[Novel food sources: from GMO to the broadening of Russia's bioresource base].

The modern strategy of humanity food providing is aimed at finding the exit from the food crisis in the shortest possible time, by the end of XXI century food and feed production should increase by at least 70%. These tasks solution implies not only the use of science-oriented technologies, but also the expansion of the food base by means of novel food sources, which don't have a history of safe use. In the Russian Federation the formation of novel food's safety assessment approaches is regulated at the state level and is the most important requirement for the possibility of usage. Russian experience of the second half of the XX century in the area of novel food sources' biomedical research unites two stages. The first of them dates back to the middle of the 1960s', when the Soviet scientists, in particular, the workforce of the Institute of Nutrition of the USSR Academy of Medical Sciences, under the leadership of Academician A.A. Pokrovskii, have developed the evaluation approaches of the biological value and safety of microbial synthesized protein. The second stage of the safety assessment research development was the work with the genetically modified organisms of plant origin (GMO), that begun in the middle of the 1990s'. Since the moment of formation in 1995-1996, 9 methodical guidelines that regulate methods of safety assessment and control over GMO have been developed. Comprehensively formed by 2020, safety assessment system has been used in the framework of 27 GMO lines state registration that passed a whole cycle of medical and biological research and were allowed for use in nutrition of the population of the Eurasian Economic Union. Within the framework of these research a considerable amount of factual material has been accumulated, a regulatory and methodological basis has been built, and a substantial background for further fundamental and applied scientific research in the field of development and safety assessment of novel food has been created.

[Microbiological safety of food: development of normative and methodical base].

The main results and prospects of fundamental and applied hygienic research of the laboratory of biosafety and nutrimicrobiome analysis of the Federal Research Centre of Nutrition, Biotechnology and Food Safety (hereinafter - the Institute of Nutrition) in the direction of developing a regulatory and methodological framework for assessing the microbiological safety of food are reviewed. The formation of microbiological regulation as a scientific analytical and administrative managerial process in the former USSR and the Russian Federation is considered in the context of historical data, including personal contribution of the scientists of the Institute of Nutrition and other specialists. The basic principles of regulation are emphasized: the scientific validity of the established criteria and requirements, the feasibility, technological attainability, differentiation according to the degree of danger to the health of consumers, preventive nature. The resource of the national normative and methodological base in the field of microbiological food safety at the turn of the century is characterized, the features of the introduction of the microbiological risk assessment (MRA) methodology in the substantiation of Russian norms and measures for the prevention of food infections are described. The information is given on the developed guidance documents on MRA and on the examples of norms adopted on its basis. The article covers the issues of reglamentation the requirements for food safety and reducing the spread of new pathogens Stx-Escherichia coli, Listeria monocytogenes, Enterobacter sakazakii, Campylobacter spp. in the food chain based on risk-oriented approaches. The necessity of taking specific measures for the prevention of cross-contamination in the poultry processing industry is substantiated, taking into account the evidence of the high adaptability of C. jejuni isolated from domestic raw poultry. In the sanitarian-mycological aspect, the monitoring perspective of mould fungi, taking into account their chemotypes, in cereals and non-grain plant products is shown to predict the risk of mycotoxin accumulation and take timely measures. The need to assess the impact on the population, taking into account the characteristics of consumption in the country, as well as the development of criteria for indirect risk of residues are argued for regulation of the antibiotics in food. In light of the challenges in the field of agro- and food technologies to public health at the present stage, contributing to the acceleration of microbial evolution and the emergence of new risks in food, the priority tasks of improving the regulatory and methodological base for assessing microbiological safety have been identified, with an emphasis on the introduction into the process of substantiating the norms of innovative OMICs-technologies based on the achievements of genomics, transcriptomics, proteomics, metabolomics, bioinformatics.

A 100-Year Review: Yogurt and other cultured dairy products.

