EU Legislation

1. EU Legislation Jane McClenaghan BscHons, DipION Nutritional Therapist

2. Are you aware…? • Food Supplements Directive • Traditional Herbal Medicines Products Directive • Nutritional and Health Claims Regulation

3. ROI Medicines Act • Any nutrient above 1 times the RDA is a medicine

4. RDA’s Vitamins Vitamin A 800 μg Vitamin D 5 μg Vitamin E 10 mg Vitamin C 60 mg Thiamin 1.4 mg Riboflavin 1.6 mg Niacin 18 mg Vitamin B6 2 mg Folic acid 200 μg Vitamin B12 1 μg Biotin 0.15 mg Pantothenic acid 6 mg Minerals Calcium 800 mg Phosphorus 800 mg Iron 14 mg Magnesium 300 mg Zinc 15 mg Iodine 150 μg

5. Food Supplements Directive First proposed in 1988

6. Aims of the Directive • Recognition of the existence of food supplements • Harmonisation of legislation across the community • Recognition that not all groups achieve nutritional goals through diet • Recognition that some consumers choose to supplement their diet for lifestyle or other reasons • To ensure consumer protection through safety and labelling criteria • To define food supplements • To define conformance criteria

7. Aims of the Directive 8. To establish a positive list of vitamins and minerals that may be used in food supplements 9. Recognition of scientific and technological innovation 10. Recognition that excessive vitamin/mineral intake may cause adverse effects so that maximum levels of intake need to be set 11. Recognition that supplement levels should be significant 12. A requirement on government to provide efficient monitoring

8. The creation of Positive Lists Within 5 [from 2003] years the Commission shall submit to the European Parliament and the Council a report on the advisability of establishing specific rules, including, where appropriate, positive lists, on categories of nutrients or of other substances with a nutritional or physiological effect.

9. Draft Maximum Permitted Levels Due to be published end April 2009 … may not be published for another year …implementation may be 2-3 years away

10. The Maximum Permitted Level Debate • nutrients for which there is no risk of over consumption (eg: some B group vitamins) • nutrients for which there is a low risk of over consumption (eg vitamin C, magnesium) • nutrients for which there is a risk of excessive intake (eg Vitamin A, Folic acid, iron)

11. The Maximum Permitted Level Debate nutrients for which there is no risk of over consumption Option 1: No numerical maximum amounts established. Option 2: Numerical maximum amounts (not based on safety)

12. The Maximum Permitted Level Debate nutrients for which there is a low risk of over consumption Option 1: Numerical maximum amounts Option 2: Numerical maximum amounts with advisory statements.

13. The Maximum Permitted Level Debate nutrients for which there is a risk of excessive intake Option 1: Numerical maximum amounts. Option 2: Numerical maximum amounts with restrictions.

14. Nutrition Claims Claims which state, suggest or imply that a food has particular beneficial nutritional properties due to: • The energy value it provides, provides at a reduced or increased rate, or does not provide • The nutrients or other substances it contains, contains in reduced or increased proportions, or does not contain

15. Health Claims Claims which state, suggest or imply that a relationship exists between a food category, • a food or one of its constituents and health. • Only ‘approved’ health claims may be made.

16. Health claims not permitted • Claims which suggest that health can be affected by not consuming the food • Claims which make reference to the rate or amount of weight loss • Claims which make reference to recommendations by individual doctors or health professionals and associations other than national associations of medical, nutrition or dietetic professionals and health-related charities (national rules of individual member states apply to recommendations or endorsement by such associations and charities).

17. Traditional Herbal Medicinal Products Directive To provide a special, simplified registration procedure for certain traditional medicinal products without having to prove efficacy

18. Requirements of THMPD • Safety (published bibliographical) • Quality (pharmaceutical GMP) • Tradition 30 years demonstrated use 15 years use in E.U.

19. Drug-Nutrient Interactions Jane McClenaghan BscHons, DipION Nutritional Therapist

20. ‘Killer Grapefruit alert to Slimmers’ • The Sun, 3 April 2009

21. How drugs & nutrients interact… • 1. Depletions • interference with nutrient absorption • interference with metabolic pathways • depletion of nutrients • 2. Adverse reaction of drug + nutrient/food/drink • - Absorption of drug • - Bioavailability (increase or decrease) of drug • - Inhibit/modify action of drug

22. How drugs & nutrients interact… • 3. Reduction of drug side effects • 4. Risk of overdose • Enhanced bioavailability • Enhanced drug action • 5.Prevent drug action

23. Where supplementation may be beneficial… • if drug causes depletion/interference of nutrient • reduction or prevention of side-effects • supportive interaction

