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Slide 1 :

One is OK. More is better? Pamela Mason

Slide 2 :

Outline Use of food supplements RDA multivitamins Higher dose products Safe upper levels of intake Maximum levels in supplements

Slide 3 :

Sales of food supplements in the UK (2005)

Slide 4 :

The proportion of British men and women taking vitamin supplements 2000-2001

Slide 5 :

Sales of food supplements in the European Union in US$

Slide 6 :

Sales of vitamins and supplements in the US, 2005

Slide 7 :

% people in US using different types of supplements

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Why do people take food supplements? An insurance policy to supplement poor diet Improve overall health and fitness Improve performance and body building in sports and athletics To prevent or treat disease CVD, arthritis, cancer To prevent or treat various minor conditions Colds, skin, hair and nail problems

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Levels of evidence Convincing: consistent epidemiological association between exposure/intervention and disease; little contrary evidence. Evidence from RCTs, meta-analyses (C) Probable: fairly consistent epidemiological associations with some contrary evidence (PR) Possible: evidence from case-control and cross-sectional studies; insufficient evidence from RCTs (POS) Insufficient: evidence from a few studies which are suggestive; little or no evidence from RCTs (INS) WHO hierarchy, 2004

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One is OK. RDA Multivitamins Help to ensure adequate intake in people with poor diets (C ) Enhance immune function, prevent infection (INS) Reduce risk of chronic disease Cardiovascular disease (P) Cancer (P) Cataract (P)

Slide 11 :

More is better? B vitamins Vitamin C Vitamin D Vitamin E Antioxidants Calcium Omega-3 PUFAs

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Folic acid ? risk of NTDs infants (C) ? homocysteine levels (PR) ? risk of CVD (PR) Secondary prevention of CVD (POS) ? risk of cancer: colon (POS); breast (INS); cervical (INS) ? risk of depression (POS) ? risk of Alzheimer’s disease (INS)

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Vitamin C Protects vs CV disease (INS) Protects vs cancer (INS) Reduces duration of cold symptoms (PR) Prevents colds (INS)

Slide 14 :

Vitamin D Prevents deficiency in children, pregnancy, breast-feeding, elderly, lack of sunlight exposure (C) Reduces fracture risk in institutionalised elderly (C/PR) Reduces risk of falls (C/PR) Reduces CVD, cancer, diabetes mellitus INS) Improves immune function (INS)

Slide 15 :

Vitamin E Prevents CVD and MI (POS) Prevents cancer (INS) Improves immunity in older people (POS) Prevents cataracts (POS)

Slide 16 :

Antioxidants (eg, beta-carotene, C and E) ? risk of CVD (INS); vitamin E > 400 iu shown to increase risk in patients with CVD ? risk of cancer (INS); beta-carotene may increase risk in smokers ? risk of cataract (POS) ? risk of ARMD (POS) NB: There is no indication for beta-carotene supplements

Slide 17 :

Calcium ? bone mineral accretion in youngsters if poor calcium intake (PR) If adequate calcium intake (INS) ? bone loss Perimenopause (INS) Postmenopause (early) (INS) Older people; ? risk of fracture (C) ? hypertension (PR); but very small effect; clinically insignificant ? risk of colon cancer (INS) ?menstrual pain (POS) ? body weight (INS)

Slide 18 :

Long chain omega-3s

Slide 19 :

Coenzyme Q ? hypertension (POS) ? angina (INS) Secondary prevention of MI (INS) ? heart failure (INS) ? risk of breast cancer (INS) ? periodontal disease (INS) ?Exercise performance (INS)

Slide 20 :

Common cold? Vitamin C Does not prevent common cold May reduce symptoms if taken early enough Zinc Inconsistent evidence in ? cold duration; of 10 RCTs, half showed benefit, half did not.

Slide 21 :

Problems with supplements Potential toxicity Impurities Content of active ingredients Delay in diagnosis Interactions Raised expectations and false claims

Slide 22 :

Adverse effects Fat soluble vitamins (A, D and E) Beta-carotene? Vitamin B6? Vitamin C? Iron Interactions with medicines

Slide 23 :

Data on supplement and medicine use US study in 1539 adults - 44% on prescribed medicines; 20% of these using herbal or high dose vitamins UK study on 164 herbal medicine users - 59% had taken conventional medicines Canada study in 195 older patients - 97% on prescription medicines and 17% using natural health products Studies in cancer and HIV patients 50-65% using supplements/CAM

Slide 24 :

How common? Survey of 458 US patients taking prescription medicines 197 (43%) taking supplements Vitamins, minerals, ginkgo biloba, garlic, saw palmetto, ginseng 89 (45%) had potential for interaction 6% were potentially serious Arch Intern Med 2004;164:630-6

Slide 25 :

