Yes — but as food, not as medicine. A herbal supplement sold in Great Britain is regulated under food law: the Food Supplements (England) Regulations 2003, plus the general rules on safety, traceability and labelling that apply to everything edible. There is no licence, no pre-market approval and no product notification. The business registers with its local council; the product itself is assessed by nobody.
That is the honest limit of it. Regulation guarantees process — what must be printed on the pack, what must be traceable, what must not be claimed — and guarantees nothing about effect. The Traditional Herbal Registration run by the MHRA is the scheme people confuse this with, and even a THR is granted on 30 years of traditional use rather than on evidence that the product works.
'Regulated' is one of the most reassuring words in retail and one of the least informative. Herbal supplements sold in the UK are regulated. So is bread. So is a bag of frozen peas. The useful questions are which rules apply, who applies them, and what those rules were built to guarantee.
The short answer is that a herbal supplement sold in Great Britain is regulated as food, and is not licensed as a medicine. Almost everything odd about the category follows from that one sentence, including the careful wording on the packs and the dagger symbols in the small print.
Are herbal supplements regulated in the UK, and who regulates them?
The legal definition is narrow and worth reading once. A food supplement is any food whose purpose is to supplement the normal diet, and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination, and which is sold in dose form. A tablet, a capsule, a measured sachet. That is the whole category.
In England the specific rules are the Food Supplements (England) Regulations 2003, with near-identical regulations in Scotland and Wales. Above them sit the general rules that apply to anything edible: retained Regulation (EC) No 178/2002, which sets out food safety and traceability duties, and retained Regulation (EU) No 1169/2011, which governs the information given to consumers about food.
Three names come up and they do different jobs. The Food Standards Agency (FSA) leads on food supplement safety in England, Wales and Northern Ireland. Policy and legislation on food supplements in England sit with the Department of Health and Social Care (DHSC). Enforcement is local: trading standards and environmental health officers at your council, who inspect, take samples and prosecute.
No licence, no approval, no notification
Nobody in government checks a food supplement before it goes on sale. The guidance says so plainly: food supplements, like other foods, are not required to demonstrate their effectiveness before marketing, nor are they subject to prior approval unless they are genetically modified or novel. There is not even a notification step. The UK decided not to require prior notification of supplement products, and DHSC does not authorise or check the composition or labelling of individual products. No licence exists for a food supplement, so no brand can hold one.
What is required is registration of the business, not approval of the product. Anyone who makes, imports, distributes or sells food supplements must register with their local authority as a food business operator, at least 28 days before trading. Registration is free and cannot be refused. It records that you exist. It says nothing about what you sell.
There is one genuine pre-market gate, and it catches ingredients rather than finished packs. Under retained Regulation (EU) 2015/2283, an ingredient with no significant history of consumption in Great Britain or the EU before 15 May 1997 counts as a 'novel food', and must pass a safety assessment and be authorised before it can be sold at all. Long-established plants are not novel. The gate exists for the unfamiliar.
Underneath all of it is one blunt rule, Article 14 of retained Regulation (EC) No 178/2002: food shall not be placed on the market if it is unsafe. That duty sits on the business, and it is enforced after the fact rather than cleared in advance.
What is a THR, and how does it differ from a food supplement?
This is where most of the confusion in the category lives. Great Britain has a second, entirely separate route for plant-based products: the Traditional Herbal Registration, or THR, run by the Medicines and Healthcare products Regulatory Agency (MHRA). A product with a THR is a medicine. A food supplement is not.
Under the THR scheme a herbal medicinal product is assessed for quality and safety to medicines standards. What it is not assessed for is effectiveness. In place of clinical evidence the applicant must show a history of use: a minimum of 30 years, of which at least 15 must normally have been in the EU or EEA. The permitted indication — what the label says the product is traditionally used for — comes from that history, not from proof that it works. The MHRA grants a THR only for minor conditions where medical supervision is not required.
How to spot a THR product on a shelf
A THR product carries a nine-digit registration number beginning with the letters THR on the container or packaging, and may also carry the THR certification mark, which is optional rather than compulsory. The registered wording normally ends with the phrase 'based on traditional use only'. That phrase is doing real work. It is the regulator stating, on the label, that tradition rather than proof is the basis for what the pack says.
| Herbal medicine with a THR | Herbal food supplement |
|---|---|
| Regulated as a medicine by the MHRA | Regulated as food: policy DHSC, safety FSA, enforcement by your council |
| Quality and safety assessed before it may be sold | No pre-market assessment, approval or notification |
| Indication drawn from 30 years of traditional use | No health claim at all unless it is on the GB register |
| Nine-digit THR number on the pack | The words 'food supplement' on the pack |
| Effectiveness not assessed | Effectiveness not assessed |
The last row is the one people miss. A THR is not evidence that a herbal product works. It is a quality and safety registration attached to a claim built from tradition — a higher bar than food law in what it checks, stopping at the same place food law does on the question of effect.