The history of the last 100 years of the science and technology of yogurt, sour cream, cultured butter, cultured buttermilk, kefir, and acidophilus milk has been one of continuous development and improvement. Yogurt leads the cultured dairy product category in terms of volume of production in the United States and recent research activity. Legal definitions of yogurt, sour cream and acidified sour cream, and cultured milk, including cultured buttermilk, are presented in the United States Code of Federal Regulations and summarized here. A tremendous amount of research has been done on traditional and novel ingredients, starter cultures and probiotics, mix processing, packaging, chemical aspects, physical and sensory properties, microstructure, specialized products, composition, quality and safety of yogurt and various manufacturing methods, addition of flavorings, viscosity measurements, and probiotic use for sour cream. Over time, there have arisen alternative manufacturing methods, flavor problems, addition of flavorings, and use of probiotics for cultured buttermilk. Many health benefits are provided by yogurt and other cultured dairy products. One hundred years of testing and development have led to wider uses of cultured dairy products and new processing methods for enhanced shelf life and safety. Future research directions will likely include investigating the effects of probiotic dairy products on gut microbiota and overall health.

Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

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.

The Rise and Fall of Universal Salt Iodization in Vietnam: Lessons Learned for Designing Sustainable Food Fortification Programs With a Public Health Impact.

BACKGROUND: In 2005, more than 90% of Vietnamese households were using adequately iodized salt, and urinary iodine concentration among women of reproductive age was in the optimal range. However, household coverage declined thereafter to 45% in 2011, and urinary iodine concentration levels indicated inadequate iodine intake. OBJECTIVE: To review the strengths and weaknesses of the Vietnamese universal salt iodization program from its inception to the current day and to discuss why achievements made by 2005 were not sustained. METHODS: Qualitative review of program documents and semistructured interviews with national stakeholders. RESULTS: National legislation for mandatory salt iodization was revoked in 2005, and the political importance of the program was downgraded with consequential effects on budget, staff, and authority. CONCLUSIONS: The Vietnamese salt iodization program, as it was initially designed and implemented, was unsustainable, as salt iodization was not practiced as an industry norm but as a government-funded activity. An effective and sustainable salt iodization program needs to be reestablished for the long-term elimination of iodine deficiency, building upon lessons learned from the past and programs in neighboring countries. The new program will need to include mandatory legislation, including salt for food processing; industry responsibility for the cost of fortificant; government commitment for enforcement through routine food control systems and monitoring of iodine status through existing health/nutrition assessments; and intersectoral collaboration and management of the program. Many of the lessons would apply equally to universal salt iodization programs in other countries and indeed to food fortification programs in general.

Tragedy, transformation, and triumph: comparing the factors and forces that led to the adoption of the 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States.

The 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States were two of the earliest pieces of legislation to provide generalized regulation of food and drugs on a national scale. While significant scholarly attention has been given to explaining the factors and forces that led to the passage of each Act independent of the other, few books or articles have directly compared the similar individuals and events that led to the adoption of both Acts. This paper attempts to fill that gap. Through a comparative examination, this paper reveals that four main components were key to the national pure food and drug movements in both countries: individuals who crusaded for national adulteration legislation; tragedies that shocked the public into calling for reform; press and publicity that was willing and able to bring the evils of adulteration to the forefront of the public mind; and a transformation of the social, political, and economic systems, which created atmospheres conducive to reform. This paper aims to shed new light on the 1860 Adulteration Act and the 1906 Pure Food and Drug Act--two acts that derive their importance not just from the effect that they directly had on the regulation of food and drugs but also as some of the earliest examples of western governments coming to recognize the need for national regulation to protect the public from harm and coming to embrace their changing role as spearheads of modern regulatory states.

Defining, regulating and using saccharin at the outset of the industrial food era (1888-1914).

This paper focuses on the in-depth debates on saccharin that took place around 1900. In numerous discussions among chemists and physicians the sweetener was defined and redefined in a complex way and with a clear lack of agreement among experts. Nevertheless, this fact did not hinder the search for an international agreement on the regulation of saccharin in the food market. This paper analyses these discussions by building on the new trends in material culture studies, and estimates the real impact of medical and chemical expertise on international agreements.

Food allergen law and the Food Allergen Labeling and Consumer Protection Act of 2004: falling short of true protection for food allergy sufferers.

