Food supplements

In the UK most products described as food supplements (such as vitamins, minerals or amino acids) are regulated as foods and subject to the provisions of general food law such as the Food Safety Act. If you sell food supplements you must register as a Food Business Operator (FBO) with the environmental health service at your local authority.


What is a food supplement

A food supplement is defined as ‘any food for the purpose of which is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination and is sold in dose form’. 

What is the role of the FSA?
food supplements
~~The FSA’s main role regarding food supplements is enforcement (setting enforcement policy, co-ordination and advice) with specific responsibility for:
• General food law, food safety legislation and food controls.
• Novel foods
• Chemical risk assessments
• Labelling requirements under the EU Food Information to Consumers Regulation (EU FIC) in Wales and Northern Ireland (Defra in England)
• Enforcement, Incidents and National Food Crime Unit (NFCU).

Local authorities are responsible for the enforcement of food supplements legislation in addition to general food law and food safety legislation. Trading standards officers generally undertake this role. Local authorities do not enforce legislation relating to medicinal products –MHRA is responsible for enforcement in this area .

Department of Health acts as the Competent Authority for the EU legislation on Food Supplements and coordinates policy across the devolved authorities and with other relevant government departments. FSA is responsible for the enforcement of these regulations with local authorities.

MHRA has responsibility for medicinal products (including enforcement) which includes traditional herbal medicines. Herbal substances can be used in both medicines and foods, but where the use is for a medical purpose (either by virtue of the mode of action or the claims that are made) then the MHRA may regard the product, (not the substance), to be medicine. The MHRA has a separate registration scheme, based on traditional use, for certain herbal medicines.
Herbal substances are referred to as botanicals under food law. Products may be considered by the MHRA Borderline Section on a case by case basis to determine whether if the product should be classified as a medicine. The MHRA’s Borderline Section only become involved where there may be doubt regarding a product’s regulatory status, either over the botanical itself, the entire formulation, or the presentation of the product. If a product is not considered medicinal product they typically default to being a food supplement. 

The regulatory landscape for food supplements is complex. The current legislative framework creates overlapping areas of responsibility between several different bodies:

• Food Standards Agency (FSA), Food Standards Agency Wales (FSAW) and Food Standards Agency Northern Ireland (FSANI)
• Food Standards Scotland (FSS)
• Department of Health (DH)
• Home Office (HO)
• Medicine and Healthcare products Regulatory Agency (MHRA)
• Local authorities (LA)
• Welsh Government (WG)



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