The MHRA also decides the hard cases. Where it is unclear whether a plant product should be a food supplement or a medicine, the question goes to the agency's medicines borderline section and its view settles it. A product presented as treating or preventing disease is a medicinal product whatever the seller calls it. That is why food information rules flatly prohibit attributing to any food the property of preventing, treating or curing a human disease — Article 7(3) of retained Regulation (EU) No 1169/2011.
AllMaleUp holds no THR and does not seek one. It is a food supplement, sold under food law like any other food, and no authority has approved, endorsed or verified it.
Why can a supplement label not say what a botanical does?
What a food may say about itself is governed by yet another instrument, retained Regulation (EC) No 1924/2006. A nutrition claim states, suggests or implies that a food has beneficial nutritional properties because of what it contains or lacks. A health claim states, suggests or implies that a relationship exists between a food, or one of its constituents, and health. The second is the tightly controlled one, and the definition is deliberately wide: suggesting counts, implying counts.
Since 1 January 2021 Great Britain has kept its own list. Only claims appearing as authorised on the Great Britain nutrition and health claims register may be used here, and applications for new ones are assessed by the UK Nutrition and Health Claims Committee. A claim that is not on the register may not be used, however strongly the seller believes it.
Why zinc and vitamin C have authorised claims
Zinc and vitamin C are the straightforward examples. Both are nutrients with established reference intakes and well-characterised evidence. Dossiers were submitted, assessed and accepted, so they appear on the register with fixed wording and fixed conditions of use, usually a minimum amount per portion before the wording may be used at all. The entry belongs to the substance and the evidence behind it, not to the brand printing it. Any company meeting the conditions may use it, and none may strengthen it.
Botanicals never reached that stage. Some 4,637 general function claims were consolidated and submitted to the European Food Safety Authority for assessment. In 2010 the European Commission asked it to suspend the evaluation of claims for botanical substances and finish the others first. 1,548 botanical claims were set aside at that point. They are still there. Great Britain inherited the position at the end of the transition period, and the government's line is that 'on hold' claims may continue to be used pending a decision following a call for evidence.
'On hold' means neither authorised nor rejected. It is a queue rather than a verdict, and it has not moved since 2010. The conditions are narrow. A Department of Health bulletin from 2014, still the reference document, states that a botanical claim counts as on hold only where it relates to the same plant part as a claim on the original list, with the same wording, the same health relationship and the same proposed conditions of use. It must still satisfy the general articles of the Regulation, must be scientifically substantiated, and anyone using it must be able to justify it. The bulletin adds two warnings: many of the proposed wordings may not be acceptable under general food labelling rules at all, and some would be read as medicinal claims, which must never be made on a food.
The honest reading is that this is not permission to say something useful. It is a technicality that has outlived the process it belonged to. None of the six plants in the AllMaleUp tablet holds an authorised health claim in Great Britain, and none is made for them. Where a brand does rest on the on-hold list, the defensible convention is to mark the wording with a dagger, describe the plant and how it has been used rather than any effect on the body, and footnote it plainly as not authorised. A dagger is not a loophole being worked quietly. It is the opposite: a flag that the sentence in front of it has never been approved by anyone.
What does ‘regulated’ actually guarantee for the buyer?
Set the claims argument aside and a substantial body of obligation remains, most of it invisible to the buyer. It is worth knowing, because it is the part that is genuinely enforced.
The label has a compulsory contents list. Regulation 6 of the Food Supplements (England) Regulations 2003 requires all of the following:
- the name under which the product is sold must be 'food supplement';
- the categories of the vitamins, minerals or other substances with a nutritional or physiological effect, and the amount of each, declared for the recommended daily portion;
- the portion of the product recommended for daily consumption;
- a warning not to exceed the stated recommended daily dose;
- a statement that food supplements should not be used as a substitute for a varied diet;
- a statement that the product should be stored out of the reach of young children.
The labelling must also not imply that a varied and balanced diet cannot provide appropriate quantities of nutrients in general. Above that sit the ordinary food information rules: an ingredient list, allergen declarations, net quantity, a date, storage conditions and the name and address of the business responsible for the product.
Traceability: one step back and one step forward
Traceability is the second thing the rules genuinely deliver. Article 18 of retained Regulation (EC) No 178/2002 requires every food business to be able to identify who supplied it and which businesses it supplied — one step back and one step forward. Batch coding is how that is done in practice. Ours is printed on the side of the carton beside the best-before date, and the certificate of analysis for that production run is filed against it.
It also helps to know what the reassuring phrases on a pack are not. A tablet pressed in the UK on a GMP-registered line and tested at a laboratory accredited to ISO/IEC 17025 has been made and checked to recognised standards. Neither is a government approval of the product, and neither says anything about effect. They describe how something was made and who was judged competent to test it, and nothing beyond that.