In 2004, Congress mandated labeling of food allergens on packaged foods for the first time by passing the Food Allergen Labeling and Consumer Protection Act (FALCPA). FALCPA requires that manufacturers of foods containing one of the eight major allergens responsible for 90 percent of food allergies either state on the food's packaging that the food contains the allergen, or refers to the allergen by a name easily understandable by consumers in the ingredients listing. Despite this important first step in protecting consumers with food allergies, FALCPA left unregulated the use of conditional precautionary statements (e.g., "may contain [allergen]"), which many manufacturers have used as a low-cost shield to liability. Further, FALCPA applies only to packaged foods, and does not mandate listing of food allergen ingredients in restaurants. This article discusses the history of food allergen litigation in the United States, highlighting the problems plaintiffs have faced in seeking recovery for allergic reactions to a defendants' food product, and some of the practical difficulties still extant due to the lack of regulation of precautionary statements. Also presented is a review of the Massachusetts Food Allergy Awareness Act, the first state legislation requiring restaurants to take an active role in educating employees and consumers about the presence and dangers of food allergens.

[Hexa-sabbath. Foreign matter and vital substances, experts and the critical consumer in the FRG during the 1950s and 1960s]. / Hexa-Sabbat. Fremdstoffe und Vitalstoffe, Experten und der kritische Verbraucher in der BRD der 1950er und 1960er Jahre.

In the late Fifties and early Sixties the regulation of food additives represented a remarkable turning point in German consumer politics, establishing a debate about decision making and policy advice, altering the discourse of purity and contamination, and inaugurating a new political actor, the organized critical consumer. The amendment of the Food Law in December 1958 functioned as a negotiation process between representatives of science, industry and the state, which was institutionalized in the Senate Commissions of the German Research Foundation. While these Commissions for preservatives, foreign matter and colorants worked behind closed doors, a public discourse about the "toxic condition" of modern life and the negative role of the pharmaceutical and chemical industry gained strength. The debate about the admission of hexamethylenetetramine (hexa) took part at a crucial moment. Hexa was used as a preservative in the fish industry. But its anti microbial effectiveness was caused by the decomposition of hexa to formaldehyde. Despite the commission's verdict against hexa, the lobbying activities of the industry granted it a reprieve. In the media, the case of hexa was seen as a touchstone for the capacity of negotiated decision making and the ability of rational scientists to resist the demands of industry. Finally, in 1963 it was the new political actor of the organized critical consumer, heir and successor to the housewife federations as well as to "purists" advocating life reform, who, supported by the media, enforced the prohibition of hexa as a preservative.

Regulation of trans fats: the gap, the Polder, and McDonald's French fries.

Lowering the intake of trans fatty acids (TFA) probably reduces the incidence of coronary heart disease. Estimates of the reduction vary from 4% based on changes in plasma LDL and HDL concentrations alone, to > 20% based on epidemiological associations when TFA intake is lowered by 2% of energy (5 g/day). Even the lowest estimate represents enough cases to justify measures to reduce TFA intake. In The Netherlands, a major reduction in TFA content of retail foods has been achieved in the 1990s through efforts of industry; government intervention has been minimal. Societal pressure is now helping to reduce the TFA content of fast foods. McDonald's French fries in The Netherlands now have less than 4% trans and 24% saturates, as opposed to 21% trans and 21% saturates in the USA. This illustrates the feasibility of reducing TFA in fast foods without increasing saturates. As a result of these developments, dairy and meat have become the major remaining source of TFA in Europe. The question whether these ruminant TFA have the same effect on coronary heart disease risk as industrial TFA has not been settled.

FDA milestones.

Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848. The following chronology describes some of the milestones in the history of food and drug regulation in the United States.

The history of efforts to regulate dietary supplements in the USA.

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.

Uma análise histórico-crítica sobre o desenvolvimento das normas brasileiras relacionadas a queijos artesanais / [A critical-historical analysis of the continuous development of Brazilian legislation related to artisanal cheeses]

Diferentes tipos de queijos artesanais são produzidos, comercializados e consumidos no Brasil, o que impulsiona o constante desenvolvimento de normas por órgãos oficiais, como o Mapa. A criação do Suasa e do Sisbi-POA foi fundamental para esse setor, por permitir um sistema de equivalência na fiscalização e por ampliar a distribuição. Ainda, o Mapa passou a permitir que queijos artesanais produzidos com leite cru pudessem ser maturados em um período inferior a 60 dias, desde que comprovada sua inocuidade. A redução do tempo de maturação é um tema controverso e polêmico, já que não há critérios específicos que estudos científicos devem contemplar, o que permite múltiplas interpretações de dados. Com a criação e a regulamentação do selo Arte, a fiscalização dos produtos artesanais foi designada aos órgãos de agricultura, pecuária e de saúde pública, em complementação à atribuição já prevista pelo Mapa e pelo Sisbi-POA. Ainda, o selo Arte atribui aos órgãos de inspeção uma função orientadora, atividade que deveria ser prioritariamente executada por agências de extensão e associações. As normas que balizam a produção e comercialização de produtos artesanais devem ser frequentemente atualizadas, devido aos constantes avanços científicos na área e para assegurar a oferta de produtos com qualidade e inócuos aos consumidores.(AU)

