Within the EU, manufacturers of food including food supplements must prove so-called ‘health claims’ for the respective products and apply for authorization of these claims at the European Commission. This assessment has been suspended for plants and their preparations used in foods. In contrast to this, herbal medicinal products – often mixed up with food supplements by consumers – must undergo an assessment and marketing authorisation procedure.
‘Strengthens your natural body´s defenses’, ‘Promotes energetic metabolism’, ‘Contributes to the normal function of your immune system’ – health claims like these can often be found on food packaging notably on food supplements. Particularly in the case of products containing plants, consumers can barely distinguish between botanical food supplements and tested and approved herbal medicinal products.
An EU Regulation stipulates the formal requirements for health claims on food. Pursuant to this regulation, health claims are only allowed if they have been established by generally accepted scientific data, if they are authorised in accordance with this regulation and if they are included in a positive list of authorised claims.
Harm for consumers and manufacturers
In 2010, the European Commission suspended the assessment of health claims for botanical ingredients for an indefinite period of time. It can be assumed that many of these health claims would not stand up to scrutiny, as the health-preserving effect cannot often reliably be proven. The suspension of the obligation of the manufacturers of the respective products to provide evidence for the claims harms consumers and manufacturers of food supplements and medicinal products. Consumers are potentially misled if they trust in claims that are not scientifically based. Manufacturers of food supplements containing plants must fear damage to their image, as long as the EU does not confirm evidence for their health claims. The manufacturers of herbal medicinal products are confronted with competitive disadvantages because in contrast to food supplements their products must undergo an official assessment and marketing authorization procedure which hampers market access.
In 2012 the EU posed an alternative for discussion: Health Claims which have been used for a long period of time should be legitimized due to this ‘tradition’ and by borrowing the scientific evidence for traditional herbal medicinal products. This alternative is questionable because it would undermine the original intention of the health claims regulation, i.e. to generate evidence for health claims on food and to improve consumer protection. The result would be products which are similar to medicinal products but do not fulfil the requirements for marketing authorisation of medicinal products. For the consumers the differences between an assessed and authorised medicinal product and an unexamined botanical food supplement would become even more obscure.
Consequent implementation of the EU regulation is better
Consequent implementation of the health claims regulation would not only create benefits for the consumers by providing them generally with deeper confidence in health claims on food. Uniform EU-wide regulation of health claims for food and food supplements as currently stipulated by the European health claims regulation would also be positive for the free movement of goods.