Who we help > Food / Cosmetic / Device
Food / Cosmetic / Device
Is your Product a Medicine – or not?
CambReg can help you to determine this
We can:
- Advise on the classification of your product by identifying the correct regulatory status.
- Advise on data requirements according to the classification of your product
- Prepare the relevant regulatory file, submit and gain approval or advise on compliance
- Review label claims and if possible prevent your product being considered as a medicine
What is a borderline substance?
A healthcare product which does not distinctly fall into a particular area is referred to as a ‘borderline product’. This term is used when a product is not clearly identifiable as a medicine and may be, for example, a cosmetic or food supplement. There are 3 main borderlines:
- Medicinal Product/Medical Device
- Medicinal Product/Food & Food Supplements
- Medicinal Product/Cosmetic
For such products it is important to define their primary function to determine which side of the borderline they fall and which set of regulations must be followed before placing them on the market.
Where does my product fit?
Not sure then give us a call on 01480 465755
Medicinal claims
If a borderline product contains a pharmacologically active substance or makes a medicinal claim then it would automatically fall within the definition of a medicinal product and would be subject to medicines control, requiring approval through EU Marketing Authorisation procedures (or National UK procedures in the event of Britain’s departure form the EU). A product which does not meet these criteria may still subject to other EU regulations such as the medical devices directive or the food safety and food labelling legislation rather than medicines control - see below.
1. Medicine/Medical Device borderline
The term medical device covers an extremely wide range of products including, for example: first aid bandages, tongue depressors, hip prostheses, X-ray equipment, ECG, heart valves, spectacles and dental materials. In general, if a product acts pharmacologically, immunologically or metabolically it is unlikely to be considered to be a medical device. In order to determine whether a product is a device or a medicine, the definitions of both need to be considered, along with the claims for the product, the mode of action on the human body and intended purpose of the product.
If your product falls within the Medical devices regulations CambReg can inform you on classification and route to conformance. We can help with QA compliance, technical file preparation and completion of the CE-marking process as necessary.
2. Medicine/Food & Food Supplements
Foods
There are many food products on the market that are termed nutraceuticals. The dictionary definition of a nutraceutical is, “any food or food ingredient which is considered to have a beneficial effect on health”. The description nutraceutical is broadly used and can refer to anything from a vitamin supplement to an energy enhancing drink.
The name implies that nutraceuticals have medicinal properties, although they are in fact food types. Claims regarding the beneficial effects of nutraceuticals can only be “health claims” and not “medicinal claims”. For instance the claims must not state that by eating/taking the nutraceutical a disease will be prevented or cured but only that it may help to improve health, possibly assisting in the avoidance of the onset of illness.
If a claim is made that implied medicinal benefit regarding a nutraceutical product, the product would then be required to comply with the regulatory requirements for medicines control
Nutraceuticals are required to comply with food law; The Food Safety Act 1990 and legislation covering their labelling and advertising.
Food Supplements
Food supplements (nutritional supplements, nutraceuticals or dietary supplements) are covered by import regulations and European and national laws and regulations on food safety; food supplements; enzymes, food additives and flavourings; nutrition and health claims, and novel foods.
EU Directive 2002/46/EC establish standards for food supplements containing vitamins and minerals.
According to the regulatory requirements, products should be classified as food supplements or as medicinal products not only on the basis of composition but also on the basis of presentation. Therefore proper labelling plays crucial role in retaining food supplement classification throughout the registration process.
If you are interested to know more about this relatively grey area of food supplements or wish to reduce the risk of product recall / withdrawal; please get in touch with us to have a confidential discussion.
3. Medicine/Cosmetic
A cosmetic is defined as (refer to Article 1 93/35/EEC) “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.”. The definition is based on two aspects, the target site of application and the principal function.
The main objective of the cosmetics directive is to ensure safety, therefore each product has to subjected to a safety assessment before placing them on the market
If your product can be shown to be cosmetic and not medicinal then it will be subject to the regulations set down in the cosmetics directive.
We can put an end to the uncertainties you may have concerning your borderline products
From evaluations of single products and summarising regulatory guidelines in a report, to analysis of entire product portfolios our team at CambReg can offer advice on whether your product is classed as a food supplement, nutraceutical, traditional herbal product, medical device or as a medicine. This will help greatly in making the adjustments you may need to comply with the various Directiv