Different artisanal cheeses are produced, commercialized and consumed in Brazil, leading to a constant development of related rules by the MAPA and other official agencies. The establishment of two national programs (SUASA and SISBI-POA) allowed an equivalence in inspection system and an expanded distribution. Also, MAPA allowed ripening time lower than 60 days for artisanal raw milk cheeses, based on scientific studies that assure their safety. However, lowering the ripening period is still controversial, once there are no proper established criteria for such scientific studies, leading to potential multiple interpretation of data. The newly established ARTE certification transferred the inspection responsibilities of artisanal products to secretaries of agriculture, livestock and health, in support of what was already predicated by MAPA and SISBI-POA. Based on ARTE certification, the inspection service must also provide orientation guidance to producers, which should be done specifically by extension organs and associations. The norms that guide the production and commercialization of these artisanal products often need to be updated, but based on well-established methodologies and procedures, to ensure the distribution of suitable products to consumers.(AU)

The history and future of food fortification in the United States: a public health perspective.

For more than 50 years, the United States federal government has regulated food fortification. During this time, the nutritional situation in the United States has improved greatly, whereas scientific information about the role of vitamins and minerals in human growth and development has increased exponentially. Concurrently, government authority to regulate food fortification has declined. This paper provides a brief history of U.S. food fortification policy and describes the contribution of food fortification to U.S. nutrient intakes. The paper highlights future directions of food fortification in the United States in light of these important developments, and addresses the issue of risk and the need to balance deficiency and toxicity in a generally well nourished population.

Health claims: history, current regulatory status, and consumer research.

During the past 13 years regulatory and consumer communications policies on health claims have been hotly debated and have evolved from a nonregulatory action policy by which health claims were written by manufacturers to one in which claims are carefully proscribed and legally allowed by regulatory agencies. Unfortunately, health claims are not used to full public health potential. This review examines the scientific literature to determine the most effective way to communicate health claims to consumers. The results of health claims studies suggest an evolution in consumer preferences: from complete non-product-specific information in the middle to late 1980s to shorter product-specific claims in 1995 and 1996. Comprehension research suggests that shorter health claims communicate most effectively. Related label research shows that effective messages suggest action, contain text, and graphics, and are placed on the front panel. In conclusion, effective health claims: Are concise Relate to a consumer need or task to be solved Appear on the front panel Combine text and graphics using color Provide an additional benefit beyond the label (e.g., increase the production and availability of more nutritious products and increase consumers' knowledge of nutrition and health).

Generally recognized as safe (GRAS): history and description.

Generally recognized as safe (GRAS), a system for review and approval of ingredients for addition to food, was conceived at a time when the need for a less doctrinaire review of food ingredients was critical. The GRAS approval process for a food ingredient relies on the judgment of "...experts qualified by scientific training and experience to evaluate its safety..." the end product of which is no better or worse than that by FDA, but often more expeditious. The process and requirements for a successful GRAS determination are discussed and compared with that of the food additive petition (FAP) process. The future of the GRAS process is assured by its history of successful performance, bringing safe food ingredients to the consumer in a timely manner.

Observations at the interface of mutation research and regulatory policy.

Between 1970 and 1975 developments in environmental mutagenesis proceeded with amazing speed. These developments were both structural and conceptual in nature. A new infrastructure was built and new concepts about how best to protect consumers from exposures to mutagens emerged. The internal dynamics within the Food and Drug Administration played an important role and is discussed with regard to modifications in testing protocols as well as changes in the overall approach used to protect consumers. It is clear that this exciting period in the early days of environmental mutagenesis has provided a base for growth and development of the field and continues to affect and guide future developments.