For years now, food business operators wishing to make health claims on botanicals have had to make do with the so-called pending claims (or to bite the bullet and apply for a proprietary health claim, with very little chance for success). Using the on-hold (pending) botanical claims is a legal grey area, though; what’s more, they can only be used for such botanicals that actually have had health claims filed for them in the first place.
This limitation of health claim usage does not just apply to product label claims; only last year, a court decision (Court of Justice of the European Union, Case C-19/15) at the highest level was made, to the effect that the Nutrition and Health Claims Regulation (NHCR, EC 1924/2006) also extends to B2B communication (e.g., ingredient manufacturer to end product manufacturer), and to communication from businesses to healthcare professionals.
This means that unauthorized health claims cannot be made in these kinds of communication either, same as on product labels, even though they do not target end consumers directly.
“A new approach for botanicals is required, be it in finally resolving the issue of how to evaluate botanical health claims, or in defining sector-specific regulations for botanicals (and possibly for probiotics as well).”
Ingredient manufacturers communicating with potential finished product manufacturers, to name one example, can’t make any health-related claims on their products if no corresponding pending or authorized health claims exist (e.g., if it concerns a health effect that has only recently been discovered, or if it concerns a botanical for which no health claims have been filed). Not even if said communication is just a handout at a trade fair (i.e., when it does not even reach the end consumer at all).
This is especially bitter if proprietary trial data is available, since it cannot be used either to substantiate any claims without first filing for—and winning—a proprietary health claim on the basis of that data.
A number of industry professionals have been voicing their discontent with the current EU regulatory framework for a while now.
Despite a wealth of data substantiating health benefits of botanicals, food business operators are effectively censored from mentioning them, unless a similar health claim was applied for more than five years ago. However, science has moved on since then, meaning that those health effects that have meanwhile been uncovered cannot be communicated at all (unless, again, a food business operator intends to tackle the seemingly insurmountable hurdle of filing for a proprietary botanical health claim).
The NHCR was originally drawn up to protect consumers from misleading or false health claims on product labels. What it has accomplished instead is stifling innovation in the botanical and probiotic sectors, fostering insecurity among innovators, and hindering the communication of scientific knowledge even among industry professionals.
The way things look now, some natural substances or groups of substances may never gain a positive opinion on a filed health claim from the European Food Safety Authority (EFSA) as long as the authority does not let go of its current measuring stick of what constitutes a proven health benefit. Probiotics and prebiotics are premier among the affected substances. Plant-based food substances, though, are also held to a higher standard than, paradoxically, Traditional Herbal Medicinal Products, and their chances of gaining a health claim approval are not very high either.
As a result of all this, the botanical health sector is idling and, in some cases, receding in Europe, while probiotic market growth is soaring everywhere but in Europe.
Adapting to the Environment
Rather than lament the dismal state of health claims in Europe, let us focus on ways food business operators are dealing with the situation.
For foods, the lack of options to make health claims based on most botanicals has resulted in two approaches: either making use of generic (article 13.1) health claims, or circumventing the NHCR altogether by making “emotional” or “wellness” claims.
This last option has resulted in some unusual and even hilarious wording as marketers stretched their creative muscles trying to come up with catchy reasons why their products are better than their competitors’ without mentioning health effects at all.
One of the most famous of these, and one of the oldest, is Red Bull’s famous “gives you wings” slogan. Regulators have confirmed that this is not a health claim, but it is nevertheless effective.
Supplements, however, do not have that option. Consumers buy them for their health effects, and emotional marketing, including a promise of being given wings, will hardly influence their purchasing decisions.
Meanwhile, EFSA has tried to make the system of applying for health claims more “user friendly” by publishing guidelines for how health claim applications should be worded and what information they should contain. The most important bit of a health claim application is the supporting evidence (i.e., clinical trials), but characterization of the food in question and characterization of the health effects are equally important. Despite those guidance documents, food business operators wishing to jump the hurdle of filing for a proprietary health claim are advised to seek the help of experienced consultancies such as analyze & realize GmbH.
In any case, a new approach for botanicals is required, be it in finally resolving the issue of how to evaluate botanical health claims, or in defining sector-specific regulations for botanicals (and possibly for probiotics as well). Time will tell if and when the present situation will resolve, and what that resolution will look like.
analyze & realize ag
Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: firstname.lastname@example.org; Website: www.analyze-realize.com.