Is the supplement industry regulated?

A gate and a patrol: the four points at which UK supplements are regulated, composition, labelling, claims and safety, and why all four are real rules with real penalties

Is the supplement industry regulated is a question that gets a confident yes from one side and a confident no from the other, and both sides are right about different things, which is why the question keeps being asked. The honest answer separates two ideas that the word regulated runs together: whether there are rules, and whether anyone stands at the door. In the UK there are rules at four points, and they are real rules with real penalties; and there is no one at the door, because supplements are foods and foods are not approved before sale. The first idea is a set of rulebooks and the second is a gate, and the industry has the first and not the second, which the rest of this page sets out as a gate and a patrol.

The first point is composition. The supplement regulations carry a positive list of the vitamins and minerals that may be used and the chemical forms they may be used in, so that a product containing a form not on the list is unlawful whatever its merits; and the medicines regulator decides whether a substance is a medicine by its function or its presentation, so that a product containing a substance that acts as a medicine, or is presented as one, is an unlicensed medicine and unlawful to sell as a food. The second point is labelling. The food information rules and the supplement regulations together require the name, the ingredients in descending order, the allergens emphasised, each nutrient per daily dose and as a percentage of the reference value, the recommended dose, the warning not to exceed it, the statement that a supplement is not a substitute for a varied diet, the date, and the name and address of the responsible operator; a label missing any of them is an offence. The third point is claims. The register of authorised health claims lists the claims a food may make and the conditions for making them, and a claim not on the register, or made without meeting its conditions, is an offence under the nutrition and health claims rules; this is the point at which the UK is stricter than most of the world, since a structure-and-function claim with a disclaimer, which an American label may carry, is simply unlawful here. The fourth point is safety. General food law requires that food placed on the market be safe, places the duty to ensure it on the food business operator, requires traceability one step back and one step forward, and requires the operator to withdraw and recall unsafe food and to inform the authorities; the contaminant regulations set maximum levels for lead, cadmium, mercury and inorganic arsenic in supplements as sold, and a product above them is unsafe by law.

Those four points are regulation in any ordinary sense, and a business that breaks any of them can be prosecuted, fined, ordered to withdraw product and, for a medicine sold as a food, imprisoned. A person who says the industry is unregulated has not read them. What such a person has noticed is the next section.

Four points of regulation set out, with the patrol that enforces them and the gate that does not exist, what the patrol catches and misses, why medicines have a gate, what the buyer does at the door, the worked example and the verdict in the next section.

The patrol, not the gate: how the four points are enforced after the fact, what the patrol catches and misses, why medicines have a gate and foods do not, what the buyer does at the door the state does not man, the worked example, and the verdict

None of the four points is checked before a product goes on sale. There is no application, no dossier, no approval and no licence for a food supplement; a business formulates a product, labels it, and sells it, certifying to itself that the four points are met, and the state finds out whether they were met afterwards, if at all. Enforcement is a patrol: local authority trading standards and environmental health officers inspect food businesses and sample products, the food safety authority runs surveillance and issues withdrawals and recalls, the medicines regulator investigates products sold as foods that are medicines and publishes what it finds, and the advertising regulators act on claims in advertising on complaint. The patrol is competent and its records are public, and it is a patrol: it walks past most premises most of the time, it samples a small fraction of products, it acts on complaint more than on initiative, and it catches a product after it has been sold rather than before. A business that intends to comply has four rulebooks to comply with; a business that does not intend to has a fair chance of selling for some time before the patrol arrives, and that is the thing people mean when they say the industry is unregulated.

What the patrol catches is visible in the regulators' records: products with undeclared medicines, products with contaminants above the limits, undeclared allergens, unlawful claims that attracted a complaint, labels that were inspected. What it misses is everything that is unlawful and uncomplained-of, which includes the dose below label that no one tested, the claim on a listing no one reported, the botanical no one analysed and the imported tub no one inspected; the patrol's reach is proportional to its sampling, and its sampling is small against the number of products. The gate that medicines have is why the two systems feel so different: a medicine must prove its safety, quality and efficacy to the regulator before it is sold, its manufacturing site is inspected on a schedule, and its marketing is pre-vetted, because a medicine is designed to act on the body and the harm of a bad one is large; a food must be safe and lawful and the business says so itself, because a food is not designed to act and the harm of a bad one is usually small. A supplement sits awkwardly across the line, a food in law that is bought for what it does, and the absence of a gate is the price of being a food.

