Functional food ingredient quality: Opportunities to improve public health by compendial standardization

Functional food ingredients often include well-characterized dietary supplement ingredients, and are expected to deliver corroborated structure/function declarations and may support health claims. A compendial monograph for a functional food ingredient, as exemplified in the Food Chemicals Codex (FCC), is vetted and made official by elected volunteer experts in the Food Ingredients Expert Committee of the Council of Experts of the United States Pharmacopeial Convention (USP). As a result, manufacturers and other stakeholders can use these public standards to conduct tests that assure the quality of functional foods and food ingredients in commerce. FCC monographs complement adherence to current good manufacturing practices for foods and dietary supplements, and provide minimum quality standards during safety and exposure evaluation.     

Adulteration of Dietary Supplements by the Illegal Addition of Synthetic Drugs: A Review

In the last few years, the consumption of dietary supplements, especially those having plants as ingredients, has been increasing due to the common idea that they are natural products posing no risks to human health. In the European Union and the United States, dietary supplements are legally considered as foods/special category of foods, thus are not being submitted to any safety assessment prior to their commercialization. Among the issues that can affect safety, adulteration by the illegal addition of pharmaceutical substances or their analogs is of major concern since unscrupulous producers can falsify these products to provide for quick effects and to increase sales. This review discusses the various classes of synthetic drugs most frequently described as being illegally added to dietary supplements marketed for weight loss, muscle building/sport performance and sexual performance enhancement. Information regarding regulation and consumption is also presented. Finally, several conventional and advanced analytical techniques used to detect and identify different adulterants in dietary supplements and therefore also in foods, with particular emphasis on plant food supplements, are critically described. This review demonstrates that dietary supplement adulteration is an emerging food safety problem and that an effective control by food regulatory authorities is needed to safeguard consumers.     

Low‐calorie Sweeteners and Other Sugar Substitutes: A Review of the Safety Issues

Sugar‐free or reduced‐sugar foods and beverages are very popular in the United States and other countries, and the sweeteners that make them possible are among the most conspicuous ingredients in the food supply. Extensive scientific research has demonstrated the safety of the 5 low‐calorie sweeteners currently approved for use in foods in the United States–acesulfame K, aspartame, neotame, saccharin, and sucralose. A controversial animal cancer study of aspartame conducted using unusual methodology is currently being reviewed by regulatory authorities in several countries. No other issues about the safety of these 5 sweeteners remain unresolved at the present time. Three other low‐calorie sweeteners currently used in some other countries–alitame, cyclamate, and steviol glycosides–are not approved as food ingredients in the United States. Steviol glycosides may be sold as a dietary supplement, but marketing this product as a food ingredient in the United States is illegal. A variety of polyols (sugar alcohols) and other bulk sweeteners are also accepted for use in the United States. The only significant health issue pertaining to polyols, most of which are incompletely digested, is the potential for gastrointestinal discomfort with excessive use. The availability of a variety of safe sweeteners is of benefit to consumers because it enables food manufacturers to formulate a variety of good‐tasting sweet foods and beverages that are safe for the teeth and lower in calorie content than sugar‐sweetened foods.     

Defining the Public Health Threat of Dietary Supplement Fraud

Adverse health events resulting from dietary supplement fraud (DSF)—fraud conducted for economic gain using dietary supplements—have received increased recognition from agencies and industry. There is a growing awareness that this issue represents a significant public health threat. With increasing consumption of supplements, there are increasing consequences—good and bad—for food science and food safety. “Dietary supplements” are a special category of food that consists of finished products (for example, a vitamin D tablet) that contain 1 or more dietary ingredients. “Dietary ingredients” are the components of those finished products (for example, vitamin D added to a food product such as breakfast cereal). Due to a number of factors, potentially harmful dietary supplements reach—and often remain—in the market. DSF is a type of product fraud, as is food fraud, which is often classified by the U.S. Food and Drug Administration as Economically Motivated Adulteration (EMA). Since the adulterants are unconventional, DSF may represent an even greater public health threat than traditional dietary supplement safety issues (though it is important to note that adulteration is only one type of fraud). Criminology concepts such as situational crime prevention and the crime triangle deepen understanding of the relationship of fraud opportunity as it relates to fraudsters and established hurdles to fraud. The purpose of this research is to provide a comprehensive overview on the public health threat of DSF, and to focus on altering current intervention and response‐based approaches that are prevention‐based.     

