What supplement legislation do you need to know to start a supplement company in the UK?
Legislation is always a complex topic and supplement legislation is no exception. It is important that your product performs exactly the way that it is presented. It also needs to be safe and marketed in a reasonable and legitimate manner.
Selling supplements in the UK is relatively straightforward. All you need is a registered manufacturer, registration as an FBO and a legally compliant formula with the correct labelling and you are ready to sell. However, there are rules surrounding medicinal ingredients and Novel Foods that you should be aware of before diving in.
Different countries have different legislation and it can be a challenge to work out what you need to know. Luckily we have put together this guide to legislation for supplements in the UK.
You should be aware that, in order to sell supplements overseas, a company must adhere to each country’s regulations regarding what is considered “medicine”, so you need to be careful if importing or exporting.
How is supplement legislation regulated?
Ingredient use is carefully monitored to ensure that supplements comply with the law regarding classifications of ingredients and quantities used. Supplements must comply with these requirements or they will be taken off the market and the retailers could face legal action. For the sake of legislation, supplements are classified as food products.
Supplements sold in the UK are regulated in accordance with the Dietary Supplements Safety Act and the Food Supplements (England) Regulations 2003.
These acts ensure that businesses do not include anything in food, remove anything from food or treat food in any way which means it would be damaging to the health of people eating it.
They also ensure that the food which businesses serve or sell is of the nature, substance or quality which consumers would expect and that the food is labelled, advertised and presented in a way that is not false or misleading.
Who is responsible for supplement regulation in the UK?
In the UK supplements are regulated by the Department of Health who are assisted by other legislative bodies such as the MHRA and the EFSA. Other organisations carry out a similar role in other countries, such as the FDA in the USA.
While supplements are regulated by the UK government, some European laws still apply to supplements post-Brexit. One example of this is the ruling around Novel Foods which impact the ingredients that are usable in supplements.
What are Novel Foods?
European countries have a classification of food called ‘Novel Foods’ which contains any ingredients that do not have a history of consumption in Europe before 15 May 1997.
Ingredients that are Novel Foods can be approved or unapproved. Of the Novel Food ingredients, only those that are approved should be used in supplements.
For more information on Novel Foods, take a look at the European Commission’s website.
Want to sell your own supplements?
Do Supplements Need to be Registered?
Food supplements come under the remit of ‘food products’ rather than medicine so do not have as strict regulation. This means that you don’t need to register products before release if you use a registered manufacturer and the products are shipped to you sealed, but the health claims that you can use are fewer in number and less powerful than those of medicines.
Your company needs to be registered as a Food Business Operator (FBO) in order for you to sell in the UK, so be aware of this and register if required.
In addition, there are certain words or stamps that require additional assessment of the product before they can be used.
For example, if you would like to list your product as Organic then it must meet the required standards for an organic product. This will then be checked by the Soil Association. If they deem the product is organic then you will be permitted to include their logo on packaging and advertise the product as Organic.
Effect of supplement legislation on your product labels
Your label and promotion must comply with the regulations and not contain anything interpreted as an unapproved health claim.
You must include accurate ingredient lists and clearly display information like batch number and expiration date.
Here is some more information on supplement labels and what you need to be aware of before getting them printed.
Conclusion
Your supplements need to meet local requirements for the labels, the marketing, how they are manufactured and the formula itself.
It is your responsibility to research what supplement legislation applies to your products and understand what is expected.
A good manufacturer may be able to advise on some aspects of this. For example, if you’re using an ingredient that they know isn’t permitted for use in supplements they should tell you. However, manufacturers often make supplements for a wide range of clients in different markets and potentially different countries.
Countries have different laws surrounding supplements which do not always line up. Manufacturers may not be up to date with all of the information specific to where you will sell your supplement.
Be communicative of what you need and expect at all stages of the process of supplement manufacture.
Whether speaking to a supplier, manufacturer, legislative body, printer, marketing company, website developer or anyone else involved in the process. You need to control your product’s contents and promotion to ensure the information is correct.
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