Food Supplements Regulations

Regulation

Food supplements are regulated under food law, which is based on the principle that products must be safe for consumption and not misleadingly labelled. Food law does not permit any food to make any claim, or imply that it can treat, prevent or cure any disease or adverse medical condition.

Read our Q&A on the regulation of food supplements to find out more

Food supplements are regulated under food law. All food law in the UK sits under the over-arching Food Safety Act of 1990 (as amended by subsequent legislation).

Much of the food law in the UK comes from the EU and has been enacted into UK law. Until the UK leaves the European Union, legislation from the EU, such as the General Food Law Regulation (Regulation (EC) No 178/2002), remains the basis of UK food law. The future of food law is yet to be confirmed by the UK Government. The Food Standards Agency has more information regarding the regulatory framework for foods here.

It remains the responsibility of the manufacturer, importer or distributor to comply with all of the relevant legislation.

Legislation which covers food supplements includes:

The underpinning principles of food law are that products have to be safe for consumption and not misleadingly labelled.  Since 1990, increasing levels of regulation have been applied to foods, including to food supplements.  This is intended to increase consumer protection and help consumers make informed choices through improved labelling requirements.

Food law regulates the content, labelling and promotion of food products, including food supplements.

There is no requirement for food supplements to be licenced or registered with the UK Government. However, all foods sold within the UK must comply with all relevant food law.

The Food Safety Act deals with all stages of food production and marketing, from farming, hygiene and preparation, through to consumption. Food is defined (in line with the General Food Law Regulation) as “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans” which includes food supplements.

The Food Safety Act establishes requirements for food safety and places the responsibility for this on the businesses that grow, produce, process, store, distribute and sell food.  The main responsibilities of food businesses under the Act are to:

  • Ensure that nothing is included or removed from food, or used to treat food, which would be damaging to the health of the people who will eat it
  • Ensure that food served or sold is of the nature, substance and quality demanded by consumers.
  • Ensure that all food is labelled, advertised and presented in a way that is not misleading.

The three main offences under the Act are rendering food injurious to health, selling, to the purchaser’s prejudice, food which is not of the nature or substance or quality demanded and falsely or misleadingly describing or presenting food.

The Food Supplements Directive lists the vitamins and minerals which are permitted for use in food supplements.  The lists have been amended several times and the safety of the substances on the list has been assessed and approved by the European Food Safety Authority (EFSA).  The amendments to the lists of substances permitted for use in food supplements can be found on the Commission website.

The European Commission has not yet begun this work and currently the UK industry works to the safe upper levels (SULs) established by the 2003 report by the Expert Group on Vitamins and Minerals and the EU Nutrient Reference Values (NRV) of vitamins and minerals.

The Food Information for Consumers Regulation regulates labelling requirements and other information which must be made available to consumers at point of purchase.  It applies to all foods, including food supplements.

The Nutrition and Health Claims Regulation (EC/1924/2006) was implemented to improve consumer protection in labelling claims.  All foods which make claims, including food supplements, sold within the EU must comply with this Regulation.

Herbal substances come from plants and many are used in both food supplements and medicinal products. For example, sage, ginseng and garlic can all be found in both food supplements and herbal remedies.

A herbal product will be considered a medicinal product if medicinal claims are made about it i.e. that it can prevent, treat or cure disease.

Such products are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and display the Traditional Herbal Registration (THR) logo if they have been approved for sale. The Traditional Herbal Medicines Directive and the national implementing legislation The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 does not permit the sale of herbal medicines in the UK unless they carry the logo.

Herbal products may also be classified and placed on the market as food provided they don’t fulfill the definition of medicinal products and that they comply with the applicable UK food law. In particular, herbal products marketed in the form of food supplements should comply with Directive 2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on nutrition and health claims made on food.

No. Food law does not permit any food to make any claim, or imply that it can treat, prevent or cure any disease or adverse medical condition.

Food supplements are intended to supplement the diet; they are not medicines and therefore should never imply that they can do more than maintain and support health.   Food supplements cannot claim or imply that they can replace a varied and balanced diet.

Food supplements can make claims about specific health benefits or nutrition claims under the Nutrition and Health Claims Regulation (EC/1924/2006).  See ‘How are claims made about food supplements regulated?’ for more information.

To improve consumer protection in labelling claims, the European Union put the Nutrition and Health Claims Regulation (EC/1924/2006) in place in 2006.  All foods which make claims, including food supplements, sold within the EU must comply with this regulation.

A health claim is a direct, indirect or implied claim, in words, pictures or any other representation that suggests that consumption of any product making the claim carries a specific health benefit (e.g. Calcium is needed for the maintenance of normal bones).

A nutrition claim is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a nutrient or other substance (e.g. high in vitamin C, low in fat).

The Nutrition and Health Claims Regulation (EC/1924/2006)  applies to all commercial communications about food (any communication intended to persuade the final consumer to purchase a product).  This includes packaging, labelling and all forms of advertising including catalogues, web advertising, social media and company web pages.

Any claim permitted for use on foods (which may be a health or a nutrition claim) is scientifically assessed by the European Food Safety Authority (EFSA) and, if given a favourable opinion, is then authorised for use by the European Commission.  Once authorised, the claim is put onto a central list of permitted claims which can be used in the advertising, promotion and labelling of food products.

The Advertising Codes enforced by the Advertising Standards Authority (ASA) reflect the requirements of the Nutrition and Health Claims Regulation and refer to other legislation as appropriate.

The Advertising Codes only apply to marketing communications and advertisements covered by the ASA remit which is defined more narrowly than “commercial communications” under the Nutrition and Health Claims Regulation.  For more information see the ASA’s website which also includes information regarding how they work with other bodies including the Department of Health in relation to health and nutrition claims made on food, including food supplements.

The Department of Health has responsibility for national and EU legislation on food supplements within England.  The responsibility for the policy area of food supplements legislation in Wales rests with the Welsh Assembly.  The Food Standards Agency Devolved Administrations of Scotland, and Northern Ireland are responsible for national legislation in their own administrations where separate but similar Regulations apply.

The legislation is enforced through local Trading Standards Offices and Port Health Authorities.

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