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. Following the UK’s departure from the EU on 31 January 2020, EU Regulations and tertiary legislation relating to food and nutrition have been retained as UK law under the powers contained within the European Union (Withdrawal) Act 2018. Retained legislation from the EU, such as retained General Food Law Regulation (Regulation (EC) No 178/2002) as amended by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019, remains the basis of UK food law.
The Protocol on Ireland/Northern Ireland (NIP) means that EU legislation relating to food and nutrition (as specified in Annex II) will continue to be directly applicable in Northern Ireland. Food placed on the Northern Ireland market needs to comply with EU food law. Retained EU law (as amended) only applies to Great Britain (that is, England, Scotland and Wales).
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:
Separate but similar legislation is enacted for England and for the Devolved Administrations of Scotland, Wales and Northern Ireland. All food supplements legislation can be found at http://www.legislation.gov.uk
Insert the words “food supplements” into the title box on this page and search. Twelve pieces of legislation (three for each administration) will be displayed.
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 licensed 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:
The three main offences under the Act are:
The Food Supplements Directive lists the vitamins and minerals which are permitted for use in food supplements in the EU, including Northern Ireland. 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 vitamins and minerals and their chemical forms which are permitted for use in food supplements in Great Britain have been listed in Schedule I and II of The Nutrition (Amendment etc) (EU Exit) 2019. This list can also be accessed from the Great Britain register on the addition of vitamins and minerals and of certain other substances to foods (Great Britain VMS Register).
Currently the UK industry works to the safe upper levels (SULs) established in 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, sold within the EU, including Northern Ireland. The Food (Amendment etc) (EU Exit) 2019 and The Food (Amendment etc) (EU Exit) 2020 regulate labelling requirements for all foods, including food supplements, sold within Great Britain.
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, including Northern Ireland, must comply with this Regulation. All foods which make claims, including food supplements, sold within Great Britain must comply with The Nutrition (Amendment etc) (EU Exit) 2019 and The Nutrition (Amendment etc) (EU Exit) 2020.
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 medicines.
A herbal product will be considered a medicinal product if medicinal claims are made about it; that is, it claims that it can prevent, treat or cure disease.
Apart from these claims, it should also have medicinal properties.
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.
A THR is only granted if the medicine is used for minor health conditions where medical supervision is not required (for example, to alleviate symptoms of a cold).
Useful guidance from MHRA on what is considered a medicinal product before applying for a THR can be found here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/872742/GN8_FINAL_10_03_2020__combined_.pdf
Prior to 1 January 2021 the MHRA required evidence that the product or a corresponding product had been used for a period of 15 years within the EU/EEA.
From 1 January 2021, the MHRA may be able to accept the 15 years of traditional evidence from a wider range of countries in addition to EU/EEA countries.
Suitable countries will be those that have a level of pharmacovigilance equivalent to that of the UK.
This is to ensure that any safety issues have been properly identified to support the traditional use of the product.
The MHRA will publish a list of suitable countries for this purpose which will be updated as new entries arise.
More information can be found here https://www.gov.uk/guidance/guidance-on-new-provisions-for-traditional-herbal-medicinal-products-and-homoeopathic-medicinal-products
Herbal products may also be classified and placed on the market as food provided they do not fulfil 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 if sold within the EU, including Northern Ireland.
If sold within Great Britain, herbal products marketed in the form of food supplements should comply with the relevant national and EU retained legislations, in particular with the Food Supplements Regulations and The Nutrition (Amendment etc) (EU Exit) 2019 and The Nutrition (Amendment etc) (EU Exit) 2020.
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) and retained regulation. See ‘How are claims made about food supplements regulated?’ for more information.
To improve consumer protection in labelling claims, the EU 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, including Northern Ireland, must comply with this regulation. Claims made for foods, including food supplements, sold in Great Britain must comply with Retained Nutrition and Health Claims Regulation (EC/1924/2006) as amended by The Nutrition (Amendment etc) (EU Exit) 2019 and The Nutrition (Amendment etc) (EU Exit) 2020.
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) and retained legislation apply 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.
In the EU, including Northern Ireland, 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.
In Great Britain, the Nutrition and Health Claims Committee (UKNHCC) is responsible for scientifically assessing new nutrition and health claims. If the committee approves a claim, it is then authorised by the UK authorities. Claims permitted for use in Great Britain can be found in the Great Britain nutrition and health claims (NHC) register.
The Advertising Codes enforced by the Advertising Standards Authority (ASA) reflect some of the requirements of the Nutrition and Health Claims Regulation and refer to other legislation as appropriate. However, the Advertising Codes only apply to marketing communications and advertisements covered by the ASA remit, which are defined more narrowly than “commercial communications” under the Nutrition and Health Claims Regulation. For example, the ASA would not rule on the compliance of food packaging in shops. For more information see the ASA’s website which also includes information regarding how it works with other bodies, including the Department of Health and Social Care, in relation to health and nutrition claims made on food and food supplements.
The Department of Health and Social Care has responsibility for national and EU retained 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.