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Dietary supplement use in the United States is widespread and increasing, especially among certain population groups, such as older Americans. The science surrounding dietary supplements has evolved substantially over the last few decades since their formal regulation in 1994. Much has been learned about the mechanisms of action of many dietary supplement ingredients, but the evidence on their health effects is still building. As is true of much nutrition research, there are many studies that point to health effects, but not all are at the level of scientific evidence (e.g., randomized controlled interventions), rigor, or quality needed for definitive statements of efficacy regarding clinical end points. New technologies and approaches are being applied to the science of dietary supplements, including nutrigenomics and microbiome analysis, data science, artificial intelligence (AI), and machine learning-all of which can elevate the science behind dietary supplements. Products can contain an array of bioactive compounds derived from foods as well as from medicinal plants, which creates enormous challenges in data collection and management. Clinical applications, particularly those aimed at providing personalized nutrition options for patients, have become more sophisticated as dietary supplements are incorporated increasingly into clinical practice and self-care. The goals of this article are to provide historical context for the regulation and science of dietary supplements, identify research resources, and suggest some future directions for science in this field.
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Suplementos Dietéticos , Humanos , Inteligencia Artificial , Suplementos Dietéticos/historia , Suplementos Dietéticos/normas , Nutrigenómica , Estados UnidosRESUMEN
NHANES needs urgent attention to ensure its future, which is facing emerging challenges associated with data collection, stagnant funding that has undercut innovation, and the increased call for granular data for subpopulations and groups at risk. The concerns do not rest merely on securing more funding but focus on the need for a constructive review of the survey to explore new approaches and identify appropriate change. This white paper, developed under the auspices of the ASN's Committee on Advocacy and Science Policy (CASP), is a call to the nutrition community to advocate for and support activities to prepare NHANES for future success in a changing nutrition world. Furthermore, because NHANES is much more than a nutrition survey and serves the needs of many in health fields and even commercial arenas, effective advocacy must be grounded in alliances among the survey's diverse stakeholders so that the full range of expertise and interests can engage. This article highlights the complicated nature of the survey along with key overarching challenges to underscore the importance of a measured, thoughtful, comprehensive, and collaborative approach to considering the future of NHANES. Starting-point questions are identified for the purposes of focusing dialog, discussion forums, and research. In particular, the CASP calls for a National Academies of Sciences, Engineering, and Medicine study on NHANES to articulate an actionable framework for NHANES going forward. With a well-informed and integrated set of goals and recommendations that could be provided by such a study, a secure future for NHANES is more readily achievable.
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Estado Nutricional , Humanos , Encuestas Nutricionales , Encuestas y CuestionariosAsunto(s)
COVID-19 , SARS-CoV-2 , Antioxidantes , Dieta Occidental , Humanos , Estrés Oxidativo , PandemiasRESUMEN
BACKGROUND: The US faces remarkable food and nutrition challenges. A new federal effort to strengthen and coordinate nutrition research could rapidly generate the evidence base needed to address these multiple national challenges. However, the relevant characteristics of such an effort have been uncertain. OBJECTIVES: Our aim was to provide an objective, informative summary of 1) the mounting diet-related health burdens facing our nation and corresponding economic, health equity, national security, and sustainability implications; 2) the current federal nutrition research landscape and existing mechanisms for its coordination; 3) the opportunities for and potential impact of new fundamental, clinical, public health, food and agricultural, and translational scientific discoveries; and 4) the various options for further strengthening and coordinating federal nutrition research, including corresponding advantages, disadvantages, and potential executive and legislative considerations. METHODS: We reviewed government and other published documents on federal nutrition research; held various discussions with expert groups, advocacy organizations, and scientific societies; and held in-person or phone meetings with >50 federal staff in executive and legislative roles, as well as with a variety of other stakeholders in academic, industry, and nongovernment organizations. RESULTS: Stark national nutrition challenges were identified. More Americans are sick than are healthy, largely from rising diet-related illnesses. These conditions create tremendous strains on productivity, health care costs, health disparities, government budgets, US economic competitiveness, and military readiness. The coronavirus disease 2019 (COVID-19) outbreak has further laid bare these strains, including food insecurity, major diet-related comorbidities for poor outcomes from COVID-19 such as diabetes, hypertension, and obesity, and insufficient surveillance on and coordination of our food system. More than 10 federal departments and agencies currently invest in critical nutrition research, yet with relatively flat investments over several decades. Coordination also remains suboptimal, documented by multiple governmental reports over 50 years. Greater harmonization and expansion of federal investment in nutrition science, not a silo-ing or rearrangement of existing investments, has tremendous potential to generate new discoveries to improve and sustain the health of all Americans. Two identified key strategies to achieve this were as follows: 1) a new authority for robust cross-governmental coordination of nutrition research and other nutrition-related policy and 2) strengthened authority, investment, and coordination for nutrition research within the NIH. These strategies were found to be complementary, together catalyzing important new science, partnerships, coordination, and returns on investment. Additional complementary actions to accelerate federal nutrition research were identified at the USDA. CONCLUSIONS: The need and opportunities for strengthened federal nutrition research are clear, with specific identified options to help create the new leadership, strategic planning, coordination, and investment the nation requires to address the multiple nutrition-related challenges and grasp the opportunities before us.
