The Multiple Benefits of Multivitamins Taylor C. Wallace, PhD, FACN Senior Director, Scientific & Regulatory Affairs Council for Responsible

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1 The Multiple Benefits of Multivitamins Taylor C. Wallace, PhD, FACN Senior Director, Scientific & Regulatory Affairs Council for Responsible Nutrition

2 Disclosures The Council for Responsible Nutri4on (CRN), founded in 1973 and based in Washington, D.C., is the leading trade associa4on represen4ng dietary supplement manufacturers and ingredient suppliers. CRN companies produce a large por4on of the dietary supplements marketed in the United States and globally. Our member companies manufacture popular na4onal brands as well as the store brands marketed by major supermarkets, drug store and discount chains. These products also include those marketed through natural food stores and mainstream direct selling companies. In addi4on to complying with a host of federal and state regula4ons governing dietary supplements, our 90+ manufacturer and supplier members also agree to adhere to voluntary guidelines for manufacturing, marke4ng and CRN s Code of Ethics.

3 Presentation Outline Presenta/on Outline Mul4vitamins 101 Where do American s get their nutrients? A systema4c review of mul4vitamin use and mortality, cardiovascular disease, and cancer in healthy individuals. Comments specific to Mursu et al. (2011) Conclusion and final remarks

4 Learning Objectives Micronutrient sufficiency is currently not being achieved through food solu4ons in large por4ons of the popula4on. Modest for4fica4on with use of age and gender specific mul4vitamins is needed for American s to achieve sufficiency without exceeding the UL. Mul4vitamins are safe among healthy popula4ons and rarely led to excessive intakes when consumed as directed. Mul4vitamins help fill nutrient gaps when the diet is not sufficient and have a marked effect on maintaining normal physiological func4ons and preven4ng chronic disease onset.

5 Multivitamins % of consumers use supplements. 52% are regular users. Users take dietary supplements: Overall health/wellness (53%); to fill nutrient gaps (35%); healthy Ageing (26%); heart health (26%). Consumers trust medical professionals, pharmacists and registered die4cians for reliable informa4on. They least trust radio ads, TV, celebri4es, and salespeople CRN Consumer Survey on Dietary Supplements (n = 2006)

6 Multivitamins % of consumers have taken a mul4vitamin in the last 12 months. Males (48%); Females (56%) Age y (45%); Age y (54%); Age 55+ y (56%) 42% of consumers take a mul4vitamin regularly. 36% take them daily; 5% take them most days of the week. 76% of dietary supplement users take mul4vitamins CRN Consumer Survey on Dietary Supplements (n = 2006)

7 Multivitamins 101: What Consumers Think Effec4veness Safety Not At All Confident 3% Not too Confident 10% Don't Know 12% Very Confident 34% Not too Confident 8% Not At All Confident 3% Don't Know 9% Very Confident 43% Somewhat Confident 41% Somewhat Confident 37% 2012 CRN Consumer Survey on Dietary Supplements (n = 2006)

8 Where Do American s Get Their Nutrients?

9 America s Vitamin Intake (%<EAR) Naturally occuring Enriched/for4fied Dietary supplements 25 0 * Denotes AI (not EAR) J Nutr. 2011;141:

America s Vitamin Intake (%<EAR) 100 75 50 Naturally occuring Enriched/for4fied

10 America s Vitamin Intake (%<EAR) Naturally occuring Enriched/for4fied Dietary supplements 25 0 Thiamin Riboflavin Niacin Folate J Nutr. 2011;141:

11 America s Mineral Intake (%<EAR) Naturally occuring Enriched/for4fied Dietary supplements 25 0 * Denotes AI (not EAR) J Nutr. 2011;141:

12 Implications It seems as though we have more key nutrients of concern than originally thought and fewer food solu4ons! 2010 Dietary Guidelines for Americans list Ca, K, Vitamin D and fiber as key nutrients of concern.