So here is the honest answer. Herbal supplements in the UK are regulated, and regulated fairly thoroughly, on composition, safety, traceability, record-keeping and wording. They are not assessed for whether they do anything, by anyone, at any point. No official body has looked at the specific pack in your hand and formed a view on it, and none will unless something goes wrong. 'Regulated' describes a process. It is not a seal of approval, and a brand that presents it as one is telling you something the rules do not say.
Which is why the signals worth using are the ones you can check rather than the ones you have to take on trust. Every AllMaleUp tablet carries 100 mg of six botanicals — Ginseng 25 mg, Maca 25 mg, Tribulus 20 mg, Guarana 10 mg, Ashwagandha 10 mg and Catuaba 10 mg — with a maximum of one tablet in any 24-hour period. Those numbers are what is printed on the back of the pack, and they can be set against any other pack on the shelf. Quote the batch code to hello@maleup.co.uk and the certificate of analysis for that run comes back to you.
Regulation sets a floor. It requires a business to be registered, to keep records, to print certain things and to refrain from printing others. Everything above that floor — the declared weights, the named origins, the testing, the willingness to send a customer the paperwork for their own batch — is a choice rather than a rule. That is the part worth judging, and the only part where brands in this category actually differ.
- Food supplements are regulated as food in Great Britain, not licensed as medicines.
- No licence, no pre-market approval and no product notification exists for a supplement.
- A THR is an MHRA medicines registration built on 30 years of traditional use, not on proof of effect.
- 1,548 botanical claims have sat ‘on hold’ — neither authorised nor rejected — since 2010.
- ‘Regulated’ guarantees labelling, safety and traceability. It does not guarantee effect.
Common questions
Are herbal supplements regulated in the UK?
Yes, but as food rather than as medicine. A herbal supplement sold in Great Britain falls under food law — the Food Supplements (England) Regulations 2003, together with the general rules on safety, traceability and consumer information. It is not licensed by the MHRA and holds no marketing authorisation, because no licence exists for a food supplement to hold.
Who regulates food supplements in the UK?
Three bodies, doing different jobs. The Food Standards Agency leads on food supplement safety in England, Wales and Northern Ireland. Policy and legislation on food supplements in England sit with the Department of Health and Social Care. Day-to-day enforcement is local: trading standards and environmental health officers at your council inspect, sample and prosecute.
Do supplements need approval before they can be sold in the UK?
No. Food supplements, like other foods, are not required to demonstrate effectiveness before marketing, and are not subject to prior approval unless they are genetically modified or novel. The UK does not require prior notification of products either. The business must register with its local authority at least 28 days before trading, which registers the company rather than the product.
What is the difference between a THR herbal medicine and a food supplement?
A Traditional Herbal Registration is a medicines registration granted by the MHRA. Quality and safety are assessed to medicines standards, and the indication is drawn from at least 30 years of traditional use rather than from clinical evidence. THR products carry a nine-digit number beginning THR. A food supplement has none of that and is sold under food law.
Why do supplement labels put a dagger next to botanical ingredients?
The dagger marks wording that rests on an ‘on-hold’ botanical claim under retained Regulation (EC) 1924/2006 — a claim neither authorised nor rejected since the assessment was suspended in 2010. It flags that the sentence is not an authorised health claim. It is a warning to the reader rather than a loophole for the brand.
Does ‘regulated’ mean a supplement has been checked or approved?
No. Regulation covers composition, safety, traceability, record-keeping and what may or may not be printed. It does not cover whether a product does anything, and no official body reviews an individual pack before sale. The Department of Health and Social Care does not authorise or check the composition or labelling of individual products.
- Food supplements guidance — GOV.UK
- The Food Supplements (England) Regulations 2003 — legislation.gov.uk
- Guidance notes on legislation implementing Directive 2002/46/EC — GOV.UK Source for the statement that DHSC does not authorise or check individual products.
- Apply for a traditional herbal registration (THR) — MHRA
- Great Britain nutrition and health claims (NHC) register — GOV.UK
- Regulation (EC) 178/2002, Article 14 — food safety requirements — legislation.gov.uk
- General function health claims — Article 13 — EFSA 1,548 botanical claims placed on hold.
Six botanicals, 100 mg per tablet, every weight printed on the carton: Ginseng 25 mg, Maca 25 mg, Tribulus 20 mg, Guarana 10 mg, Ashwagandha 10 mg, Catuaba 10 mg. Maximum one tablet in any 24-hour period. Pressed in the UK on a GMP-registered line.
See the packs →† Describes the traditional use of these botanicals (UK 'on-hold' botanical claims under retained Regulation (EC) 1924/2006). Not authorised EFSA health claims. AllMaleUp is a food supplement, not a medicine.