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Infecciones por Coronavirus/complicaciones , Trastornos Nutricionales/complicaciones , Fenómenos Fisiológicos de la Nutrición , Neumonía Viral/complicaciones , Investigación/normas , COVID-19 , Costo de Enfermedad , Costos de la Atención en Salud , Disparidades en Atención de Salud/economía , Humanos , Personal Militar , National Institutes of Health (U.S.)/economía , Trastornos Nutricionales/economía , Trastornos Nutricionales/epidemiología , Pandemias , Estados Unidos/epidemiología , United States Department of Agriculture/economía , United States Dept. of Health and Human Services/economíaRESUMEN
The Office of Dietary Supplements, the National Institute on Minority Health and Health Disparities, the National Institute on Aging, and the National Institute of Diabetes and Digestive and Kidney Diseases, all components of the U.S. National Institutes of Health, co-sponsored an expert panel meeting to discuss the vitamin D paradox in Black Americans. The paradox is that despite markedly low (or "deficient") measures of vitamin D status in Black Americans, the incidence of falls, fractures, or osteopenia are significantly lower compared to White American counterparts with similar vitamin D status. Six panelists were invited to engage in guided discussions on the state of the science with respect to key knowledge gaps impacting vitamin D status and bone health. They were also asked to reflect on best approaches for advancing the science. A central theme throughout the discussions was that there may be many factors that impact Vitamin D levels in Black Americans and understanding these factors may be key to understanding mechanisms for improving bone health in all populations. Data presented showed that although adiposity, skin pigmentation, vitamin D binding protein polymorphisms, and genetics all contributed to differences in 25(OH)D levels in Black vs. White Americans, no one factor alone could fully explain the vitamin D paradox in Black Americans. However, the panelists did agree that the paradox is significant and warrants further investigation. There was consensus that Black Americans gained no skeletal benefits from high doses of vitamin D supplementation, and that high levels of the biomarker of vitamin D status, serum 25-hydroxyvitamin D or 25(OH)D, in this population are almost certain to result in adverse effects. Some panelists proposed that additional studies are needed so that the Institute of Medicine (IOM) can better define the safe upper limits of vitamin D intake in this and other subpopulations. Others suggested a need for better, more generalizable biomarkers of bone health to advance the science.
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Due to the extensive use of botanical dietary supplements by consumers in the United States, there is a need for appropriate research and data to support safety assessments. Complexity and variability, both natural and introduced, of botanical dietary supplements make research on these products difficult. Botanical dietary supplements are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 1994 Dietary Supplement Health and Education Act (DSHEA). They are regulated as a category of food, which differs from the regulation of pharmaceutical products. Both manufacturers and the FDA are faced with the challenge of determining the best approaches for evaluating and monitoring the safety of botanical products. High quality botanicals research requires accurate identification and characterization of the material being studied. Inconsistent results in efficacy studies of botanical dietary supplements have led to efforts to improve the rigor and reproducibility of research in the field. Addressing the challenges associated with botanical dietary supplement safety is a global effort requiring coordination between numerous stakeholders, including researchers, suppliers, manufacturers, and regulators, all of whom play a role in ensuring that high quality products are available on the market.
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Suplementos Dietéticos/efectos adversos , Extractos Vegetales/efectos adversos , Inocuidad de los Alimentos , Humanos , Fitoterapia , Extractos Vegetales/químicaRESUMEN
Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.
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Investigación Biomédica/legislación & jurisprudencia , Suplementos Dietéticos , Política de Salud/legislación & jurisprudencia , Animales , Investigación Biomédica/normas , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Suplementos Dietéticos/efectos adversos , Suplementos Dietéticos/clasificación , Suplementos Dietéticos/normas , Regulación Gubernamental , Humanos , Formulación de Políticas , Control de Calidad , Medición de Riesgo , Terminología como AsuntoRESUMEN
Until a decade ago, no dietary supplement (DS) databases with open access for public use existed in the United States. They were needed by researchers, since half of American adults use dietary DSs and, without information on supplement use and composition, exposures could not be estimated. These articles on Challenges and Future Directions for Dietary Supplement Databases describe subsequent progress. They begin by describing why information on DSs is needed by the government and how it is used to ensure the health of the public. Current developments include: application of DS information to meet public health needs; research efforts on DS quality, efficacy, and safety (as conducted by the Office of Dietary Supplements and other federal agencies); enhanced regulatory activities implemented by the FDA Office of Dietary Supplement Programs, the FDA Office of Enforcement, and the Federal Trade Commission; and initiatives for broader development and dissemination of DS databases for commercial and public use. Other contributions in this journal supplement describe the challenges of working with DSs and the progress that has been made. Additional articles describe surveys of DS use among the general US population and also among special groups such as high supplement users, illustrating why there is a need in the United States for information on supplements. Likely directions for the future of DS science are summarized.