13 What About Excessive Intakes?

14 Excessive Intakes from Food + Supplements Excessive intakes of minerals in adults is low. o Ca (4.5%), Fe (12.1%), Zn (11.2%) and Mg (3.6%). o None severely exceeded the UL. Excessive intakes of vitamins in adults are even lower. o Folate (~7.0%), Vit A (~3.0%), Vit B6 (3.5%), and Vit C (1.6%). o None severely exceeded the UL. Sources: o Am J Clin Nutr. 2012; 94(5): o J Acad Nutr Diet. 2012;112(5):

15 What About At Risk Populations?

Inadequate Intakes Among Children (%<EAR) 100 75 50 Non- Users of Supplements Users

16 Inadequate Intakes Among Children (%<EAR) Non- Users of Supplements Users of Supplements 25 0 * All dietary supplements combined. J Pediatr. 2012; (in press)

17 Micronutrient Insufficiency Among Children Even with the use of supplements more than 1/3 of children failed to meet calcium and vitamin D recommenda4ons. Children > 8 y would have been otherwise inadequate for Mg, P, vitamin A, C, & E had it not been for dietary supplements. o Mul4vitamins are #1 supplement used by children. Personalized nutri4on approach: Age and gender- specific mul4vitamins may be a solu4on. J Pediatr. 2012; (in press)

18 Excessive Intakes in Children 2-18 y (%>UL) 60 Non- Users of Supplements Users of Supplments Iron Zinc Copper Folic Acid Vitamin A * All dietary supplements combined. J Pediatr. 2012; (in press)

19 Multivitamin Use in Healthy Individuals

20 2006 NIH Consensus Conference The present evidence is insufficient to recommend either for or against the use of MVMs by the American public to prevent chronic disease. (htp://consensus.nih.gov/2006/mul4vitaminstatement.htm#q5) 27 references included. Mostly single nutrient RCTs. Today we have amount of data specific to mul4vitamins and mul4ple nutrient interac4ons.

21 What Does the Current Data Say in Regards to Multivitamin Use in Healthy Individuals?

22 Systema/c Disclosures Review A Systema/c Review of Mul/vitamin Use and Mortality, Cardiovascular Disease, and Cancer in Healthy Individuals Dominik D. Alexander 1, PhD, MSPH; Douglas L. Weed 2, MD, PhD; Ellen Chang 3, ScD; Muhima A. Mohamed 4, MPH; Laura Elkayam 5, MPH Exponent Inc., Health Sciences, Boulder 1, Menlo Park 3, Bellevue 4, Chicago 5 ; DLW Consul4ng Services 2

23 Methods 210 studies iden4fied Inclusion criteria: o Present in the peer- reviewed literature o Prospec4ve design o Simultaneous use of 3 or more vitamins/minerals o Evaluated death from all causes, CVD and cancer o Nutrient deficient or un- healthy popula4ons excluded

24 Methods 210 studies iden4fied o 61 didn t assess vitamin/mineral intake o 49 evaluated specific supplements and disease outcomes o 50 of nutrient deficient or un- healthy popula4ons o 16 evaluated specific chronic diseases o 17 review ar4cles 17 Studies Included (16 prospec4ve & 1 RCT)

25 Results from prospective studies of multivitamins and overall mortality Study name Subgroup within study Statistics for each study Rate ratio and 95% CI Rate Lower Upper ratio limit limit Hercberg et al (overall) Antioxidant, daily Hercberg et al (sex X group) Antioxidant, daily Hercberg et al (men) Antioxidant, daily Hercberg et al (women) Antioxidant, daily Kim et al (men) Supplements at baseline Kim et al (men) Supplements; both baseline and follow-up Kim et al (men) Supplements; either baseline or follow-up Kim et al (women) Supplements; at baseline Kim et al (women) Supplements; both baseline and follow-up Kim et al (women) Supplements; either baseline or follow-up Li et al Antioxidant vitamins Li et al Any vitamin/mineral Li et al Multivitamins Losonczy et al Multiple vitamins/minerals Messerer et al Mul tivi tami n, occasi onal Messerer et al Mul tivi tami n, regul ar Mursu et al Mul tivi tami n, dai l y Neuhouser et al Any multivitamin Neuhouser et al Mul tivi tami n Neuhouser et al Multivitamin with minerals Neuhouser et al Stress multivitamin Park 2011 (men) Multivitamin, at least weekly Park 2011 (women) Multivitamin, at least weekly Pocobelli et al Multivitamin use, 10+ yrs Pocobelli et al Multivitamin use, 1-3 yrs Pocobelli et al Multivitamin use, 4-6 yrs Pocobelli et al Multivitamin use, 7-9 yrs Rimm et al multiple vitamin pills/week for 5+ yrs Rimm et al Current users, 1-3 pills/wk Rimm et al Current users, 4-7 pills/wk Sahyoun et al Multivitamins + C or E Watkins et al (men) Mul tivi tami n Watkins et al (men) Multivitamin + A, C, or E Watkins et al (women) Mul tivi tami n Watkins et al (women) Multivitamin + A, C, or E

