, and the issues regarding the design of research to substantiate such claims.

Claims are used to support public health advocacy and marketing. Their evidence base is variable. Claims are made on (i) nutrient content, (ii) comparative merits, (iii) health benefits, and (iv) medical benefits. Experience with therapeutic agents has aided the development of recommendations for the substantiation of health claims for foods and food components, with which dietary supplements would be included. An EU Concerted Activity, Functional Food Science in Europe, suggested that such claims should be based on the general outcomes of 'enhanced function' and 'reduced risk of disease'. A further EU Concerted Activity, The Process for the Assessment of Scientific Support for Claims on Foods, proposed that the evidence base should provide: a characterization of the food or food component to which the claimed effect is attributed; human data, primarily from intervention studies that represent the target populations for the claim; a dose-response relationship: evidence of allowing for confounders including lifestyle, consumption patterns, background diet and food matrix; an appropriate duration for the study; a measure of compliance; and have adequate statistical power to test the hypothesis. When ideal endpoints are not easily accessible for measurement, validated and quality assured markers of the intermediate or final outcomes could be used, as long as their relationship is well characterized. Overall, the totality and coherence of published and unpublished evidence should be considered. Assessments for substantiation need expert judgement, weighting of the strength of the claim, and intelligent use of the criteria applied on an individual basis with respect both to gaps in knowledge and to any need for new knowledge and data.

Nutraceuticals are food or food ingredients that have defined physiological effects. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, "optimal nutrition" the concept of enhanced performance--both physically and mentally--and reduction of disease risk factors. In this paper the focus is mainly on legislation governing botanical-sourced nutraceuticals in the European Union (EU). Nutraceutical concept in general has been defined. Different pieces of legislation influencing botanical nutraceuticals are described. The issue of the borderline between food and drug is discussed. The regulatory status of botanical nutraceuticals as food supplement, food ingredient, functional and fortified food, novel foods and foods for particular nutritional use in the diversified, complex and ever-changing European regulatory environment is described. Botanical nutraceuticals present additional problems because of their complex nature and composition particularly with respect to the quality aspects, which in turn affect safety parameters and overall efficacy of the products. Quality issues relating to botanical sources, growth conditions, end products, their specifications and other technical criteria are highlighted. Guiding principles to be observed for conducting in vitro, in vivo studies in animals and their impact on clinical safety data are discussed. Finally, health claims, their types and criteria of substantiation in light of ongoing discussions with regard to the EU frame work of regulation on nutrition and health claims and role of process for the assessment of scientific support for claims (PASSCLAIM) initiative is discussed. The concept of grading of evidence to substantiate different claims and to establish standards, which should not be revoked or reversed by emerging science at a later stage has been considered. These issues are crucial and are being discussed at EU Parliament and Commission level during the development of the health claim regulations.

The FDA estimates that US citizens spend more than $ 8.5 billion a year on dietary supplements and world wide the market is estimated at more than $ 60 billion. However, although a majority of consumers express confidence in the safety of these products, 74% believe the government should be more involved in ensuring that these products are safe and efficacious. Recent regulatory initiatives such as the imminent adoption of cGMPs for dietary supplements in the US, implementation of cGMPs in Canada and the recent EU dietary supplement initiative represent legislative and industry response to public clamor for more comprehensive oversight of dietary supplements. Regardless of mandated practices, the majority of dietary supplement manufacturers have done an excellent job of protecting the safety and quality of their products. The promulgation of these cGMPs will help ensure consumers that equal standards are followed throughout the industry. For some companies with established processes based on existing food or pharmaceutical cGMP regulations, the transition will be relatively painless while, for many, it will represent a significant increase in the level of documentation and testing. However, consumers deserve and demand that products meet standards for safety and quality and the implementation of cGMPs for these products are an important first step. Although the cGMPs are designed to ensure products are safe from a standpoint of identity, purity, quality, strength and composition, they do not address preclinical or clinical testing of ingredients for safety or efficacy. This would involve ingredients meeting the requirements of Generally Recognized as Safe (GRAS) status or going through the New Dietary Ingredient (NDI) process.

