Dietary Supplements Database Update

Dietary Supplements Database Update Johanna T Dwyer, D.Sc. Office of Dietary Supplements NIH Rationale  Dietary supplement exposure is high: >50%  $18 billion/yr  Public health impact unknown  Tools to validly document and quantify intakes lacking 2 DSID Needed to quantify exposure/public health impact of dietary supplements:  Validated/standardized instruments to collect data  Composition of dietary supplements  Validated tools to analyze data  Validated approaches to merge with dietary intakes to obtain total intakes 3 DSID Need for DSID  Accurate measurement of intakes and exposures requires: Databases of DS labels (NCHS/CDC) and ingredients (USDA) Methods and reference materials program  DS databases not yet based on analytical data Amounts of ingredients in DS unknown except for label claims 4 DSID Ultimate Goal for Dietary Supplement Databases Use improved databases to research role of dietary supplements in across life cycle - optimal physical and mental health - disease prevention, risk factor reduction - effects on biological systems, and physiological impact  Make available to public  Reach out and inform public 5 DSID 6 DSID  ODS Dietary Supplement Ingredient Databases DSID  Label databases  NHANES label database  NHANES-ODS  Industry foundation label database pilot: now readying SOW for a procurement  Analytically verified database  ARS-ODS dietary supplement ingredient database 7 DSID Progress in Dietary Supplement Data Base Development Label databases • NHANES at NCHS Analytically Validated Dietary Supplement Ingredient Database (DSID) at ARS/USDA •Industry foundation •Congressionally requested Information to public Use to research role of dietary supplements on health 8 DSID Dietary Supplement Database  Preliminary work:  ODS workshops with other Federal agencies, academic researchers, and the private sector  Outcome: DS ingredient database needed & feasible  Published in J Nutrition 133: 573S-634S 2003  J. Food Comp.Analysisi 17; 493-500 2004  J. Food Comp. Analysis 18: in press  Need is there:  Much NIH and other research involves DS  Total intakes of nutrients and DS exposures depend on accurate measures of DS intake, since intakes so high for some groups  Some evidence of drug-DS interactions 9 DSID 1. Dietary Supplement Ingredient Database Immediate Goals:  Improve methods by linking dietary supplement label declarations in Supplement Facts box for products used in NHANES with data on composition from validated chemical analyses  Prioritized analyses based on exposure (from NHANES 19992000), validity of methods, availability of reference materials, NIH and other agency interest  Nutrients & other constituents of public health concern first priority - vitamins A, B-6, B-12,C,D,E & folic acid/folate - Minerals: calcium, iron, magnesium, potassium, selenium, sodium, zinc - Other: beta carotene, omega 3’s (EPA,DHA,ALA) , caffeine (FDA)  Partners: Agricultural Research Service, USDA NIST inDOC 10 DSID FDA for caffeine 1.DSID Dietary Supplement Ingredient Database  Today Implementing plan for collection of analytical information on DS ingredients using ARS contractors In Process:  Focus first on  multivitamin-mineral supplements, antacids, vitamins E,C, B calcium, other single mineral supplements & caffeine  Pilot with labs analyzing reference materials completed completion.  Future:  Implement sampling plan to collect DS and complete analyses  Integrate data with NHANES label-based data base  Tackle other high public health priority nutrients and botanicals 11 DSID 2.NHANES Dietary Supplement Label Database Goals:  Provide information on selected ingredients declared in Supplement Facts labels for dietary supplements used in NHANES (mostly nutrients)  Make information publicly available  Facilitate analysis of total nutrient intakes (food plus dietary supplements) in NHANES and other research Partners: NHANES/NCHS/CDC/USDHHS 12 DSID 2.NHANES label-based DS database Today:  DS frequency of use in NHANES and label informatin available to public on web at NHANES website In process:  Document DS intakes in NHANES  Total intakes of nutrients, frequency of consumption, dose, etc.  