26 Results from prospective studies of multivitamins and cardiovascular disease Study name Subgroup within study Statistics for each study Rate ratio and 95% CI Rate Lower Upper ratio limit limit Hercberg et al (overall) Antioxidant, daily Hercberg et al (women) Antioxidant, daily Herceberg et al (sex X group) Antioxidant, daily Li et al Antioxidant vitamins Li et al Any vitamin/mineral Li et al Multivitamin Losonczy et al Multiple vitamins/minerals Messerer et al Mul tivi tami n, occasi onal Messerer et al Mul tivi tami n, regul ar Muntwyler et al Multivitamin Muntwyler et al (w/o major CVD risk factors) Multivitamin Mursu et al Mul tivi tami n, dai l y Park et al (men) Multivitamin, at least week Park et al (women) Multivitamin, at least week Pocobelli et al Multivitamin, >0-2 days/wk Pocobelli et al Multivitamin, 3-5 days/wk Pocobelli et al Multivitamin, 6-7 days/wk Rautiainen et al (no hx of CVD) Multivitamin Rautiainen et al (no hx of CVD) Multivitamin + other supplements Rautiainen et al [fatal MI) Multivitamin Rautiainen et al [fatal MI) Multivitamin + other supplements Rautiainen et al (hx of CVD) Mul tivi tami n Rautiainen et al (hx of CVD) Multivitamin + other supplements Watkins et al (men; no hx of heart disease) Mul tivi tami n Watkins et al (men; no hx of heart disease) Mul tivi tami n + A, C, or E Watkins et al (men; hx of heart disease) Mul tivi tami n Watkins et al (men; hx of heart disease) Mul tivi tami n + A, C, or E Watkins et al (women; no hx of heart disease) Mul tivi tami n Watkins et al (women; no hx of heart disease) Mul tivi tami n + A, C, or E Watkins et al (women; hx of heart disease) Mul tivi tami n Watkins et al (women; hx of heart disease) Mul tivi tami n + A, C, or E

27 Results from prospective studies of multivitamins and cancer Study name Subgroup within study Statistics for each study Rate ratio and 95% CI Rate Lower Upper ratio limit limit Hercberg et al (overall) Antioxidant, daily Hercberg et al (men) Antioxidant, daily Hercberg et al (women) Antioxidant, daily Hercberg et al (sex X group) Antioxidant, daily Kim et al (men) Supplements at baseline Kim et al (men) Supplements; both baseline and follow-up Kim et al (men) Supplements; either baseline or follow-up Kim et al (women) Supplements at baseline Kim et al (women) Supplements; both baseline and follow-up Kim et al (women) Supplements; either baseline or follow-up Li et al Antioxidant vitamins Li et al Any vitamin/mineral Li et al Multivitamin Losonczy et al Multiple vitamins/minerals Messerer et al Mul tivi tami n, occasi onal Messerer et al Mul tivi tami n, regul ar Mursu et al Mul tivi tami n, dai l y Park et al (men) Multivitamin, at least weekly Park et al (women) Multivitamin, at least weekly Pocobelli et al Multivitamin, >0-2 days/wk Pocobelli et al Multivitamin, 3-5 days/wk Pocobelli et al Multivitamin, 6-7 days/wk Watkins et al (men; no hx of cancer) Mul tivi tami n Watkins et al (men; no hx of cancer) Multivitamin + A, C, or E Watkins et al (men; hx of cancer) Mul tivi tami n Watkins et al (men; hx of cancer) Mul tivi tami n + A, C, or E Watkins et al (women; no hx of cancer) Mul tivi tami n Watkins et al (women; no hx of cancer) Multivitamin + A, C, or E Watkins et al (women; hx of cancer) Mul tivi tami n Watkins et al (women; hx of cancer) Mul tivi tami n + A, C, or E

28 Study Conclusion Based on review of the available scien4fic evidence, nutri4onal supplementa4on with mul4vitamins does not appear to increase total mortality, cardiovascular disease, or cancer, and may provide a modest protec/ve benefit, par4cularly for cardiovascular disease and when ideally combined with a healthy and balanced diet.