Feasibility of Including Green Tea Products for an Analytically Verified Dietary Supplement Database

The Dietary Supplement Ingredient Database (DSID) is a federally funded, publicly accessible dietary supplement database that currently contains analytically derived information on micronutrients in selected adult and children's multivitamin and mineral (MVM) supplements. Other constituents in dietary supplement products such as botanicals are also of interest and thus are being considered for inclusion in the DSID. Thirty‐eight constituents, mainly botanicals were identified and prioritized by a federal interagency committee. Green tea was selected from this list as the botanical for expansion of the DSID. This article describes the process for prioritizing dietary ingredients in the DSID. It also discusses the criteria for inclusion of these ingredients, and the approach for selecting and testing products for the green tea pilot study.     

Current regulatory guidelines and resources to support research of dietary supplements in the United States

Abstract

The U.S. Dietary Supplement Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the Food and Drug Administration (FDA). DSHEA outlined the legal definition, labeling requirements, and process for adverse event reporting for dietary supplements. FDA also issued formal guidance on current Good Manufacturing Practice to ensure that processes for preparation, packaging, labeling, and storage of supplements and ingredients are documented and meet specifications to ensure purity, composition, and strength. However, efficacy of dietary supplements is not required under U.S. law. Despite regulations to improve the marketplace, many challenges remain; as a result, the quality and safety of products available can be highly variable, especially for botanical and herbal products. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety. This review will highlight the existing American regulatory framework for dietary supplements and will describe the remaining regulatory barriers to ensuring that safe and high-quality dietary supplements are offered in the marketplace.     

Anatoxin-a and its metabolites in blue-green algae food supplements from Canada and Portugal

Blue-green algae and spirulina are marketed in health food stores and over the Internet as food supplements in Canada, the United States, and Europe. The reported benefits of consuming these products include improved digestion, strengthening of the immune system, and relief from the symptoms of attention deficit disorder. Some of these products have been found to contain elevated concentrations of microcystins, which are known hepatotoxins. In addition to producing microcystins, Anabaena sp. and Aphanizomenon sp. also produce the potent neurotoxin anatoxin-a. Samples of food supplements containing blue-green algae and spirulina were collected in Portugal and from urban centers across Canada in 2005. Extracts of these supplements were analyzed to determine the presence and concentrations of anatoxin-a and its two main metabolites, dihydroanatoxin-a and epoxyanatoxin-a. Initial analyses were performed using high-performance liquid chromatography (HPLC) with fluorescence detection, and confirmation required the use of LC with tandem mass spectrometry (LC-MS-MS). The HPLC with fluorescence detection indicated no anatoxin-a, but four samples were suspected to contain either dihydroanatoxin-a or epoxyanatoxin-a at 0.1 to 0.2 microg/g. LC-MS-MS results, however, indicated no trace of either transformation product in any sample analyzed. The detection limits for anatoxin-a, dihydroanatoxin-a, and epoxyanatoxin-a were similar for both fluorescence detection (0.2 to 0.3, 0.4 to 1.4, and 0.2 to 1.5 pg on the column, respectively) and mass spectrometry (0.3 to 1.5, 0.3 to 0.8, and 0.5 to 0.8 pg on the column, respectively). Because of the higher specificity of the LC-MS-MS analysis, all tested food supplement samples were considered free of anatoxin-a and its transformation products.     

