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.

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 RESULTS: National legislation for mandatory salt iodization was revoked in 2005, and the political importance of the program was downgraded with consequential effects on budget, staff, and authority.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.

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.

Overview of local, state, and national government legislation restricting trans fats.

Trans fats, also known as partially hydrogenated oils, have long been associated with cardiovascular disease. In 2003, the Food and Drug Administration mandated that trans fat content of ≥0.5 g be listed on food labeling; the next year, the World Health Organization released a recommended daily limit on trans fat intake. During the following decade, legislatures in different municipal and state governments moved trans fat regulation forward, whereas many food companies decided to independently phase out trans fat in their products. The advancement of these parallel processes suggests an emerging best practices phenomenon, integrating public health, law, and the food industry. With both legislation and markets seemingly favoring a limitation on trans fat content in foods, attention has once again shifted to the Food and Drug Administration for a ruling on the safety of trans fats.

History and overview of DSHEA.

The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994, had two primary goals: to ensure continued consumer access to a wide variety of dietary supplements, and to provide consumers with more information about the intended use of dietary supplements. It accomplished these goals, and more, without changing the fundamental regulatory status of dietary supplements as a category of foods. This article explores the history and reasoning behind the major provisions of the Act and reflects on the impact of each during 15 years of experience under DSHEA.

Dietéticos, alimentos-medicamentos y especialidades farmacéuticas, durante la década de los años 40 del siglo XX: desarrollo legislativo y análisis de productos / Dietetic products, therapeutical foods and other pharmaceutical items during de 40s in the 20th century: legal development and product analysis

Fundamentos: Durante la década de los años 40 se introdujeron en la legislación española normativas encaminadas a ordenar el sector de los productos dietéticos, diferenciando los alimentos propiamente dichos pero con un valor dietético, de aquellos con propiedades terapéuticas o aplicaciones especiales. En este trabajo se ha realizado un análisis de los productos dietéticos existentes en España en la década de 1940. Material y método: Se ha procedido al análisis de los productos dietéticos existentes en el mercado español en la década de 1940 a partir de los datos que figuran en la primera edición del Diccionario Español de Especialidades Farmacéuticas CDEDEF) del año 1946. Resultados: Se han analizado un total de 326 especialidades, de las cuales un 20,2 % se declaran como alimentos, un 8,6 % como "alimento dietético" y únicamente un 1,8% como alimento-medicamento. Se concedía mayor importancia al enriquecimiento con minerales (35%) en comparación con el vitamínico (8%).EI 67% de las especialidades se definen como alimentos (alimentos completos, alimentos vegetales, reconstituyentes, tónicos, etc.) y un 40,5% como adecuados para estados carenciales (básicamente raquitismo y anemia). Conclusiones: Durante este período era relativamente habitual la preparación de productos dietéticos por parte de laboratorios no especializados de forma exclusiva a los mismos. Se observa un elevado grado de confusión terminológico y también en cuanto a las propiedades y características de los productos (AU)

Bakcground: During the 40s new legal developments and norms were introduced in Spanish law in order to regulate the sector of dietetic products and supplements, identifying foods with a dietetic added value from those with therapeutical properties or especial indications. In this paper an analysis of existing dietetic products in the Spanish market in the 40s presented. Methods: An analysis of existing dietetic products in the Spanish market in the 40s was conductes. Products were identified based on the first edition of the Spanish dictionary of Pharmaceutical products published in 1946. Results: A total of 326 different products were identified and included in this analysis. 20,2% were classified as foods; 8,6% as "dietetic foods" and only 1,8% as therapeutical foods. Foods fortified with minerals were more frequent (35%) than those fortified with vitamins (8%).67% of the products were defined as foods (complete foods, vegetable foods, invigorating foods, tonics, etc.) and 40,5% were defined as adequate for deficiency situations, basically rickets and anemia. Conclusions: Dietetic products were common pharmaceutical specialties in the 40s in Spain. These products were often manufactured by non-specific pharmaceutical companies. Terms and specific names were often confused in relation to product properties and charateristics (AU)

Legislação brasileira referente à rotulagem nutricional de alimentos / Brazilian food labeling regulations

O objetivo deste trabalho é apresentar uma reflexão sobre a evolução histórica da legislação brasileira de alimentos sob o aspecto da rotulagem nutricional, contextualizando as principais leis das últimas quatro décadas, destacando os avanços e identificando os pontos críticos que ainda necessitam de aprimoramento. De uma forma geral pode-se afirmar que, ao longo dos últimos 40 anos, o Brasil aperfeiçoou a sua legislação, incorporando evidências científicas nos regulamentos buscando melhorar a qualidade dos alimentos e promover a Saúde Pública, levando em consideração a realidade brasileira. Contudo, com a publicação da Resolução n° 360 da Diretoria Colegiada da Agência Nacional de Vigilância Sanitária em 2003, que retira a obrigatoriedade da declaração dos conteúdos de ferro, cálcio e colesterol dos rótulos, pode-se afirmar que ocorreu uma involução em relação à saúde pública, embora a Resolução tenha mérito em relação à harmonização da legislação com os países membros do Mercosul, permitindo o livre comércio entre estes. Esforços devem ser envidados para que as empresas mantenham a declaração dos nutrientes que deixaram de ser obrigatórios. Ademais, é importante atualizar regulamentos já ultrapassados, incorporar conhecimento novo, preencher lacunas e recomendar ações integradas e contínuas de educação alimentar subsidiadas por pesquisas científicas. A rotulagem nutricional de alimentos é um apoio valioso para os consumidores, dando-lhes a oportunidade de conhecer a composição do alimento, a segurança quanto à ingestão de nutrientes e energia, bem como informações importantes para a manutenção de sua saúde. A legislação na área de alimentos deve ser vista como estratégia para auxiliar na redução dos índices de obesidade, das deficiências nutricionais e das doenças crônicas não-transmissíveis associadas ao padrão de consumo.

The objective of this work is to present a reflection on the historical evolution of the Brazilian food legislation and to emphasize nutritional labeling. The main regulations which have been under way for the four past decades were highlighted as well as some topics in the regulations which should be improved. From a general point of view, during this period, advances in the legislation have been observed, considering that scientific reports were incorporated in the regulations intending to improve food quality and to promote public health on account of the specific demands of the Brazilian reality. Nevertheless, according to the Regulation nr.360 of the Collegiate Directorate of the Agência Nacional de Vigilância Sanitária in 2003, which states that the declaration of iron, calcium and cholesterol contents is not obligatory anymore, an involution could be assumed regarding public health. Yet, the regulation has its merit by uniformizing the legislation of the countries which compose the Mercosul, providing free trading. Efforts should be made in order to maintain on food labels the nutrients whose declaration is not obligatory anymore. Moreover, it seems to be important to update the regulations, to fill in gaps and to recommend integrated actions of education in food, based on scientific evidences. Food labels have been an useful tool to consumers by giving them the opportunity to know about the composition, nutrient and energy contents as well as informations regarding health maintenance. Food legislation should be considered a strategy to help reduce obesity, nutritional deficiencies and even to prevent the most common chronic noncommunicable diseases associated with intake patterns.

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.