20. SUPPLEMENTS Flashcards
THIS MODULE COVERS: • Supplements: Why use them, legislation, manufacturing, administration, cost excipients, dosages and absorption. • Natural v. synthetic supplements. • Different types and forms of nutritional supplements. • Mineral, vitamin and EFA supplements.
What is a food supplement defined as?
A concentrated source of a vitamin, mineral or other substance with a nutritional or physiological effect, alone, or in combination, sold in dose form.
Do herbal products have food supplement status?
Herbal products do not have food supplement status since they are classed as medicines.
Why use supplements?
- For deficiency states: Deficiency symptoms are end-stage symptoms associated with an extended lack of a particular vitamin, mineral or other nutrient.
- For therapeutic uses: Insufficiency can be identified when there is under-functioning of certain biochemical pathways, by nutritional evaluation, or by identification of other symptoms. Most disease starts and progresses due to an insufficiency of specific vitamins or minerals.
- For preventative health: Supplements are used to address any nutrient insufficiencies in order to maintain optimal health and wellness.
Name FIVE causative factors for supplements being needed.
- Food processing reduces nutrient content: best to eat whole organic food, locally sourced, in season and minimally processed.
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Food additives deplete nutrients:
Many food additives are toxic, depleting the body of essential nutrients and impairing nutrient absorption. -
Weakened digestion:
Due to refined, low-quality food and medications. -
Stressful lifestyles:
Depletes nutrients including calcium, magnesium and zinc. -
Nutrient depletion at birth: Potential heavy
metal and chemical toxicity of the parents. - Soil is depleted: Zinc, manganese, chromium, molybdenum, calcium and magnesium.
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High-yield crops are deficient in certain
nutrients: After years of intensive cultivation. - Fertilisers: Do not supply enough trace minerals to plants.
- Pesticides deplete soil: Kill soil microorganisms needed to create nutrients for plants, thereby causing lower nutrient content.
- Long-distance transportation: Crops lose much of their nutritional value.
Where can we find what vitamin and mineral substances are permitted for use in food supplements?
The EU Food Supplements Directive gives a list of the vitamins and minerals, including the form in which they may be used, in the manufacture of food supplements.
It contains a legal requirement for the setting of maximum and minimum levels for vitamins and minerals in food supplements.
New sources of vitamins and minerals may be added to these lists if safety information is submitted and approved by the European Food Safety Authority (EFSA).
How is food supplements regulated in Ireland?
Ireland is regulated by EU legislation on food supplements.
The Food Safety Authority of Ireland (FSAI) oversees the implementation of all relevant legislation for food supplements.
How are food supplements regulated in the US?
All prescription and non-prescription drugs are regulated in the United States by the Food and Drug Administration (FDA).
In the US, dietary supplements are treated as a special category of food with different regulations to drugs. They are considered safe until proven otherwise.
Which organisation is responsible for licensing medicines in the UK?
The Medicines and Healthcare Products Regulatory Agency (MHRA).
What regulates medicinal products, medical devices and cosmetics?
The Health Products Regulatory Authority (HPRA).
What has the responsibility for national and EU legislation on food supplements in:
- England
- Wales
- Scotland and Northern Ireland?
- The Department of Health in England.
- The Welsh Assembly in Wales
- the local Food Standards Agencies in Scotland and Northern Ireland.
Compliance is monitored and enforced by local trading standards authorities but if pharmacologically-active substances or herbs are part of the product they will be sent to the MHRA for assessment.
How are herbal products regulated?
Many herbal ingredients are classified as medicines. Herbal products are regulated by the Traditional Herbal Medicines (THM) Directive, which is administered in the UK by the MHRA.
What claims are prohibited on the labels?
- Medicinal claims.
- Presentation or labelling that infers that a supplement can prevent, treat or cure human disease.
- Reference to the rate or amount of weight loss.
- Reference to recommendations of individual doctors or health professionals.
- Health claims on alcoholic beverages.
- Claims which suggest that health could be affected by not consuming the food.
What checks are involved for animal-based supplements?
Any facility involved in the manufacture of animal-based supplements such as fish oils and glucosamine needs to be registered and approved by the European Commission.
Checks include where the animal was caught, farmed, handled, manufactured, extracted and packaged and the approval
number must be displayed on the label.
Contaminants such as PCBs, dioxins and heavy metals must be within EU ‘acceptable levels’ for supplements.
Are genetically modified (GM) ingredients allowed in supplements?
Ingredients from GM organisms are only permitted for use in supplements if authorised under the Regulation on genetically modified food and feed.
This regulation requires companies to declare the presence of GM materials on food product and supplement labels.
The accidental presence of GM material may still occur in a non-GM crop via transference in nature; e.g. via windborne pollen.
What does GMP stand for? Are companies required to be GMP-approved?
Good Manufacturing Practice.
In the UK, supplement companies are required to manufacture with ‘due diligence’. There is a legal requirement that all products must be ‘fit for purpose’.
Many companies are GMP compliant (self-regulated) but not GMP approved. This means that supplements may be produced
to GMP standard with rigorous quality control, production and distribution procedures but without having actual GMP approval.
Few companies in the UK are GMP approved - most of these are Australian or American companies as they have to meet the standards set by the Therapeutics Goods Act (TGA) or Food and Drug Administration (FDA) in their respective countries.
What do tests carried out by the regulatory agencies check in supplements?
High or unacceptable levels of heavy metals, solvent residue, aflatoxins, or herbicides and pesticides.
UK law limits contaminants such as arsenic; EU legislation limits amounts of materials such as mercury, lead and cadmium.
What is overage?
Ingredients may degrade over a supplement’s shelf life. Reputable supplement companies will add extra so that the amount left at the end of its shelf life still meets the label claim. This is called overage.
eg. fish oil, whey protein
How the way certain ingredients are processed can affect their quality?
Fish oil and omega plant oils need to be cold-pressed to minimise oxidation; whey protein needs to be specially filtered to remove lactose, hormones, etc.
Cheaper extraction and processing methods reduce the effectiveness of the supplement and affects its safety profile.
Compare tablets to capsules supplementation.
Tablets: Cheaper, easier to produce large quantities. Generally contain more excipients so try to avoid.
Capsules: Fewer excipients but not efficient for large doses.
Compare powders to liquids supplementation.
Powders: Good for bigger doses; e.g. glutamine. Not suitable for sticky ingredients, ones that attract moisture, e.g. phosphatidyl serine or fruit powders, where there is a toxicity risk, or where ingredients are unstable.
Liquids: Excellent absorption but more expensive and less stable. Many, such as fish oils, need antioxidants such as vitamin E added to prevent oxidation.
What are the advantages of enteric formulations?
Excipients, such as shellac or cellulose acetate phthalate (CAP) ensure tablets survive stomach acid so that they don’t release contents until the small intestine. Commonly used for good garlic capsules.
Name a good form of supplements to enable probiotics to survive the stomach acid and reactivate in the intestines.
Spore form
Why do we need chewable formulations of supplements?
As vitamins and minerals may taste unpleasant, most vitamin and mineral powders are coated before they are compressed into tablets.
Cheaper slow-release tablets contain ______________ to hold the tablets together longer.
hydrogenated fats