Liposomes in nutrition

The dietary supplement industry is growing in dynamic ways. There are broad ranges of ingredients that have established health benefits, and use of nutritional supplements is at an all time high. Most attention in the literature has been on treatment benefits and ingredient claims. Select researchers are now focusing on routes of administration, efficiency of absorption, absorption criteria, improving bioavailability and product formulation technology. Liposomes, microscopic lipid vesicles, usually formed from phospholipids, have been used to change the pharmacokinetics profile of, not only drugs, but herbs, vitamins and enzymes. Because of their unique properties liposomes are able to enhance the performance of products by increasing ingredient solubility, improving ingredient bioavailability and in vitro and in vivo stability. This article reviews liposomes, their chemistry and structure, and current liposome technology with respect to applications in nutrition.     

Welche Bedeutung besitzt die Mehrfachverwendung von Nahrungsergänzungsmitteln? Daten einer deutschlandweiten Verbraucherbefragung

Today the use of dietary supplements in the form of vitamin and mineral preparations is partially widespread. Apart from their importance in relation to health, wellbeing and prevention the risk assessment of dietary supplements and a safe total nutrient intake play a crucial role. The supply of various products with same ingredients and the associated cumulative intakes of substances can be seen as a potential problem. Data on this were not yet available. The aim of this present analysis was to capture and further characterize the multiple use of dietary supplements in adult men and women. The data for this study was obtained from a representative survey in cooperation with the Society for Consumer, market and sales research (GfK) in Germany with 1.070 dietary supplement users. In 94 % of the cases, the supply of a specific nutrient came from a single preparation. With an increasing number of dietary supplements used, the mean vitamin and mineral intake increased as expected, at the same time, the number of supplement users dropped significantly. An exceedance of the Tolerable Upper Intake Level (UL) was of relevance mainly in view of magnesium. 68 % of the magnesium users exceeded the UL with the intake of a single product. Overall, the data obtained here indicated that vitamins and minerals were not taken multiple via different preparations. In this collective, multiple exposures via different dietary supplements harbored no exposed risk.     

美国保健食品监管及标准现状

美国保健食品又称为膳食补充剂,是指以维生素、矿物质、氨基酸、草药(或其他草本植物)或以上成分经浓缩、配方、提取或混合形成的产品,主要由美国食品和药物管理局(Food and Drug Administration, FDA)负责监管。美国保健食品与我国的保健食品在产品类别、原料及形态等方面具有一定的相似性,因此美国保健食品目前的监管和标准现状对于我国保健食品有相当的借鉴意义。本文以美国保健食品(膳食补充剂)相关监管法规、产品标准作为研究对象,重点分析了美国保健食品在范畴、产品、原料、功能声称、标签、生产经营等方面的规定。同时介绍和分析美国膳食补充剂药典(dietary supplement compendium, DSC)的主要内容,为完善我国保健食品的监管体系、理顺监管职责、提升标准水平提供了技术依据。     

进口保健食品在我国注册备案情况及发展趋势

目的分析申请进口保健食品的"瓶颈"及原因,并提出进口保健食品未来的发展管理趋势。方法通过对我国上市的进口保健食品注册和备案产品总数、保健功能、原料及申请国家情况的统计分析,梳理进口保健食品注册备案法规,并对已获得注册和备案的进口保健食品建立数据库,通过excel软件进行描述性分类统计分析。结果根据进口注册的保健食品总量分析,2003年以前批准的产品占65%,2003年以后批准的产品占35%;注册产品保健功能以增强免疫力最多,其次为辅助降血脂,申报的保健功能涉及18个;申请备案的保健食品中保健功能以补充钙最多,其次是维生素D,申报的营养素涉及17个;进口保健食品注册和备案申请最多的是美国,涉及国家达到15个。结论面对巨大的国内消费市场,在我国获得注册批准证书和备案凭证的进口保健食品数量却不足一千个,远低于国外上市健康产品种类。这与我国对进口保健食品法规要求较严,国外保健食品类似产品管理不同等有关。作为进口到中国的保健食品,必须确保产品长期食用的安全性。未来随着保健食品原料目录的调整及法规完善,更多符合我国法律法规要求的进口保健食品将给国人带来更多的健康选择。     

加强我国保健食品监督管理的探讨

本文探讨了从强化保健食品行业准入、保健食品功效成分审查的角度，通过信息共事、广泛宣传、信用档案、中立分析等手段，积极支持和鼓励保健食品消费者，通过法律手段维护自己合法权益，进而在审查、监督、维权三个环节，建立适合我国国情的全方位、多层次的保健食品监督管理机制。     

Clean label: Why this ingredient but not that one?