24. Avoid if.. • Adverse reaction • Reduced drug absorption or bioavailability

25. General Cautions…

26. Be Aware... • Vitamin A • Do not use doses over 10,000iu a day with Roaccutane • Toxicity

27. Be Aware... • Niacin • Up to 500mg may enhance effects of statins But… • High doses may increase risk of myopathy • = So limit to 50mg

28. Be Aware... • Folic acid • Anti-convulsants (e.g. Tegretol & Epilim) may reduce folic acid absorption • So supplementation recommended (refer to GP) Methotrexate works by blocking folic acid activation. • Avoid folic acid with Methotrexate

29. Be Aware... • Vitamin E • Care with aspirin • Avoid high doses

30. Be Aware... • Vitamin K • Avoid with anti-coagulants CoQ10 • Avoid with anti-coagulants (similar structure to Vit K)

31. Be Aware... • Calcium • Care with calcium channel blockers (e.g. Verapamil) • May reverse blood pressure lowering effects

32. Be Aware... • Potassium = elevated blood K levels with • ACE inhibitors • K-sparing diuretics • NSAID indomethacin • Antibacterial drugs (e.g. trimethoprim) • Avoid ‘Lo-salt’ and ‘Solo’

33. Be Aware... • 5-HTP • Increases serotonin levels • Avoid with SSRI’s unless under medical supervision

34. Be Aware... • St John’s wort • Contraceptive pill – may reduce effectiveness • Migraine – increased incidence • SSRI’s – side effects = nausea, confusion, sweating, fatigue • Theophylline • Digoxin • Warfarin • Anti-convulsant drugs • HIV meds

35. Be Aware... • Liquorice • Glycyrrhizin stimulates production of adrenal hormones and reduces breakdown of steroids • Risk of overdose with corticosteroids or adrenaline meds • Side effects with K-depleting diuretics • Use DGL

36. Key drugs-nutrient interactions... • Oral contraceptive pill • Anti-coagulants • Anti-depressants • Statins • Corticosteroids

37. Oral Contraceptive Pill • Q = What medication are you on? • A = anti-depressants, blood thinners, antacids, painkillers…

38. Oral Contraceptive Pill • Contraceptive • Treatment of endometriosis, menstrual irregularities • Treatment of acne

39. Oral Contraceptive PillDepletion/interference… • Folic acid • Magnesium • Vitamin B6 • Zinc • B vitamins (B1, B2, B3, B12) • Vitamin C • Manganese

40. Oral Contraceptive PillPossible increase in levels of… • Iron (re. reduced menses) • Calcium (re. increased absorption) • Copper (re. increased absorption) • Vitamin A (increased serum levels) • Tobacco (increased damage)

41. Oral Contraceptive PillSupplementation • A good quality B complex • Magnesium • Zinc • Vitamin C (500mg) • Manganese • Liver support

42. Anti-coagulants • Warfarin • Aspirin • Heparin

43. Anti-coagulants • To slow rate of blood clot formation • Prevention of blood clots after surgery • To dissolve blood clots

44. Anti-coagulantsAdverse supplement combination … • Korean ginseng • Devil’s claw • Dong quai • Fenugreek • Garlic • Ginger • Gingko • Horse chestnut • Papain • Quinine • Red clover • Vitamin D • Vitamin K • Vitamin E • Fish oils • Bromelain • Feverfew • Medicinal mushrooms • Pau d’arco

45. Anti-depressants... • 5-HTP – side effects • Korean ginseng – side effects • St John’s wort – possible side effects • Folic acid – low blood levels folic acid = poor response to SSRI’s (supplement 200mcg a day) • Gingko – sexual dysfunction • Alcohol – dizziness/drowsiness

46. Anti-depressants… Supplementation… • Gingko (where appropriate) • Folic acid

47. Statins… HMG- CoA reductase inhibitors that block production of cholesterol

48. Statins… • coQ10 – deceased serum levels • Niacin – possible myopathy at high doses • Vitamin A – blood levels increased • Fibre – oat bran & pectin – reduced absorption • Grapefruit juice – increase blood levels • Niacin – enhanced effectiveness of statins (500mg 3 x day) • Vit E – statin +300iu vit E improved blood vessel elasticity • Milk thistle – to reduce liver toxicity • Food – take with food (increase blood levels)

49. Corticosteroids… • Magnesium – increased blood loss • Potassium – increased blood loss – increase K foods in diet • Vit B6 – increased loss, so supplement to prevent deficiency • Vit D – reduced activation, so increased possibility of bone loss • Sodium – retention • Liquorice – may increase side effects, re. reduced liver clearance • Alcohol – irritation to stomach • Vit A - may reverse benefits of drug • Vit A – may help wound healing

50. Advice for Practitioners… Knowledge is power… Keep informed…