Since the new Health Claims Regulation (EC 1924/2006) came into effect in 2007, it has become obvious the European Food Safety Authority (EFSA) is using pharmaceutical-like measures to evaluate health claim applications. This process has led to the rejection of most claim applications, leaving manufacturers with so-called “generic” (Article 13.1) health claims.
 
Generic health claims are generally accepted claims made on vitamins and minerals based on textbook knowledge and tradition. Everyone can use these claims, provided the conditions of use are met, while new claims involving new science (Article 13.5) are specific to the products for which they were applied. Therefore, it has become an option to use generic health claims rather than make a time-consuming and costly claim application for a new health claim.
 
While generic claims give rise to a range of opportunities, they are currently limited to tried and trusted vitamins and minerals, leaving little to no room for botanicals, let alone completely new ingredients. Evaluation of botanical health claims has been put on hold by EFSA, and no one knows when this will change.
 
So if manufacturers wish to include botanicals in their dietary supplement products, currently, they are not allowed to make health claims. However, it is still possible to make health claims, and even disease-related claims, on traditional herbal medicinal products containing the same botanicals. The reason for this apparent paradox is that a dietary supplement in Europe may not, by definition, claim to prevent or cure a disease.
 
Still, it is undeniable that botanicals—including common foods—have pharmacological action in certain dosages. Regulations do not forbid the inclusion of those botanicals in dietary supplements, provided the product demonstrates no pharmacological action. Therefore, many manufacturers include botanicals in their food supplements at dosages beneath the pharmacologically active level, using the “contains” nutritional claim, and hoping for consumer awareness about the actions of the botanical in question—actions that they are forbidden to claim explicitly on the label.
 
However, this strategy makes the purchasing decision contingent on consumer awareness of the health benefits of the botanicals—a risky proposition, especially in the case of completely new ingredients or ingredients whose health benefits are not generally known.
 
Important questions for new product developers include: How knowledgeable are consumers about the pharmacological action of any given food ingredient? How accepting are they of new ingredients?
 
To answer these questions, German researchers recently conducted a study investigating consumer characteristics and how they influence their purchasing decisions.According to the results, it seems that consumers’ awareness about botanicals and other active ingredients such as glucosamine or lycopene increases with the onset of physical ailments connected to those ingredients—at least in Germany (the studied territory). Therefore, a willingness to adopt informed self-medication can be deduced, which increases the more an ailment becomes a problem, and most notably with age.
 
However, as soon as the subjects were treated by a physician, this willingness to learn about ingredients declined. Apparently, subjects at that stage were willing to leave it all in the hands of a professional and stopped self-medicating.
 
It seems, therefore, there is indeed a demographic of consumers who actively seek education about health benefits of active ingredients—those consumers ill enough to want to be cured, but not too ill to do it without the help of a physician.
 
As food becomes medicine—or to put it another way, as food supplements begin to populate that gray zone between food and pharma—it becomes important to capture this demographic of consumers willing to self-medicate and be informed about the health benefits of foods. It seems that consumers are more willing to do this as they become aware of health issues.