Consumer demand for natural and clean label foods continues to grow. This study aims to measure consumers’ perceived naturalness of food ingredients and further to investigate factors affecting their acceptability. Yogurt was chosen as the focal food of interest. A total of 20 common yogurt ingredients within the categories of sugars, stabilizers/thickening agents, preservatives, and coloring agents were selected. An online survey was administered to 526 yogurt consumers in the United States to evaluate the degrees of naturalness, familiarity, and acceptability of the selected ingredients. The degrees of acceptability were rated again when information regarding the functionalities and sources was given. Socio-demographic information was also collected. Results showed that the perceived naturalness of the coloring agents and preservatives varied substantially within each category. In contrast, the selected sugars were perceived as more natural, while stabilizers/thickening agents were perceived as less natural. These findings suggest that food manufacturers may focus on stabilizers/thickening agents in clean label reformulations. Results also showed that providing information regarding ingredient source, but not functionality, improved acceptability for some ingredients. This finding carries implications in that food manufacturers may consider including source information on their ingredient lists, and that regulatory agencies may need to set further guidelines for providing information on food labels. Additionally, some socio-demographic factors, such as consumers’ age and their knowledge on food ingredients, seem to be linked to the perceived naturalness and acceptability of ingredients. Understanding the link between socio-demographic characteristics and the acceptability of specific ingredients may help food manufacturers to market their products to specific demographic groups.     

Updating chemical profiling of red ginseng via the elucidation of two geometric isomers of ginsenosides Rg9 and Rg10

With the increasing popularity of dietary supplements, the quantitative analysis and quality control of their constituents have emerged as a significant regulatory and safety challenge. Ginseng, the root of Panax ginseng, has been used as a folk medicine to improve immunity, provide nutrition and diminish fatigue. Steam-processed ginseng, commonly called “red ginseng” in Korea and China, is prevalent as a dietary supplement. The different processing methods for the production of ginseng products could lead to quantitative and qualitative variations in biologically active compounds, such as the ginsenosides, present in the products. Herein, we have verified that ginsenoside Rf was transformed into two geometric isomers of ginsenoside Rg9, e.g., (20E)- and (20Z)-ginsenosides Rg9, and another ginsenoside here designated Rg10, which was inappropriately reported as ginsenoside Rg8 in a previous study. This study could be of practical use in the establishment of a comprehensive chemical profile of red ginseng for the quality control and standardization of commercial dietary supplements.     

Coenzyme Q10 supplementation: Efficacy,safety, and formulation challenges

World population growth and aging are posing unprecedented challenges in sustaining the health of 9.1 billion people that will be occupying the planet by 2050. Although noncommunicable diseases such as cardiovascular and neurodegenerative diseases, cancer, and diabetes are among the top 10 global causes of death, they can be prevented by risk factor reduction, early detection, and adequate treatment. Since a healthy diet along with dietary supplementation could play an important role to reduce morbidity and cut off its associated health care costs, research in the food and nutrition area is required to find solutions to global challenges affecting health. As a result of the healthy living trend, dietary supplements category is growing fast, leading to an urgent need for dietitians, physicians, and policy makers to broaden the scientific evidence on the efficacy and safety of a wide range of active ingredients. Coenzyme Q10 (CoQ10), as the third most consumed dietary supplement, and as a potential candidate for the treatment of various noncommunicable diseases that are among the global top 10 causes of death, has gained interest over years. Scientific evidence regarding mainly CoQ10 efficacy and safety, as well as formulation challenges, is addressed in this review.     

