- Category: usually a food supplement, regulated as food.[1]
- Contaminant limits: lead 3.0, cadmium 1.0 and mercury 0.1 mg/kg as sold in Great Britain.[2]
- Claims: only health claims authorised on the GB register.[3][4]
- Medicines line: claims to treat or prevent disease can make a product a medicine in the MHRA’s view.[5]
Shilajit as a food supplement
Under the Food Supplements (England) Regulations 2003 and their equivalents in Scotland, Wales and Northern Ireland, a food supplement is a food sold in dose form to supplement the normal diet. The regulations require food supplements to be sold to consumers prepacked, set labelling requirements, and are enforced by each local food authority.[1] FSA guidance adds that anyone selling food supplements must register as a food business with their local authority.[6]
Being a food supplement does not mean a product has been approved. There is no product-by-product pre-market check for ordinary supplements; responsibility for compliance sits with the business selling it.
Is shilajit a novel food?
A novel food is one without a significant history of consumption before May 1997, which needs authorisation before it can be sold. For the EU, the European Commission’s Novel Food Status Catalogue entry for mumijo (shilajit) is reported as not novel when used in food supplements, but novel in other foods.[7]
For Great Britain, Food Standards Scotland states that EU novel food status decisions made before 11pm on 31 December 2020 still apply unless a contrary GB statement has been published.[8] We have not found a GB statement specific to shilajit, and we could not confirm when the EU catalogue entry was made, so its GB status is not certain. In practice:
- Shilajit in capsules, resin or powder sold as a supplementConsistent with the EU catalogue position.
- Shilajit added to ordinary foods or drinksSuch as coffee, chocolate or honey: may require novel food authorisation. Businesses should confirm with the FSA.
Isolated fulvic acid is a separate case: it is reported as novel in the EU catalogue for both supplements and other foods.[7]
When a shilajit product becomes a medicine
The MHRA decides whether a product’s claims or its active substances mean it should be regulated as a medicinal product. Food supplements are generally covered by food law unless they are presented for medicinal uses.[5] A shilajit product marketed as treating erectile dysfunction, infertility, diabetes or any other disease is being presented as a medicine, which brings medicines law into play.
This is also why claims rules matter so much for shilajit: the line between an unauthorised health claim and a medicinal claim is often crossed in the same sentence. See what UK sellers can and can’t claim.
What a lawful UK shilajit product needs
| Requirement | What it means in practice | Source |
|---|---|---|
| Prepacked, in dose form | Sold sealed with a defined serving | [1] |
| Correct labelling | Name of the responsible business, plus supplement-specific statements | [1][6] |
| Contaminants within limits | Lead, cadmium and mercury below GB maximum levels as sold | [2] |
| Authorised claims only | No health claims unless on the GB register | [3][4] |
| No medicinal claims | No claims to treat, prevent or cure disease | [5] |
| Registered business | Seller registered as a food business with its local authority | [6] |
Northern Ireland
In Northern Ireland, food supplement law is covered by the Windsor Framework, and supplements sold there must include an NI or EU address for the food business.[6] Contaminant limits in NI follow EU rules, which may differ from GB.
Buying from outside the UK and competing in sport
Products bought directly from overseas sellers may not have been made to UK labelling and contaminant standards, and UK consumer protections are harder to use. See UK delivery, imports and customs. Athletes have an extra layer: strict liability under anti-doping rules, with UK Anti-Doping advising batch-tested supplements.[9] See sport and anti-doping.
Common questions
Is shilajit banned in the UK?
We are not aware of any UK ban. It is widely sold as a food supplement. Individual products can still break food, claims or medicines rules.
Do shilajit products need approval before sale?
Not product by product, as long as they are ordinary food supplements. The seller must register as a food business and is responsible for compliance.[6]
Are shilajit gummies legal?
Gummies sold in measured doses are usually marketed as food supplements. Shilajit added to everyday foods may raise novel food questions; businesses should check with the FSA.
Who do I report an illegal shilajit product to?
Your local Trading Standards or the FSA for safety and labelling, the ASA for adverts, and the MHRA for medicinal claims or side effects. See reporting a problem.
Sources & further reading
Primary research, regulators and standards bodies are cited first. A source being listed here does not mean it supports every claim made by sellers; it supports the specific statement it is attached to.
- UK Government. The Food Supplements (England) Regulations 2003 (SI 2003/1387). legislation.gov.uk, 2003. View source (opens in a new tab) [UK legislation]
- European Commission (UK version on legislation.gov.uk). Commission Regulation (EC) No 629/2008 amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs. legislation.gov.uk, 2008. View source (opens in a new tab) [UK legislation (retained)]
- Department of Health and Social Care. Great Britain nutrition and health claims (NHC) register. GOV.UK. View source (opens in a new tab) [Official register]
- Committee of Advertising Practice. UK Code of Non-broadcast Advertising (CAP Code), Section 15: Food, food supplements and associated health or nutritional claims. asa.org.uk. View source (opens in a new tab) [Advertising code]
- Medicines and Healthcare products Regulatory Agency. Borderline products: how to tell if your product is a medicine. GOV.UK. View source (opens in a new tab) [Regulator guidance]
- Food Standards Agency. Food supplements: business guidance. food.gov.uk. View source (opens in a new tab) [Regulator guidance]
- Verbraucherzentrale. Mumijo bei Darmproblemen? (reports the EU Novel Food Status Catalogue position on mumijo and fulvic acid). verbraucherzentrale.de, 2025. View source (opens in a new tab) [Consumer organisation guidance (German)]
- Food Standards Scotland. Consultation process on novel food status. foodstandards.gov.scot. View source (opens in a new tab) [Regulator guidance]
- UK Anti-Doping (UKAD). Clean Sport Essentials pocket guide. ukad.org.uk, 2021. View source (opens in a new tab) [Anti-doping guidance]