Update values for products now on the market  Make label database more user friendly Future:  Better estimates of total nutrient intake  More analytical substantiation of DS label values  Botanicals of high public health interest  Examine possibilities for integrating with universal label database 13 DSID 3. Nationwide Dietary Supplement Label Database Congressional Language:  “ The committee ..expects ODS to contract with industry non-profit associations or foundations which currently have and maintain a database of dietary supplement labels to develop, create, continually update, maintain and make available to government and research entities a database of all supplement labels sold in the United States. The creation of this database would allow ODS to have access for research purposes to all known supplements manufactured in the United States and to allow access by other Federal agencies for ensuring safety to consumers, through the mandatory listing of ingredients in these products on the label, who purchase supplements manufactured and /or sold in the US “  Pg 170 Committee Report NIH Appropriations 2005-6 Senate 14 DSID 3.Nationwide Dietary Supplement Label Database Immediate Goals:  Test the feasibility of developing a dietary supplement label database of all DS marketed in the USA  Build on labels already collected by a private industry foundation sponsored by National Nutritional Foods Association and the NHANES label database  1 yr pilot:  Focus on nutrients, research uses in pilot  Partners: Not yet determined Sole source issued and responded to by RTI NNFA , after two federal panel technical reviews procurement was not made SOW and RFP under consideration by ODS for full and open competition and contract for publicly available database 15 DSID 3.Nationwide Dietary Supplement Label Database Today:      Congressional language 2004 concept approved by NCAAM Council 1/05 , sole source approved, SOW , RFP issued 6/05; review 8/05 failed reissued as pilot 09/05, review 10/05 for pilot failed now reconsidering SOW and seeking partners; full and open competition sought In process:  Federal Tech Review of sole source NNFA pilot application 10/05  Next steps await review Future:     Complete information on nutrients & other DS ingredients sold/marketed in USA Publicly available, free More user-friendly source of information Better exposure assessment 16 DSID Databases all sides of the same coin NHANES label-based DS database  DS label values for nutrients in products reported by NHANES participants 19992000  DSID Dietary Supplement Ingredient Database Database of all DS labels DS label values for nutrients, other ingredients, claims, etc. for all products sold in USA 17 DSID Analytically validated DSID Related Projects Today:  Motivations for DS use completed & papers started  Supplements to U Hawaii for validity reliability DS use studies  Supplement to U Minnesota to develop DS software  Meetings with many gvt groups on structured vocabularies In process:  Consider incorporating revised questions on DS use in HNIS, NHANES  Publish data on DS motivations for DS use Future:  Incorporate valid and reliable questions on DS use into HNIS, NHANES other federal population based surveys  Develop user friendly system for categorizing and naming DS  Develop tools for public that are valid, reliable and user-friendly for 18 better exposure assessment DSID ODS Objective: Quantify intakes of nutrients/ bioactive constituents in dietary supplements (DS)  Enhance database development 19 DSID Challenges in setting up a dietary supplement compositional database 1. Categorizing product types in the database 2. 3. Identifying nutrients/components of public health interest in these products Quantifying those nutrients/components 20 DSID Challenges: DS Products, Components and Quantities Iron Daidzein Omega 3 Multivitamin Mineral Products MVM for seniors 25 mg 100 mcgm 15 mg 10 mg 200 mcgm 30 mg MVM for children 21 2 mg DSID 2 mcgm 2 mg Challenge #1 Categorizing products in the database Categorizing Products : Best ways to categorize products depends on purpose—one logical grouping Grain & grain products Bread Cereal 23 DSID Foods: Conventions accepted for categories  Source/origin  Use in meals  Nutrients rich sources of nutrients 24 DSID Drug category conventions also exist  Intended or end use or function:  Chemical names 25 DSID DS: Conventions not yet identified Many schemes possible  Origin  Brand/manufacturer  End use  Chemical content  Market share 26 DSID Categorizing Products: DS Database : Multivitamin Mineral Products MVM for seniors MVM for children 27 DSID Problems: DS Categorization  Today: Myriad classifications used Different purposes Logic not always clear Categorization of convenience common Decisions subjective rather than objective  Implications Makes comparison between studies difficult Variability of nutrients within categories often great Categories often not  Homogeneous  mutually exclusive DSID 28 