How Supplements Are Regulated: EU vs US vs UK

This content describes regulatory frameworks for the supplement industry. It is educational and not medical or legal advice.

Why the same product can be sold differently in different countries

A supplement sold in California may carry claims that the same supplement, sold in Dublin, cannot legally make on the label. A product compliant in the UK may need reformulation to be compliant in the EU. The reverse also happens — products approved in one jurisdiction face restrictions in another.

These differences are not accidental. They reflect three different regulatory philosophies that emerged from three different legislative histories. This page describes those frameworks at a level a non-specialist can use to understand why supplement marketing varies so much across borders.

This is general regulatory information, not legal advice. Brands operating across jurisdictions should consult counsel.

The headline difference, in one paragraph

The United States treats supplements as a food category with light pre-market scrutiny and broad permitted "structure/function" claims. The European Union treats supplements as a food category with stricter pre-market controls on ingredients and a closed list of permitted health claims that have been individually evaluated by EFSA. The United Kingdom, post-Brexit, inherited the EU framework but has begun to diverge in specific areas, with the Food Standards Agency as the primary regulator.

The practical effect: a US supplement can be marketed with claims that would require either reformulation, claim removal, or a successful health-claim authorisation in the EU and UK.

United States: the DSHEA framework

The legislation

The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the foundational US supplement law. It defined "dietary supplement" as a category distinct from food additives and drugs, and set the framework that still governs the industry today.

Under DSHEA:

• Supplements are treated as a food category, not as drugs
• The FDA does not pre-approve supplements before they go to market
• Manufacturers are responsible for their products' safety
• Manufacturers can make "structure/function" claims without prior FDA approval, with a disclaimer
• The FDA can act against unsafe products after they reach market

What "structure/function" claims allow

A structure/function claim describes how an ingredient affects normal body structure or function. Examples in common use:

• "Supports healthy immune function"
• "Promotes restful sleep"
• "Helps maintain cardiovascular health"
• "Supports cognitive performance"

These claims do not require pre-approval, but they require a specific disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Disease claims — claims that a product can prevent, treat, cure, or mitigate a disease — are not permitted on supplements. The line between a structure/function claim and a disease claim is contested and FDA enforcement is variable.

FDA's role post-market

The FDA can:

• Inspect manufacturing facilities (Good Manufacturing Practice rules apply)
• Take action against adulterated or misbranded products
• Issue warning letters
• Seize products
• Pursue injunctions and criminal prosecutions in severe cases

The FDA's resources for supplement enforcement are limited relative to the size of the industry. Enforcement is selective.

The result

The US framework prioritises consumer access and industry flexibility. Bringing a new supplement to market is relatively fast. The trade-off is reduced consumer protection — adulterated, mislabelled, and ineffective products reach US shelves regularly, and post-market action follows rather than prevents harm.

European Union: the EFSA framework

The legislation

EU supplement regulation rests on several interlocking instruments:

• Food Supplements Directive 2002/46/EC — Defined supplements at the EU level, harmonised vitamin and mineral lists, set labelling rules
• Regulation (EC) 1925/2006 — Addition of vitamins, minerals, and other substances to foods
• Health Claims Regulation (EC) 1924/2006 — Controls what nutrition and health claims can be made on food (including supplement) labels
• General Food Law Regulation (EC) 178/2002 — Food safety framework underpinning all of the above

The European Food Safety Authority (EFSA) is the scientific authority that evaluates submitted health claims. The European Commission decides whether to authorise them based on EFSA's opinions.

The Health Claims Register

This is the most important difference from the US framework.

Under Regulation 1924/2006, food and supplement labels can only carry health claims that appear on the EU Register of authorised health claims. Each authorised claim has a specific permitted wording and specific conditions of use.

Examples of authorised claims include:

• "Vitamin D contributes to the normal function of the immune system"
• "Magnesium contributes to a reduction of tiredness and fatigue"
• "Vitamin C contributes to the normal function of the immune system"

Each authorised claim was evaluated by EFSA for scientific substantiation before being added to the register. Thousands of submitted claims were rejected because the supporting evidence was judged insufficient.

The register also contains claims that have been rejected. Brands cannot legally make those claims in the EU even if they are permitted in other jurisdictions.

Health claims for botanicals

Health claims for botanicals (e.g., ashwagandha, rhodiola, ginseng) are largely held "on hold" rather than authorised. This is a long-running area of regulatory complexity — botanicals were among the substances for which the EU could not agree on substantiation standards. National rules vary across member states for botanical claims pending EU resolution.

Nutrient claims and front-of-pack

Nutrition claims (e.g., "source of vitamin C") are also regulated under 1924/2006 with specific conditions for each claim.

The result

The EU framework prioritises consumer protection over industry flexibility. Bringing a new claim to market requires a scientific dossier that EFSA finds persuasive. The trade-off is slower innovation in claim language, and a regulatory regime that small brands often struggle with.

United Kingdom: post-Brexit divergence

Inherited framework

After the UK's exit from the EU, EU regulations were transposed into UK law. The Food Standards Agency (in England, Wales, and Northern Ireland) and Food Standards Scotland are the principal regulators. The substantive rules largely mirror the EU framework as of the transition date.

Where divergence is emerging

The UK has begun to diverge from EU rules in specific areas:

• CBD (cannabidiol) — The FSA established its own novel food validation list and process for CBD products, with deadlines that operated independently of EU timelines
• Novel foods generally — The UK has its own novel food authorisation process; products authorised in the EU after the transition date are not automatically permitted in the UK
• Health claims register — The Great Britain Register of Nutrition and Health Claims is now maintained separately from the EU register. Most entries are identical, but the registers can drift apart over time

Northern Ireland operates under a hybrid regime — EU rules continue to apply to many food products under the Windsor Framework.

What this means in practice

Brands selling into the UK should not assume EU compliance equals UK compliance, especially for products containing CBD, novel foods, or newer ingredients. The regulatory regimes are likely to continue diverging over the coming years.

The result

The UK is currently in a transitional position. The framework is recognisably EU-style — closed list of permitted claims, pre-market scrutiny of novel ingredients — but the specifics increasingly differ.

Quick comparison

What this means for consumers

Three practical implications:

1. Claim language is not evidence. A product with a strong-sounding US structure/function claim has not necessarily been evaluated for that claim. The same product would have to make a much narrower claim — or no claim — in the EU.

2. Geography affects what you can buy. Some products available in the US are not legally sold in the EU or UK, either because their ingredients are not approved or because their claims are not permitted in the local form. The reverse is rarer but happens.

3. Regulatory frameworks are imperfect everywhere. None of the three regimes catches every misleading claim. Consumer protection laws supplement the food-specific frameworks (e.g., Unfair Commercial Practices in the EU, FTC enforcement in the US, ASA in the UK), but enforcement resources are limited relative to the volume of claims being made daily.

Related Proco pages

• The wellness economy in 2026
• How to read a clinical trial
• Healthspan vs lifespan: what longevity research measures
• Health claims and consumer protection: where regulators draw the line (coming soon)

Sources

Proco provides educational, research-based information. This page describes regulatory frameworks at a general level. It is not legal advice. Brands operating across jurisdictions should consult regulatory counsel. Consumers with questions about specific products and labelling should contact their national food safety authority.

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