The term "health/functional food" (HFF) refers to food supplements containing nutrients or other substances (in a concentrated form) that have a nutritional or physiological effect whose purpose is to supplement the normal diet. The Korean Health/Functional Food Act that came into effect in 2004 requires these products to be marketed in measured doses, such as in pills, tablets, capsules, and liquids. HFFs are of two types: generic and product-specific. There are 37 ingredients listed in the act for generic HFFs, and if an HFF contains a new active ingredient that is not included in the generic 37 products, it is considered a product-specific HFF. The standardization, safety, and efficacy of a new active ingredient are reviewed by the Korean Food and Drug Administration in order to receive approval as a product-specific HFF. Conforming with international standards and protecting public health requires constant upgrading of the Health/Functional Food Act.

Objectives: Probiotic and prebiotic products manufactured in South Africa were identified and health and content claims stated on the labels were evaluated according to available scientific evidence, the proposed South African regulations in the Foodstuffs, Cosmetics and Disinfectants Act (Act No. 54 of 1972, www.doh.gov.za), and microbial assessment., Results: The range of products identified included probiotic- and/or prebiotic-containing supplements (capsules), food items fortified with probiotics and/or prebiotics, and fermented food containing probiotics, e.g. dairy products. Most of the health-related claims on the labels of the identified products do not comply with proposed South African regulations. However, results also indicate that the proposed South African regulations should be reconsidered to include an additional 5 claims, for which scientifically sound evidence is available. The claims regarding probiotic strains, viable cell numbers, prebiotic type and concentration stated on the labels of the products are mostly in line with the proposed South African regulations. The actual viable cell content of 3 out of 5 probiotic supplements readily available on the South African market did not comply with the content claim stated on the label. However, this problem did not seem to affect the inhibitory activity of the probiotic strains against indicator strains isolated from faeces of patients diagnosed with AIDS. To validate this finding in vivo assessments should be implemented before considering the need to include a wider range of prescribed viable cell numbers in the proposed South African regulations., Conclusions: The proposed South African regulations regarding probiotic- and prebiotic-containing products should be revised based on the results of this research, and the manufacturers of these products should be held responsible for providing the consumer with scientifically sound and legally correct information.

Consumers are confronted with a vast array of food and dietary supplement products claiming to improve health, manage conditions, and reduce disease risks. Most consumers are unaware of the legal requirements, regulatory processes, and scientific evaluation that underlie these label statements. Labeling for foods and dietary supplements is regulated by the US Food and Drug Administration (FDA). Regulations cover 3 main types of health-related statements: health claims, structure/function claims, and nutrient content claims. Health claims must be supported by "significant scientific agreement" among experts that the claimed benefit of a food or food component on a disease or health-related condition is true. When significant scientific agreement is lacking, qualifying statements may be required on the label to describe the strength of the evidence that supports the claim. Structure/function claims describe an effect of a product on body structure or function, and whereas these claims must be truthful and not misleading, they are not subject to premarket scientific review and approval. Nutrient content claims describe the level of a nutrient in a food or supplement and require FDA approval. By understanding the regulatory framework behind label statements and claims, health care professionals can better assist their patients and clients in making informed decisions.

The articles contains the results of modern legislative base, regulating food supplements turnover in the USA, some European contries, as well as passed by European Parliament.

Dietary supplements are increasingly popular. Supplements include substances such as vitamins, minerals, amino acids, essential fatty acids, fibers and botanicals. Directive 2002/46/EC foresees the use as food supplements of vitamins and minerals listed in the Annexes to the Directive. The Directive challenged the importance of a European regulatory framework for this products to be adopted by the member states. To date herbal products without any therapeutic activity have been included in food supplements. This review summarizes the main legislations on food supplements focusing on herbal products or derivatives.

Food supplements are foodstuffs. Food which is not safe shall not be placed on the market. Adherence to the laws which aim for the safety of food ensures that food supplements are safe. Unfortunately, there are still gaps in the legislation for food supplements. However, even intrinsically safe foods can bear a risk for the consumer if not used appropriately, for example if food supplements are consumed instead of healthy diets or if food supplements are used as substitutes for indicated drugs.

An understanding of the legal and regulatory requirements for foods, including dietary supplements and so-called functional foods, helps to focus attention on the special challenges that exist, which range from safety determinations to claim substantiation and consumer understanding. This article provides an overview of the Food and Drug Administration's regulatory framework for these products; it also highlights issues that are emerging and will require consideration and dialog.

The article presents the history of food supplements' origin. The main requirements to them are given an account of the main legislative and normative documents, regulating the composition and considered as an important instrument for improving the structure and quality of nutrition of the population.