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      Dietary Supplements: Regulatory Challenges and Research Resources

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          Abstract

          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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          Most cited references119

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          Update on NHANES Dietary Data: Focus on Collection, Release, Analytical Considerations, and Uses to Inform Public Policy12

          NHANES is the cornerstone for national nutrition monitoring to inform nutrition and health policy. Nutritional assessment in NHANES is described with a focus on dietary data collection, analysis, and uses in nutrition monitoring. NHANES has been collecting thorough data on diet, nutritional status, and chronic disease in cross-sectional surveys with nationally representative samples since the early 1970s. Continuous data collection began in 1999 with public data release in 2-y cycles on ∼10,000 participants. In 2002, the Continuing Survey of Food Intakes by Individuals and the NHANES dietary component were merged, forming a consolidated dietary data collection known as What We Eat in America; since then, 24-h recalls have been collected on 2 d using the USDA’s Automated Multiple-Pass Method. Detailed and targeted food-frequency questionnaires have been collected in some NHANES cycles. Dietary supplement use data have been collected (in detail since 2007) so that total nutrient intakes can be described for the population. The continuous NHANES can adapt its content to address emerging public health needs and reflect federal priorities. Changes in data collection methods are made after expert input and validation/crossover studies. NHANES dietary data are used to describe intake of foods, nutrients, food groups, and dietary patterns by the US population and large sociodemographic groups to plan and evaluate nutrition programs and policies. Usual dietary intake distributions can be estimated after adjusting for day-to-day variation. NHANES remains open and flexible to incorporate improvements while maintaining data quality and providing timely data to track the nation’s nutrition and health status. In summary, NHANES collects dietary data in the context of its broad, multipurpose goals; the strengths and limitations of these data are also discussed in this review.
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            Trends in Dietary Supplement Use Among US Adults From 1999-2012.

            Dietary supplements are commonly used by US adults; yet, little is known about recent trends in supplement use.
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              Why US adults use dietary supplements.

              Dietary supplements are used by more than half of adults, although to our knowledge, the reasons motivating use have not been previously examined in US adults using nationally representative data. The purpose of this analysis was to examine motivations for dietary supplement use, characterize the types of products used for the most commonly reported motivations, and to examine the role of physicians and health care practitioners in guiding choices about dietary supplements. Data from adults (≥20 years; n = 11 956) were examined in the 2007-2010 National Health and Nutrition Examination Survey, a nationally representative, cross-sectional, population-based survey. The most commonly reported reasons for using supplements were to "improve" (45%) or "maintain" (33%) overall health. Women used calcium products for "bone health" (36%), whereas men were more likely to report supplement use for "heart health or to lower cholesterol" (18%). Older adults (≥60 years) were more likely than younger individuals to report motivations related to site-specific reasons like heart, bone and joint, and eye health. Only 23% of products were used based on recommendations of a health care provider. Multivitamin-mineral products were the most frequently reported type of supplement taken, followed by calcium and ω-3 or fish oil supplements. Supplement users are more likely to report very good or excellent health, have health insurance, use alcohol moderately, eschew cigarette smoking, and exercise more frequently than nonusers. Supplement users reported motivations related to overall health more commonly than for supplementing nutrients from food intakes. Use of supplements was related to more favorable health and lifestyle choices. Less than a quarter of supplements used by adults were recommended by a physician or health care provider.
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                Author and article information

                Journal
                Nutrients
                Nutrients
                nutrients
                Nutrients
                MDPI
                2072-6643
                04 January 2018
                January 2018
                : 10
                : 1
                : 41
                Affiliations
                [1 ]Office of Dietary Supplements, National Institutes of Health, Bethesda, MD 20892-7517, USA; coatesp@ 123456od.nih.gov
                [2 ]National Center for Natural Products Research, University of Mississippi, MS 38677, USA; mjsmith073@ 123456olemiss.edu or m.j.smith@ 123456westernsydney.edu.au
                [3 ]National Institute of Complementary Medicine, Western Sydney University, Penrith, NSW 2751, Australia
                Author notes
                [* ]Correspondence: dwyerj1@ 123456od.nih.gov ; Tel.: +1-301-496-0048
                Article
                nutrients-10-00041
                10.3390/nu10010041
                5793269
                29300341
                957de8f3-2230-4be3-8ece-980c64cf91b3
                © 2018 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 09 November 2017
                : 12 December 2017
                Categories
                Review

                Nutrition & Dietetics
                dietary supplements,food supplements,supplement science,scientific challenges,regulatory challenges,natural health product,complementary medicine,traditional medicines,national institutes of health,office of dietary supplements

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