蜂蜜中植物源性毒性成分的研究进展

蜂蜜是天然的甜味剂、膳食补充剂,有广泛的药用功效,但与欧美等国家相比,我国在食用蜂蜜中毒机制及毒性成分阐明上还有待进行深入的研究。本文对我国食用蜂蜜中毒事件、临床症状、中毒原因、植物源性毒性成分及其毒性等进行综述,为开展蜂蜜中植物源性毒性成分研究及提升蜂蜜安全标准提供参考。     

Monitoring of the amphetamine-like substances in dietary supplements by LC-PDA and LC–MS/MS

Recently, amphetamine-like substances derived from the β-phenylethylamine core structure have been detected in dietary supplements. Especially, β-methylphenylethylamine (BMPEA), an amphetamine isomer, has been found in dietary supplements labeled as containing Acacia rigidula. The U. S. Food and Drug Administration determined that BMPEA is not naturally present in food and does not meet the statutory definition of a dietary ingredient. In addition, BMPEA has been classified as a psychotropic drug in South Korea and a doping substance by the World Anti-Doping Agency. The aim of this study was to determine whether dietary supplements contained amphetamine and amphetamine-like substance, including β-phenylethylamine (β-PEA) and BMPEA using LC-PDA and LC–MS/MS. In 10 of 110 samples, illegally added compounds were detected in the following ranges; β-PEA 1.4–122.0 mg/g and BMPEA 4.7–37.6 mg/g. This study will contribute to enhancement of food safety in the South Korea.     

Popular Ethnic Foods in the United States: A Historical and Safety Perspective

In recent years, a dramatic increase in the demand for ethnic foods in the United States has been observed. Interestingly, with their rise in popularity, more foodborne illness outbreaks associated with ethnic foods have also been reported. Despite a more than 200‐y history of ethnic foods in the United States, there is a paucity of information about them. Furthermore, there is also a lack of research on food safety issues involving ethnic foods. Therefore, this paper provides a comprehensive overview of ethnic foods, including the history, types, popularity, characteristics, ingredients, and consumer attitudes toward them. Importantly, this review provides an analysis of the statistics of foodborne illness outbreaks associated with ethnic foods based on data from the Centers for Disease Control and Prevention (CDC). The breakdown of etiology of ethnic foods identified the number of total outbreaks, the causative microorganisms, the food vectors, and the locations where foodborne disease outbreaks have occurred. Also covered is a review of the Hazard Analysis Critical Control Point (HACCP) system implementation, food safety training, and inspection score systems related to ethnic foods and how these can serve as effective tools for the prevention of foodborne illness outbreaks. This study contributes to the body of food safety literature by providing helpful information about ethnic foods in the United States.     

DSHEA's third-party literature exemption; mail order sales, direct marketing, and Internet use

This article examines ways in which marketers of dietary supplements can make use of the "third-party literature" section of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This provision permits persons or entities, other than manufacturers or distributors, to distribute to consumers certain publications in connection with the sale of particular supplements. These publications may include statements about the therapeutic benefits of such products without subjecting the products to regulation by the Food and Drug Administration (FDA) as unapproved new drugs. Specifically, this article addresses the following: Can a dietary supplement manufacturer or distributor send third-party literature about a dietary supplement to a customer in a mail order sales transaction? Can third-party literature be disseminated by mail with dietary supplement catalogues only? Can third-party literature be disseminated by sales representatives engaged in direct marketing of dietary supplements? Can third-party literature appear on the Internet? The answer appears to be affirmative in each of these situations.     

一切源于“天然”——访科宁中国营养与健康事业部销售经理 黄冰

<正>据有关专家预计,2006年国内和国际的食品及饮料配料产业会继续增长,并将围绕“安全与健康”的两大主题投入更多的关注。一方面基于当前国民营养健康的状况正面临挑战,另一方面源于国民的健康意识越来越增强,使得那些添加了天然的、功能性的食品配料产品受到了格外的欢迎,更多的健康素材和配料已然成为各大食品及饮料生产企业的“俏手货”。