Supplements in practice - Legislation

Question 1

Legislation Link

Answer 1

• A summary of information on legislation relating to the sale of food supplements (including links to the relevant legislation) should be downloaded and added to your lecture notes by copying & pasting the link:
  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/204303/Supplements_Summary__Jan_2012__DH_FINAL.doc.pdf

Question 2

EU Food Supplements Directive

Answer 2

• The EU Food Supplements Directive 2002/46 specifies the vitamin and mineral substances permitted for use in food supplements and identifies the units of measurement, labelling, presentation and advertising allowed.

Question 3

Link: Vitamin and Minerals list

Answer 3

• Schedules 1 and 2 of this Directive give a list of the vitamins and minerals, including the form in which they may be used, in the manufacture of food supplements.
  http://www.legislation.gov.uk/uksi/2003/1387/schedule/1/made
• There are no requirements for other substances such as essential fatty acids, amino acids or other nutrients or botanicals to be listed.
• New sources of vitamins and minerals may be added to these positive lists if safety information is submitted and approved by the European Food Safety Authority (EFSA).

Question 4

Food regulation links for Ireland and EU

Answer 4

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.
https://www.fsai.ie/legislation/food_legislation/food_supplement.html
* For Irish regulations on food supplements: http://www.irishstatutebook.ie/2003/en/si/0539.html
* For EU information on food supplements:
https://ec.europa.eu/food/safety/labelling_nutrition/supplements_en
* Additional information can be accessed at: https://www.efsa.europa.eu/en/topics/topic/food-supplements

Question 5

Other countries legislation

Answer 5

Other countries vary in their legislation:
* 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.
* For up-to-date information on food supplements in the UK:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_130237
* The Alliance for Natural Health also provides regular updates and information:
* https://www.anhinternational.org/
www.anh-usa.org(US)

Question 6

Safe levels in supplements:

Answer 6

• The EU Food Supplements Directive contains a legal requirement for the setting of maximum and minimum levels for vitamins and minerals in food supplements.
• Useful information on Supplements and Supplement Safety based on the EU Directives is available at Dr Alan Stewart’s website: www.stewartnutrition.co.uk
• Safe Upper Levels and Guidance Levels of Vitamins and Mineral can be found at:
  http://www.stewartnutrition.co.uk/supplement_safety/safe_upper_levels_and_guidance_levels_for_vitamins_and_minerals.html

Question 7

Classification of supplements: Licensed medicines:

Answer 7

1. Licensed medicines:
   * The Medicines and Healthcare Products Regulatory Agency (MHRA) licenses medicines in the UK.
   * The definition of a medicine or medical device may be interpreted to include food, cosmetics or supplements. Further information at:
   https://www.gov.uk/guidance/decide-if-your-product-is-a-medicine-or-a-medical-device
   * Food supplements: Covered by food laws.
   * Medicines law: Not harmonised across the EU. What’s freely sold in one EU Member State as a food may be classified as medicinal in another EU State.
   * IRL: The Health Products Regulatory Authority (HPRA) regulates medicinal products, medical devices and cosmetics. http://www.hpra.ie/homepage/medicines/regulatory-information/classification-of-medicines
   * USA: Prescription and non-prescription drugs are regulated by the FDA.
   * The FDA considers new drugs to be unsafe until proven safe through clinical trials.
   * Dietary supplements are considered safe until proven otherwise. https://www.fda.gov/food/dietary-supplements

Question 8

Classification of supplements: Unlicensed preparations:

Answer 8

2. Unlicensed preparations:
   * The Department of Health has responsibility for national and EU legislation on food supplements within England. The Welsh Assembly is responsible in Wales, whilst the local Food Standards Agencies are responsible 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.

Question 9

Classification of supplements: Herbal products:

Answer 9

3. Herbal products:
   * 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.

Question 10

Health claims:

Answer 10

• No medicinal claims on labels are permitted; no presentation or labelling is allowed that infers that a supplement can prevent, treat or cure human disease.

Question 11

Prohibited claims:*

Answer 11

• 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.

Question 12

Animal-based supplements:

Answer 12

• 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.

Question 13

Genetically modified (GM) food and feed regulation.

Answer 13

• Ingredients from GM organisms are only permitted for use in supplements if authorised under Regulation (EC) 1829/2003 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.
• Information on GM food regulations at: https://www.food.gov.uk/gmfoods/gm/
  https://www.food.gov.uk/safety-hygiene/genetically-modified-foods