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Suplementos Dietéticos , Bases de Datos Factuales , Suplementos Dietéticos/efectos adversos , Suplementos Dietéticos/normas , Industria de Alimentos/legislación & jurisprudencia , Industria de Alimentos/normas , Etiquetado de Alimentos/legislación & jurisprudencia , Etiquetado de Alimentos/normas , Inocuidad de los Alimentos , Análisis de Peligros y Puntos de Control Críticos , Humanos , Legislación Alimentaria , Salud Pública , Estados Unidos , United States Food and Drug Administration/legislación & jurisprudenciaRESUMEN
Launched in 2008, the Dietary Supplement Label Database (DSLD) permits the search of any term that appears anywhere on product labels. Since then, the database's search and download features have been periodically improved to enhance use for researchers and consumers. In this review, we describe how to customize searches and identify products and ingredients of interest to users in the DSLD, and provide the limitations of working with information derived from dietary supplement product labels. This article describes how data derived from information printed on product labels are entered and organized in the DSLD. Among the challenges are determining the chemical forms, types of extract, and amounts of dietary ingredients, especially when these are components of proprietary blends. The FDA announced new dietary supplement labeling regulations in May 2016. The 2017 DSLD has been updated to reflect them. These new regulations and examples cited in this article refer to this redesigned version of the DSLD. Search selection characteristics such as for product type and intended user group are as described in FDA guidance and regulations for dietary supplements. For this reason, some age groups (such as teens and seniors) and marketing recommendations for use (e.g., weight loss, performance, and other disease- or condition-specific claims) are not included in the search selections. The DSLD user interface features will be revised periodically to reflect regulatory and technologic developments to enhance user experience. A comprehensive database derived from analytically verified data on composition would be preferable to label data, but is not feasible for technical, logistic, and financial reasons. Therefore, a database derived from information printed on product labels is the only practical option at present for researchers, clinicians, and consumers interested in the composition of these products.
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Bases de Datos Factuales , Suplementos Dietéticos , Etiquetado de Alimentos , Suplementos Dietéticos/análisis , Etiquetado de Alimentos/legislación & jurisprudencia , Etiquetado de Alimentos/normas , Etiquetado de Alimentos/estadística & datos numéricos , Humanos , Legislación Alimentaria , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Since 2005, the National Institute of Standards and Technology (NIST) has collaborated with the National Institutes of Health (NIH), Office of Dietary Supplements (ODS) to improve the quality of measurements related to human nutritional markers of vitamin D status. In support of the NIH-ODS Vitamin D Initiative, including the Vitamin D Standardization Program (VDSP), NIST efforts have focused on (1) development of validated analytical methods, including reference measurement procedures (RMPs); (2) development of Standard Reference Materials (SRMs); (3) value assignment of critical study samples using NIST RMPs; and (4) development and coordination of laboratory measurement QA programs. As a result of this collaboration, NIST has developed RMPs for 25-hydroxyvitamin D2 [25(OH)D2], 25(OH)D3, and 24R,25-dihydroxyvitamin D3 [24R,25(OH)2D3]; disseminated serum-based SRMs with values assigned for 25(OH)D2, 25(OH)D3, 3-epi-25(OH)D3, and 24R,25(OH)2D3; assigned values for critical samples for VDSP studies, including an extensive interlaboratory comparison and reference material commutability study; provided an accuracy basis for the Vitamin D External Quality Assurance Scheme; coordinated the first accuracy-based measurement QA program for the determination of 25(OH)D2, 25(OH)D3, and 3-epi-25(OH)D3 in human serum/plasma; and developed methods and SRMs for the determination of vitamin D and 25(OH)D in food and supplement matrix SRMs. The details of these activities and their benefit and impact to the NIH-ODS Vitamin D Initiative are described.
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25-Hidroxivitamina D 2/sangre , Análisis Químico de la Sangre/normas , Humanos , National Institutes of Health (U.S.) , Control de Calidad , Estados Unidos , Vitamina DRESUMEN
The Vitamin D Standardization Program (VDSP) has collaborated with numerous groups and agencies to assemble a set of tools, i.e., a reference measurement system, that can be used to establish the traceability of 25-hydroxyvitamin D [25(OH)D] assays to relevant reference measurement procedures and reference materials. This is done with the goal of verifying end-user laboratory performance using precise statistical criteria to determine whether a specific assay is standardized. The purpose of this paper was to outline a set of steps that routine clinical and research laboratories can use to standardize their 25(OH)D assays using these tools. These steps apply to laboratories using commercially developed immunoassay measurement systems as well as in-house assays, usually based on high HPLC or LC tandem MS measurement systems. The steps are (1) initial calibration, (2) initial assessment of accuracy and bias, (3) assessment of total percent CV and mean bias, (4) use of trueness controls, and (5) participation in accuracy-based performance testing and/or external quality assessment schemes. The goal of each laboratory assay is to have a total CV of ≤10% and mean bias of ≤5%. Rigorous and less rigorous but low-cost options for meeting these statistical criteria are provided. Research laboratories who infrequently measure 25(OH)D are advised to repeat steps 1-4 for every measurement cycle. For users of commercial immunoassays who have relatively little control over standardization, we present an option for using trueness controls to develop a master equation that can be used to standardize results to the reference methods.