Who regulates dietary supplements in the United Kingdom?

October 14, 2025 •

4 min read

The UK supplements market, valued at over £500 million in 2024, is subject to a robust, multi-layered regulatory system to protect consumer health. This article explains who regulates dietary supplements in the United Kingdom?, detailing the responsibilities of the various government agencies involved in their oversight.

Quick Summary

Regulation of dietary supplements in the UK is a shared responsibility between agencies, including the Food Standards Agency (FSA), the Medicines and Healthcare products Regulatory Agency (MHRA), and local Trading Standards.

Key Points

FSA as Primary Regulator: The Food Standards Agency oversees most food supplements, regulating them under general food law and specific legislation like the Food Supplements Regulations 2003.
MHRA's Medicinal Oversight: The Medicines and Healthcare products Regulatory Agency becomes involved when a supplement is classified as a medicinal product due to its claims or ingredients.
Local Enforcement: Local authority Trading Standards and Environmental Health departments are responsible for enforcing regulations at the point of sale and investigating complaints.
Post-Brexit Divergence: After Brexit, Great Britain and Northern Ireland have separate but similar regulatory frameworks, with Northern Ireland continuing to align with EU rules for areas like Novel Foods.
Claim Limitations: Food supplements cannot make medicinal claims. General health claims must be scientifically substantiated and are overseen by the FSA in GB.
Novel Food Approval: Ingredients without a significant history of use require a pre-market safety assessment, handled by the FSA in Great Britain and EFSA in Northern Ireland.

The regulation of dietary supplements in the UK is a complex process involving several key governmental bodies and pieces of legislation. Unlike pharmaceutical drugs that require pre-market authorisation, most food supplements do not, placing a significant burden on manufacturers and importers to ensure compliance with the rules. This system is designed to protect public health by governing everything from product composition and manufacturing standards to labelling and advertising claims.

The Food Standards Agency (FSA): Primary Food Regulator

The Food Standards Agency (FSA) is the primary regulatory body for food supplements in England and Wales, with Food Standards Scotland (FSS) performing the equivalent role north of the border. Since dietary supplements are legally classified as 'food products', they fall under general food law, which the FSA oversees. The FSA's responsibilities include:

Composition and Ingredients: Ensuring that supplements contain only substances deemed safe for human consumption. This includes retaining lists of permitted vitamins and minerals for use in food supplements.
Novel Foods: Managing the approval process for any ingredient that did not have a significant history of consumption in the UK or EU before May 1997. A rigorous safety assessment is required before these can be sold.
Labelling and Presentation: Enforcing strict rules on how supplements must be labelled. This ensures consumers are provided with accurate and non-misleading information, such as nutritional content, daily dosage, and a 'food supplement' declaration.
Post-Market Checks: Conducting inspections of manufacturing sites and testing products to ensure they comply with legal requirements after they have been placed on the market.

The Post-Brexit Regulatory Landscape

Brexit introduced a split in the regulatory approach. While most of the pre-existing EU food law was retained as UK law for Great Britain (England, Scotland, and Wales), Northern Ireland continues to align with EU regulations under the Northern Ireland Protocol. This means businesses must navigate a distinct system depending on their target market within the UK. For example, while the FSA manages Novel Food approvals for Great Britain, the European Food Safety Authority (EFSA) handles approvals for Northern Ireland.

The Medicines and Healthcare products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a critical, yet distinct, role in the regulation of supplements. While most supplements are classified as food, they are reclassified as medicinal products if they are presented as having properties to treat, prevent, or cure a disease. This shifts their oversight to the MHRA, which is the body responsible for ensuring the safety and effectiveness of medicines and medical devices. If a product is determined to be a medicine, it cannot be legally sold in the UK without a marketing authorisation from the MHRA.

Common triggers for MHRA intervention include:

Medicinal Claims: Advertisements or packaging suggesting a product can cure or treat an illness, such as 'cures arthritis'.
Ingredient Composition: Certain herbal ingredients or high doses of substances may push a product over the 'medicinal' threshold.
Misleading Presentation: The overall presentation of the product may imply a medicinal use, even without explicit claims.

Enforcement by Local Trading Standards

At the local level, the rules set by the FSA and other relevant legislation are enforced by local authority Trading Standards and Environmental Health departments. These teams conduct inspections and investigate consumer complaints related to food safety, fraudulent labelling, and misleading advertising. This localized enforcement mechanism is a crucial part of the UK's regulatory framework, providing a frontline defence against non-compliant or unsafe products.

A Comparison of FSA and MHRA Roles


Aspect	Food Standards Agency (FSA)	Medicines and Healthcare products Regulatory Agency (MHRA)
Primary Function	Regulates food supplements classified as food.	Regulates products classified as medicines.
Scope of Authority	Controls composition, labelling, and health claims for general wellness.	Manages products making medicinal claims (e.g., to treat or cure a disease).
Pre-Market Approval	Not required, though Novel Foods need approval.	Requires marketing authorisation for medicinal products.
Key Legislation	Food Supplements (England) Regulations 2003, retained EU food law.	Medicines Act 1968, related medicines legislation.
Examples	A vitamin C tablet marketed to 'support the immune system'.	A herbal product promoted to 'cure indigestion'.

Conclusion

The regulation of dietary supplements in the UK relies on a collaborative effort between the Food Standards Agency and the Medicines and Healthcare products Regulatory Agency, with enforcement delegated to local Trading Standards. The key distinction lies in the product's classification: if it acts as a food for general dietary support, the FSA has jurisdiction; if it makes medicinal claims, the MHRA takes over. This dual-agency approach, combined with post-Brexit regulatory adjustments for Great Britain and Northern Ireland, creates a structured system to protect consumer health by ensuring products are safe, accurately labelled, and truthfully advertised.

Frequently Asked Questions

The FSA regulates supplements classified as food, focusing on composition, labelling, and general health claims. The MHRA regulates products that are deemed medicinal, such as those making claims to treat or cure diseases.

Yes. Under the Northern Ireland Protocol, Northern Ireland remains aligned with EU food law and regulations, including those concerning food supplements and Novel Foods, while Great Britain operates under its own retained and amended domestic law.

No, most food supplements do not require pre-market licensing or registration to be sold in the UK. However, it is the manufacturer or importer's responsibility to ensure the product complies with all relevant regulations.

Food supplements are strictly prohibited from making medicinal claims, which suggest they can treat, cure, or prevent any human disease or medical condition. Any product making such a claim would be reclassified as a medicinal product and fall under MHRA regulation.

Local Trading Standards and Environmental Health departments within local authorities are responsible for enforcing food law, including supplement regulations, and investigating breaches in their area.

A 'Novel Food' is any food ingredient that was not widely consumed by people in the UK or EU before May 1997. These ingredients require a specific pre-market authorisation from the FSA (for GB) or EFSA (for NI) based on a safety assessment.

If a food supplement is found to be non-compliant with regulations, enforcement action may be taken by the relevant authority, such as the FSA, MHRA, or local Trading Standards. This could lead to the product being removed from the market, fines, or other penalties.