A buzz about new super food that does wonders to the immune system or is recommended as the miracle detox product keeps haunting the media. Like ghosts, these claims tend to lack evidence. Clever and creative marketing strategies to boost sales? Or could there be solid scientific evidence about food that is good for our health?
Lots of these products are available in form of food supplements. What is that?
According to the food supplements Directive (Directive 2002/46/EC), food supplements are defined as foodstuffs that are meant to supplement the normal diet. Thus, they are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and others, designed to be taken in measured small unit quantities. The respective nutrients can be vitamins, minerals, herbal extracts and other ingredients.
These products are made according to the manufacturing standards, but that does not necessarily guarantee their effectiveness or even safety. So how can one be sure to buy a product that is both safe as well as effective?
A lot of food and food supplements available in the EU bear nutrition claims and/or health claims. A nutrition claim states that the product contains certain nutritional properties, such as “high protein”, “fat-free” or “source of omega-3 fatty acids”. A health claim is any statement on labels about a relationship between the product and health, pointing to possible health benefits resulting from consuming that particular product.
So, who decides who can get a claim and what is needed in order to receive one?
The area of health claims in Europe was unregulated until the end of 2006 when Regulation (EC) No 1924/2006 was published. Since then, claims about food and food supplements cannot be made unless they are authorised by the European Food Safety Authority (EFSA) and listed on a register. Any misleading by false claims without using scientific evidence will lead to serious legal consequences. This not only protects consumers but also promotes innovation and ensures fair competition. The strength of scientific evidence needed in the EU to substantiate a health claim is described as “generally accepted scientific evidence of beneficial physiological effect in humans”. The EFSA decides whether the evidence is substantiated or not.
The next question appears logically: “How is this evidence created?”
Endorsed by laws and regulations starting with the ICH-GCP, formulating the right questions and using sound scientific methods used in order to validate pertinence of a hypothetical claim by producing high quality data. Once the data have been produced and evaluated, usually by conducting a prospective, double-blind, controlled clinical study, an application to EFSA for a specific claim can be made, which will then take time to evaluate the quality and the relevance of the data produced. If the application is successful, the tested product will receive the claim and the manufacturer will have the right to have this information visible on its package. Thus, the consumers do not have to fear any more false marketing tricks, at least in the EU.
Fed up with poltergeists as well?
The MEDIACC crew can help.
We like straight forward procedures and support manufactures with integrity and liability, with EU bureaucratic entanglements posing no threat to us. We are prepared! Challenge us and introduce us to your product like others on the market did.
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