eu legislation
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EU Legislation. Jane McClenaghan BscHons, DipION Nutritional Therapist. Are you aware…?. Food Supplements Directive Traditional Herbal Medicines Products Directive Nutritional and Health Claims Regulation. ROI Medicines Act. Any nutrient above 1 times the RDA is a medicine. RDA’s. - PowerPoint PPT PresentationTRANSCRIPT
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EU Legislation
Jane McClenaghan BscHons, DipIONNutritional Therapist
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Are you aware…?
1. Food Supplements Directive2. Traditional Herbal Medicines Products
Directive3. Nutritional and Health Claims Regulation
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ROI Medicines Act
Any nutrient above 1 times the RDA is a medicine
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VitaminsVitamin A 800 μgVitamin D 5 μgVitamin E 10 mgVitamin C 60 mgThiamin 1.4 mgRiboflavin 1.6 mgNiacin 18 mgVitamin B6 2 mgFolic acid 200 μgVitamin B12 1 μgBiotin 0.15 mgPantothenic acid 6 mg
MineralsCalcium 800 mgPhosphorus 800 mgIron 14 mgMagnesium 300 mgZinc 15 mgIodine 150 μg
RDA’s
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Food Supplements Directive
First proposed in 1988
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Aims of the Directive
1. Recognition of the existence of food supplements2. Harmonisation of legislation across the
community3. Recognition that not all groups achieve nutritional
goals through diet4. Recognition that some consumers choose to
supplement their diet for lifestyle or other reasons5. To ensure consumer protection through safety
and labelling criteria6. To define food supplements7. To define conformance criteria
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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
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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.
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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
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1. nutrients for which there is no risk of over consumption (eg: some B group vitamins)
2. nutrients for which there is a low risk of over consumption (eg vitamin C, magnesium)
3. nutrients for which there is a risk of excessive intake (eg Vitamin A, Folic acid, iron)
The Maximum Permitted Level Debate
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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)
The Maximum Permitted Level Debate
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nutrients for which there is a low risk of over consumption
Option 1: Numerical maximum amounts Option 2: Numerical maximum amounts with
advisory statements.
The Maximum Permitted Level Debate
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nutrients for which there is a risk of excessive intake
Option 1: Numerical maximum amounts.
Option 2: Numerical maximum amounts with restrictions.
The Maximum Permitted Level Debate
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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
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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.
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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).
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Traditional Herbal Medicinal Products Directive
To provide a special, simplified registration
procedure for certain traditional medicinal products without having to prove efficacy
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Requirements of THMPD
• Safety (published bibliographical)
• Quality (pharmaceutical GMP)• Tradition
30 years demonstrated use15 years use in E.U.
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Drug-Nutrient Interactions
Jane McClenaghan BscHons, DipIONNutritional Therapist
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‘Killer Grapefruit alert to Slimmers’
The Sun, 3 April 2009
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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
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How drugs & nutrients interact…
3. Reduction of drug side effects
4. Risk of overdose- Enhanced bioavailability- Enhanced drug action
5.Prevent drug action
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Where supplementation may be beneficial…
if drug causes depletion/interference of nutrient
reduction or prevention of side-effects
supportive interaction
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Avoid if..
× Adverse reaction× Reduced drug absorption or bioavailability
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General Cautions…
Betaine HCl AspirinNSAIDs
Licorice Blood pressure meds(use deglycyrrhised)
Psyllium May delay absorptionLeave 2 hours
Valerian Drowsiness with sedatives
Acne drugs With vit A may cause high blood levels vit A
Antacids Decrease folic acid absorption
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Be Aware...Vitamin A×Do not use doses over
10,000iu a day with Roaccutane×Toxicity
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Be Aware...NiacinUp to 500mg may enhance
effects of statinsBut… ×High doses may increase risk of myopathy
= So limit to 50mg
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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
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Be Aware...Vitamin E× Care with aspirin× Avoid high doses
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Be Aware...Vitamin K× Avoid with anti-coagulants
CoQ10 × Avoid with anti-coagulants
(similar structure to Vit K)
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Be Aware...Calcium× Care with calcium channel
blockers (e.g. Verapamil)× May reverse blood pressure
lowering effects
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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’
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Be Aware...5-HTP× Increases serotonin levels× Avoid with SSRI’s unless under
medical supervision
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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
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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
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Key drugs-nutrient interactions...
1. Oral contraceptive pill2. Anti-coagulants3. Anti-depressants4. Statins5. Corticosteroids
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Oral Contraceptive Pill
Q = What medication are you on?
A = anti-depressants, blood thinners, antacids, painkillers…
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Oral Contraceptive Pill
Contraceptive Treatment of endometriosis, menstrual
irregularities Treatment of acne
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Oral Contraceptive PillDepletion/interference…
× Folic acid × Magnesium× Vitamin B6× Zinc× B vitamins (B1, B2, B3, B12)× Vitamin C× Manganese
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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)
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Oral Contraceptive PillSupplementation
A good quality B complex MagnesiumZincVitamin C (500mg)ManganeseLiver support
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Anti-coagulants
Warfarin Aspirin Heparin
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Anti-coagulants
To slow rate of blood clot formation
Prevention of blood clots after surgery
To dissolve blood clots
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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
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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
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Anti-depressants…
Supplementation…Gingko (where appropriate)Folic acid
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Statins…
HMG- CoA reductase inhibitors that block production of cholesterol
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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 elasticityMilk thistle – to reduce liver toxicityFood – take with food (increase blood levels)
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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 drugVit A – may help wound healing
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Advice for Practitioners…
Knowledge is power… Keep informed…