Principles: Categorization of DS for Research Purposes  Identify & standardize useful classification schemes for various uses  Explicit rationale/ logic & categorization criteria  Homogeneity  Mutually exclusive categories 29 DSID Challenge #2 Identify nutrients/ components of public health interest to put into the database Identify Nutritients/Bioactive Components: DS Database Iron Daidzein Omega 3 Multivitamin Mineral Products MVM for seniors MVM for children 31 DSID Challenge 2: Identify and prioritize nutrients/components of greatest public health interest  Need list of nutrients/components of importance  Dietary supplements contain many nutrients/components  Can’t do all at once and interest only on some of these  Select most critical components –priority ranking 32 DSID Basis for deciding on critical components  Frequency of consumption (NHANES)  Public health significance (DRI nutrients so of known benefit, nutrient known to be short in diets, potential safety concerns)  Availability of methods and reference materials  Federal agency interest 33 DSID Dietary Supplement Ingredient Database Priority List: Phase 1  Calcium, iron, magnesium, selenium, zinc  Folate Vitamins A, Bcarotene B6, B12, C, D, E  Omega-3 fatty acids  Potassium  Sodium  Iodine 34 DSID       Phase 2 B1, B2, niacin, pantothenic acid, biotin Vitamin K Copper, chromium, manganese, molybdenum Phosphorus Lycopene, lutein, Ginkgo, isoflavones Caffeine Challenge #3 Quantifying priority nutrients/components Big Problem for Dietary Supplements  Few publicly available chemically analyzed values for DS  NHANES database--only values declared on label available 36 DSID Quantifying Nutritients/Bioactive Components in DS Database Iron Daidzein Omega 3 Multivitamin Mineral Products MVM for seniors 25 mg 100 mcgm 15 mg 10 mg 200 mcgm 30 mg MVM for children 37 2 mg DSID 2 mcgm 2 mg Challenge #3: Quantify priority nutrients/components  Nutrients: straightforward:  Active components known  Also in foods  Analytical methods often validated  although matrix varies, method can be validated  Benefits & public health importance known 38 DSID Saw Palmetto 39 DSID Challenge #3: Quantify priority nutrients/components Botanicals: problematic  Active component largely unknown  Analytical methods not developed  Form not necessarily same as in foods  Efficacy often not established  Public health relevance unknown 40 DSID Ginkgo biloba 41 DSID Challenge #3: Issues in quantifying priority nutrients/components  Availability of analytical methods  Availability of reference materials  Necessary level of accuracy  Developing appropriate sampling plans. 42 DSID Availability of reference materials  Problem: Reference standards lacking to standardize chemical analysis of dietary supplements  Steps toward a Solution: AOAC Methods validation Develop standard reference materials (SRM) or certified reference materials (CRM) for dietary supplements that labs can use 43 DSID Standard Reference Materials (SRM )  Cooperative agreement with National Institute of Standards and Technology (NIST) to prepare SRM Multivitamin-mineral supplement Ephedra, ginkgo, saw palmetto, St John’s wort, bitter orange, green tea, beta carotene, alpha tocoperol Also NIST will update cod liver oil SRM to show individual fatty acids 44 DSID St. John’s wort 45 DSID Needed analytical accuracy  Certain vitamins, minerals and other nutrients need high accuracy Why: high public health import  Ex folic acid, calcium, D  Need estimates of total dietary intake  Botanicals: depends on substance 46 DSID Developing appropriate sampling plans  Sampling weighted by frequency of use  Marketing sectors for products defined to begin process 47 DSID DS Marketing Sectors 500 450 400 350 300 250 200 150 100 50 0 Alternative medical practitioners Natural/health stores VMS supplement stores Clubs Convenience 48 DSID Direct Sales Grocers Druggists Direct marketing Proposed ODS/ARS/USDA Pilot to test current labs ability to analyze VMS commonly consumed in NHANES 99-2000  1 Methods for foods ok for DS?  2. Do labels reflect actual contents of the DS? 3. Variability between lots? 49 DSID Progress toward analytically supported Dietary Supplement Data Base NHANES label-based Dietary Supplement Database DSID Dietary Supplement ingredient database at ARS Goal :Analytically supported Dietary Supplement Database 50 DSID Process DEVELOP CRITERIA -methods -labs IDENTIFY -methods -labs -pilot We are here PROVIDE SAMPLES to labs TELL STAKEHOLDERS DRAFT & ISSUE RFP 51 DSID Visit the ODS home page http://ods.od.nih.gov 52 DSID Give us your views! 53 DSID