2007 Annual Report 1a.Objectives (from AD-416) To acquire and develop representative and accurate compositional values for nutrients and other nutritional components in dietary supplements. To develop a generic data documentation and evaluation system to assess the quality of data for nutritional supplements, to provide for the continuous monitoring of dietary supplement composition data, to establish guidelines for the generation and dissemination of high quality data. 1b.Approach (from AD-416) This project will develop and implement an expert system to evaluate the quality and representativeness of existing estimates for specific nutrients in nutritional supplements. Priorities for new nutrient analyses will be identified and ranked for those supplements which contribute up to 80% of the intake of specific nutrients for a representative sample of the U.S. population. Where nutrient data are inadequate for high priority dietary supplements, new values will be generated by analytical determination, calculation, or consultation with the dietary supplement industry. Samples of supplements to be analyzed will be selected using a probability-based approach and nationwide sampling. Valid chemical methods including rigorous analytical quality control will be employed. Effective modes of data dissemination will be developed to address the needs of data users. 3.Progress Report Nutrient Data Laboratory (NDL) is working with the Office of Dietary Supplements, National Institutes of Health, to develop a Dietary Supplement Ingredient Database (DSID) in response to needs expressed by the public health research community. A key goal of the DSID is to report levels of nutrients and other bioactive components in dietary supplements (DS). The foundation of the DS database will be analytical data, a foundation similar to that used in USDA food databases. Initially pilot studies were conducted to develop procedures for purchasing and shipping products and analytical samples, to select qualified laboratories, to evaluate methods for sample handling and analysis, and to develop quality control procedures for nutrients often contained in a multivitamin/mineral (MVM) matrix (defined as n>2 vitamins). Pilot study results were published in 2007. Subsequently, a percent Daily Value (%DV) study was conducted to test for systematic relationships between label and analytical values for 23 nutrients at up to 4 common %DV levels in adult MVMs. Each nutrient was analyzed in 18 to 24 products. Findings from the pilot studies and %DV study were used to optimize sample selection, data collection and evaluation, and appropriate reviews for planning further research. In 2007 statistical evaluation of the %DV study data was reported at scientific meetings. Also durning FY2007, Phase 1 of a nationwide adult MVM study was conducted. The objectives were to obtain nationally representative estimates for high priority vitamins and minerals in commonly reported adult MVMs and to assess variability within and among products. A sampling plan was developed to obtain the top 35 adult MVMs in specific market channels in up to six geographic regions. Nutrient levels in each product were analyzed by qualified laboratories, using rigorous quality control protocols. Statistical analysis for 20 nutrients was completed and preliminary results were summarized. The sampling plan for Phase 2 of the adult MVM study was developed using National Health and Nutrition Examination Survey 2003-04 records to identify representative lower market-share MVMs. About 75 products were purchased in six geographic locations from various market channels and sent to qualified laboratories. Laboratory analysis of samples was completed. Data are being reviewed and evaluated. To apply analytical results to make reasonable estimates of nutrient content for DS including products not chemically analyzed, NDL scientists consulted with a statistician to consider options for regression analysis using analytical data from the % DV study and the adult MVM study. These analyses will be used to develop a preliminary data set for actual nutrient content and variability within and among products for the first data release, DSID-1. These data will enable scientists to more accurately estimate nutrient intake from DS and to assess the relationship of intake to health. 4.Accomplishments Publication of Multivitamin/mineral Pilot Study Data Results: Challenges associated with analysis of multivitamin/mineral (MVM) products (defined as containing two or more vitamins) were identified and investigated. Pilot studies were conducted to address the identification of appropriate analytical methods, sample preparation protocols, and experienced laboratories for the analysis of 12 vitamins and 11 minerals in adult MVMs. The results were published in the Journal of Food Composition and Analysis (see publications). These preliminary studies support the plans for additional studies to apply to the development of the analytically-based Dietary Supplement Ingredient Database (DSID). Total intakes from foods and supplements are needed to evaluate the associations between dietary components and health. The DSID will complement estimates of nutrient intake from supplements provided in databases which report only label values. This accomplishment addresses National Program 107 Action Plan Component 1: Composition of Foods. Caffeine Content of Dietary Supplement Products: As part of a study initiating the development of an analytically validated Dietary Supplement Ingredient Database (DSID) in the United States (US), 53 representative caffeine-containing dietary supplement products were identified and analyzed for caffeine content. Caffeine intake per serving and per day was calculated using the maximum recommendations on each product label. For the products analyzed in this study, a wide range of caffeine levels (representing a total intake of 1 to >800 mg/day) was documented. For products having a label amount for comparison (n=28), 89% had analytically based caffeine levels/day within 20% of the amount indicated on the package. Lot-to-lot variability (number of lots sampled of the same product were either two or three) for caffeine in most products (72%) was <10%. These results were published in Analytical and Bioanalytical Chemistry (see publication list). The study included use of standard reference materials (SRMs) in the quality control protocols and indicated that these materials were excellent tools for the development of accurate methods of analysis and for method validation for caffeine in dietary supplements. This accomplishment addresses National Program 107 Action Plan Component 1: Composition of Foods. Label Values for Nutrients in Dietary Supplements: To test for systematic relationships between nutrient label values and analytical values in adult multivitamin/mineral (MVM) products (defined as two or more vitamins) and for applications to future studies, data from the percent Daily Value (%DV) study were evaluated using quality control protocols. The results indicated that variability differed by nutrient. These data provided valuable information regarding labeled versus analytical value per nutrient, laboratory variability per nutrient and per lot, and manufacturer variability. The findings from this study enabled development of the adult MVM study plans regarding analysis protocols for specific nutrients and provided valuable data for statistical applications. This accomplishment addresses National Program 107 Action Plan Component 1: Composition of Foods. 5.Significant Activities that Support Special Target Populations None 6.Technology Transfer Number of non-peer reviewed presentations and proceedings 5 Number of newspaper articles and other presentations for non-science audiences 1 Review Publications Roseland, J.M., Holden, J.M., Andrews, K., Zhao, L., Schweitzer, A., Harnly, J.M., Wolf, W.R., Perry, C., Dwyer, J., Picciano, M., Betz, J., Saldanha, L., Yetley, E., Fisher, K., Sharpless, K. 2007. Dietary Supplement Ingredient Database (DSID): Preliminary USDA studies on composition of adult multivitamin/mineral supplements. Journal of Food Composition and Analysis. 21(1): S69-S77. Available: doi:10.1016/j.fca.2007.07.009. Dwyer, J.T., Picciano, M., Betz, J.M., Fisher, K.D., Saldanha, L.G., Yetley, E.A., Coates, P.M., Milner, J., Whitted, J., Burt, V., Radimer, K., Wilger, J., Sharpless, K.E., Holden, J.M., Schweitzer, A., Andrews, K., Roseland, J.M., Zhao, C., Harnly, J.M., Wolf, W.R., Perry, C.R. 2007. Progress in developing dietary supplement databases: The analytically validated Dietary Supplement Ingredient Database (DSID) and Dietary Supplement Label Databases (DSLD). Journal of Food Composition and Analysis. Available: doi:10.1016/j.jfca.2007.07.010.