29 Similar Findings: The PHS II Adverse Events Absent Poten4al Protec4ve Effect

30 Similar Findings: The PHS II PHS II Par4cipants were very HEALTHY! Characteristic Multivitamin Placebo Mean BMI Current Smokers 3.5% 3.7% Exercise 1/week 62.2% 60.7% Fruit &Vegetable Consump4on 4.26 servings/d 4.19 servings/d *Adapted from Gaziano et al. (2012).

31 Comments Specific to Mursu et al. (2011)

32 Commentary Disclosures An Industry Perspec/ve: Dietary Supplements and Mortality Rates in Older Women Taylor C. Wallace, PhD, FACN 1 ; Douglas MacKay, ND 1 ; Barry W. Ritz, PhD 2 ; Michael McBurney, PhD 3 ; Andrew Shao, PhD 4 ; John Miller, BS 5 ; James Brooks, PhD 6 ; and Lewis Hendricks, MS 7 - The Council for Responsible Nutri4on Senior Scien4fic Advisory Commitee Council for Responsible Nutri4on 1 ; Atrium Innova4ons 2 ; DSM Nutri4onal Products North America 3 ; Herbalife Interna4onal of America Inc 4 ; GNLD Interna4onal 5 ; Pharmavite LLC 6 ; Innophos Inc 7 Accepted; In Press (Journal of Dietary Supplements)

33 1. Non-users Were Poorly Defined Authors fail to report mortality among users and true non- users. o Mul4vitamin users could have been users of 1 dietary supplement. The authors failed to address the mortality rate of a specific mul4ple- or single- nutrient supplement compared with the por4on that con4nued to be true nonusers throughout the study. Publically funded dataset has no data sharing plan.

34 Non-users Were Poorly Defined Thus no inverse associa/on of mul/vitamins with total mortality emerged from the analysis.

35 2. Supplement Users Were Healthier Supplement users had a lower prevalence of: o Diabetes mellitus, high blood pressure and smoking habits o Body mass index and waist- to- hip ra4o Supplement users were more: o Physically ac4ve and likely to use estrogen replacement therapy. Supplement users also had: o A lower intake of energy, total fat, monounsaturated faty acids, and saturated faty acids, as well as a higher intake of protein, carbohydrates, polyunsaturated faty acids, alcohol, whole- grain products, fruits, and vegetables compared with nonusers.

36 3. The # of Supplement Users Increased At baseline, supplement users comprised 62.7% of the study popula4on. By 2004, surviving supplement users in the study comprised 85.1% of the study popula4on. Year Users Total Change (%) ,329 38, ,278 19, *Adapted from Mursu et al. (2011).

37 4. An Additional Consideration for Iron RR, 2.01 for par4cipants repor4ng use of >400 mg/d. o Dosages of iron at >400 mg/d are extremely unlikely in over- the- counter iron supplement products. o If in fact there was a correla4on, this would most certainly have comprised cases in which the par4cipants were under a doctor s care for anemia of chronic disease or other blood iron deficiencies, and were receiving treatment using prescrip4on- only iron- containing medica4ons. NHANES and other consump4on data contradict.

38 Future CRN Foundation Research

39 Future CRN Foundation Research Nutrient dispari4es in the U.S. stra4fied by gender, age, race/ethnicity and income level. Possible stra4fica4on based on vegetarian status. Data specific to mul4vitamins and nutrient adequacy among consumers.

40 Final Remarks & Thoughts

41 Final Remarks & Thoughts Micronutrient sufficiency is currently not being achieved through food solu4ons in large por4ons of the popula4on. Modest for4fica4on with use of age and gender specific mul4vitamins to achieve sufficiency and not exceed the UL. o Diet specific (i.e. mul4vitamins for vegetarians)

42 Final Remarks & Thoughts Mul4vitamins are safe among healthy popula4ons and rarely led to excessive intakes when consumed as directed. Mul4vitamins fill the gap when the diet is not sufficient and thus have a marked effect on maintaining normal body func4ons. Adequate nutri4on is key to prevent chronic disease onset.

43 Taylor C. Wallace, PhD Senior Director, Scien4fic & Regulatory Affairs Council for Responsible Nutri4on P: E: Questions???

Fortification s Contribution to Meeting Dietary Nutrient Recommendations. Eric Hentges, PhD May 17, 2012

Fortification s Contribution to eeting Dietary Nutrient Recommendations Eric Hentges, PhD ay 17, 2012 Disclosure of interest Currently Executive Director of ILSI North America a non-profit research foundation