How Symprove is regulated

As healthcare professionals you may get asked by your patients why they cannot find any information on our commercial website about conditions Symprove has scientifically been proven to be effective for.

Symprove is a food

Under UK law Symprove is considered a food supplement and must abide by the same regulations other foods manufacturers in the UK adhere to.

These regulations stipulate that, despite having high quality clinical studies demonstrating Symprove’s unique efficacy for people with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), we are not allowed to mention the results on our commercial website aimed at the general public or make health-related claims about Symprove to them.

Only specifically authorised medical foods/products can make these claims to the public and to be able to do this the product must pass stringent medical testing and safety and surveillance standards. This is a very difficult and expensive process to go through and, although we have the evidence to support Symprove, we aren’t a large corporation (yet) and don’t currently have the resources to go through this.

Until we have the means to undertake this testing we will remain true to our high standards and reputation and comply with all the regulations placed upon us - even if this means we cannot share all of our good news with our customers directly.

Unfortunately this is not true of all other food supplement companies and some choose not to comply with the legislation, which is why your patients may see health claims made by other food supplement companies (even when they may not have any clinical trials on their finished product to support the claims). The industry is largely self-regulated and in general a complaint needs to be made before sanctioning takes place.

The different regulations covering manufacturing, marketing and supplying food supplements include:

As a manufacturer

We ensure we comply with all of the relevant health and safety, food safety (FSA and EFSA), labelling and traceability requirements which cover products for human consumption which are made in the UK.

We have processes embedded into our quality management system, and have regular internal and external audits, to make sure we not only comply with the regulations, but continue to improve on our standards.

As a marketer and supplier

The rules for food marketing are defined by the European Food Safety Authority (EFSA) with additional guidance from the Food Safety Authority (FSA) in the UK.

The EFSA governs what claims can be made to the public about food. No food can mention a disease name, symptoms or similar, nor can it mention any words such as ‘treat’, ‘cure’, ‘relief’ - as these can imply health benefits. The use of the term ‘probiotic’ falls under this umbrella.

There are a few exceptions - for example in the case of vitamins

The rules for medical marketing are defined by the European Medicines Agency (EMA) with some additional guidance from the Medicines and Healthcare Products Regulatory Authority (MHRA) in the UK.

The EMA/MHRA govern the claims that can be made about a product to health professionals and govern how a product can be made available e.g. prescription or over-the-counter. Only specifically authorised products can make claims (as described above).

Questions

If you have any questions about the regulations surrounding food supplements then please do not hesitate to contact us.