This is the fact that surprises most manufacturers entering the UK market: food supplements do not require pre-market approval in Great Britain. There's no licensing step equivalent to MHRA's medicine authorisation. But "no approval" doesn't mean "no requirements” you still must notify the relevant authority before sale, comply with detailed labelling and ingredient rules, and separately clear any genuinely novel ingredient through a real pre-market safety assessment. Confusing "no approval" with "no compliance obligation" is the single most common, avoidable mistake entering this market.

Who Regulates What

Food supplements are regulated by legislation made separately in each UK nation, though the underlying rules remain closely aligned post-Brexit since most EU regulations were retained as domestic law:

   - England, Wales, Northern Ireland*: Food Standards Agency (FSA)

 - Scotland: Food Standards Scotland (FSS)


 The harmonized legal definition across all four nations: a food supplement is any food intended to supplement the normal diet, serving as a concentrated source of a vitamin, mineral, or other substance with nutritional or physiological effect, sold in dose form (capsules, tablets, liquid measures, etc.).

 *Northern Ireland sits under the Windsor Framework, so in practice it continues to follow EU food supplement rules alongside FSA oversight — worth checking separately if you distribute there.

The Notification Step You Cannot Skip

Businesses manufacturing, importing, distributing or selling food supplements in the UK must register as a Food Business Operator (FBO) with their local authority before commencing food business activities. Registration enables the local authority to carry out official controls and monitor compliance with food safety legislation. Unlike medicines or cosmetics, there is no general requirement to obtain pre-market approval or submit a product notification for individual food supplements, unless another regulatory regime—such as the UK Novel Foods Regulation—applies.

Foundational Legislation

The core legal basis rests on the Food Supplements (England) Regulations 2003 (SI 2003/1387), and equivalent legislation in Scotland, Wales, and Northern Ireland — all implementing Directive 2002/46/EC and referring back to its Annexes for permitted vitamin and mineral substances. As of 1 January 2021, responsibility for food supplement regulation transferred fully from EU institutions to UK authorities, via the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 and 2020 (reflected through the Windsor Framework for Northern Ireland specifically).

Ingredient Compliance

Vitamins and minerals must comply with the permitted lists established under the Food Supplements Regulations. Other ingredients, including botanicals and amino acids, must comply with general food safety legislation and any applicable UK-specific restrictions.

Novel Foods: A Real, Substantive Approval Gate

This is the one place where "no pre-market approval" genuinely doesn't apply: if your product contains an ingredient without a significant history of consumption in the UK or EU before 15 May 1997, it qualifies as a novel food and requires full authorisation under the UK Novel Foods Regulation (assimilated Regulation (EU) 2015/2283), processed through the FSA's Novel Foods Guidance pathway. This requires dossier compilation and, where needed, consultation with the FSA — a genuinely demanding, pre-market safety assessment process, not a notification formality. CBD-containing supplements are the most commonly affected category right now — the FSA has run an active compliance initiative requiring CBD food products specifically to undergo novel food authorisation, and applications as of 2026 are still progressing through the risk assessment pipeline. The FSA maintains a public list of CBD products linked to a credible novel food application. Businesses should ensure that CBD food products are either supported by an appropriate authorisation or included on the FSA's public list, as products outside these arrangements are not expected to remain on the market.

Mandatory Labelling Elements

Under Regulation 6 of the Food Supplement Regulations 2003, labels must include:

• - The term "Food Supplement" specifically — not "Dietary Supplement," a US-convention term that doesn't satisfy UK labelling rules
•   Business name and address — either the marketing business's name, or the importing business's address
•  Full ingredient list, with common allergens specifically emphasized
  
• Conditions for use, including recommended daily dosage and a warning not to exceed it
  
•  Storage instructions, including a statement to keep out of reach of young children.
  
• A "use by" or "best before" date
• A nutritional declaration stating names and amounts of vitamins, minerals, and other active substances (amino acids, fatty acids, plant extracts, etc.)

The name and address of the responsible food business operator established in the UK, or, where applicable, the importer responsible for placing the product on the UK market.

Health Claims: Authorized List Only

Only health and nutrition claims appearing on the UK Register of Nutrition and Health Claims are permitted. Claims suggesting a supplement can cure, treat, or prevent disease are not allowed under any circumstances — these crosses from food-supplement territory into medicinal-claim territory, which the MHRA, not the FSA, regulates. Marketing material faces the same standard as labelling itself, governed by the Advertising Standards Authority's CAP Code.

Recent Register Reform Worth Knowing About

Since 1 April 2025, a new Great Britain-wide statutory instrument — the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 — has changed how certain "regulated products" are authorised and published. This reform is worth knowing about, but its scope is narrower than it might first appear. It applies to novel foods, food/feed additives, food enzymes, flavorings, food contact materials, GMOs, and smoke flavorings — not to food supplement notification generally. Two things changed: periodic (previously ten-yearly) renewal requirements for feed additives, GMOs, and smoke flavorings were removed, and new authorizations now take effect via ministerial decision and publication in the official FSA/FSS register rather than being written into a fresh statutory instrument each time. Existing authorizations, including novel food authorizations relevant to supplement ingredients like CBD, remain valid with no expiry date unless suspended, modified, or revoked. If you're working from a pre-2025 reference to a specific novel food or additive authorisation, confirm its current status against the FSA/FSS register rather than assuming the original legislative citation still applies unchanged.

Post-Market Surveillance, Not Pre-Market Review

Food supplements are subject to post-market enforcement by local authorities, supported by the Food Standards Agency and Food Standards Scotland through surveillance programs, sampling activities and coordinated enforcement where necessary. Businesses should maintain appropriate traceability and batch and complaint records to facilitate investigations and product recalls where required.

A Real Borderline Risk: Looking Too Much Like a Medicine

How OMC Medical Can Help

OMC Medical manages UK food supplement notification with Trading Standards, reviews formulations against the permitted ingredient lists, determines whether any ingredient triggers novel food authorization (particularly relevant for CBD-containing products), and ensures labelling and claims comply with the UK Register of Nutrition and Health Claims.