Use of DRIs at the U.S. Food and Drug Administration

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1 Use of DRIs at the U.S. Food and Drug Administration Paula R. Trumbo, PhD Nutrition Programs Office of Nutrition and Food Labeling Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration National Academy of Sciences/National Academy of Medicine January 9, 2017

2 Outline Use of the DRIs at FDA 1. Food Labeling Nutrition & Supplement Facts labels Daily Values Nutrients of public health significance Nutrient content claims Health claims 2. Approval of food additives for fortification of foods 2

3 Nutrition & Supplement Facts Labels Different labels for foods intended for use by different subpopulations General population (4 years of age and older) Pregnant and lactating women Young children (1-3 years) Infants (through 12 months of age) 3

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5 Use of the DRIs & AMDRs* Tool used in setting most Daily Values (DV) Identify nutrients of public health significance for mandatory declaration on the Nutrition Facts label *Acceptable Macronutrient Distribution Range 5

6 Some DVs Based on RDAs* and AIs* Individuals (4 years and older) Highest RDA or AI for 4 years and older Pregnant & lactating women Highest RDA or AI for pregnant & lactating women Young children RDA or AI for 1-3 years Infants RDA or AI for infants 7-12 months of age *RDA, Recommended Dietary Allowance; AI, Adequate Intake 6

7 DVs Tolerable Upper Intake Level UL used to set DV when majority of population consumes in excess of a nutrient UL - DV for sodium UL of 2,300 mg/d (14 y and older) Age-specific ULs compared with DVs to evaluate whether DVs are higher than the ULs 7

8 DVs for Macronutrients Fat Upper AMDR* of 35% calories (78 g) Protein Existing DV of 10% of calories (50 g), 50 g close to the RDA for men (56 g) and women (46 g) Carbohydrate 100% - (35% [Fat] +10% [Protein]) = 55% of calories (275 g) *Acceptable Macronutrient Distribution Range 8

Updated DVs Sodium 2,400 2,300 mg Dietary Fiber 25 28 g

9 Updated DVs Sodium 2,400 2,300 mg Dietary Fiber g Vitamin D µg Calcium 1,000 1,300 mg Potassium 3,500 4,700 mg 9

10 Nutrients of Public Health Significance 1) Existence of a quantitative intake recommendation AND 2) Public health significance a) Well-established evidence for a relationship between a nutrient and chronic disease risk (e.g., health claims), a health-related condition, or a health-related physiological endpoint OR RDA or AI that is based on chronic disease risk, a health-related condition, or a nutrient deficiency with clinical significance for which inadequate intakes of these nutrients are likely to have important clinical consequences (e.g., potassium and blood pressure) 10

11 Nutrients of Public Health Significance b) Evaluation of nutrient intake (NHANES) Use of EAR* to assess prevalence of nutrient inadequacy in populations Use of AI to assess low probability of nutrient adequacy in populations c) Evaluation of nutrient status (NHANES) Use of status biomarkers, when available d) Prevalence of chronic disease, health-related condition, or a health-related physiological endpoint *EAR, Estimated Average Requirement 11

12 Calcium EAR/RDA based on bone health, including risk of fractures Health claim calcium and risk of osteoporosis High prevalence of osteoporosis 37% of US population (4 y +) had usual calcium intakes* below the weighted EAR * From conventional foods & dietary supplements 12

13 Vitamin D EAR/RDA based on bone health Health claim Vitamin D & osteoporosis High prevalence of osteoporosis 62% of US population (4 y +) had usual vitamin D intakes* below the weighted EAR 24% of US population had serum 25(OH)D concentrations at levels that indicate risk for inadequacy (30-50 nmol/l) *From conventional foods and dietary supplements 13

14 Potassium AI was set at a level that would maintain blood pressure, reduce adverse effects of sodium chloride intake on blood pressure & reduce risk of recurrent kidney stones Health claim on blood pressure & stroke High prevalence of high blood pressure 2.4% of US population had potassium intakes* above the AI, indicating that the probability of adequate potassium status is low * From conventional foods & dietary supplements 14

15 Vitamin A EAR/RDA based on liver stores 34% of US population had usual intakes* below the EAR 0.3% of those 6 years & older had serum retinol concentration below 20 µg/dl Distribution of serum retinol indicated no deficiency Symptoms of vitamin A deficiency are not common in the US * From conventional foods & dietary supplements 15

16 Vitamin C EAR/RDA based on estimates of body pool or tissue levels of vitamin C that are required for antioxidant protection with minimal urinary loss 28% of US population had usual vitamin C intakes* below the EAR 6% had serum vitamin C concentrations below 11.4 µmol/l Symptoms of vitamin C deficiency are not common in the US *From conventional foods & dietary supplements 16

17 Nutrients of Public Health Significance Vitamin D & potassium are now mandatory on the label Calcium & iron remain on the label Vitamins A & C are no longer mandatory on the label but can be declared voluntarily 17

18 Nutrient Content Claims Describes the nutrient content of foods (free, low, good source, excellent source, reduced, healthy) For example, vitamins and minerals (except sodium) Good source 10-19% DV per RACC* Excellent source/high 20% DV per RACC * Reference amount customarily consumed 18

19 Health Claims Health claims describe the relationship between a food/food component & a disease or health related condition FDA conducts a premarket science review to evaluate the claimed relationship & the strength of the evidence (authorized or qualified health claim) If a relationship exists, then the claim must meet certain regulatory requirements for a product to bear the claim 19

20 Health Claim Requirements For a product (per RACC) to bear a health claim, must contain: - At least 20% of DV (if available), when nutrient is substance of the health claim - At least 10% DV for one of the nutrients of public health significance (vitamins A or C, iron or calcium), or protein or dietary fiber ( Jelly Bean Rule ) - Less than specified levels for total fat, saturated fat, cholesterol, & sodium (disqualifying levels) 20

21 Food Additive Regulations for Fortification Used UL as primary basis for assessing safety of vitamin D Used NHANES to evaluate exposure at the 90th percentile of intake from all food sources of vitamin D & dietary supplements Compared 90th percentile of intake to the ULs as part of safety assessment 21

22 Use of the DRIs Identify nutrients of public health significance for the Nutrition Facts label - Basis of DRIs (sufficiency versus chronic disease) considered Plan for individuals - RDAs, AIs and UL used to set DVs for many nutrients - AMDR used to set Daily Value for certain macronutrients Assess prevalence of nutrient (in)adequacy within populations - EARs used to assess nutrient adequacy within populations - AIs used to assess a low prevalence of inadequate intakes Estimate the percentage of population at potential risk of an adverse effect from excessive nutrient intake - ULs used in the approval of vitamins as food additives 22

Applying the DRI Framework to Chronic Disease Endpoints

Applying the DRI Framework to Chronic Disease Endpoints Paula R. Trumbo, Ph.D. U.S. Food and Drug Administration Institute of Medicine, Food and Nutrition Board Workshop Development of DRIs, 1994-2004: