1. Senior management commitment
What’s the difference between food and pharmaceutical products?
In this article we look at the difference between a food product and a pharmaceutical product, and how supplements are certified.
We’ve noticed over the past couple of years, that a good proportion of the enquires that we get from businesses who are looking to implement certification for the first time – are producing supplements.
This has meant that we’ve had to get really clear on whether a supplement is food or pharmaceutical. It’s also meant that we’ve learnt about the different ways in which the two industries are regulated.
Here’s what we’ve learnt.
Governance
The food industry in the UK is governed by the Food Standards Agency (FSA).
The pharmaceutical industry in the UK is governed by the Medicines and Healthcare products Regulatory Agency (MHRA).
Medicines and Healthcare products Regulatory Agency
The MHRA regulate the following products:
- Medicines and vaccines
- Medical devices
- Blood components
- E-cigarettes
- Traditional herbal and homeopathic remedies
Is a supplement a food or a pharmaceutical product?
The FSA define a food supplement as:
“Any food the purpose of which 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 is sold in dose form.”
Food supplements | Food Standards Agency
Article 1 of Directive 2001/83/EC define a medicinal product either:
- “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings.”
- “Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
Therefore, a supplement is classed as food, not as a pharmaceutical (medicinal) product, as it doesn’t treat or prevent disease – but rather to supplement the diet.
What certification is suitable for supplements?
As supplements are a food, they can be certified to GFSI recognised food standards, such as BRCGS (scope 15), IFS, SQF, FSSC22000 etc.
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