At the door the state does not man, the buyer stands. The four points can each be checked from the tub and the public records, which the earlier pages in this section cover: the form against the positive list and the ingredient against the medicines regulator's lists, the label against the mandatory particulars, the claim against the register, and safety against the contaminant limits by asking for the certificate of analysis. The worked example is read against the four: {FL} is magnesium bisglycinate, a form on the positive list, with no substance the medicines regulator treats as a medicine; its label carries the particulars, the dose of 300mg elemental at 80% of the reference value, the statements and a UK responsible operator's address; its claims, normal muscle function, normal psychological function and the reduction of tiredness and fatigue, are from the register with nothing beyond; and its safety duty is discharged by batch testing for lead, mercury, arsenic and cadmium against the contaminant limits by ICP-MS at an accredited UK lab with the certificate by lot on request, and by UK manufacture under GMP and BRC, 180 capsules for £19.99 at 22p a day. The full label breakdown is here.

The verdict: the supplement industry is regulated at four points, composition, labelling, claims and safety, under rulebooks with real penalties, and it is enforced by a patrol rather than a gate, with no product approved before sale and the rules checked afterwards by sampling and complaint. Unregulated means there is no gate, which is true; regulated means there are four rulebooks, which is also true; and the thing the absence of a gate costs the buyer is that the four points are checked by the buyer or not at all. A product that can show its form on the list, its label to the rules, its claims on the register and its certificate against the limits has passed a gate the state never built.

What to check on the label

Questions people also ask

Are supplements regulated in the UK?

Yes, at four points under food law, with real penalties: composition, under a positive list of permitted vitamin and mineral forms and a prohibition on substances that are medicines by function or presentation; labelling, under the food information and supplement rules that set the mandatory particulars; claims, under the register of authorised health claims, with anything not on it unlawful; and safety, under general food law that makes the business responsible for safe food, traceability and recall, with contaminant limits for four metals; what the UK does not have is a gate, since no supplement is approved before sale, and the rules are enforced afterwards by a patrol of local authority officers and the regulators.

Why isn't the supplement industry regulated like medicines?

Because a supplement is a food in law and a medicine is not, and the two systems were built for different harms: a medicine is designed to act on the body and the harm of a bad one is large, so it must prove safety, quality and efficacy to the regulator before sale, have its site inspected on a schedule and have its marketing pre-vetted; a food is not designed to act and the harm of a bad one is usually small, so it must be safe and lawful and the business certifies that to itself, with the state checking afterwards; a supplement sits across the line, a food bought for what it does, and the absence of a gate is the price of being a food, which the buyer pays by checking the four points the gate would have.

Who enforces supplement regulations in the UK?

A patrol rather than a gatekeeper: local authority trading standards and environmental health officers inspect food businesses and sample products against the composition, labelling and claims rules; the food safety authority runs surveillance, issues withdrawals and recalls and publishes them; the medicines regulator investigates products sold as foods that contain or are medicines and publishes what it finds; and the advertising regulators act on claims in advertising on complaint; the patrol is competent and its records are public, and it samples a small fraction of products, acts more on complaint than on initiative, and catches a product after it has been sold rather than before.

Can a supplement be sold in the UK without approval?

Yes, and every one of them is: there is no application, dossier, approval or licence for a food supplement, a business formulates, labels and sells, certifying to itself that the four points are met, and the state finds out afterwards if at all; a novel ingredient without a history of use needs authorisation under the novel foods rules, a substance that is a medicine cannot be sold as a food at all, and a product that breaks the composition, labelling, claims or safety rules is unlawful from the day it is sold, but none of that is checked at a gate, which is why a buyer checks the four points from the tub and the public records.

Does this site's magnesium meet the four points of regulation?

Read against each: its composition is magnesium bisglycinate, a form on the positive list, with no substance the medicines regulator treats as a medicine; its label carries the mandatory particulars, the dose of 300mg elemental at 80% of the reference value, the statements and a UK responsible operator's address; its claims for normal muscle function, normal psychological function and the reduction of tiredness and fatigue are from the register with nothing beyond; and its safety duty is discharged by batch testing for lead, mercury, arsenic and cadmium against the contaminant limits at an accredited UK lab with the certificate by lot on request, and by UK manufacture under GMP and BRC, at 22p a day.

Sources

1. The Food Supplements (England) Regulations 2003 (food supplements are regulated as foods in the UK). https://www.legislation.gov.uk/uksi/2003/1387/contents/made
2. The Food Standards Agency's food supplements guidance: supplements are regulated as foods, with local authority trading standards and environmental health enforcing labelling, safety and claims law. https://www.food.gov.uk/business-guidance/food-supplements
3. Retained Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, and the Great Britain nutrition and health claims register. https://www.gov.uk/government/publications/great-britain-nutrition-and-health-claims-nhc-register
4. The MHRA's borderline guidance: a product is a medicine if it is presented as treating or preventing disease or has a significant pharmacological, immunological or metabolic action, determined case by case on presentation and function. https://www.gov.uk/government/publications/a-guide-to-what-is-a-medicinal-product

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