EU Legislation

Jane McClenaghan BscHons, DipIONNutritional Therapist

Are you aware…?

1. Food Supplements Directive2. Traditional Herbal Medicines Products

Directive3. Nutritional and Health Claims Regulation

ROI Medicines Act

Any nutrient above 1 times the RDA is a medicine

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

Food Supplements Directive

First proposed in 1988

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

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

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.

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Due to be published end April 2009… may not be published for another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

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

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

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

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

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

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.

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).

Traditional Herbal Medicinal Products Directive

To provide a special, simplified registration

procedure for certain traditional medicinal products without having to prove efficacy

Requirements of THMPD

• Safety (published bibliographical)

• Quality (pharmaceutical GMP)• Tradition

30 years demonstrated use15 years use in E.U.

Drug-Nutrient Interactions

Jane McClenaghan BscHons, DipIONNutritional Therapist

‘Killer Grapefruit alert to Slimmers’

The Sun, 3 April 2009

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

How drugs & nutrients interact…

3. Reduction of drug side effects

4. Risk of overdose- Enhanced bioavailability- Enhanced drug action

5.Prevent drug action

Where supplementation may be beneficial…

if drug causes depletion/interference of nutrient

reduction or prevention of side-effects

supportive interaction

Avoid if..

× Adverse reaction× Reduced drug absorption or bioavailability

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

Be Aware...Vitamin A×Do not use doses over

10,000iu a day with Roaccutane×Toxicity

Be Aware...NiacinUp to 500mg may enhance

effects of statinsBut… ×High doses may increase risk of myopathy

= So limit to 50mg

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

Be Aware...Vitamin E× Care with aspirin× Avoid high doses

Be Aware...Vitamin K× Avoid with anti-coagulants

CoQ10 × Avoid with anti-coagulants

(similar structure to Vit K)

Be Aware...Calcium× Care with calcium channel

blockers (e.g. Verapamil)× May reverse blood pressure

lowering effects

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’

Be Aware...5-HTP× Increases serotonin levels× Avoid with SSRI’s unless under

medical supervision

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

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

Key drugs-nutrient interactions...

1. Oral contraceptive pill2. Anti-coagulants3. Anti-depressants4. Statins5. Corticosteroids

Oral Contraceptive Pill

Q = What medication are you on?

A = anti-depressants, blood thinners, antacids, painkillers…

Oral Contraceptive Pill

Contraceptive Treatment of endometriosis, menstrual

irregularities Treatment of acne

Oral Contraceptive PillDepletion/interference…

× Folic acid × Magnesium× Vitamin B6× Zinc× B vitamins (B1, B2, B3, B12)× Vitamin C× Manganese

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)

Oral Contraceptive PillSupplementation

A good quality B complex MagnesiumZincVitamin C (500mg)ManganeseLiver support

Anti-coagulants

Warfarin Aspirin Heparin

Anti-coagulants

To slow rate of blood clot formation

Prevention of blood clots after surgery

To dissolve blood clots

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

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

Anti-depressants…

Supplementation…Gingko (where appropriate)Folic acid

Statins…

HMG- CoA reductase inhibitors that block production of cholesterol

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)

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

Advice for Practitioners…

Knowledge is power… Keep informed…