Safe upper levels European Health Products Manufacturers (EHPM)/ Council for Responsible Nutrition (CRN) US Institute of Medicine, Food and Nutrition Board European Food Safety Authority (EFSA) UK Expert Vitamin and Group (EVM) Australia/New Zealand governments

Slide 26 :

ULs for selected vitamins

Slide 27 :

ULs for selected minerals

Slide 28 :

Slide 29 :

Dose response relationship NOAEL No observed adverse effect level Highest intake at which no adverse effect observed LOAEL Lowest adverse effect level Lowest intake at which an adverse effect demonstrated

Slide 30 :

Slide 31 :

UL = NOAEL (or LOAEL) Uncertainty factor

Slide 32 :

Maximum permitted levels (MPLs) EC Food Supplements Directive 2002/46/EC makes provisions for setting MPLs for vitamins and minerals Directive states that in setting these levels: “account should be taken of ULs, as established by scientific risk assessment, based on generally acceptable scientific data, and intakes of these nutrients from the normal diet.” “due account should be taken of reference intake amounts, i.e., the amounts necessary to ensure nutritional sufficiency.”

Slide 33 :

Proposed models for setting MPLs ERNA/EHPM model German (BfR) model Danish model* French model* ILSI model* * Focus on food fortification

Slide 34 :

ERNA/EHPM model Divides vitamins and mineral into 3 categories of risk Calculates population safety index (PSI)

Slide 35 :

Population Safety Index PSI = UL- (MHI + IW) RLV UL = Upper Level MHI = mean highest intake from dietary sources (97.5 per centile of average male adult intake from studies in UK, Ireland, Italy, Netherlands IW = potential intake from water RLV= Reference Labelling Value (= EU RDA)

Slide 36 :

PSI cut offs

Slide 37 :

Categorisation of vitamins and minerals according to risk of exceeding UL at high intakes

Slide 38 :

German model* R=UL-DINF R=Residual amount available for addition to supplements (Rs) + amount available for addition to fortified foods (RF) UL = upper level DINF = Estimated level of nutrient intake from non-fortified food at 95 or 97.5 percentile Multi-exposure factor (MEF) (based on exposure to multiple supplements and/or fortified foods) MLs = Rs/MEF MLF=RF/MEF *German Federal Institute for Risk Assessment (BfR)

Slide 39 :

Example: folic acid R= UL-DINF R= (1000-0)µg/day = 1000µg/day R = Rs+RF = (400+600)µg/day MLs = Rs/MEF = 400/1 = 400µg/day MLF=RF/MEF = 600/3 = 200µg/day

Slide 40 :

Categorisation of nutrients according to risk of excessive intake High: Margin between RDA (or intake) and UL is very narrow (< 5) (egg, vitamin A, Cu, Fe, Zn) Moderate: UL is 5-100 times above RDA (or intake) (egg, vitamin E, K, C, B6, Mg, Mo) Low: No UL set (egg, vitamin B1, B2, B12, Cr)

Slide 41 :

Categorisation of nutrients according to risk of inadequate intake Risk of clinical deficiency (egg, folate, iodine, vitamin D) 2. Uncertainty about risk of clinical deficiency (inadequate data) (egg, vitamin K, biotin, F, Zn, Se) 3. No indication of inadequate nutrient intake (egg, vitamin B1, B2, Cu) 4. Indication of nutrient intake above RDA (egg, vitamin B6, B12, Na, Cl, P)

Slide 42 :

MLs for vitamins proposed by ERNA and BfR

Slide 43 :

MLs for minerals proposed by ERNA and BfR

Slide 44 :

EU Discussion Paper EU Discussion Paper on setting of MPLs published June 2006 Responses published on Europa website http://ec.europa.eu/food/food/labellingnutrition/supplements/resp_discus_paper_amount_vitamins.htm

Slide 45 :

Responses to EU Discussion Paper Should MPLs be set for all vitamins and minerals even when risk of AEs is low or non-existent even at high levels of intake? Should separate MPLs be set for supplements and fortified foods? Should separate MPLs be set for different population groups? Should RDAs be taken into account when setting MPLs?

Slide 46 :

FSA suggested options Option 1: establish one maximum level (ML) for each vitamin and mineral throughout the EU taking into account data on highest intakes from dietary sources across member states. Option 2: establish common MLs as option 1, but with higher MLs where evidence that dietary intakes at a national level are lower than figure used in Option 1 or a national expert opinion supports safe supplemental intakes Option 3*: same as Option 2, but national MLs replaced by national guidance levels; would allow single dose supplements to be sold at discretion of national governments provided they carried warning labels. Option preferred by FSA

Slide 47 :

Advantages and disadvantages of FSA options

Slide 48 :

What next? Proposed levels for agreement by member states put forward in the Standing Committee of the Food Chain during next 2 years.

Slide 49 :

Conclusions One a day is OK More can be better But not always

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